CALIBRATION SERUM LEVEL 3 (CAL 3)

CAT. NO. CAL 2351 LOT NO. 1024UE

SIZE: 20 x 5ml EXPIRY: 2020-12-28

GTIN: 05055273200966

INTENDED USE
For use as a Calibrator in clinical chemistry assays. RANDOX Calibration Sera are based on lyophilised human serum.
The concentrations and activities are suitable for calibration of clinical chemistry assays on a wide range of automatic analysers.
Constituent concentrations are available at 2 levels.

SAFETY PRECAUTIONS AND WARNINGS

Human source material, from which this product has been derived, has been tested at donor level for the Human Immunodeficiency
Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and found to be NON-
REACTIVE. FDA approved methods have been used to conduct these tests.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples
should be handled as though capable of transmitting infectious diseases and disposed of accordingly.
For in vitro diagnostic use only.

STORAGE AND STABILITY

Unreconstituted serum is stable up to the expiry date shown on the side of each individual bottle. Once reconstituted, the
components of the Calibration Sera are stable for 8 hours at +15ºC to +25°C, 7 days at +2°C to +8°C, and 28 days at –20°C when
frozen once (see limitations).

PREPARATION FOR USE

Serum must only be reconstituted using the following procedure:
1. Open the vial carefully, avoiding any loss of material.
2. Reconstitute by pipetting exactly 5 ml of distilled water at +15ºC to +25ºC, into the vial.
3. Replace the rubber stopper and leave to stand for 30 minutes out of bright light before use.
4. Swirl gently several times during the reconstitution period to ensure that the contents are completely dissolved.
5. Prior to use, mix the contents by inverting the vial. Do not shake the vial as the formation of foam should be avoided.
Ensure that no lyophilised material remains unreconstituted.
6. The serum is then ready for use with either a manual test or with an automated instrument.

MATERIALS PROVIDED
Calibration Serum - Level 3
Cat No. CAL 2351 20 x 5ml

MATERIALS REQUIRED BUT NOT PROVIDED

Calibrated pipette, double deionised water.

LIMITATIONS
After reconstitution, Bicarbonate is stable for 8 hours in the closed bottle and 1 hour in the open bottle.
For Total and Prostatic Acid Phosphatase, the material should be stabilised by adding 1 drop (25 µl - 30 µl) of 0.7M Acetic acid
solution to 1 ml of the serum exactly 30 minutes after reconstitution. After stabilisation, Total & Prostatic Acid Phosphatase are stable
for 2 hours at +15ºC to +25°C, 2 days at +2°C to +8°C, and 28 days when frozen once at –20°C.
Alkaline Phosphatase levels in the reconstituted serum will rise over the stability period. It is recommended that the reconstituted
serum be allowed to stand for 1 hour at +15ºC to +25°C before measurement.
Bilirubin in the serum is light sensitive and it is recommended that the serum is stored in the dark. Stored in the dark, it is stable for
1 day at +2°C to +8°C. Do not store at +15°C to +25°C. Do not freeze.
Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components. Different lot numbers of
this calibrator should not be interchanged, as the values assigned to the calibrators vary from lot to lot.

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 CAL2351 - Lot No. 1024UE

VALUE ASSIGNMENT
Each batch of serum is distributed to approximately 3000 laboratories worldwide and values are assigned by a consensus of results
obtained by these laboratories. The Calibration values for each instrument have been determined in at least 10 independent
laboratories. Values are verified against a master lot of calibrator, which is traceable to reference methods or reference materials. In
some cases, values may be assigned at Randox Laboratories in comparison to a master lot of calibrator, which is traceable to reference
methods or reference materials.

If an instrument specific value is not available, refer to the Mean of all Instruments section. If necessary, contact Randox Laboratories -
Technical Services, Northern Ireland, tel: +44 (0) 28 9445 1070 or email [email protected].

NOTES
® All trademarks recognised.

(1) Values established by reference laboratories officially recognised by the Federal Chamber of Physicians in Germany.
(2) DGKC: German Society for Clinical Chemistry.
(3) IFCC: International Federation of Clinical Chemistry.
(4) SCE : Scandinavian Committee on Enzymes.

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KALIBRIERUNGSSERUM LEVEL 3 (KAL 3)
KAT.-NR. CAL 2351 CHARGEN-NR. 1024UE
GRÖSSE: 20 x 5 ml ABLAUFDATUM: 2020-12-28

GTIN: 05055273200966

BESTIMMUNGSGEMÄSSE VERWENDUNG
Zur Verwendung als Kalibrator in klinisch-chemischen Assays. RANDOX Kalibrierseren basieren auf lyophilisiertem humanem Serum.
Die Konzentrationen und Aktivitäten eignen sich für die Kalibrierung von Assays der klinischen Chemie auf einer Vielzahl von
automatischen Analysatoren. Konstituentenkonzentrationen sind in 2 Levels erhältlich.

SICHERHEITSMASSREGELN UND WARNUNGEN

Das menschliche Ausgangsmaterial, aus dem dieses Produkt hergestellt wurde, ist auf der Spenderebene auf Antikörper gegen das
Humane Immundefizienz-Virus (HIV 1, HIV 2), Hepatitis-B-Oberflächenantigen (HbsAg) und das Hepatitis-C-Virus (HCV) untersucht
und für NICHT REAKTIV befunden. Zur Durchführung dieser Tests sind von der FDA zugelassene Methoden verwendet worden.
Da jedoch keine Methode vollkommene Sicherheit zur Abwesenheit infektiöser Stoffe bietet, sollten dieses Material und alle
Patientenproben so behandelt und entsorgt werden, als seien sie in der Lage, Infektionskrankheiten zu übertragen.
Nur zur Verwendung in der In-Vitro-Diagnose.

LAGERUNG UND STABILITÄT

Nicht rekonstituiertes Serum ist bis zu dem auf der Seite jeder einzelnen Flasche angegebenen Verfallsdatum stabil. Nach der
Rekonstitution sind die Komponenten der Kalibrierseren 8 Stunden bei +15 ºC bis +25 °C, 7 Tage bei +2 °C bis +8 °C und 28 Tage
bei -20 °C bei einmaligem Einfrieren stabil (siehe Einschränkungen).

VORBEREITUNG ZUM GEBRAUCH

Das Serum darf nur unter Anwendung des folgenden Verfahrens rekonstruiert werden:
1. Das Fläschchen vorsichtig öffnn und Materialverlust vermeiden.
2. Rekonstitution durch Pipettieren von genau 5 ml destilliertem Wasser bei +15 ºC bis +25 ºC in das Probengefäß.
3. Den Gummistopfen wieder aufsetzen und vor Gebrauch 30 Minuten außerhalb von grellem Licht stehen lassen.
4. Während der Rekonstitutionsphase mehrmals sanft umrühren, um sicherzustellen, dass der Inhalt vollständig aufgelöst ist.
5. Vor der Verwendung den Inhalt durch Umdrehen der Ampulle mischen. Die Ampulle nicht schütteln, da Schaumbildung zu
vermeiden ist.
Sicherstellen, dass kein lyophilisiertes Material unrekonstituiert bleibt.
6. Das Serum ist dann bereit für die Verwendung, entweder in einem manuellen Test oder in einem automatischen Instrument.

GELIEFERTES MATERIAL
Kalibrierserum - Level 3
Kat.-Nr. CAL 2351 20 x 5 ml

BENÖTIGTES MATERIAL, DAS NICHT MITGELIEFERT WIRD

Kalibrierte Pipette, doppelt entionisiertes Wasser.

EINSCHRÄNKUNGEN
Nach der Rekonstitution ist Bicarbonat in der geschlossenen Flasche 8 Stunden und in der offenen Flasche 1 Stunde stabil.
Für die Gesamt- und die prostataspezifische saure Phosphatase sollte das Material durch Hinzufügen eines Tropfens (25 µl–30 µl) von
0,7M Essigsäurelösung pro 1 ml Serum genau 30 Minuten nach der Aufbereitung stabilisiert werden. Nach der Stabilisierung sind die
Gesamt- und die prostataspezifische saure Phosphatase 2 Stunden lang bei +15 ºC bis +25 °C, 2 Tage bei +2 °C bis +8 °C und 28 Tage
bei -20 °C bei einmaligem Einfrieren stabil.
Der Spiegel der alkalischen Phosphatase im rekonstituierten Serum steigt im Verlauf des Stabilitätszeitraums. Es wird empfohlen, das
aufbereitete Serum vor der Messung 1 Stunde bei +15 °C bis +25 °C ruhen zu lassen.
Das Bilirubin im Serum ist lichtempfindlich, und es wird empfohlen, das Serum dunkel zu lagern. Bei lichtgeschützter Lagerung
1 Tag bei +2 °C bis +8 °C. Nicht bei +15 °C bis +25 °C lagern. Nicht einfrieren.
Bakterielle Verunreinigung des rekonstituierten Serums beeinträchtigt die Stabilität zahlreicher Komponenten. Die verschiedenen
Chargennummern dieses Kalibrators dürfen nicht ausgetauscht werden, da die den Kalibratoren zugewiesenen Werte von Charge zu
Charge unterschiedlich sind.

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 CAL2351 - 1024UE

ZUWEISUNG VON WERTEN

Jede Serum-Charge wird an etwa 3.000 Labors weltweit verteilt und die Werte werden anhand der übereinstimmenden Ergebnisse
dieser Labors zugewiesen. Die Kalibrierwerte für jedes Gerät wurden in mindestens 10 unabhängigen Labors ermittelt. Die Werte
werden gegen eine Master-Charge des Kalibrators verifiziert, die auf Referenzmethoden oder Referenzmaterialien rückführbar ist. In
einigen Fällen können bei Randox Laboratories Werte im Vergleich zu einer Master-Charge von Kalibratoren vergeben werden, die
auf Referenzmethoden oder Referenzmaterialien rückführbar ist.

Falls ein gerätespezifischer Wert nicht verfügbar ist, beachten Sie bitte den Abschnitt „Mittelwert aller Geräte“. Wenden Sie sich bei
Bedarf bitte an Randox Laboratories, Technischer Support, Nordirland – Tel.: +44 (0) 28 9445 1070 oder senden Sie uns eine E-Mail
an [email protected].

HINWEISE
® Alle Marken werden anerkannt.

(1) Die Referenzmethodenwerte wurden von Referenzlaboratorien ermittelt, die von der deutschen Bundesärztekammer
anerkannt sind.
(2) DGKC: Deutsche Gesellschaft für Klinische Chemie
(3) IFCC: Internationale Gesellschaft für Klinische Chemie
(4) SCE: Skandinavische Gesellschaft für Klinische Chemie

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SUERO DE CALIBRACIÓN NIVEL 3 (CAL 3)
N.º CAT. CAL 2351 LOTE N.º 1024UE
TAMAÑO: 20 x 5 ml CADUCIDAD: 2020-12-28

GTIN: 05055273200966
USO PREVISTO
Para su uso como calibrador en sistemas de análisis químicos clínicos. El suero de calibración de Randox se basa en suero humano
liofilizado.
Las concentraciones y actividades son adecuadas para la calibración de sistemas de análisis químicos clínicos en una amplia gama de
analizadores automáticos. Las concentraciones de los componentes están disponibles en dos niveles.

ADVERTENCIAS Y PRECAUCIONES DE SEGURIDAD

Los donantes del material de origen humano del que procede este producto se han sometido a pruebas de detección del anticuerpo
del virus de la inmunodeficiencia humana (VIH 1 y VIH 2), el anticuerpo del virus de la hepatitis C (VHC) y el antígeno de superficie de
la hepatitis B (HBsAG), y los resultados han sido NEGATIVOS. Dichas pruebas se han llevado a cabo utilizando métodos aprobados
por la FDA estadounidense.
No obstante, ya que ningún método puede garantizar por completo la ausencia de agentes infecciosos, este material y todas las
muestras de pacientes han de manipularse como si fueran capaces de transmitir enfermedades infecciosas, y eliminarse conforme a
ello.
Solo para uso diagnóstico in vitro.

ALMACENAMIENTO Y ESTABILIDAD
El suero no reconstituido es estable hasta la fecha de caducidad que aparece en el lateral de cada frasco. Una vez reconstituidos, los
componentes de los sueros de calibración son estables durante 8 horas a una temperatura de +15 ºC a +25 °C; durante 7 días a una
temperatura de +2 °C a +8 °C; y 28 días a -20 °C cuando se congela una vez (ver las limitaciones).

PREPARACIÓN PARA SU USO

El suero debe reconstituirse únicamente con el procedimiento siguiente:
1. Abrir el vial con cuidado, evitando cualquier pérdida de material.
2. Reconstituir pipeteando en el vial exactamente 5 ml de agua destilada, a una temperatura de +15 ºC a +25 ºC.
3. Antes de utilizarlo, volver a colocar el tapón de goma y dejar reposar durante 30 minutos protegido de la luz.
4. Agitar suavemente varias veces durante el período de reconstitución para asegurarse de que el contenido se disuelve por
completo.
5. Antes de utilizarlo, invertir el vial para mezclar el contenido. No agitar el vial; debe evitarse la formación de espuma.
Asegurarse de que no hay restos de material liofilizado sin reconstituir.
6. El suero está listo para su uso con una prueba manual o con un instrumento automatizado.

MATERIALES SUMINISTRADOS
Suero de calibración - Nivel 3
N.º cat. CAL 2351 20 x 5 ml

MATERIALES NECESARIOS PERO NO SUMINISTRADOS

Pipeta calibrada, agua bidestilada.

LIMITACIONES
Una vez reconstituido, el bicarbonato es estable durante 8 horas en el frasco cerrado y 1 hora en el frasco abierto.
En el caso de la fosfatasa ácida prostática y total, el material se debe estabilizar añadiendo 1 gota (de 25 a 30 µl) de solución de ácido
acético 0,7 M a 1 ml de suero exactamente 30 minutos después de la reconstitución. Tras la estabilización, la fosfatasa ácida prostática
y total es estable durante 2 horas a una temperatura de +15 °C a +25 °C, 2 días a una temperatura de +2 °C a +8 °C, y 28 días
cuando se congela una vez a -20 °C.
Los niveles de fosfatasa alcalina en el suero reconstituido aumentarán durante el período de estabilidad. Se recomienda dejar reposar
el suero reconstituido durante 1 hora a una temperatura de +15 ºC a +25 ºC antes de medir.
La bilirrubina presente en el suero es fotosensible, por lo que se recomienda almacenar el suero en un lugar oscuro. Almacenado en
un lugar oscuro, es estable durante 1 día a una temperatura de +2 °C a +8 °C. No almacenar a temperaturas de +15 °C a +25 °C. No
congelar.
La contaminación bacteriana del suero reconstituido reducirá la estabilidad de muchos componentes. No deben mezclarse diferentes
números de lote de este calibrador porque los valores asignados a los calibradores varían de un lote a otro.

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 CAL2351 - 1024UE

ASIGNACIÓN DE VALORES
Cada lote de suero se envía a unos 3000 laboratorios de todo el mundo, y los valores se consensúan a partir de los resultados
obtenidos por estos laboratorios. Los valores de calibración para cada instrumento han sido determinados en al menos 10 laboratorios
independientes. Los valores son verificados respecto a un lote maestro de calibrador, cuya trazabilidad se ha establecido con relación a
los métodos o materiales de referencia. En algunos casos, los valores pueden ser asignados en Randox Laboratories respecto a un lote
maestro de calibrador, cuya trazabilidad se puede establecer con relación a los métodos o materiales de referencia.

Si el valor específico de un instrumento no está disponible, consulte la sección Media de todos los instrumentos. Si fuera necesario,
póngase en contacto con el servicio técnico de Randox Laboratories, en Irlanda del Norte, tel: +44 (0)28 9445 1070 o por correo
electrónico a: [email protected].

Notas
® Todas las marcas reconocidas.

(1) Los valores han sido establecidos por laboratorios de referencia reconocidos oficialmente por la Cámara Federal de Médicos
de Alemania.
(2) DGKC: Sociedad Alemana de Química Clínica.
(3) IFCC Federación Internacional de Química Clínica.
(4) SCE: Comité Escandinavo sobre Enzimas.

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SÉRUM DE CALIBRATION NIVEAU 3 (CAL 3)
N°. REF: CAL 2351 N° DE LOT: 1024UE
TAILLE: 20 x 5ml EXP: 2020-12-28

GTIN: 05055273200966

UTILISATION PRÉVUE
Pour utilisation comme calibreur dans les analyses de chimie clinique. Les sérums de calibration RANDOX sont basés sur du sérum
humain lyophilisé.
Les concentrations et les activités conviennent à la calibration des analyses de chimie clinique sur une large gamme d’analyseurs
automatiques. Les concentrations du composant sont disponibles en 2 niveaux.

PRÉCAUTIONS LIÉES À LA SÉCURITÉ ET AVERTISSEMENTS

Le matériel d’origine humaine à partir duquel ce produit a été dérivé a été testé au niveau du donneur pour les anticorps du virus de
l’immunodéficience humaine (VIH 1, VIH 2), les antigènes de surface de l’hépatite B (AgHBs) et les anticorps du virus de l’hépatite C
(VHC) et se sont avérés NON RÉACTIFS. Les méthodes approuvées par la FDA ont été utilisées pour réaliser ces tests.
Cependant, vu qu’aucune méthode ne peut garantir complètement l’absence d’agents infectieux, ce matériel et tous les échantillons
des patients doivent être manipulés comme s’ils étaient potentiellement infectieux et doivent être éliminés en conséquence.
Pour diagnostic in vitro uniquement.

STOCKAGE ET STABILITÉ
Le sérum non reconstitué est stable jusqu’à la date d’expiration figurant sur le côté de chaque bouteille individuelle. Une fois
reconstitués, les composants des sérums de calibration sont stables pendant 8 heures entre +15 °C et +25 °C, 7 jours entre +2 °C et
+8 °C et 28 jours à -20 °C après une congélation unique (voir les limitations).

PRÉPARATION POUR UTILISATION

Le sérum doit uniquement être reconstitué selon la procédure suivante :
1. Ouvrir le flacon avec précaution, en évitant toute perte de matériel.
2. Reconstituer en pipetant exactement 5 ml d’eau distillée entre +15 ° et +25 °C dans le flacon.
3. Replacer le bouchon en caoutchouc et laisser reposer pendant 30 minutes à l’abri d’une lumière vive avant utilisation.
4. Remuer doucement plusieurs fois pendant la période de reconstitution pour s’assurer de la dissolution complète du contenu.
5. Avant utilisation, mélanger le contenu en retournant le flacon. Ne pas secouer le flacon pour éviter la formation de mousse.
S’assurer de la reconstitution totale du matériel lyophilisé.
6. Le sérum est alors prêt à être utilisé avec un test manuel ou un instrument automatisé.

MATÉRIEL FOURNI
Sérum de calibration - Niveau 3
Cat No. CAL 2351 20 x 5 ml

MATÉRIEL NÉCESSAIRE MAIS NON FOURNI

Pipette calibrée, eau doublement déionisée.

LIMITATIONS
Après reconstitution, le bicarbonate est stable pendant 8 heures dans la bouteille fermée et 1 heure dans la bouteille ouverte.
Pour la phosphatase acide totale et prostatique, le matériel doit être stabilisé en ajoutant 1 goutte (25 µl à 30 µl) de solution d’acide
acétique 0,7 M à 1 ml de sérum exactement 30 minutes après la reconstitution. Après stabilisation, la phosphatase acide totale &
prostatique est stable pendant 2 heures entre +15 °C et +25 °C, 2 jours entre +2 °C et +8 °C et 28 jours après une congélation
unique à -20 °C.
Les taux de phosphatase alcaline dans le sérum reconstitué vont augmenter pendant la période de stabilité. Il est recommandé de
laisser reposer le sérum reconstitué pendant 1 heure entre +15 °C et +25 °C avant la mesure.
La bilirubine dans le sérum étant sensible à la lumière, il est recommandé de stocker le sérum à l’abri de la lumière. Conservé à l’abri
de la lumière, il reste stable pendant 1 jour entre +2 °C et +8 °C. Ne pas conserver entre +15 °C et +25 °C. Ne pas congeler.
Une contamination bactérienne du sérum reconstitué entraînera une diminution de la stabilité de nombreux composants. Les
différents numéros de lot de ce calibreur ne doivent pas être intervertis, étant donné que les valeurs attribuées aux calibreurs varient
d’un lot à l’autre.

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 CAL2351 - 1024UE

ATTRIBUTION DES VALEURS

Chaque lot de sérum est distribué à environ 3 000 laboratoires à travers le monde et les valeurs sont attribuées par un consensus des
résultats obtenus par ces laboratoires. Les valeurs de calibration pour chaque instrument ont été déterminées dans au moins
10 laboratoires indépendants. Les valeurs sont vérifiées par un lot maître de calibreur, qui est traçable par rapport à des méthodes de
référence ou à des matériaux de référence. Dans certains cas, les valeurs peuvent être attribuées à Randox Laboratories par
comparaison à un lot maître de calibreur, qui est traçable par rapport à des méthodes de référence ou à des matériaux de référence.

Si une valeur spécifique à un instrument n’est pas disponible, se référer à la section Moyenne de tous les instruments. Si nécessaire,
contacter Randox Laboratories - Support technique, Irlande du Nord, tél. : +44 (0) 28 9445 1070 ou email
[email protected]

REMARQUES
® Toutes marques commerciales reconnues.

(1) Les valeurs sont établies par des laboratoires de référence officiellement reconnus par la Federal Chamber of Physicians
(Chambre fédérale des médecins) en Allemagne.
(2) DGKC : German Society for Clinical Chemistry (Société allemande de chimie clinique)
(3) IFCC : International Federation of Clinical Chemistry (Fédération internationale de chimie clinique)
(4) SCE : Scandinavian Committee on Enzymes (Comité scandinavien sur les enzymes)

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SIERO DI CALIBRAZIONE LIVELLO 3 (CAL 3)
CAT. N. CAL 2351 DIMENSIONE: 20 x 5ml
LOT N. 1024UE SCAD: 2020-12-28
GTIN: 05055273200966

FINALITA’ D’USO
Da utilizzare come Calibratore in dosaggi di chimica clinica. I sieri di Calibrazione RANDOX sono a base di siero umano liofilo.
Le concentrazioni e le attività sono adatte per la calibrazione di dosaggi di chimica clinica su un’ampia varietà di analizzatori automatici.
Le concentrazioni dei costituenti sono disponibili a 2 livelli.

AVVERTENZE E MISURE PRECAUZIONALI

Il materiale di origine umana da cui è derivato questo prodotto è stato testato sui donatori, e ha dato ESITO NEGATIVO, per
l’anticorpo del virus da Immunodeficienza Umana (HIV 1, HIV 2), per l’Antigene di Superficie del virus dell’Epatite B (HbsAg), e per
l’anticorpo del virus dell’Epatite C (HCV). Per questi test sono stati usati metodi approvati dall’FDA.
Poiché nessun metodo di indagine può dare assoluta garanzia di assenza di questi agenti infettivi, si raccomanda di trattare e smaltire il
prodotto e tutti i campioni dei pazienti con cautela.
Solo per uso diagnostico IN VITRO.

CONSERVAZIONE E STABILITA’
Il siero non ricostituito è stabile fino alla data di scadenza mostrata sul lato di ogni fiala. Una volta ricostituite, le componenti dei sieri di
Calibrazione sono stabili per 8 ore a +15°C - +25°C, 7 giorni a +2°C - +8°C e 28 giorni a -20°C se congelati una volta (vedi
limitazioni).

PREPARAZIONE PER L’USO

Il siero deve essere ricostituito solo usando la seguente procedura:
1. Aprire la fiala con attenzione, evitando la perdita di materiale.
2. Ricostituire con esattamente 5ml di acqua distillata a +15°C - +25°C, nella fiala.
3. Rimettere il tappo di gomma e lasciare per 30 minuti al riparo della luce.
4. Agitare delicatamente diverse volte durante la ricostituzione per assicurarsi che il contenuto sia completamente dissolto.
5. Prima dell’uso, mescolare il contenuto invertendo la fiala. Non scuotere la fiala poiché deve essere evitata la formazione di schiuma.
Assicurarsi che non rimanga materiale liofilo non ricostituito.
6. Il siero è quindi pronto per l’uso sia per test in manuale che per strumenti automatizzati.

MATERIALI FORNITI
Siero di Calibrazione - Livello 3
Cat N. CAL2351 20 x 5ml

MATERIALI NECESSARI MA NON FORNITI

Pipetta, acqua deionizzata.

LIMITAZIONI
Dopo ricostituzione, il Bicarbonato è stabile per 8 ore nella fiala chiusa e 1 ora nella fiala aperta.
Per la Fosfatasi Acida Totale e Prostatica, il materiale deve essere stabilizzato aggiungendo 1 goccia (25l - 30l) di una soluzione di
Acido Acetico 0.7M ad 1ml di siero esattamente 30 minuti dopo la ricostituzione. Dopo la stabilizzazione, la Fosfatasi Acida Totale e
Prostatica è stabile per 2 ore a +15°C - +25°C, 2 giorni a +2°C - +8°C e 28 giorni se congelata una volta a -20°C.
I livelli di Fosfatasi Alcalina nel siero ricostituito aumentano superando il periodo di stabilità. Si raccomanda di lasciare il siero
ricostituito per 1 ora a +15°C - +25°C prima della misura.
La Bilirubina nel siero è sensibile alla luce e si raccomanda di conservare il siero al buio. Conservato al buio è stabile per 1 giorno a
+2°C - +8°C. Non conservare a +15°C - +25°C. Non congelare.
La contaminazione batterica del siero ricostituito causa la diminuzione della stabilità di molte componenti. Non devono essere
scambiati diversi lotti di questo calibratore poiché i valori assegnati ai calibratori variano al variare del lotto.

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 CAL2351 - 1024UE

ASSEGNAZIONE DEL VALORE

Ogni lotto di siero è distribuito a circa 3000 laboratori nel mondo ed i valori sono assegnati dal consenso dei risultati ottenuti da
questi laboratori. Sono stati determinati i valori di calibrazione per ogni strumento in almeno 10 laboratori indipendenti. I valori sono
stati verificati contro un lotto di calibratore master che è tracciabile a metodi di riferimento o materiali di riferimento. In alcuni casi i
valori possono essere assegnati presso Randox Laboratories mediante confronto contro un lotto di calibratore master che è
tracciabile a metodi di riferimento o materiali di riferimento.

Se qualche valore strumento specifico non è disponibile, fare riferimento alla sezione Media di Tutti gli Strumenti. Se necessario
contattare Randox Laboratories - Technical Services, Northern Ireland, tel: +44 (0) 28 9445 1070 o inviare un’email a
[email protected]

NOTE
® All trademarks recognised.

(1) Values established by reference laboratories officially recognised by the Federal Chamber of Physicians in Germany.
(2) DGKC : German Society for Clinical Chemistry
(3) IFCC : International Federation of Clinical Chemistry
(4) SCE : Scandinavian Committee on Enzymes

03 Jan 19 pq

PAG 2 DI 2
SUROWICA KALIBRACYJNA POZIOM 3
(Calibration Serum Level 3 - Cal 3)
Nr kat.: CAL 2351 Op: 20 x 5ml
Nr Serii: 1024UE Data ważn.: 2020-12-28
GTIN: 05055273200966
CHARAKTERYSTYKA
Produkt ten jest przeznaczony do wykonywania Kalibracji analizatorów do Chemii Klinicznej. Multikalibrator firmy Randox jest
liofilizowaną surowicą pochodzenia ludzkiego przeznaczoną do kalibracji badań laboratoryjnych.
Multikalibratory oferowane są dla 2 poziomów stężeń chemicznych parametrów analitycznych.
Stężenia jak i zakres działania są odpowiednie do kalibracji badań laboratoryjnych wykonywanych na szerokim zakresie automatycznych
analizatorów.

OSTRZEŻENIE
Ludzkie surowice pochodzą od dawców przebadanych testami zaakceptowanymi przez FDA na obecność przeciwciał anty-HIV1 i anty-
HIV 2, HBs Ag oraz przeciwciał anty-HCV. TESTY TE DAŁY WYNIKI UJEMNE.
Ponieważ jednak, nieznana jest metoda pozwalająca z całą pewnością wykluczyć obecność czynnika zakaźnego, materiał ten jak i próbki
pobrane od pacjentów należy traktować, jako potencjalnie zakaźny.
Tylko do diagnostyki IN VITRO.

PRZECHOWYWANIE I TRWAŁOŚĆ
Liofilizowany multikalibrator przechowywany w temp. od +2 do +8°C posiada trwałość która jest podana zarówno na opakowaniu, jak
i na każdej buteleczce. Po rekonstytucji składniki multikalibratora są trwałe 8 godzin w temp. od 15°C do +25°C lub 7 dni w temp. od
+2°C to +8°C i 28 dni w temp. –20°C, jeżeli zamrożony jest tylko raz (patrz ograniczenia).

PRZYGOTOWANIE DO UŻYTKU
Surowica może być rekonstytuowana tylko przestrzegając poniższej procedury:
1. Otworzyć buteleczkę ostrożnie, tak, aby nie utracić liofilizatu.
2. Rekonstytuować, odmierzając bezpośrednio do fiolki, dokładnie 5 ml destylowanej wody o temp. od +15 do +25°C.
3. Zamknąć buteleczkę, uprzednio wyjętym, gumowym korkiem i pozostawić w zaciemnionym miejscu na 30 minut.
4. Delikatnie przechylając buteleczkę całkowicie rozpuścić jej zawartość.
5. Odwrócić buteleczkę, aby zapewnić rozpuszczenie liofilizatu osadzającego się na gumowym korku. Nie wstrząsać buteleczką
by uniknąć spienienia. Upewnić się czy nie pozostał nierozpuszczony liofilizat.
6. Tak przygotowana surowica jest gotowa do użycia zarówno do metody manualnej jak i przy użyciu większości
automatycznych analizatorów.

DOSTARCZONY MATERIAŁ
Surowica kalibracyjna. Poziom 3 (wartości podwyższone)
Numer kat. CAL2351 20x5ml

POTRZEBNE MATERIAŁY LECZ NIE DOSTARCZONE

Skalibrowana pipeta, podwójnie dejonizowana woda.

OGRANICZENIA
Po rekonstytucji, dwuwęglany są stabilne 8 godzin, kiedy butelka jest zamknięta i 1 godzinę w butelce otwartej. W przypadku kwaśnej
fosfatazy całkowitej i sterczowej materiał powinien być stabilizowany przez dodanie 1 kropli ( 25-30 μl ) 0,7 M kwasu octowego do 1
ml surowicy kalibracyjnej dokładnie 30 min. po rekonstytucji. Po stabilizacji fosfataza kwaśna całkowita i sterczowa są trwałe co
najmniej 2 godziny w temp. od 15°C do +25°C, 2 dni w temp. +2°C do +8°C i 28 dni przy jednorazowym zamrożeniu w temp. –20°C.
Ponieważ aktywność fosfatazy zasadowej w materiale kontrolnym stale wzrasta w ciągu całego procesu stabilizacji zaleca się
pozostawienie rekonstytuowanej surowicy w temperaturze od +15°C do +25°C, co najmniej 1 godzinę przed jej użyciem.
Bilirubina w surowicy jest bardzo wrażliwa na bezpośrednie działanie światła, dlatego zaleca się przechowywanie surowicy kalibracyjnej
w miejscu zaciemnionym. Przechowywana w tych warunkach jest trwała 1 dzień temp. od +2°C do +8°C. Nie przechowywać w temp.
od +15 do +25°C. Nie zamrażać.
Zanieczyszczenie bakteryjne rekonstytuowanej surowicy wpływa na spadek stabilności wielu komponentów. Materiału o różnych
numerach serii nie wolno mieszać, ponieważ oznaczone wartości kalibratora są zmienne z serii na serię.

PAGE 1 OF 2
 CAL2351 - 1024UE

METRYKOWANIE
Każda seria multikalibratora jest wysyłana do około 3000 laboratoriów na całym świecie w celu wyznaczenia wartości dla
poszczególnych parametrów. Wartości dla poszczególnych analizatorów wyznaczane są, w co najmniej 10 niezależnych laboratoriach.
Wartości weryfikuje się porównując je do znanych wartości serii kontrolnej kalibratora, który to jest porównywalny do metod
referencyjnych bądź materiału referencyjnego. W niektórych przypadkach wartości mogą być wyznaczane w Laboratoriach firmy
Randox w porównaniu do znanych wartości serii kontrolnej kalibratora, który to jest porównywalny do metod referencyjnych bądź
materiału referencyjnego.

Jeżeli w ulotce występuje brak wartości parametru dla danego analizatora, należy się odnieść do sekcji Mean of All Instruments
(Średnia ze wszystkich analizatorów). Jeśli zachodzi konieczność prosimy kontaktować się z przedstawicielem handlowym lub
bezpośrednio obsługą techniczną firny Randox w Irlandii Północnej pod nr tel.: +44 (0) 28 9445 1070 lub email
[email protected] (język angielski).

UWAGI
® Wszystkie znaki towarowe uznane.

(1) Wartości ustanowione przez laboratoria referencyjne oficjalnie uznawane przez Federalną Izbę Lekarską w Niemczech.
(2) DGKC: Niemieckie Towarzystwo Chemii Klinicznej.
(3) IFCC: Międzynarodowa Federacja Chemii Klinicznej.
(4) SCE: Skandynawski Komitet d/s Enzymów.

03 Jan 19 pq

PAGE 2 OF 2
CALIBRATION SERUM - LEVEL 3 (CAL 3)
Nº CAT. CAL 2350 Nº LOT. 1024UE
TAMANHO: 20 x 5ml VALIDADE: 2020-12-28

GTIN: 05055273200966

UTILIZAÇÃO
Para utilização como calibrador em ensaios de química clínica. Os soros de calibração RANDOX baseiam-se em soro humano
liofilizado.
As concentrações e as atividades são adequadas para calibração de ensaios de química clínica num vasto leque de analisadores
automáticos. As concentrações dos constituintes estão disponíveis em 2 níveis.

AVISOS E PRECAUÇÕES DE SEGURANÇA

O material de origem humana do qual foi derivado este produto foi testado a nível dos dadores para deteção de anticorpos do Vírus
da Imunodeficiência Humana (VIH 1, VIH 2), do Antigénio de Superfície da Hepatite B (HbsAg) e de anticorpos do Vírus da Hepatite C
(VHC), tendo ficado demonstrado que era NÃO REATIVO. Foram utilizados métodos aprovados pela FDA na condução destes testes.
No entanto, como nenhum método pode assegurar com toda a certeza a inexistência de agentes infeciosos, este material e todas as
amostras de pacientes devem ser tratadas como passíveis de transmitir doença infeciosa, devendo ser descartadas em conformidade.
Apenas para utilização em diagnóstico in vitro.

ESTABILIDADE E CONSERVAÇÃO
O soro não reconstituído permanece estável até à data de validade apresentada na parte lateral de cada frasco. Uma vez
reconstituídos, os componentes dos soros de calibração permanecem estáveis durante 8 horas de +15ºC a +25°C, 7 dias de +2ºC a
+8°C e 1 mês a -20°C quando congelado uma vez (ver Limitações).

PREPARAÇÃO PARA UTILIZAÇÃO

O soro só pode ser reconstituído utilizando o seguinte procedimento:
1. Abrir o frasco cuidadosamente, evitando a perda do material liofilizado.
2. Reconstituir pipetando exatamente 5 ml de água destilada de +15 a +25 °C, para dentro do frasco.
3. Volte a colocar a tampa de borracha e deixe repousar durante 30 minutos antes de utilizar.
4. Fazer rodar suavemente o frasco durante o período de reconstituição, para assegurar que o conteúdo dissolve completamente.
5. Antes de utilizar, homogeneizar o conteúdo invertendo o frasco. Não agitar o frasco, uma vez que a formação de espuma deve ser
evitada. Verificar que não fica material liofilizado por reconstituir.
6. O soro está então pronto a utilizar tanto num teste manual como num analisador automático.

MATERIAIS FORNECIDOS
Soro de calibração - Nível 3
Nº Cat CAL 2351 20 x 5ml

MATERIAIS NECESSÁRIOS MAS NÃO FORNECIDOS

Pipeta calibrada, água bi-desionizada.

LIMITAÇÕES
Após a reconstituição, o bicarbonato permanece estável durante 8 horas no frasco fechado e 1 hora no frasco aberto.
No caso da Fosfatase Ácida Total e Prostática, o material deve ser estabilizado adicionando 1 gota (25-30μl) de solução de ácido
acético a 0,7M a 1ml de soro exatamente 30 minutos após a reconstituição. Após a estabilização, as Fosfatases Ácida Total e Prostática
permanecem estáveis durante 2 horas de +15ºC a +25°C, 2 dias de +2°C a +8°C e 1 mês a -20°C, quando congeladas uma vez.
Os níveis de Fosfatase Alcalina do soro reconstituído sobem durante o período de estabilidade. Recomenda-se que o soro
reconstituído fique em repouso durante 1 hora a +15ºC to +25°C antes da medição. A bilirrubina do soro é fotossensível, sendo por
isso recomendado que o soro seja armazenado ao abrigo da luz. Armazenado ao abrigo da luz, permanece estável durante 1 dia de
+2°C a +8°C. Não armazenar a temperaturas entre +15°C e +25°C. Não congelar.
A contaminação bacteriana do soro reconstituído provoca uma redução da estabilidade de muitos componentes. Diferentes números
de lotes deste calibrador não devem ser misturados, uma vez que os valores atribuídos aos calibradores variam de lote para lote.

PÁG. 1 DE 2
 CAL2351 – 1024UE

ATRIBUIÇÃO DE VALORES
Cada lote de soro é distribuído por cerca de 3000 laboratórios em todo o mundo e os valores são atribuídos a partir de um consenso
dos resultados obtidos por esses laboratórios. Os valores de Calibração de cada equipamento foram determinados em pelo menos 10
laboratórios independentes. Os valores são verificados contra um lote mestre de calibrador, que é rastreável para métodos de
referência ou materiais de referência. Em alguns casos, podem ser atribuídos valores nos Randox Laboratories em comparação com
um lote mestre de calibrador, que é rastreável para métodos de referência ou materiais de referência.

Se não estiver disponível um valor de um equipamento específico, consulte a seção referente à Média de Todos os Equipamentos. Se
necessário, contate o Serviço de Assistência Técnica dos Randox Laboratories, Northern Ireland, tel: +44 (0) 28 9445 1070 ou envie
um e-mail para [email protected].

NOTAS
® As marcas comerciais são todas reconhecidas.

(1) Os valores estabelecidos por laboratórios de referência oficialmente reconhecidos pela Federal Chamber of Physicians in
Germany.
(2) DGKC: German Society for Clinical Chemistry
(3) IFCC: International Federation of Clinical Chemistry
(4) SCE: Scandinavian Committee on Enzymes

03 Jan 19 pq

PÁG. 2 DE 2
CALIBRATION SERUM - LEVEL 3 (CAL 3)
KAT.Č. CAL2351 VEĽKOSŤ: 20 x 5ml
Č. ŠARŽE: 1024UE DÁTUM EXPIRÁCIE: 2020-12-28

GTIN: 05055273200966
POUŽITIE
Tento produkt je určený na kalibráciu biochemických analýz. RANDOX Kalibračné serum je založené na lyofilizovanom ľudskom sére.
Koncentrácie a aktivity sú vhodné na kalibráciu biochemických analýz na širokom spektre automatických analyzátorov. Zložkové
koncentrácie sú dostupné pre 2 hladiny.

BEZPEČNOSTNÉ OPATRENIA A UPOZORNENIA

Materiál ľudského zdroja, z ktorého bol tento produkt vytvorený, bol testovaný na úrovni darcu na protilátky HIV 1, HIV 2,
povrchovému antigénu hepatitídy B (HBsAg) a na protilátky vírusu hepatitídy C (HCV) a zistilo sa, že sú NEREAKTÍVNE. Na vykonanie
týchto testov sa použili metódy schválené FDA. Keďže však žiadna metóda nemôže poskytnúť úplnú záruku, pokiaľ ide o neprítomnosť
infekčných látok, s týmto materiálom a všetkými vzorkami pacientov by sa malo zaobchádzať tak, ako by boli schopné prenášať infekčné
choroby a následne ich zlikvidovať podľa toho.
Len na diagnostické in vitro použitie.

SKLADOVANIE A STABILITA
OTVORENÉ: Sérum po rekonštitúcii je stabilné 8 hodín pri teplote +15°C až +25°C alebo 7 dní pri +2°C až +8°C, a 28 dní po
zamrazení pri teplote –20°C. (Viď sekciu OBMEDZENIA)

NEOTVORENÉ: Stabilné do dátumu expirácie uvedeného na jednotlivých fľaštičkách.

PRÍPRAVA
Sérum musí byť rekonštituované použitím nasledovného postupu.
1. Opatrne otvorte fľaštičku, zabráňte stratám produktu
2. Rekonštitujte pipetovaním presne 5 ml destilovanej vody pri teplote +15°C až +25°C do fľaštičky.
3. Zatvrote s gumenou zátkou a nechajte stáť 30 minút mimo priameho svetla.
4. Jemne zavírte niekoľko krát počas procesu rekonštitúcie a uistite sa, že obsah je úplne rozpustený.
5. Pred samotným použitím, premiešajte obsah prevátením fľaštičky. Netraste fľaštičkou, vyhnite sa tvorbe peny. Uistite sa, že všetok
lyofilizovaný materiál je rekonštituovaný.
6. Následne je sérum pripravené na použitie pre manuálne alebo automatizované systémy.

POSKYTOVANÝ MATERIÁL
Calibration Serum - Level 3
KAT.Č. CAL2351 20 x 5ml

POŽADOVANÝ MATERIÁL, KTORÝ NIE JE POSKYTOVANÝ

Objemové pipety, dvojito destilovaná voda

OBMEDZENIA
Po rekonštitúcii je bikarbonát stabilný 8 hodín v uzavretej fľaštičke a 1 hodinu v otvorenej.
Pre celkovú a prostatickú kyslú fosfatázu by mal byť materiál stabilizovaný pridaním 1 kvapky (25µl - 30µl) 0.7M roztoku kyseliny
octovej do 1 ml séra presne 30 minút po rekonštitúcii. Po stabilizácii je celková a prostatická fosfatáza stabilná 2 hodiny pri teplote
+15°C až +25°C, 2 dni pri +2°C až +8°C, a 28 dní ak sú jednorázovo zamrazené pri –20°C.
Hladiny alkalickej fosfatázy v rekonštituovanom sére sa budú zvyšovať počas obdobia stability. Pred samotným meraním sa odporúča
nechať rekonštituované sérum stáť 1 hodinu pri teplote +15°C až +25°C.
Bilirubín v sére je citlivý na svetlo a odporúča sa, aby sa sérum skladovalo v tme. Pri skladovaní v tme je stabilný 1 dni pri +2°C až +8°C.
Neskladujte pri teplote +15°C až +25°C. Nezamrazujte.
Bakteriálna kontaminácia rekonštituovaného séra spôsobí zníženie stability mnohých zložiek. Rôzne šarze tejto kontroly by sa nemali
miešať, pretože cieľové hodnoty medzi šaržami sa líšia.

PAGE 1 OF 2
 CAL2351 - 1024UE

PRIDELENÉ CIEĽOVÉ HODNOTY

Každá šarža séra je posielaná približne 3000 laboratóriám po celom svete a hodnoty sú pridelené na základe konsenzu výsledkov
obdržaných týmito laboratóriami. Kalibračné hodnoty pre každý analyzátor boli stanovené v najmenej 10 nezávislých od seba
laboratóriách. Hodnoty sú následne verifikované podľa hlavnej šarže kalibrátora, ktorý je odvodený od referenčnej metódy alebo
referenčného materiálu. V niektorých prípadoch môžu byť cieľové hodnoty pridelené spoločnosťou Randox Laboratories v porovnaní s
hlavnou šaržou kalibrátora, ktorý je odvodený od referenčných metód alebo referečných materiálov.

Ak nie je uvedená hodnota špecifická pre Váš analyzátor, obráťte sa na sekciu “Mean of all Instruments” v príbalovom liste. V prípade
nutnosti, kontaktujte svojho obchodného zástupcu alebo Randox Laboratories - Technical Services, Severné Írsko, tel: +44 (0) 28 9445
1070 alebo email [email protected].

POZNÁMKY
® Všetky ochranné známky sú uznávané.

(1) Hodnoty stanovené referenčnými laboratóriami úradne uznanými Spolkovou komorov lekárov v Nemecku.
(2) DGKC: Nemecká spoločnosť pre klinickú chémiu.
(3) IFCC: Medzinárodná federácia klinickej chémie.
(4) SCE: Škandinávsky výbor pre enzýmy.

03 Jan 19 pq

PAGE 2 OF 2
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Abbott Alinity/ Architect c/ci Systems® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 29.4 Bromocresol Green
g/dl 2.94
g/l 27.7 Bromocresol Purple
g/dl 2.77
Alkaline Phosphatase U/l 318 AMP optimised to IFCC 37°C
U/l 312 AMP optimised to NVKC/SFBC 37°C
U/l 313 AMP non-optimised 37°C
U/l 300 Colorimetric 37°C
ALT (GPT) U/l 142 Tris buffer without P5P 37°C
Amylase Pancreatic U/I 258 Immunoinhibition EPS substrate 37°C
Amylase Total U/I 323 Abbott Architect Non-IFCC Cal. 37°C
U/I 357 Abbott Architect IFCC Cal. 37°C
AST (GOT) U/l 139 Tris buffer without P5P 37°C
Bicarbonate mmol/l 17.0 Enzymatic
Bile Acids µmol/l 44.6 Enzymatic Colorimetric
Bilirubin Direct µmol/l 27.6 Diazo with Sulphanilic Acid
mg/dl 1.61
µmol/l 27.7 Diazo with Dichloroaniline (DCA)
mg/dl 1.62
Bilirubin Total µmol/l 84.2 Diazo with Dichloroaniline (DCA)
mg/dl 4.93
µmol/l 85.0 Diazo with Sulphanilic Acid
mg/dl 4.97
µmol/l 83.2 Diazonium ion
mg/dl 4.86
Calcium mmol/l 3.25 Arsenazo III
mg/dl 13.0
Chloride mmol/l 116 ISE indirect
Cholesterol mmol/l 7.16 Cholesterol Oxidase
mg/dl 276
Cholinesterase U/l 6142 Colorimetric Butyrylthiocholine 37°C
CK Total U/l 537 CK-NAC serum start (DGKC) 37°C
U/l 530 CK-NAC (IFCC) 37°C
Copper µmol/l 20.8 Colorimetric
µg/dl 132
Creatinine µmol/l 384 Alkaline picrate no deproteinization
mg/dl 4.34
µmol/l 371 Enzymatic UV method
mg/dl 4.19

Page 1 of 3
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Abbott Alinity/ Architect c/ci Systems® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Creatinine µmol/l 371 Creatinine PAP method
mg/dl 4.19
µmol/l 380 Jaffe rate blanked
mg/dl 4.30
µmol/l 388 IDMS traceable
mg/dl 4.39
gamma-GT U/I 174 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
U/I 171 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
Glucose mmol/l 15.6 Hexokinase
mg/dl 281
mmol/l 15.8 Glucose oxidase
mg/dl 285
Iron µmol/l 38.7 Colorimetric with ppt.
µg/dl 216
µmol/l 38.1 Colorimetric without ppt.
µg/dl 213
Lactate mmol/l 5.87 Colorimetric Lactate Oxidase
mg/dl 52.9
LD (LDH) U/l 364 L->P 37°C
U/l 358 L->P IFCC 37°C
Lipase U/I 57 Other Colorimetric 37°C
Lithium mmol/l 2.02 Spectrophotometric
mg/dl 1.40
Magnesium mmol/l 1.78 Arsenazo III
mg/dl 4.33
mmol/l 1.75 Xylidyl Blue
mg/dl 4.25
mmol/l 1.77 Enzymatic
mg/dl 4.30
Phosphate Inorganic mmol/l 2.33 Phosphomolybdate enzymatic
mg/dl 7.22
mmol/l 2.36 Phosphomolybdate UV
mg/dl 7.32
Potassium mmol/l 6.19 ISE method - indirect
Protein Total g/l 46.7 Biuret reaction end point
g/dl 4.67
g/l 46.7 Biuret reaction kinetic
g/dl 4.67
Sodium mmol/l 162 ISE method - indirect
TIBC µmol/l 46.9 FE+UIBC(saturation with iron)
µg/dl 262
µmol/l 41.9 Calculated from Transferrin
µg/dl 234

Page 2 of 3
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Abbott Alinity/ Architect c/ci Systems® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Triglycerides mmol/l 2.94 Lipase/GPO-PAP no correction
mg/dl 260
mmol/l 2.94 L/G Kinase EP. no correction
mg/dl 260
mmol/l 2.91 Lipase/Glycerol Dehydrogenase
mg/dl 258
UIBC µmol/l 8.68 Direct Colorimetric
µg/dl 48.5
Urea mmol/l 20.2 Urease end point
mg/dl 121
mmol/l 20.4 Urease kinetic
mg/dl 123
mmol/l 20.4 BUN
mg/dl 57.3
Uric Acid (Urate) mmol/l 0.566 Uricase peroxidase with ascorbate oxidase
mg/dl 9.51
mmol/l 0.567 Uricase peroxidase no ascorbate oxidase
mg/dl 9.53
mmol/l 0.564 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 9.48

Page 3 of 3
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

ABX Pentra 400® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 29.1 Bromocresol Green
g/dl 2.91
Alkaline Phosphatase U/l 324 AMP optimised to IFCC 37°C
ALT (GPT) U/l 164 Tris buffer without P5P 37°C
AST (GOT) U/l 156 Tris buffer without P5P 37°C
Bilirubin Direct µmol/l 24.8 Diazo with Dichloroaniline (DCA)
mg/dl 1.45
Bilirubin Total µmol/l 88.1 Diazo with Dichloroaniline (DCA)
mg/dl 5.16
Calcium mmol/l 3.39 Arsenazo III
mg/dl 13.6
Chloride mmol/l 116 ISE indirect
Cholesterol mmol/l 7.46 Cholesterol Oxidase
mg/dl 288
Creatinine µmol/l 361 Alkaline picrate no deproteinization
mg/dl 4.08
µmol/l 382 Jaffe rate blanked compensated (-18 µmol/l)
mg/dl 4.32
gamma-GT U/I 185 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
U/I 185 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
Glucose mmol/l 15.6 Glucose oxidase
mg/dl 281
Iron µmol/l 35.2 Colorimetric without ppt.
µg/dl 197
Magnesium mmol/l 1.72 Xylidyl Blue
mg/dl 4.18
Phosphate Inorganic mmol/l 2.65 Phosphomolybdate UV
mg/dl 8.22
Potassium mmol/l 6.00 ISE method - indirect
Protein Total g/l 48.8 Biuret reaction end point
g/dl 4.88
Sodium mmol/l 160 ISE method - indirect
Triglycerides mmol/l 3.04 Lipase/GPO-PAP no correction
mg/dl 269
Urea mmol/l 18.5 Urease end point
mg/dl 111
mmol/l 19.6 Urease kinetic
mg/dl 118
mmol/l 19.6 BUN
mg/dl 55.0

Page 1 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

ABX Pentra 400® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Uric Acid (Urate) mmol/l 0.575 Uricase peroxidase with ascorbate oxidase
mg/dl 9.66

Page 2 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Beckman Coulter AU Series® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
a-HBDH U/I 407 Oxobutyrate < 10 mmol/l 37°C
Albumin g/l 27.7 Bromocresol Green
g/dl 2.77
g/l 28.0 Bromocresol Purple
g/dl 2.80
Alkaline Phosphatase U/l 387 AMP optimised to IFCC 37°C
ALT (GPT) U/l 149 Tris buffer without P5P 37°C
U/l 146 Beckman (Extinction Coefficient) 37°C
Amylase Total U/I 295 pNP Maltotrioside substrates 37°C
U/I 295 Beckman Synchron CX4/CX5/CX7 37°C
U/I 292 Beckman Coulter - blocked pNPG7 37°C
U/I 285 Beckman CNPG3 (Extinction Coeff) 37°C
AST (GOT) U/l 151 Tris buffer without P5P 37°C
U/l 151 Beckman (Extinction Coefficient) 37°C
Bicarbonate mmol/l 17.9 Enzymatic
Bilirubin Direct µmol/l 22.1 Dichlorophenyl Diazonium (DPD)
mg/dl 1.29
Bilirubin Total µmol/l 84.5 Diazo with Dichloroaniline (DCA)
mg/dl 4.94
µmol/l 94.1 Diazo with Sulphanilic Acid
mg/dl 5.51
µmol/l 83.7 Dichlorophenyl Diazonium (DPD)
mg/dl 4.90
µmol/l 84.1 DPD (Beckman AU)
mg/dl 4.92
Calcium mmol/l 3.21 Cresolphthalein complexone
mg/dl 12.9
mmol/l 3.23 Arsenazo III
mg/dl 12.9
Chloride mmol/l 115 ISE indirect
Cholesterol mmol/l 7.34 Cholesterol Oxidase
mg/dl 283
Cholinesterase U/l 5076 Colorimetric Butyrylthiocholine 37°C
CK Total U/l 548 CK-NAC serum start (DGKC) 37°C
U/l 559 CK-NAC substrate start (DGKC) 37°C
U/l 532 CK-NAC (IFCC) 37°C
U/l 532 Beckman CK-NAC (Extinction Coeff) 37°C
Copper µmol/l 25.4 Colorimetric
µg/dl 161

Page 1 of 3
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Beckman Coulter AU Series® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Creatinine µmol/l 349 Alkaline picrate no deproteinization
mg/dl 3.94
µmol/l 375 Enzymatic UV method
mg/dl 4.23
µmol/l 374 Creatinine PAP method
mg/dl 4.22
µmol/l 347 Jaffe rate blanked
mg/dl 3.92
µmol/l 369 Jaffe rate blanked compensated (-18 µmol/l)
mg/dl 4.17
µmol/l 363 IDMS traceable
mg/dl 4.10
D-3-Hydroxybutyrate mmol/l 1.15 Tris buffer 100mmol pH 8.5
gamma-GT U/I 182 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
U/I 149 Gamma glutamyl-4-nitroanilide 37°C
U/I 177 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 182 Beckman Szasz (Extinction Coeff) 37°C
GLDH U/I 30 Triethanolamine buffer 50 mmol 37°C
Glucose mmol/l 15.8 Hexokinase
mg/dl 285
mmol/l 15.8 Glucose oxidase
mg/dl 285
Iron µmol/l 38.7 Colorimetric with ppt.
µg/dl 216
µmol/l 38.2 Colorimetric without ppt.
µg/dl 214
Lactate mmol/l 5.42 Colorimetric Lactate Oxidase
mg/dl 48.8
LD (LDH) U/l 357 L->P 37°C
U/l 797 P->L Scandinavian & Dutch 37°C
U/l 366 L->P IFCC 37°C
U/l 355 L to P Beckman (Extinction Coeff) 37°C
Lipase U/I 60 Other Colorimetric 37°C
U/I 50 Roche Colorimetric 37°C
U/I 77 Randox Colorimetric 37°C
Lithium mmol/l 2.04 Spectrophotometric
mg/dl 1.42
Magnesium mmol/l 1.82 Xylidyl Blue
mg/dl 4.42
Phosphate Inorganic mmol/l 2.41 Phosphomolybdate UV
mg/dl 7.47
Potassium mmol/l 6.15 ISE method - indirect
Protein Total g/l 46.0 Biuret reaction end point
g/dl 4.60

Page 2 of 3
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Beckman Coulter AU Series® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Protein Total g/l 46.1 Biuret reaction kinetic
g/dl 4.61
Sodium mmol/l 161 ISE method - indirect
TIBC µmol/l 48.1 FE+UIBC(saturation with iron)
µg/dl 269
Triglycerides mmol/l 2.97 Lipase/GPO-PAP no correction
mg/dl 263
mmol/l 2.97 L/G Kinase EP. no correction
mg/dl 263
Urea mmol/l 20.0 Urease end point
mg/dl 120
mmol/l 20.1 Urease kinetic
mg/dl 121
mmol/l 20.1 BUN
mg/dl 56.4
Uric Acid (Urate) mmol/l 0.587 Uricase peroxidase with ascorbate oxidase
mg/dl 9.86
mmol/l 0.585 Uricase peroxidase no ascorbate oxidase
mg/dl 9.83
mmol/l 0.582 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 9.78

Page 3 of 3
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Beckman CX4/5/7/9/LX20® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 30.5 Bromocresol Green
g/dl 3.05
g/l 29.0 Bromocresol Purple
g/dl 2.90
Alkaline Phosphatase U/l 350 p-Nitrophenylphosphate AMP 37°C
ALT (GPT) U/l 137 Tris buffer without P5P 37°C
Amylase Total U/I 298 Beckman Synchron AMY7 37°C
AST (GOT) U/l 141 Tris buffer without P5P 37°C
Bicarbonate mmol/l 17.5 Differential rate pH change
Bilirubin Direct µmol/l 15.0 Diazo with Sulphanilic Acid
mg/dl 0.878
Bilirubin Total µmol/l 82.9 Diazo with Sulphanilic Acid
mg/dl 4.85
Calcium mmol/l 3.12 Ion selective electrode
mg/dl 12.5
Chloride mmol/l 115 ISE indirect
Cholesterol mmol/l 7.23 Cholesterol Oxidase
mg/dl 279
CK Total U/l 527 Monothioglycerol 37°C
Creatinine µmol/l 372 Alkaline picrate no deproteinization
mg/dl 4.20
µmol/l 371 IDMS traceable
mg/dl 4.19
gamma-GT U/I 147 Gamma glutamyl-4-nitroanilide 37°C
Glucose mmol/l 15.2 Hexokinase
mg/dl 274
mmol/l 15.2 Glucose oxidase
mg/dl 274
Iron µmol/l 37.7 Colorimetric without ppt.
µg/dl 211
Lactate mmol/l 5.14 Colorimetric Lactate Oxidase
mg/dl 46.3
LD (LDH) U/l 302 L->P 37°C
Lipase U/I 68 Other Colorimetric 37°C
Magnesium mmol/l 1.74 Calmagite
mg/dl 4.23
Phosphate Inorganic mmol/l 2.46 Phosphomolybdate UV
mg/dl 7.63
Potassium mmol/l 6.16 ISE method - indirect

Page 1 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Beckman CX4/5/7/9/LX20® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Protein Total g/l 45.9 Biuret reaction CX4/5/7
g/dl 4.59
g/l 46.1 Biuret reaction end point
g/dl 4.61
g/l 44.2 Biuret reaction kinetic
g/dl 4.42
Sodium mmol/l 161 ISE method - indirect
Triglycerides mmol/l 3.11 L/G Kinase EP. no correction
mg/dl 275
Urea mmol/l 20.5 Urease kinetic
mg/dl 123
mmol/l 20.5 BUN
mg/dl 57.5
Uric Acid (Urate) mmol/l 0.545 Uricase peroxidase no ascorbate oxidase
mg/dl 9.16

Page 2 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Beckman DxC600/800® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 30.5 Bromocresol Green
g/dl 3.05
g/l 29.0 Bromocresol Purple
g/dl 2.90
Alkaline Phosphatase U/l 335 AMP optimised to IFCC 37°C
U/l 339 AMP non-optimised 37°C
ALT (GPT) U/l 137 Tris buffer without P5P 37°C
U/l 132 Tris buffer SCE 37°C
Amylase Total U/I 299 Beckman Synchron AMY7 37°C
AST (GOT) U/l 140 Tris buffer without P5P 37°C
U/l 139 Tris buffer SCE 37°C
Bicarbonate mmol/l 17.4 Differential rate pH change
mmol/l 18.0 Ion selective electrode
Bilirubin Direct µmol/l 14.8 Diazo with Sulphanilic Acid
mg/dl 0.866
Bilirubin Total µmol/l 82.9 Diazo with Sulphanilic Acid
mg/dl 4.85
Calcium mmol/l 3.12 Ion selective electrode
mg/dl 12.5
Chloride mmol/l 115 ISE indirect
Cholesterol mmol/l 7.22 Cholesterol Oxidase
mg/dl 279
Cholinesterase U/l 5470 Colorimetric Butyrylthiocholine 37°C
CK Total U/l 524 Monothioglycerol 37°C
Creatinine µmol/l 371 Alkaline picrate no deproteinization
mg/dl 4.19
µmol/l 368 Jaffe rate blanked
mg/dl 4.16
µmol/l 371 IDMS traceable
mg/dl 4.19
gamma-GT U/I 146 Gamma glutamyl-4-nitroanilide 37°C
Glucose mmol/l 15.2 Hexokinase
mg/dl 274
mmol/l 15.1 Oxygen electrode
mg/dl 272
mmol/l 15.2 Glucose oxidase
mg/dl 274
Iron µmol/l 38.6 Colorimetric without ppt.
µg/dl 216

Page 1 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Beckman DxC600/800® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Lactate mmol/l 5.14 Colorimetric Lactate Oxidase
mg/dl 46.3
LD (LDH) U/l 299 L->P 37°C
U/l 948 Pyruvate 1.4 mM - Beckman LD-P 37°C
U/l 287 L->P IFCC 37°C
Lipase U/I 70 Other Colorimetric 37°C
Lithium mmol/l 2.03 Spectrophotometric
mg/dl 1.41
Magnesium mmol/l 1.75 Calmagite
mg/dl 4.25
Phosphate Inorganic mmol/l 2.44 Phosphomolybdate UV
mg/dl 7.56
Potassium mmol/l 6.15 ISE method - indirect
Protein Total g/l 46.1 Biuret reaction end point
g/dl 4.61
g/l 44.1 Biuret reaction kinetic
g/dl 4.41
Sodium mmol/l 160 ISE method - indirect
Triglycerides mmol/l 3.10 Lipase/GPO-PAP no correction
mg/dl 274
mmol/l 3.11 L/G Kinase EP. no correction
mg/dl 275
Urea mmol/l 20.6 Urease end point
mg/dl 124
mmol/l 20.4 Urease kinetic
mg/dl 123
mmol/l 20.4 BUN
mg/dl 57.3
Uric Acid (Urate) mmol/l 0.544 Uricase peroxidase no ascorbate oxidase
mg/dl 9.14

Page 2 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

BIOSYSTEMS A15 Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 31.5 Bromocresol Green
g/dl 3.15
Alkaline Phosphatase U/l 338 AMP optimised to IFCC 37°C
U/I 263 AMP optimised to IFCC 30°C
U/I 216 AMP optimised to IFCC 25°C
ALT (GPT) U/l 162 Tris buffer without P5P 37°C
U/I 120 Tris buffer without P5P 30°C
U/I 91 Tris buffer without P5P 25°C
AST (GOT) U/l 152 Tris buffer without P5P 37°C
U/I 103 Tris buffer without P5P 30°C
U/I 72 Tris buffer without P5P 25°C
Bilirubin Direct µmol/l 27.7 Diazo with Sulphanilic Acid
mg/dl 1.62
Bilirubin Total µmol/l 89.2 Diazo with Sulphanilic Acid
mg/dl 5.22
Cholesterol mmol/l 7.53 Cholesterol Oxidase
mg/dl 291
Glucose mmol/l 16.3 Glucose oxidase
mg/dl 293
Protein Total g/l 49.3 Biuret reaction end point
g/dl 4.93
Triglycerides mmol/l 2.92 Lipase/GPO-PAP no correction
mg/dl 258
Urea mmol/l 19.1 Urease kinetic
mg/dl 115
mmol/l 19.1 BUN
mg/dl 53.6
Uric Acid (Urate) mmol/l 0.544 Uricase peroxidase with ascorbate oxidase
mg/dl 9.14
mmol/l 0.586 Uricase peroxidase no ascorbate oxidase
mg/dl 9.84

Page 1 of 1
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

BIOSYSTEMS A25 Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 31.9 Bromocresol Green
g/dl 3.19
ALT (GPT) U/l 155 Tris buffer without P5P 37°C
U/I 115 Tris buffer without P5P 30°C
U/I 87 Tris buffer without P5P 25°C
AST (GOT) U/l 155 Tris buffer without P5P 37°C
U/I 105 Tris buffer without P5P 30°C
U/I 74 Tris buffer without P5P 25°C
Bilirubin Total µmol/l 84.2 Diazo with Sulphanilic Acid
mg/dl 4.93
Calcium mmol/l 3.20 Arsenazo III
mg/dl 12.8
Cholesterol mmol/l 7.48 Cholesterol Oxidase
mg/dl 289
Glucose mmol/l 15.7 Glucose oxidase
mg/dl 283
Protein Total g/l 45.2 Biuret reaction end point
g/dl 4.52
Triglycerides mmol/l 3.01 Lipase/GPO-PAP no correction
mg/dl 266
Urea mmol/l 18.5 Urease kinetic
mg/dl 111
mmol/l 18.5 BUN
mg/dl 51.9
Uric Acid (Urate) mmol/l 0.580 Uricase peroxidase no ascorbate oxidase
mg/dl 9.74

Page 1 of 1
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Biotechnica/Wiener BT and CB Series Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 28.3 Bromocresol Green
g/dl 2.83
ALT (GPT) U/l 142 Tris buffer without P5P 37°C
U/I 105 Tris buffer without P5P 30°C
U/I 80 Tris buffer without P5P 25°C
AST (GOT) U/l 144 Tris buffer without P5P 37°C
U/I 97 Tris buffer without P5P 30°C
U/I 69 Tris buffer without P5P 25°C
Bilirubin Total µmol/l 77.5 Dichlorophenyl Diazonium (DPD)
mg/dl 4.53
Calcium mmol/l 3.09 Arsenazo III
mg/dl 12.4
Cholesterol mmol/l 7.19 Cholesterol Oxidase
mg/dl 278
CK Total U/l 507 CK-NAC (IFCC) 37°C
U/I 317 CK-NAC (IFCC) 30°C
U/I 215 CK-NAC (IFCC) 25°C
Creatinine µmol/l 339 Alkaline picrate no deproteinization
mg/dl 3.83
µmol/l 359 Creatinine PAP method
mg/dl 4.05
gamma-GT U/I 183 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 144 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C
U/I 113 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C
Glucose mmol/l 15.3 Glucose oxidase
mg/dl 276
Phosphate Inorganic mmol/l 2.40 Phosphomolybdate UV
mg/dl 7.44
Protein Total g/l 48.3 Biuret reaction end point
g/dl 4.83
Triglycerides mmol/l 2.75 Lipase/GPO-PAP no correction
mg/dl 243
Urea mmol/l 18.9 Urease kinetic
mg/dl 114
mmol/l 18.9 BUN
mg/dl 53.0
Uric Acid (Urate) mmol/l 0.561 Uricase peroxidase no ascorbate oxidase
mg/dl 9.42

Page 1 of 1
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

COBAS INTEGRA® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 31.1 Bromocresol Green
g/dl 3.11
g/l 30.1 Bromocresol Purple
g/dl 3.01
g/l 28.0 Turbidimetric Assays
g/dl 2.80
Alkaline Phosphatase U/l 289 Roche Integra AMP buffer 37°C
U/I 225 Roche Integra AMP buffer 30°C
U/I 185 Roche Integra AMP buffer 25°C
ALT (GPT) U/l 137 Tris buffer without P5P 37°C
U/I 101 Tris buffer without P5P 30°C
U/I 77 Tris buffer without P5P 25°C
Amylase Pancreatic U/I 267 Immunoinhibition EPS substrate 37°C
U/I 269 Roche EPS Liquid 37°C
Amylase Total U/I 287 Roche Integra 2-chloro-pNPG7 37°C
U/I 287 Roche liquid stable pNPG7 37°C
AST (GOT) U/l 142 Tris buffer without P5P 37°C
U/I 96 Tris buffer without P5P 30°C
U/I 68 Tris buffer without P5P 25°C
Bicarbonate mmol/l 16.6 Colorimetric
mmol/l 17.4 Enzymatic
Bilirubin Direct µmol/l 27.5 Dichlorophenyl Diazonium (DPD)
mg/dl 1.61
µmol/l 27.5 Diazo with Sulphanilic Acid
mg/dl 1.61
µmol/l 26.9 Roche JG factored
mg/dl 1.58
Bilirubin Total µmol/l 74.9 Diazo with Dichloroaniline (DCA)
mg/dl 4.38
µmol/l 75.4 Diazo with Sulphanilic Acid
mg/dl 4.41
µmol/l 75.2 Dichlorophenyl Diazonium (DPD)
mg/dl 4.40
µmol/l 74.8 Diazonium ion
mg/dl 4.38
Calcium mmol/l 3.23 Cresolphthalein complexone
mg/dl 12.9
mmol/l 3.25 NM-BAPTA
mg/dl 13.0

Page 1 of 3
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

COBAS INTEGRA® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Chloride mmol/l 117 ISE indirect
Cholesterol mmol/l 7.05 Cholesterol Oxidase
mg/dl 272
CK Total U/l 492 CK-NAC (IFCC) 37°C
U/I 308 CK-NAC (IFCC) 30°C
U/I 209 CK-NAC (IFCC) 25°C
Creatinine µmol/l 353 Alkaline picrate with deproteinization
mg/dl 3.99
µmol/l 365 Alkaline picrate no deproteinization
mg/dl 4.13
µmol/l 364 Enzymatic UV method
mg/dl 4.11
µmol/l 363 Roche Creatinine Plus
mg/dl 4.10
µmol/l 390 Jaffe rate blanked comp. (-26 µmol/l)
mg/dl 4.41
µmol/l 379 Jaffe rate blanked compensated (-18 µmol/l)
mg/dl 4.28
gamma-GT U/I 164 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
U/I 129 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C
U/I 101 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C
U/I 180 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 142 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C
U/I 111 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C
Glucose mmol/l 15.8 Hexokinase
mg/dl 285
Iron µmol/l 38.2 Colorimetric with ppt.
µg/dl 214
µmol/l 37.8 Colorimetric without ppt.
µg/dl 211
Lactate mmol/l 5.70 Colorimetric Lactate Oxidase
mg/dl 51.4
LD (LDH) U/l 678 P->L German methods 37°C
U/I 490 P->L German methods 30°C
U/I 344 P->L German methods 25°C
U/l 378 L->P IFCC 37°C
U/I 273 L->P IFCC 30°C
U/I 192 L->P IFCC 25°C
Lipase U/I 54 Roche Colorimetric 37°C
Lithium mmol/l 2.00 Ion selective electrode
mg/dl 1.39
Magnesium mmol/l 1.80 Chlorphosphonazo III
mg/dl 4.37

Page 2 of 3
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

COBAS INTEGRA® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Phosphate Inorganic mmol/l 2.47 Phosphomolybdate enzymatic
mg/dl 7.66
mmol/l 2.46 Phosphomolybdate UV
mg/dl 7.63
Potassium mmol/l 6.21 ISE method - indirect
Protein Total g/l 43.6 Biuret reaction end point
g/dl 4.36
g/l 43.7 Biuret reaction kinetic
g/dl 4.37
Sodium mmol/l 161 ISE method - indirect
TIBC µmol/l 51.4 FE+UIBC(saturation with iron)
µg/dl 287
Triglycerides mmol/l 2.98 Lipase/GPO-PAP no correction
mg/dl 264
mmol/l 3.00 Lipase/GPO-PAP 0.11mmol/l correction
mg/dl 266
mmol/l 3.00 Lipase/Glycerol Dehydrogenase
mg/dl 266
Urea mmol/l 19.4 Urease kinetic
mg/dl 117
mmol/l 19.4 BUN
mg/dl 54.4
Uric Acid (Urate) mmol/l 0.569 Uricase peroxidase with ascorbate oxidase
mg/dl 9.56
mmol/l 0.566 Uricase peroxidase no ascorbate oxidase
mg/dl 9.51
mmol/l 0.568 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 9.54

Page 3 of 3
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Elitech/Vitalab Selectra Series Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 31.0 Bromocresol Green
g/dl 3.10
Alkaline Phosphatase U/l 465 Diethanolamine buffer DEA 37°C
ALT (GPT) U/l 153 Tris buffer without P5P 37°C
AST (GOT) U/l 145 Tris buffer without P5P 37°C
Bilirubin Total µmol/l 84.7 Diazo with Sulphanilic Acid
mg/dl 4.95
Calcium mmol/l 3.25 Arsenazo III
mg/dl 13.0
Cholesterol mmol/l 7.56 Cholesterol Oxidase
mg/dl 292
CK Total U/l 510 CK-NAC (IFCC) 37°C
Creatinine µmol/l 364 Alkaline picrate no deproteinization
mg/dl 4.11
Glucose mmol/l 16.0 Glucose oxidase
mg/dl 288
Protein Total g/l 48.2 Biuret reaction end point
g/dl 4.82
Triglycerides mmol/l 2.93 Lipase/GPO-PAP no correction
mg/dl 259
Urea mmol/l 19.2 Urease kinetic
mg/dl 115
mmol/l 19.2 BUN
mg/dl 53.9
Uric Acid (Urate) mmol/l 0.593 Uricase peroxidase no ascorbate oxidase
mg/dl 9.96

Page 1 of 1
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

HITACHI SERIES® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Acid Phosphatase (Total) U/I 23.5 1-Naphthyl Phosphate substrate Kinetic 37°C
Albumin g/l 30.4 Bromocresol Green
g/dl 3.04
Alkaline Phosphatase U/l 266 Roche Integra AMP buffer 37°C
U/I 207 Roche Integra AMP buffer 30°C
U/I 170 Roche Integra AMP buffer 25°C
U/l 329 Randox AMP 37°C
U/I 256 Randox AMP 30°C
U/I 210 Randox AMP 25°C
ALT (GPT) U/l 144 Tris buffer without P5P 37°C
U/I 107 Tris buffer without P5P 30°C
U/I 81 Tris buffer without P5P 25°C
Amylase Pancreatic U/I 288 Randox Liquid Ethylidene pNPG7 37°C
Amylase Total U/I 277 Roche liquid stable pNPG7 37°C
U/I 318 Randox Liquid Ethylidene pNPG7 37°C
AST (GOT) U/l 140 Tris buffer without P5P 37°C
U/I 95 Tris buffer without P5P 30°C
U/I 67 Tris buffer without P5P 25°C
Bicarbonate mmol/l 17.3 Enzymatic
Bile Acids µmol/l 44.5 5th Generation Colorimetric
Bilirubin Total µmol/l 79.2 Dichlorophenyl Diazonium (DPD)
mg/dl 4.63
Calcium mmol/l 3.25 Cresolphthalein complexone
mg/dl 13.0
mmol/l 3.26 NM-BAPTA
mg/dl 13.1
Chloride mmol/l 113 ISE indirect
Cholesterol mmol/l 7.11 Cholesterol Oxidase
mg/dl 274
CK Total U/l 492 CK-NAC (IFCC) 37°C
U/I 308 CK-NAC (IFCC) 30°C
U/I 209 CK-NAC (IFCC) 25°C
Creatinine µmol/l 361 Roche Creatinine Plus
mg/dl 4.08
µmol/l 398 Jaffe rate blanked comp. (-26 µmol/l)
mg/dl 4.50
D-3-Hydroxybutyrate mmol/l 1.20 Tris buffer 100mmol pH 8.5
gamma-GT U/I 159 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
U/I 125 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C
U/I 98 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C

Page 1 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

HITACHI SERIES® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
gamma-GT U/I 182 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 143 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C
U/I 112 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C
U/I 185 Randox Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
U/I 146 Randox Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C
U/I 114 Randox Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C
Glucose mmol/l 15.7 Hexokinase
mg/dl 283
mmol/l 15.1 Glucose oxidase
mg/dl 272
Iron µmol/l 37.7 Colorimetric without ppt.
µg/dl 211
Magnesium mmol/l 1.80 Xylidyl Blue
mg/dl 4.37
Phosphate Inorganic mmol/l 2.37 Phosphomolybdate UV
mg/dl 7.35
Potassium mmol/l 6.26 ISE method - indirect
Protein Total g/l 46.7 Biuret reaction end point
g/dl 4.67
Sodium mmol/l 163 ISE method - indirect
Triglycerides mmol/l 3.00 Lipase/GPO-PAP no correction
mg/dl 266
Urea mmol/l 20.3 Urease kinetic
mg/dl 122
mmol/l 20.3 BUN
mg/dl 57.0
Uric Acid (Urate) mmol/l 0.542 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 9.11

Page 2 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Konelab 20/30/60®/Thermo Scientific Indiko Plus® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 28.8 Bromocresol Green
g/dl 2.88
Alkaline Phosphatase U/l 330 AMP optimised to IFCC 37°C
U/I 257 AMP optimised to IFCC 30°C
U/I 211 AMP optimised to IFCC 25°C
ALT (GPT) U/l 152 Tris buffer without P5P 37°C
U/I 112 Tris buffer without P5P 30°C
U/I 86 Tris buffer without P5P 25°C
AST (GOT) U/l 160 Tris buffer without P5P 37°C
U/I 108 Tris buffer without P5P 30°C
U/I 76 Tris buffer without P5P 25°C
Bile Acids µmol/l 47.0 Enzymatic Colorimetric
Bilirubin Direct µmol/l 25.1 Diazo with Sulphanilic Acid
mg/dl 1.47
Bilirubin Total µmol/l 78.1 Diazo with Sulphanilic Acid
mg/dl 4.57
µmol/l 77.0 Nitrobenzenediazonium salt
mg/dl 4.51
Calcium mmol/l 3.39 Arsenazo III
mg/dl 13.6
Chloride mmol/l 117 ISE direct
Cholesterol mmol/l 7.04 Cholesterol Oxidase
mg/dl 272
CK Total U/l 518 CK-NAC (IFCC) 37°C
U/I 324 CK-NAC (IFCC) 30°C
U/I 220 CK-NAC (IFCC) 25°C
Creatinine µmol/l 357 Alkaline picrate no deproteinization
mg/dl 4.03
µmol/l 362 Enzymatic UV method
mg/dl 4.10
µmol/l 381 Creatinine PAP method
mg/dl 4.30
gamma-GT U/I 174 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 137 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C
U/I 107 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C
Glucose mmol/l 15.7 Hexokinase
mg/dl 283
mmol/l 15.3 Glucose oxidase
mg/dl 276

Page 1 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Konelab 20/30/60®/Thermo Scientific Indiko Plus® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Iron µmol/l 38.3 Colorimetric without ppt.
µg/dl 214
LD (LDH) U/l 730 P->L SFBC 37°C
U/I 527 P->L SFBC 30°C
U/I 370 P->L SFBC 25°C
Magnesium mmol/l 1.65 Xylidyl Blue
mg/dl 4.01
Phosphate Inorganic mmol/l 2.43 Phosphomolybdate UV
mg/dl 7.53
Potassium mmol/l 6.03 ISE method - direct
Protein Total g/l 47.2 Biuret reaction end point
g/dl 4.72
Sodium mmol/l 157 ISE method - direct
Triglycerides mmol/l 2.97 Lipase/GPO-PAP no correction
mg/dl 263
Urea mmol/l 18.3 Urease kinetic
mg/dl 110
mmol/l 18.3 BUN
mg/dl 51.4
Uric Acid (Urate) mmol/l 0.589 Uricase peroxidase with ascorbate oxidase
mg/dl 9.90
mmol/l 0.561 Uricase peroxidase no ascorbate oxidase
mg/dl 9.42
mmol/l 0.578 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 9.71

Page 2 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

MEAN OF ALL INSTRUMENTS Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
a-HBDH U/I 406 Oxobutyrate < 10 mmol/l 37°C
U/I 307 Oxobutyrate < 10 mmol/l 30°C
U/I 230 Oxobutyrate < 10 mmol/l 25°C
Acid Phosphatase (Total) U/I 23.5 1-Naphthyl Phosphate substrate Kinetic 37°C
Albumin g/l 30.0 Bromocresol Green
g/dl 3.00
g/l 28.2 Bromocresol Purple
g/dl 2.82
g/l 27.5 Turbidimetric Assays
g/dl 2.75
Alkaline Phosphatase U/l 484 Diethanolamine buffer DEA 37°C
U/I 377 Diethanolamine buffer DEA 30°C
U/I 309 Diethanolamine buffer DEA 25°C
U/l 336 AMP optimised to IFCC 37°C
U/I 262 AMP optimised to IFCC 30°C
U/I 215 AMP optimised to IFCC 25°C
U/l 320 AMP non-optimised 37°C
U/I 249 AMP non-optimised 30°C
U/I 204 AMP non-optimised 25°C
ALT (GPT) U/l 149 Tris buffer with P5P 37°C
U/I 110 Tris buffer with P5P 30°C
U/I 84 Tris buffer with P5P 25°C
U/l 141 Tris buffer without P5P 37°C
U/I 104 Tris buffer without P5P 30°C
U/I 79 Tris buffer without P5P 25°C
U/l 133 Tris buffer SCE 37°C
U/I 98 Tris buffer SCE 30°C
U/I 75 Tris buffer SCE 25°C
Amylase Pancreatic U/I 258 Immunoinhibition EPS substrate 37°C
U/I 255 Roche EPS Liquid 37°C
U/I 288 Randox Liquid Ethylidene pNPG7 37°C
Amylase Total U/I 292 pNP Maltotrioside substrates 37°C
U/I 294 Siemens - blocked pNPG7 37°C
U/I 233 Randox Lyo. Ethylidene pNPG7 37°C
U/I 318 Randox Liquid Ethylidene pNPG7 37°C
U/I 278 BM/Roche Colorimetric pNPG7 37°C
U/I 293 Beckman Synchron CX4/CX5/CX7 37°C
U/I 343 Siemens - maltopenta/hexaoside 37°C
U/I 269 Saccharogenic 37°C

Page 1 of 6
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

MEAN OF ALL INSTRUMENTS Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Amylase Total U/I 284 Roche Integra 2-chloro-pNPG7 37°C
U/I 283 Other Roche 2-chloro-pNPG7 37°C
U/I 278 Roche liquid stable pNPG7 37°C
U/I 352 Siemens 2-chloro-pNPG3 37°C
U/I 291 Beckman Coulter - blocked pNPG7 37°C
U/I 299 Beckman Synchron AMY7 37°C
U/I 323 Abbott Architect Non-IFCC Cal. 37°C
U/I 357 Abbott Architect IFCC Cal. 37°C
U/I 285 Beckman CNPG3 (Extinction Coeff) 37°C
AST (GOT) U/l 181 Tris buffer with P5P 37°C
U/I 122 Tris buffer with P5P 30°C
U/I 86 Tris buffer with P5P 25°C
U/l 143 Tris buffer without P5P 37°C
U/I 97 Tris buffer without P5P 30°C
U/I 68 Tris buffer without P5P 25°C
U/l 139 Tris buffer SCE 37°C
U/I 94 Tris buffer SCE 30°C
U/I 66 Tris buffer SCE 25°C
Bicarbonate mmol/l 17.5 Colorimetric
mmol/l 17.4 Differential rate pH change
mmol/l 17.5 Enzymatic
mmol/l 18.5 Ion selective electrode
Bile Acids µmol/l 45.0 4th Generation Colorimetric
µmol/l 44.5 5th Generation Colorimetric
Bilirubin Direct µmol/l 25.4 Dichlorophenyl Diazonium (DPD)
mg/dl 1.49
µmol/l 27.5 Diazo with Sulphanilic Acid
mg/dl 1.61
µmol/l 27.3 Diazo with Dichloroaniline (DCA)
mg/dl 1.60
µmol/l 28.4 Oxidation to Biliverdin/Vanadate
mg/dl 1.66
Bilirubin Total µmol/l 87.8 Diazo with Dichloroaniline (DCA)
mg/dl 5.14
µmol/l 81.9 Diazo with Sulphanilic Acid
mg/dl 4.79
µmol/l 77.0 Dichlorophenyl Diazonium (DPD)
mg/dl 4.51
µmol/l 79.2 Diazonium ion
mg/dl 4.63
µmol/l 92.4 Oxidation to Biliverdin/Vanadate
mg/dl 5.41
Calcium mmol/l 3.24 Cresolphthalein complexone
mg/dl 13.0

Page 2 of 6
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

MEAN OF ALL INSTRUMENTS Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Calcium mmol/l 3.12 Ion selective electrode
mg/dl 12.5
mmol/l 3.24 Arsenazo III
mg/dl 13.0
mmol/l 3.26 NM-BAPTA
mg/dl 13.1
Chloride mmol/l 114 Colorimetric
mmol/l 115 ISE indirect
mmol/l 116 ISE direct
Cholesterol mmol/l 7.15 Cholesterol Oxidase
mg/dl 276
Cholinesterase U/l 5347 Colorimetric Butyrylthiocholine 37°C
CK Total U/l 525 CK-NAC serum start (DGKC) 37°C
U/I 329 CK-NAC serum start (DGKC) 30°C
U/I 223 CK-NAC serum start (DGKC) 25°C
U/l 515 CK-NAC substrate start (DGKC) 37°C
U/I 322 CK-NAC substrate start (DGKC) 30°C
U/I 219 CK-NAC substrate start (DGKC) 25°C
U/l 504 CK-NAC (IFCC) 37°C
U/I 316 CK-NAC (IFCC) 30°C
U/I 214 CK-NAC (IFCC) 25°C
U/l 524 Monothioglycerol 37°C
U/I 328 Monothioglycerol 30°C
U/I 223 Monothioglycerol 25°C
Copper µmol/l 26.9 Atomic absorption
µg/dl 171
µmol/l 25.4 Colorimetric
µg/dl 162
Creatinine µmol/l 358 Alkaline picrate with deproteinization
mg/dl 4.05
µmol/l 363 Alkaline picrate no deproteinization
mg/dl 4.11
µmol/l 368 Enzymatic UV method
mg/dl 4.16
µmol/l 370 Creatinine PAP method
mg/dl 4.18
µmol/l 364 Jaffe rate blanked
mg/dl 4.11
µmol/l 397 Jaffe rate blanked comp. (-26 µmol/l)
mg/dl 4.49
µmol/l 377 Jaffe rate blanked compensated (-18 µmol/l)
mg/dl 4.26

Page 3 of 6
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

MEAN OF ALL INSTRUMENTS Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Creatinine µmol/l 368 IDMS traceable
mg/dl 4.16
D-3-Hydroxybutyrate mmol/l 1.15 Tris buffer 100mmol pH 8.5
gamma-GT U/I 171 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
U/I 135 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C
U/I 106 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C
U/I 146 Gamma glutamyl-4-nitroanilide 37°C
U/I 115 Gamma glutamyl-4-nitroanilide 30°C
U/I 90 Gamma glutamyl-4-nitroanilide 25°C
U/I 180 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 142 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C
U/I 111 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C
U/I 185 Randox Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
U/I 146 Randox Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C
U/I 114 Randox Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C
GLDH U/I 27 Triethanolamine buffer 50 mmol 37°C
U/I 21 Triethanolamine buffer 50 mmol 30°C
U/I 17 Triethanolamine buffer 50 mmol 25°C
Glucose mmol/l 15.5 Glucose dehydrogenase
mg/dl 279
mmol/l 15.7 Hexokinase
mg/dl 283
mmol/l 15.2 Oxygen electrode
mg/dl 274
mmol/l 15.5 Glucose oxidase
mg/dl 279
Iron µmol/l 38.1 Colorimetric with ppt.
µg/dl 213
µmol/l 37.7 Colorimetric without ppt.
µg/dl 211
Lactate mmol/l 5.59 Colorimetric Lactate Oxidase
mg/dl 50.4
mmol/l 5.54 Enzymatic Electrode
mg/dl 49.9
mmol/l 5.36 UV LDH
mg/dl 48.3
LAP U/l 15 NAGEL 37°C
LD (LDH) U/l 329 L->P 37°C
U/I 238 L->P 30°C
U/I 167 L->P 25°C
U/l 803 P->L Scandinavian & Dutch 37°C
U/I 580 P->L Scandinavian & Dutch 30°C
U/I 407 P->L Scandinavian & Dutch 25°C

Page 4 of 6
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

MEAN OF ALL INSTRUMENTS Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
LD (LDH) U/l 696 P->L German methods 37°C
U/I 503 P->L German methods 30°C
U/I 353 P->L German methods 25°C
U/l 693 P->L SFBC 37°C
U/I 500 P->L SFBC 30°C
U/I 351 P->L SFBC 25°C
U/l 365 L->P IFCC 37°C
U/I 264 L->P IFCC 30°C
U/I 185 L->P IFCC 25°C
Lipase U/I 53 Roche Colorimetric 37°C
U/I 80 Randox Colorimetric 37°C
Lithium mmol/l 2.11 Ion selective electrode
mg/dl 1.47
mmol/l 2.04 Spectrophotometric
mg/dl 1.42
mmol/l 2.04 Randox Colorimetric
mg/dl 1.42
Magnesium mmol/l 1.78 Arsenazo III
mg/dl 4.33
mmol/l 1.75 Calmagite
mg/dl 4.25
mmol/l 1.80 Xylidyl Blue
mg/dl 4.37
mmol/l 1.77 Methylthymol blue
mg/dl 4.30
mmol/l 1.80 Chlorphosphonazo III
mg/dl 4.37
mmol/l 1.77 Enzymatic
mg/dl 4.30
Osmolality mOsm/kg 353 Calculated
mOsm/kg 385 Freezing point depression
Phosphate Inorganic mmol/l 2.39 Phosphomolybdate enzymatic
mg/dl 7.41
mmol/l 2.40 Phosphomolybdate UV
mg/dl 7.44
Potassium mmol/l 6.05 Enzymatic
mmol/l 6.14 ISE method - direct
mmol/l 6.22 ISE method - indirect
Protein Total g/l 46.1 Biuret reaction end point
g/dl 4.61
g/l 45.0 Biuret reaction kinetic
g/dl 4.50
Sodium mmol/l 158 Enzymatic

Page 5 of 6
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

MEAN OF ALL INSTRUMENTS Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Sodium mmol/l 160 ISE method - direct
mmol/l 162 ISE method - indirect
TIBC µmol/l 45.3 Removal of excess free iron
µg/dl 253
µmol/l 48.6 FE+UIBC(saturation with iron)
µg/dl 272
µmol/l 47.0 Direct Colorimetric
µg/dl 263
µmol/l 42.8 Calculated from Transferrin
µg/dl 239
µmol/l 50.2 Randox Direct
µg/dl 281
Triglycerides mmol/l 2.95 Lipase/GPO-PAP no correction
mg/dl 261
mmol/l 2.97 Lipase/GPO-PAP 0.11mmol/l correction
mg/dl 263
mmol/l 3.00 L/G Kinase EP. no correction
mg/dl 266
mmol/l 2.94 Lipase/Glycerol Dehydrogenase
mg/dl 260
Urea mmol/l 19.9 Urease end point
mg/dl 120
mmol/l 19.9 Urease kinetic
mg/dl 120
mmol/l 19.9 BUN
mg/dl 55.9
Uric Acid (Urate) mmol/l 0.542 Uricase catalase 340nm
mg/dl 9.11
mmol/l 0.565 Uricase peroxidase with ascorbate oxidase
mg/dl 9.49
mmol/l 0.561 Uricase peroxidase no ascorbate oxidase
mg/dl 9.42
mmol/l 0.558 Spectrophotometric at 280-290
mg/dl 9.37
mmol/l 0.556 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 9.34
Zinc µmol/l 37.2 Colorimetric with deproteinisation
µg/dl 243

Page 6 of 6
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

MINDRAY BS-200/300/400 Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 31.0 Bromocresol Green
g/dl 3.10
Alkaline Phosphatase U/l 462 Diethanolamine buffer DEA 37°C
U/I 360 Diethanolamine buffer DEA 30°C
U/I 295 Diethanolamine buffer DEA 25°C
U/l 342 AMP optimised to IFCC 37°C
U/I 266 AMP optimised to IFCC 30°C
U/I 219 AMP optimised to IFCC 25°C
ALT (GPT) U/l 146 Tris buffer without P5P 37°C
U/I 108 Tris buffer without P5P 30°C
U/I 82 Tris buffer without P5P 25°C
AST (GOT) U/l 150 Tris buffer without P5P 37°C
U/I 101 Tris buffer without P5P 30°C
U/I 71 Tris buffer without P5P 25°C
Bilirubin Direct µmol/l 26.3 Diazo with Sulphanilic Acid
mg/dl 1.54
Bilirubin Total µmol/l 83.9 Diazo with Sulphanilic Acid
mg/dl 4.91
µmol/l 86.2 Dichlorophenyl Diazonium (DPD)
mg/dl 5.04
µmol/l 86.6 Oxidation to Biliverdin/Vanadate
mg/dl 5.06
Calcium mmol/l 3.21 Cresolphthalein complexone
mg/dl 12.9
mmol/l 3.24 Arsenazo III
mg/dl 13.0
Chloride mmol/l 117 ISE indirect
Cholesterol mmol/l 7.32 Cholesterol Oxidase
mg/dl 283
Cholinesterase U/l 5541 Colorimetric Butyrylthiocholine 37°C
CK Total U/l 513 CK-NAC (IFCC) 37°C
U/I 321 CK-NAC (IFCC) 30°C
U/I 218 CK-NAC (IFCC) 25°C
Creatinine µmol/l 348 Alkaline picrate no deproteinization
mg/dl 3.93
µmol/l 386 Jaffe rate blanked
mg/dl 4.36
gamma-GT U/I 161 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
U/I 127 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C
U/I 99 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C

Page 1 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

MINDRAY BS-200/300/400 Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
gamma-GT U/I 176 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 139 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C
U/I 109 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C
Glucose mmol/l 15.7 Hexokinase
mg/dl 282
mmol/l 15.9 Glucose oxidase
mg/dl 287
Iron µmol/l 36.6 Colorimetric without ppt.
µg/dl 205
LD (LDH) U/l 750 P->L German methods 37°C
U/I 542 P->L German methods 30°C
U/I 380 P->L German methods 25°C
U/l 682 P->L SFBC 37°C
U/I 492 P->L SFBC 30°C
U/I 346 P->L SFBC 25°C
U/l 358 L->P IFCC 37°C
U/I 258 L->P IFCC 30°C
U/I 182 L->P IFCC 25°C
Magnesium mmol/l 1.74 Xylidyl Blue
mg/dl 4.23
Phosphate Inorganic mmol/l 2.32 Phosphomolybdate UV
mg/dl 7.19
Potassium mmol/l 6.26 ISE method - indirect
Protein Total g/l 48.7 Biuret reaction end point
g/dl 4.87
Sodium mmol/l 161 ISE method - indirect
Triglycerides mmol/l 2.93 Lipase/GPO-PAP no correction
mg/dl 259
Urea mmol/l 20.0 Urease kinetic
mg/dl 120
mmol/l 20.0 BUN
mg/dl 56.1
Uric Acid (Urate) mmol/l 0.585 Uricase peroxidase with ascorbate oxidase
mg/dl 9.83
mmol/l 0.564 Uricase peroxidase no ascorbate oxidase
mg/dl 9.48
mmol/l 0.561 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 9.42

Page 2 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Roche Cobas 6000 c501 e601 Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 30.9 Bromocresol Green
g/dl 3.09
g/l 27.4 Bromocresol Purple
g/dl 2.74
g/l 26.9 Turbidimetric Assays
g/dl 2.69
Alkaline Phosphatase U/l 284 Roche Integra AMP buffer 37°C
U/I 221 Roche Integra AMP buffer 30°C
U/I 181 Roche Integra AMP buffer 25°C
ALT (GPT) U/l 138 Tris buffer without P5P 37°C
U/I 102 Tris buffer without P5P 30°C
U/I 78 Tris buffer without P5P 25°C
Amylase Pancreatic U/I 251 Roche EPS Liquid 37°C
Amylase Total U/I 277 BM/Roche Colorimetric pNPG7 37°C
U/I 275 Roche Integra 2-chloro-pNPG7 37°C
U/I 275 Roche liquid stable pNPG7 37°C
AST (GOT) U/l 142 Tris buffer without P5P 37°C
U/I 96 Tris buffer without P5P 30°C
U/I 68 Tris buffer without P5P 25°C
Bicarbonate mmol/l 17.6 Colorimetric
mmol/l 17.4 Enzymatic
Bile Acids µmol/l 44.3 Enzymatic Colorimetric
Bilirubin Direct µmol/l 26.8 Dichlorophenyl Diazonium (DPD)
mg/dl 1.57
µmol/l 26.8 Diazo with Sulphanilic Acid
mg/dl 1.57
µmol/l 26.8 Roche JG factored
mg/dl 1.57
µmol/l 25.8 Oxidation to Biliverdin/Vanadate
mg/dl 1.51
Bilirubin Total µmol/l 77.9 Diazo with Sulphanilic Acid
mg/dl 4.56
µmol/l 77.6 Dichlorophenyl Diazonium (DPD)
mg/dl 4.54
µmol/l 78.1 Diazonium ion
mg/dl 4.57
Calcium mmol/l 3.26 Cresolphthalein complexone
mg/dl 13.1
mmol/l 3.26 NM-BAPTA
mg/dl 13.1

Page 1 of 4
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Roche Cobas 6000 c501 e601 Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Chloride mmol/l 112 ISE indirect
Cholesterol mmol/l 7.01 Cholesterol Oxidase
mg/dl 271
Cholinesterase U/l 5283 Colorimetric Butyrylthiocholine 37°C
CK Total U/l 498 CK-NAC substrate start (DGKC) 37°C
U/I 312 CK-NAC substrate start (DGKC) 30°C
U/I 212 CK-NAC substrate start (DGKC) 25°C
U/l 489 CK-NAC (IFCC) 37°C
U/I 306 CK-NAC (IFCC) 30°C
U/I 208 CK-NAC (IFCC) 25°C
Creatinine µmol/l 371 Alkaline picrate no deproteinization
mg/dl 4.19
µmol/l 375 Enzymatic UV method
mg/dl 4.24
µmol/l 376 Roche Creatinine Plus
mg/dl 4.24
µmol/l 379 Jaffe rate blanked
mg/dl 4.28
µmol/l 398 Jaffe rate blanked comp. (-26 µmol/l)
mg/dl 4.50
µmol/l 385 Jaffe rate blanked compensated (-18 µmol/l)
mg/dl 4.35
D-3-Hydroxybutyrate mmol/l 1.17 Tris buffer 100mmol pH 8.5
gamma-GT U/I 159 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
U/I 125 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C
U/I 98 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C
U/I 184 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 145 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C
U/I 114 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C
GLDH U/I 26 Triethanolamine buffer 50 mmol 37°C
U/I 20 Triethanolamine buffer 50 mmol 30°C
U/I 16 Triethanolamine buffer 50 mmol 25°C
Glucose mmol/l 15.7 Glucose dehydrogenase
mg/dl 282
mmol/l 15.6 Hexokinase
mg/dl 281
mmol/l 15.5 Glucose oxidase
mg/dl 279
Iron µmol/l 37.1 Colorimetric with ppt.
µg/dl 207
µmol/l 37.4 Colorimetric without ppt.
µg/dl 209

Page 2 of 4
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Roche Cobas 6000 c501 e601 Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Lactate mmol/l 5.58 Colorimetric Lactate Oxidase
mg/dl 50.3
LD (LDH) U/l 687 P->L German methods 37°C
U/I 496 P->L German methods 30°C
U/I 348 P->L German methods 25°C
U/l 690 P->L SFBC 37°C
U/I 498 P->L SFBC 30°C
U/I 350 P->L SFBC 25°C
U/l 363 L->P IFCC 37°C
U/I 262 L->P IFCC 30°C
U/I 184 L->P IFCC 25°C
Lipase U/I 52 Roche Colorimetric 37°C
Lithium mmol/l 2.06 Spectrophotometric
mg/dl 1.43
Magnesium mmol/l 1.80 Xylidyl Blue
mg/dl 4.37
mmol/l 1.79 Chlorphosphonazo III
mg/dl 4.35
Osmolality mOsm/kg 355 Calculated
Phosphate Inorganic mmol/l 2.40 Phosphomolybdate enzymatic
mg/dl 7.44
mmol/l 2.39 Phosphomolybdate UV
mg/dl 7.41
Potassium mmol/l 6.26 ISE method - indirect
Protein Total g/l 46.0 Biuret reaction end point
g/dl 4.60
g/l 45.8 Biuret reaction kinetic
g/dl 4.58
Sodium mmol/l 163 ISE method - indirect
TIBC µmol/l 48.6 FE+UIBC(saturation with iron)
µg/dl 272
µmol/l 44.2 Calculated from Transferrin
µg/dl 247
Triglycerides mmol/l 2.94 Lipase/GPO-PAP no correction
mg/dl 260
mmol/l 2.93 L/G Kinase EP. no correction
mg/dl 259
Urea mmol/l 19.9 Urease end point
mg/dl 120
mmol/l 19.8 Urease kinetic
mg/dl 119
mmol/l 19.8 BUN
mg/dl 55.6

Page 3 of 4
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Roche Cobas 6000 c501 e601 Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Uric Acid (Urate) mmol/l 0.547 Uricase peroxidase with ascorbate oxidase
mg/dl 9.19
mmol/l 0.547 Uricase peroxidase no ascorbate oxidase
mg/dl 9.19
mmol/l 0.546 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 9.17

Page 4 of 4
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Roche Cobas C111® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 30.8 Bromocresol Green
g/dl 3.08
Alkaline Phosphatase U/l 286 Roche Integra AMP buffer 37°C
U/I 223 Roche Integra AMP buffer 30°C
U/I 183 Roche Integra AMP buffer 25°C
U/l 268 AMP optimised to IFCC 37°C
U/I 209 AMP optimised to IFCC 30°C
U/I 171 AMP optimised to IFCC 25°C
ALT (GPT) U/l 136 Tris buffer without P5P 37°C
U/I 101 Tris buffer without P5P 30°C
U/I 77 Tris buffer without P5P 25°C
Amylase Total U/I 284 Roche liquid stable pNPG7 37°C
AST (GOT) U/l 142 Tris buffer without P5P 37°C
U/I 96 Tris buffer without P5P 30°C
U/I 68 Tris buffer without P5P 25°C
Bicarbonate mmol/l 17.2 Enzymatic
Bilirubin Direct µmol/l 28.4 Dichlorophenyl Diazonium (DPD)
mg/dl 1.66
µmol/l 27.9 Diazo with Sulphanilic Acid
mg/dl 1.63
µmol/l 27.8 Roche JG factored
mg/dl 1.63
Bilirubin Total µmol/l 73.9 Diazo with Sulphanilic Acid
mg/dl 4.33
µmol/l 75.3 Dichlorophenyl Diazonium (DPD)
mg/dl 4.40
µmol/l 77.7 Diazonium ion
mg/dl 4.54
Calcium mmol/l 3.14 Cresolphthalein complexone
mg/dl 12.6
mmol/l 3.27 NM-BAPTA
mg/dl 13.1
Chloride mmol/l 118 ISE indirect
Cholesterol mmol/l 7.18 Cholesterol Oxidase
mg/dl 277
CK Total U/l 481 CK-NAC (IFCC) 37°C
U/I 301 CK-NAC (IFCC) 30°C
U/I 204 CK-NAC (IFCC) 25°C
Creatinine µmol/l 363 Alkaline picrate no deproteinization
mg/dl 4.10

Page 1 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Roche Cobas C111® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Creatinine µmol/l 365 Roche Creatinine Plus
mg/dl 4.12
µmol/l 388 Jaffe rate blanked comp. (-26 µmol/l)
mg/dl 4.38
µmol/l 378 Jaffe rate blanked compensated (-18 µmol/l)
mg/dl 4.27
gamma-GT U/I 182 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
U/I 143 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C
U/I 112 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C
U/I 176 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 139 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C
U/I 109 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C
Glucose mmol/l 15.8 Hexokinase
mg/dl 285
LD (LDH) U/l 372 L->P IFCC 37°C
U/I 269 L->P IFCC 30°C
U/I 189 L->P IFCC 25°C
Magnesium mmol/l 1.79 Chlorphosphonazo III
mg/dl 4.35
Phosphate Inorganic mmol/l 2.45 Phosphomolybdate UV
mg/dl 7.60
Potassium mmol/l 6.16 ISE method - indirect
Protein Total g/l 48.0 Biuret reaction end point
g/dl 4.80
Sodium mmol/l 160 ISE method - indirect
Triglycerides mmol/l 2.97 Lipase/GPO-PAP no correction
mg/dl 263
Urea mmol/l 19.4 Urease kinetic
mg/dl 117
mmol/l 19.4 BUN
mg/dl 54.4
Uric Acid (Urate) mmol/l 0.558 Uricase peroxidase with ascorbate oxidase
mg/dl 9.37
mmol/l 0.555 Uricase peroxidase no ascorbate oxidase
mg/dl 9.32
mmol/l 0.575 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 9.66

Page 2 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Roche Cobas C311® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 31.0 Bromocresol Green
g/dl 3.10
g/l 27.5 Bromocresol Purple
g/dl 2.75
Alkaline Phosphatase U/l 278 Roche Integra AMP buffer 37°C
U/I 217 Roche Integra AMP buffer 30°C
U/I 178 Roche Integra AMP buffer 25°C
ALT (GPT) U/l 138 Tris buffer without P5P 37°C
U/I 102 Tris buffer without P5P 30°C
U/I 78 Tris buffer without P5P 25°C
Amylase Total U/I 279 Roche liquid stable pNPG7 37°C
AST (GOT) U/l 142 Tris buffer without P5P 37°C
U/I 96 Tris buffer without P5P 30°C
U/I 68 Tris buffer without P5P 25°C
Bicarbonate mmol/l 17.0 Enzymatic
Bilirubin Direct µmol/l 26.0 Dichlorophenyl Diazonium (DPD)
mg/dl 1.52
µmol/l 24.8 Diazo with Sulphanilic Acid
mg/dl 1.45
µmol/l 26.3 Roche JG factored
mg/dl 1.54
Bilirubin Total µmol/l 77.0 Diazo with Sulphanilic Acid
mg/dl 4.51
µmol/l 77.9 Dichlorophenyl Diazonium (DPD)
mg/dl 4.56
µmol/l 78.7 Diazonium ion
mg/dl 4.60
Calcium mmol/l 3.27 Cresolphthalein complexone
mg/dl 13.1
mmol/l 3.27 NM-BAPTA
mg/dl 13.1
Chloride mmol/l 113 ISE indirect
Cholesterol mmol/l 7.08 Cholesterol Oxidase
mg/dl 273
CK Total U/l 497 CK-NAC (IFCC) 37°C
U/I 311 CK-NAC (IFCC) 30°C
U/I 211 CK-NAC (IFCC) 25°C
Creatinine µmol/l 377 Alkaline picrate no deproteinization
mg/dl 4.26

Page 1 of 3
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Roche Cobas C311® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Creatinine µmol/l 379 Roche Creatinine Plus
mg/dl 4.29
µmol/l 403 Jaffe rate blanked comp. (-26 µmol/l)
mg/dl 4.55
gamma-GT U/I 162 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
U/I 128 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C
U/I 100 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C
U/I 187 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 147 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C
U/I 115 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C
Glucose mmol/l 15.6 Hexokinase
mg/dl 282
mmol/l 15.9 Glucose oxidase
mg/dl 287
Iron µmol/l 37.3 Colorimetric without ppt.
µg/dl 209
Lactate mmol/l 5.63 Colorimetric Lactate Oxidase
mg/dl 50.7
LD (LDH) U/l 682 P->L German methods 37°C
U/I 492 P->L German methods 30°C
U/I 346 P->L German methods 25°C
U/l 365 L->P IFCC 37°C
U/I 264 L->P IFCC 30°C
U/I 185 L->P IFCC 25°C
Lipase U/I 52 Roche Colorimetric 37°C
Magnesium mmol/l 1.81 Xylidyl Blue
mg/dl 4.40
mmol/l 1.81 Chlorphosphonazo III
mg/dl 4.40
Phosphate Inorganic mmol/l 2.41 Phosphomolybdate UV
mg/dl 7.47
Potassium mmol/l 6.30 ISE method - indirect
Protein Total g/l 46.1 Biuret reaction end point
g/dl 4.61
Sodium mmol/l 164 ISE method - indirect
TIBC µmol/l 50.2 FE+UIBC(saturation with iron)
µg/dl 281
Triglycerides mmol/l 2.96 Lipase/GPO-PAP no correction
mg/dl 262
UIBC µmol/l 12.6 Direct Colorimetric
µg/dl 70.5
Urea mmol/l 19.9 Urease kinetic
mg/dl 120

Page 2 of 3
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Roche Cobas C311® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Urea mmol/l 19.9 BUN
mg/dl 55.9
Uric Acid (Urate) mmol/l 0.551 Uricase peroxidase with ascorbate oxidase
mg/dl 9.26
mmol/l 0.555 Uricase peroxidase no ascorbate oxidase
mg/dl 9.32
mmol/l 0.557 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 9.36

Page 3 of 3
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Roche Cobas c701 / c702 / c711 Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 30.8 Bromocresol Green
g/dl 3.08
g/l 26.9 Turbidimetric Assays
g/dl 2.69
Alkaline Phosphatase U/l 264 Roche Integra AMP buffer 37°C
U/I 206 Roche Integra AMP buffer 30°C
U/I 169 Roche Integra AMP buffer 25°C
U/l 256 AMP optimised to IFCC 37°C
U/I 199 AMP optimised to IFCC 30°C
U/I 164 AMP optimised to IFCC 25°C
ALT (GPT) U/l 138 Tris buffer without P5P 37°C
U/I 102 Tris buffer without P5P 30°C
U/I 78 Tris buffer without P5P 25°C
Amylase Pancreatic U/I 256 Roche EPS Liquid 37°C
Amylase Total U/I 277 Roche liquid stable pNPG7 37°C
AST (GOT) U/l 142 Tris buffer without P5P 37°C
U/I 96 Tris buffer without P5P 30°C
U/I 68 Tris buffer without P5P 25°C
Bicarbonate mmol/l 18.2 Enzymatic
Bile Acids µmol/l 42.9 Enzymatic Colorimetric
Bilirubin Direct µmol/l 27.7 Dichlorophenyl Diazonium (DPD)
mg/dl 1.62
µmol/l 26.8 Roche JG factored
mg/dl 1.57
Bilirubin Total µmol/l 79.2 Diazo with Dichloroaniline (DCA)
mg/dl 4.63
µmol/l 75.6 Diazo with Sulphanilic Acid
mg/dl 4.42
µmol/l 76.6 Dichlorophenyl Diazonium (DPD)
mg/dl 4.48
µmol/l 77.2 Diazonium ion
mg/dl 4.52
Calcium mmol/l 3.24 Cresolphthalein complexone
mg/dl 13.0
mmol/l 3.22 Arsenazo III
mg/dl 12.9
mmol/l 3.23 NM-BAPTA
mg/dl 12.9
Chloride mmol/l 114 ISE indirect

Page 1 of 3
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Roche Cobas c701 / c702 / c711 Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Cholesterol mmol/l 7.00 Cholesterol Oxidase
mg/dl 270
Cholinesterase U/l 5139 Colorimetric Butyrylthiocholine 37°C
CK Total U/l 487 CK-NAC (IFCC) 37°C
U/I 305 CK-NAC (IFCC) 30°C
U/I 207 CK-NAC (IFCC) 25°C
Creatinine µmol/l 378 Roche Creatinine Plus
mg/dl 4.27
µmol/l 370 Jaffe rate blanked
mg/dl 4.18
µmol/l 398 Jaffe rate blanked comp. (-26 µmol/l)
mg/dl 4.50
gamma-GT U/I 153 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
U/I 121 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C
U/I 94 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C
U/I 180 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 142 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C
U/I 111 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C
Glucose mmol/l 15.5 Hexokinase
mg/dl 279
Iron µmol/l 36.5 Colorimetric without ppt.
µg/dl 204
Lactate mmol/l 5.51 Colorimetric Lactate Oxidase
mg/dl 49.6
LD (LDH) U/l 363 L->P IFCC 37°C
U/I 262 L->P IFCC 30°C
U/I 184 L->P IFCC 25°C
Lipase U/I 53 Roche Colorimetric 37°C
Lithium mmol/l 2.02 Spectrophotometric
mg/dl 1.40
Magnesium mmol/l 1.78 Xylidyl Blue
mg/dl 4.33
mmol/l 1.80 Chlorphosphonazo III
mg/dl 4.37
Phosphate Inorganic mmol/l 2.36 Phosphomolybdate UV
mg/dl 7.32
Potassium mmol/l 6.29 ISE method - indirect
Protein Total g/l 45.7 Biuret reaction end point
g/dl 4.57
Sodium mmol/l 164 ISE method - indirect
TIBC µmol/l 50.3 FE+UIBC(saturation with iron)
µg/dl 281
Triglycerides mmol/l 2.93 Lipase/GPO-PAP no correction
mg/dl 259

Page 2 of 3
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

Roche Cobas c701 / c702 / c711 Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Triglycerides mmol/l 2.91 L/G Kinase EP. no correction
mg/dl 258
Urea mmol/l 19.5 Urease kinetic
mg/dl 117
mmol/l 19.5 BUN
mg/dl 54.7
Uric Acid (Urate) mmol/l 0.548 Uricase peroxidase with ascorbate oxidase
mg/dl 9.21
mmol/l 0.541 Uricase peroxidase no ascorbate oxidase
mg/dl 9.09
mmol/l 0.543 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 9.12

Page 3 of 3
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

RX SERIES® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 30.6 Bromocresol Green
g/dl 3.06
Alkaline Phosphatase U/l 522 Diethanolamine buffer DEA 37°C
U/l 329 AMP optimised to IFCC 37°C
ALT (GPT) U/l 148 Tris buffer without P5P 37°C
Amylase Pancreatic U/I 288 Randox Liquid Ethylidene pNPG7 37°C
Amylase Total U/I 318 Randox Liquid Ethylidene pNPG7 37°C
AST (GOT) U/l 155 Tris buffer without P5P 37°C
Bile Acids µmol/l 44.5 5th Generation Colorimetric
Bilirubin Direct µmol/l 24.9 Diazo with Sulphanilic Acid
mg/dl 1.46
µmol/l 28.0 Oxidation to Biliverdin/Vanadate
mg/dl 1.64
Bilirubin Total µmol/l 81.9 Diazo with Sulphanilic Acid
mg/dl 4.79
µmol/l 83.4 Oxidation to Biliverdin/Vanadate
mg/dl 4.88
Calcium mmol/l 3.29 Arsenazo III
mg/dl 13.2
Cholesterol mmol/l 7.62 Cholesterol Oxidase
mg/dl 294
CK Total U/l 523 CK-NAC substrate start (DGKC) 37°C
U/l 554 CK-NAC (IFCC) 37°C
Creatinine µmol/l 326 Alkaline picrate no deproteinization
mg/dl 3.68
µmol/l 371 Enzymatic UV method
mg/dl 4.19
gamma-GT U/I 185 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
Glucose mmol/l 15.9 Hexokinase
mg/dl 287
mmol/l 16.3 Glucose oxidase
mg/dl 294
Iron µmol/l 39.6 Colorimetric without ppt.
µg/dl 221
Lactate mmol/l 5.40 Colorimetric Lactate Oxidase
mg/dl 48.7
LD (LDH) U/l 751 P->L German methods 37°C
U/l 357 L->P IFCC 37°C
Lipase U/I 80 Randox Colorimetric 37°C

Page 1 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

RX SERIES® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Lithium mmol/l 2.04 Colorimetric
mg/dl 1.42
Magnesium mmol/l 1.79 Xylidyl Blue
mg/dl 4.35
Phosphate Inorganic mmol/l 2.47 Phosphomolybdate UV
mg/dl 7.66
Potassium mmol/l 6.05 Enzymatic
Protein Total g/l 48.4 Biuret reaction end point
g/dl 4.84
Sodium mmol/l 158 Enzymatic
TIBC µmol/l 50.2 Direct Colorimetric
µg/dl 281
Triglycerides mmol/l 2.93 Lipase/GPO-PAP no correction
mg/dl 259
Urea mmol/l 20.4 Urease kinetic
mg/dl 123
mmol/l 20.4 BUN
mg/dl 57.3
Uric Acid (Urate) mmol/l 0.592 Uricase peroxidase no ascorbate oxidase
mg/dl 9.95
mmol/l 0.589 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 9.90

Page 2 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

SIEMENS ATELLICA / ADVIA 1200/1650/1800/2400® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 29.1 Bromocresol Green
g/dl 2.91
g/l 27.0 Bromocresol Purple
g/dl 2.70
Alkaline Phosphatase U/l 293 AMP optimised to IFCC 37°C
ALT (GPT) U/l 156 Tris buffer without P5P 37°C
Amylase Pancreatic U/I 259 Immunoinhibition EPS substrate 37°C
Amylase Total U/I 295 Siemens - blocked pNPG7 37°C
AST (GOT) U/l 153 Tris buffer without P5P 37°C
Bicarbonate mmol/l 19.0 Enzymatic
Bile Acids µmol/l 47.3 Enzymatic Colorimetric
Bilirubin Direct µmol/l 28.2 Oxidation to Biliverdin/Vanadate
mg/dl 1.65
Bilirubin Total µmol/l 92.8 Oxidation to Biliverdin/Vanadate
mg/dl 5.43
Calcium mmol/l 3.32 Cresolphthalein complexone
mg/dl 13.3
mmol/l 3.15 Arsenazo III
mg/dl 12.6
Chloride mmol/l 117 ISE indirect
Cholesterol mmol/l 7.20 Cholesterol Oxidase
mg/dl 278
Cholinesterase U/l 5825 Colorimetric Butyrylthiocholine 37°C
CK Total U/l 519 CK-NAC (IFCC) 37°C
Creatinine µmol/l 364 Alkaline picrate no deproteinization
mg/dl 4.11
µmol/l 357 Enzymatic UV method
mg/dl 4.04
µmol/l 362 Jaffe rate blanked
mg/dl 4.09
µmol/l 385 Jaffe rate blanked comp. (-26 µmol/l)
mg/dl 4.35
gamma-GT U/I 181 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
Glucose mmol/l 15.1 Hexokinase
mg/dl 271
mmol/l 15.2 Glucose oxidase
mg/dl 274
Iron µmol/l 38.0 Colorimetric without ppt.
µg/dl 212

Page 1 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

SIEMENS ATELLICA / ADVIA 1200/1650/1800/2400® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Lactate mmol/l 5.50 Colorimetric Lactate Oxidase
mg/dl 49.6
LD (LDH) U/l 707 P->L German methods 37°C
U/l 370 L->P IFCC 37°C
Lipase U/I 77 Other Colorimetric 37°C
Lithium mmol/l 2.04 Spectrophotometric
mg/dl 1.42
Magnesium mmol/l 1.81 Xylidyl Blue
mg/dl 4.40
Phosphate Inorganic mmol/l 2.42 Phosphomolybdate UV
mg/dl 7.50
Potassium mmol/l 6.29 ISE method - indirect
Protein Total g/l 46.5 Biuret reaction end point
g/dl 4.65
Sodium mmol/l 163 ISE method - indirect
TIBC µmol/l 48.0 FE+UIBC(saturation with iron)
µg/dl 268
µmol/l 46.3 Direct Colorimetric
µg/dl 259
Triglycerides mmol/l 3.00 Lipase/GPO-PAP no correction
mg/dl 266
Urea mmol/l 20.2 Urease kinetic
mg/dl 121
mmol/l 20.2 BUN
mg/dl 56.7
Uric Acid (Urate) mmol/l 0.567 Uricase peroxidase no ascorbate oxidase
mg/dl 9.53
mmol/l 0.577 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 9.69

Page 2 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

SIEMENS DIMENSION EXL® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 27.3 Bromocresol Purple
g/dl 2.73
Alkaline Phosphatase U/l 303 Siemens Dimension AMP buffer 37°C
U/l 304 AMP optimised to IFCC 37°C
ALT (GPT) U/l 152 Tris buffer with P5P 37°C
U/l 153 Siemens Dade Standard Non IFCC Correlated 37°C
Amylase Total U/I 353 Siemens 2-chloro-pNPG3 37°C
AST (GOT) U/l 177 Tris buffer with P5P 37°C
U/l 177 Siemens Dade Standard Non IFCC Correlated 37°C
Bilirubin Direct µmol/l 15.6 Diazo with Sulphanilic Acid
mg/dl 0.913
Bilirubin Total µmol/l 83.3 Diazo with Sulphanilic Acid
mg/dl 4.87
Calcium mmol/l 3.21 Cresolphthalein complexone
mg/dl 12.9
Chloride mmol/l 116 ISE indirect
Cholesterol mmol/l 6.73 Dimension-Siemens reagents
mg/dl 260
CK Total U/l 486 CK-NAC (IFCC) 37°C
Creatinine µmol/l 380 Alkaline picrate no deproteinization
mg/dl 4.30
gamma-GT U/I 185 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 214 Siemens Dimension (non IFCC) 37°C
Glucose mmol/l 15.6 Hexokinase
mg/dl 281
Iron µmol/l 35.9 Colorimetric without ppt.
µg/dl 201
Lactate mmol/l 5.65 UV LDH
mg/dl 50.9
LD (LDH) U/l 359 Siemens Dimension L-P Non IFCC 37°C
U/l 351 L->P IFCC 37°C
Lipase U/I 237 Colorimetric Siemens Dimension (LIPL Kit) 37°C
Magnesium mmol/l 1.74 Methylthymol blue
mg/dl 4.23
Phosphate Inorganic mmol/l 2.45 Phosphomolybdate UV
mg/dl 7.60
Potassium mmol/l 6.22 ISE method - indirect
Protein Total g/l 47.3 Biuret reaction end point
g/dl 4.73

Page 1 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

SIEMENS DIMENSION EXL® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Sodium mmol/l 162 ISE method - indirect
TIBC µmol/l 45.9 FE+UIBC(saturation with iron)
µg/dl 257
Triglycerides mmol/l 2.92 Lipase/GPO-PAP no correction
mg/dl 258
mmol/l 2.89 L/G Kinase EP. no correction
mg/dl 256
Urea mmol/l 20.2 Urease kinetic
mg/dl 121
mmol/l 20.2 BUN
mg/dl 56.7
Uric Acid (Urate) mmol/l 0.562 Uricase peroxidase no ascorbate oxidase
mg/dl 9.44
mmol/l 0.559 Spectrophotometric at 280-290
mg/dl 9.39

Page 2 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

SIEMENS DIMENSION RxL/Max/Xpand® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 27.5 Bromocresol Purple
g/dl 2.75
Alkaline Phosphatase U/l 301 Siemens Dimension AMP buffer 37°C
U/l 294 AMP optimised to IFCC 37°C
ALT (GPT) U/l 153 Tris buffer with P5P 37°C
U/l 151 Siemens Dade Standard Non IFCC Correlated 37°C
Amylase Total U/I 351 Siemens 2-chloro-pNPG3 37°C
AST (GOT) U/l 174 Tris buffer with P5P 37°C
U/l 177 Siemens Dade Standard Non IFCC Correlated 37°C
Bilirubin Direct µmol/l 15.5 Diazo with Sulphanilic Acid
mg/dl 0.907
Bilirubin Total µmol/l 81.7 Diazo with Sulphanilic Acid
mg/dl 4.78
Calcium mmol/l 3.22 Cresolphthalein complexone
mg/dl 12.9
Chloride mmol/l 117 ISE indirect
Cholesterol mmol/l 6.80 Dimension-Siemens reagents
mg/dl 262
CK Total U/l 491 CK-NAC (IFCC) 37°C
Creatinine µmol/l 373 Alkaline picrate no deproteinization
mg/dl 4.21
µmol/l 374 Enzymatic UV method
mg/dl 4.23
gamma-GT U/I 214 Siemens Dimension (non IFCC) 37°C
Glucose mmol/l 15.6 Hexokinase
mg/dl 282
Iron µmol/l 36.1 Colorimetric without ppt.
µg/dl 202
LD (LDH) U/l 354 Siemens Dimension L-P Non IFCC 37°C
U/l 348 L->P IFCC 37°C
Lipase U/I 237 Colorimetric Siemens Dimension (LIPL Kit) 37°C
Magnesium mmol/l 1.81 Methylthymol blue
mg/dl 4.40
Phosphate Inorganic mmol/l 2.41 Phosphomolybdate enzymatic
mg/dl 7.47
mmol/l 2.45 Phosphomolybdate UV
mg/dl 7.60
Potassium mmol/l 6.24 ISE method - indirect
Protein Total g/l 46.4 Biuret reaction end point
g/dl 4.64

Page 1 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

SIEMENS DIMENSION RxL/Max/Xpand® Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Sodium mmol/l 162 ISE method - indirect
Triglycerides mmol/l 2.93 Lipase/GPO-PAP no correction
mg/dl 259
mmol/l 2.91 Lipase/Glycerol Dehydrogenase
mg/dl 258
Urea mmol/l 20.5 Urease end point
mg/dl 123
mmol/l 20.0 Urease kinetic
mg/dl 120
mmol/l 20.0 BUN
mg/dl 56.1
Uric Acid (Urate) mmol/l 0.570 Uricase peroxidase no ascorbate oxidase
mg/dl 9.58
mmol/l 0.556 Spectrophotometric at 280-290
mg/dl 9.34

Page 2 of 2
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A

CALIBRATION SERUM LEVEL 3 (CAL 3)

URIT 8000 Series Lot No. 1024UE Cat. No. CAL2351
Size 20 x 5ml Expiry 2020-12-28
Analyte unit Target methods
Albumin g/l 30.0 Bromocresol Green
g/dl 3.00
Alkaline Phosphatase U/l 467 Diethanolamine buffer DEA 37°C
U/I 364 Diethanolamine buffer DEA 30°C
U/I 298 Diethanolamine buffer DEA 25°C
U/l 335 AMP optimised to IFCC 37°C
U/I 261 AMP optimised to IFCC 30°C
U/I 214 AMP optimised to IFCC 25°C
ALT (GPT) U/l 138 Tris buffer without P5P 37°C
U/I 102 Tris buffer without P5P 30°C
U/I 78 Tris buffer without P5P 25°C
AST (GOT) U/l 139 Tris buffer without P5P 37°C
U/I 94 Tris buffer without P5P 30°C
U/I 66 Tris buffer without P5P 25°C
Bilirubin Direct µmol/l 28.4 Dichlorophenyl Diazonium (DPD)
mg/dl 1.66
Bilirubin Total µmol/l 76.9 Dichlorophenyl Diazonium (DPD)
mg/dl 4.50
Calcium mmol/l 3.10 Arsenazo III
mg/dl 12.4
Cholesterol mmol/l 7.43 Cholesterol Oxidase
mg/dl 287
CK Total U/l 522 CK-NAC (IFCC) 37°C
U/I 327 CK-NAC (IFCC) 30°C
U/I 222 CK-NAC (IFCC) 25°C
Creatinine µmol/l 365 Alkaline picrate no deproteinization
mg/dl 4.13
Glucose mmol/l 15.4 Glucose oxidase
mg/dl 278
Magnesium mmol/l 1.72 Xylidyl Blue
mg/dl 4.18
Protein Total g/l 49.1 Biuret reaction end point
g/dl 4.91
Triglycerides mmol/l 2.92 Lipase/GPO-PAP no correction
mg/dl 258
Uric Acid (Urate) mmol/l 0.510 Uricase peroxidase no ascorbate oxidase
mg/dl 8.57

Page 1 of 1
___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com