BIOLABO

www.biolabo.fr
MANUFACTURER:
MULTICALIBRATOR
BIOLABO SAS, M u l t i p a r a me t r i c c a l ib r a t o r
Les Hautes Rives For clinical biochemistry analysis
02160, Maizy, France
REF 95015 R1 10 x 5 mL R2 1 x 60 mL
REF 95115 R1 5 x 5 mL R2 1 x 30 mL

IVD
|
TECHNICAL SUPPORT AND ORDERS
Tel: (33) 03 23 25 15 50 Made in France
[email protected]
I: corresponds to significant modifications
Latest revision : www.biolabo.fr

I INTENTED USE I SAFETY CAUTIONS (1) (2)

Calibrator multicomponent (CC). Designated for professional use in  Refer to current Safety Data Sheet available on request or on
laboratory with manual or automated procedure using reagents listed in www.biolabo.fr
the batch specific table of values.  Verify the integrity of the contents before use.
 All specimens or reagents of biological origin should be handled as
I GENERALITIES potentially infectious. Respect legislation in force in the country.
 However, no test method can offer complete assurance that infectious
MULTICALIBRATOR is suitable for clinical chemistry analysis as agents are absent. All specimens or reagents from biological origin should
follows: be handled as potentially infectious, in accordance with good laboratory
Enzymes: ALT (GPT), AST (GOT), Amylase, CK NAC, practices using appropriate precautions.
Gamma-GT, Alkaline Phosphatase (ALP), LDH.  Waste disposal: Respect legislation in force in the country.
Electrolytes: Calcium, Chloride, Iron, Magnesium, Inorganic Any serious incident that has occurred in connection with the device is
notified to the manufacturer and the competent authority of the Member State
Phosphorus, Sodium, Kalium
in which the user and/or patient is based.
Proteins: Total protein, Albumin
Lipids: Total Cholesterol, Triglycerides I REAGENTS PREPARATION
Substrates: Bilirubin, Creatinine, Glucose, Urea, Uric acid.  Open the vial R1carefully and add exactly 5 mL of diluent (vial R2).
Wait for 15 minutes at room temperature. Gently agitate before use (avoid
Added enzymes are from animal origin. the formation of foam).
 For CK, diluent with a temperature below 10°C should be used.
QUALITY CONTROL  For ALP, once reconstitute, let stand 1 hour at room temperature.
 REF 95010, REF 95110 EXATROL-N Level I  CK and bilirubin are light-sensitive.
 REF 95011, REF 95111 EXATROL-P Level II WARNING: Do not shake. Store away from light.
 External quality control program
 Control with frequency stated in technical sheet of the reagent in use. STABILITY AND STORAGE
Stored away from light, well caped in the original vial at 2-8°C,
I REAGENTS control is stable when stored and used as described in the insert:
R1 Multicalibrator Multiparametric Calibrator Unopened: Until expiry date stated on the label of the kit.
Freeze dried bovine serum Once opened:
R2 Multicalibrator Diluent  R1 must be reconstituted immediately,
Demineralized water, preservative  R2 is stable until expiry date stated on the label.
According to 1272/2008 regulation, these reagents are not classified as dangerous Once reconstituted, values are usually stable for:
 8 hours at 15-25°C or 7 days at 2-8°C.
CALIBRATION VALUES (3)  30 days at –20°C. Aliquot and freeze once only.
Discard any reconstituted calibrator if cloudy.
Refer to the Batch-Specific Table of values.
 Values were determined against International Standards (SRM : Alkaline phosphatase: increase 1 to 2 % / 24 hours at 2-8°C.
Standard Reference Material). Increase of 1 % / hour at 15-25°C.
 Each value is the median of values obtained for each analyte on LDH, CK, Bilirubin, Acid phosphatase:
several analysers. Decrease 1 to 2 % / week at-20°C.
 Values in brackets indicate the composed uncertainty taking into Acid phosphatase, LDH: decrease 1 to 2 % / 24 hours at 2-8°C.
account all the sources of error which may influence the result. Acid Phosphatase: decrease 1 % / hour at 15-25°C.
Phosphorus, Triglycerides: increase 1 to 2 % / 24 hours at 2-8°C.
I PERFORMANCES
 BIOLABO reagents and calibrators are traceable to a reference PROCEDURE
method or material, using statistical techniques and metrologically Run in accordance with the IFU of the reagent used.
controlled instrument (see batch specific table of values).
 Each value is calculated as the mean of values obtained for each LIMITES
analyte on several analysers. Factors which may influence results are bacterial contamination, precision of
 Values may vary from one lot to another, but are clearly indicated for the volume dispensed during reconstitution, respect of automated instrument
each batch. procedure, temperature control...

MATERIAL REQUIRED BUT NOT PROVIDED REFERENCES

1. Basic medical analysis laboratory equipment (1) Occupational Safety and Health Standards ; Bloodborne pathogens
2. Spectrophotometer or Biochemistry Clinical Analyzer (29CFR1910.1030) Federal Register July 1, (1998) ; 6, p.267-280
(2) Directive du conseil de l’Europe (90/679/CEE) J. O. de la communauté
européenne n°L374 du 31.12.1990, p.1-12
(3) A. VASSAULT et Al., Ann. Biol. clin., 1986, 44, 686-745
(4) BIOLABO Standard Operating Procedures

IVD H2O

Manufacturer Expiry date In vitro diagnostic Storage temperature Dematerialized water Biological risk

REF LOT 
Product Reference See Insert Batch number Store away from light Sufficient for Dilute with

CAL_DT_220_IFU_95015-95115_EN_V20220818