CALIBRATION SERUM LEVEL 2 (CAL 2)

CAT. NO. CAL 2350 GTIN: 05055273200959 SIZE: 20 x 5ml

LOT NO. 1590UN EXPIRY: 2025-07-28

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 5ml 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 2
Cat No. CAL 2350 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 (25µl - 30µl) of 0.7M Acetic
acid solution to 1ml 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 is stable for 2 days at 2 - 8°C and levels in the reconstituted serum will rise over the stability
period. It is recommended that the reconstituted serum is 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.
GLDH is stable for 1 day at 2 - 8°C.
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.
Due to the zinc content in some batches of rubber stoppers, the QC material should be aliquoted into suitable
containers without rubber stoppers and stored at +2°C to +8°C to ensure stable zinc levels throughout the stability
period.

PAGE 1 OF 2
 CAL2350 - Lot No. 1590UN

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 Method 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

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

Rev. 05 Jun ’23 me

PAGE 2 OF 2
A
CALIBRATION SERUM LEVEL 2 (CAL 2)
METHOD Lot. No. 1590UN Cat. No. CAL2350
Size 20 x 5ml Expiry 2025-07-28
Analyte unit Target methods
a-HBDH U/I 221 Oxobutyrate < 10 mmol/l 37°C
U/I 167 Oxobutyrate < 10 mmol/l 30°C
U/I 125 Oxobutyrate < 10 mmol/l 25°C
Albumin g/l 41.7 Bromocresol Green
g/dl 4.17
g/l 42.0 Bromocresol Purple
g/dl 4.20
g/l 40.1 Turbidimetric Assays
g/dl 4.01
Alkaline Phosphatase U/l 294 Diethanolamine buffer DEA 37°C
U/I 229 Diethanolamine buffer DEA 30°C
U/I 188 Diethanolamine buffer DEA 25°C
U/l 193 AMP optimised to IFCC 37°C
U/I 150 AMP optimised to IFCC 30°C
U/I 123 AMP optimised to IFCC 25°C
U/l 178 AMP non-optimised 37°C
U/I 139 AMP non-optimised 30°C
U/I 114 AMP non-optimised 25°C
ALT (GPT) U/l 40 Colorimetric 37°C
U/I 30 Colorimetric 30°C
U/I 23 Colorimetric 25°C
U/l 43 Tris buffer with P5P 37°C
U/I 32 Tris buffer with P5P 30°C
U/I 24 Tris buffer with P5P 25°C
U/l 39 Tris buffer without P5P 37°C
U/I 29 Tris buffer without P5P 30°C
U/I 22 Tris buffer without P5P 25°C
U/l 45 Tris buffer with P5P NVKC 37°C
U/I 33 Tris buffer with P5P NVKC 30°C
U/I 25 Tris buffer with P5P NVKC 25°C
Amylase Pancreatic U/I 65 Immunoinhibition EPS substrate 37°C
U/I 64 Roche EPS Liquid 37°C
U/I 80 Randox Liquid Ethylidene pNPG7 37°C
Amylase Total U/I 94 pNP Maltotrioside substrates 37°C
U/I 97 Siemens - blocked pNPG7 37°C
U/I 75 Randox Lyo. Ethylidene pNPG7 37°C
U/I 96 Randox Liquid Ethylidene pNPG7 37°C
U/I 84 Beckman Synchron CX4/CX5/CX7 37°C
U/I 90 Roche Integra 2-chloro-pNPG7 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 2 (CAL 2)
METHOD Lot. No. 1590UN Cat. No. CAL2350
Size 20 x 5ml Expiry 2025-07-28
Analyte unit Target methods
Amylase Total U/I 90 Other Roche 2-chloro-pNPG7 37°C
U/I 89 Roche liquid stable pNPG7 37°C
U/I 94 Siemens 2-chloro-pNPG3 37°C
U/I 93 Beckman Coulter - blocked pNPG7 37°C
U/I 93 Abbott Architect / Alinity cal factor 3431 37°C
U/I 81 Beckman CNPG3 (Extinction Coeff) 37°C
U/I 91 Abbott Alinity Amylase 2 37°C
U/I 93 Abbott Architect 37°C
AST (GOT) U/l 40 Colorimetric 37°C
U/I 27 Colorimetric 30°C
U/I 19 Colorimetric 25°C
U/l 59 Tris buffer with P5P 37°C
U/I 40 Tris buffer with P5P 30°C
U/I 28 Tris buffer with P5P 25°C
U/l 40 Tris buffer without P5P 37°C
U/I 27 Tris buffer without P5P 30°C
U/I 19 Tris buffer without P5P 25°C
U/l 55 Tris buffer with P5P NVKC 37°C
U/I 37 Tris buffer with P5P NVKC 30°C
U/I 26 Tris buffer with P5P NVKC 25°C
Bicarbonate mmol/l 11.9 Colorimetric
mmol/l 12.2 Differential rate pH change
mmol/l 12.2 Enzymatic
mmol/l 12.8 Ion selective electrode
Bile Acids µmol/l 23.8 4th Generation Colorimetric
µmol/l 25.2 5th Generation Colorimetric
Bilirubin Direct µmol/l 18.9 Dichlorophenyl Diazonium (DPD)
mg/dl 1.11
µmol/l 18.4 Diazo with Sulphanilic Acid
mg/dl 1.07
µmol/l 19.0 Diazo with Dichloroaniline (DCA)
mg/dl 1.11
µmol/l 15.9 Oxidation to Biliverdin/Vanadate
mg/dl 0.932
µmol/l 17.7 Modified Jendrassik
mg/dl 1.04
Bilirubin Total µmol/l 25.7 Diazo with Dichloroaniline (DCA)
mg/dl 1.50
µmol/l 26.6 Diazo with Sulphanilic Acid
mg/dl 1.55
µmol/l 24.2 Dichlorophenyl Diazonium (DPD)
mg/dl 1.41
µmol/l 24.7 Diazonium ion
mg/dl 1.44

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 2 (CAL 2)
METHOD Lot. No. 1590UN Cat. No. CAL2350
Size 20 x 5ml Expiry 2025-07-28
Analyte unit Target methods
Bilirubin Total µmol/l 29.1 Oxidation to Biliverdin/Vanadate
mg/dl 1.70
µmol/l 35.4 Modified Jendrassik
mg/dl 2.07
Calcium mmol/l 2.08 Cresolphthalein complexone
mg/dl 8.34
mmol/l 2.03 Ion selective electrode
mg/dl 8.14
mmol/l 2.11 Arsenazo III
mg/dl 8.46
mmol/l 2.09 NM-BAPTA
mg/dl 8.38
Chloride mmol/l 101 Colorimetric
mmol/l 94.2 ISE indirect
mmol/l 95.9 ISE direct
Cholesterol mmol/l 4.14 Cholesterol Oxidase - Abell Kendall
mg/dl 160
mmol/l 4.19 Cholesterol Oxidase - IDMS
mg/dl 162
mmol/l 4.07 Cholesterol Dehydrogenase
mg/dl 157
Cholinesterase U/l 6114 Colorimetric Butyrylthiocholine 37°C
CK Total U/l 205 CK-NAC serum start (DGKC) 37°C
U/I 128 CK-NAC serum start (DGKC) 30°C
U/I 87 CK-NAC serum start (DGKC) 25°C
U/l 215 CK-NAC substrate start (DGKC) 37°C
U/I 135 CK-NAC substrate start (DGKC) 30°C
U/I 91 CK-NAC substrate start (DGKC) 25°C
U/l 204 CK-NAC (IFCC) 37°C
U/I 128 CK-NAC (IFCC) 30°C
U/I 87 CK-NAC (IFCC) 25°C
Copper µmol/l 15.9 Atomic absorption
µg/dl 101
µmol/l 15.6 Colorimetric
µg/dl 99.2
Creatinine µmol/l 127 Alkaline picrate with deproteinization
mg/dl 1.43
µmol/l 130 Alkaline picrate no deproteinization
mg/dl 1.47
µmol/l 133 Enzymatic UV method
mg/dl 1.50
µmol/l 131 Creatinine PAP method
mg/dl 1.48

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 2 (CAL 2)
METHOD Lot. No. 1590UN Cat. No. CAL2350
Size 20 x 5ml Expiry 2025-07-28
Analyte unit Target methods
Creatinine µmol/l 131 Jaffe rate blanked
mg/dl 1.48
µmol/l 157 Jaffe rate blanked comp. (-26 µmol/l)
mg/dl 1.77
µmol/l 145 Jaffe rate blanked compensated (-18 µmol/l)
mg/dl 1.64
µmol/l 127 IDMS traceable
mg/dl 1.43
gamma-GT U/I 49 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
U/I 39 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C
U/I 30 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C
U/I 49 Gamma glutamyl-4-nitroanilide 37°C
U/I 39 Gamma glutamyl-4-nitroanilide 30°C
U/I 30 Gamma glutamyl-4-nitroanilide 25°C
U/I 49 DCL gamma glutamyl-3-carboxy-4-nitroanilide 37°C
U/I 39 DCL gamma glutamyl-3-carboxy-4-nitroanilide 30°C
U/I 30 DCL gamma glutamyl-3-carboxy-4-nitroanilide 25°C
U/I 51 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 40 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C
U/I 31 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C
GLDH U/I 17 Triethanolamine buffer 50 mmol 37°C
U/I 13 Triethanolamine buffer 50 mmol 30°C
U/I 11 Triethanolamine buffer 50 mmol 25°C
Glucose mmol/l 6.22 Glucose dehydrogenase
mg/dl 112
mmol/l 6.30 Hexokinase
mg/dl 114
mmol/l 6.46 Glucose oxidase
mg/dl 116
Iron µmol/l 19.9 Colorimetric with ppt.
µg/dl 111
µmol/l 19.8 Colorimetric without ppt.
µg/dl 111
Lactate mmol/l 1.71 Ion selective electrode
mg/dl 15.4
mmol/l 1.51 Colorimetric Lactate Oxidase
mg/dl 13.6
LD (LDH) U/l 213 L->P 37°C
U/I 154 L->P 30°C
U/I 108 L->P 25°C
U/l 464 P->L Scandinavian & Dutch 37°C
U/I 335 P->L Scandinavian & Dutch 30°C
U/I 235 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 2 (CAL 2)
METHOD Lot. No. 1590UN Cat. No. CAL2350
Size 20 x 5ml Expiry 2025-07-28
Analyte unit Target methods
LD (LDH) U/l 443 P->L German methods 37°C
U/I 320 P->L German methods 30°C
U/I 225 P->L German methods 25°C
U/l 429 P->L SFBC 37°C
U/I 310 P->L SFBC 30°C
U/I 218 P->L SFBC 25°C
U/l 220 L->P IFCC 37°C
U/I 159 L->P IFCC 30°C
U/I 112 L->P IFCC 25°C
Lipase U/I 32 Other Colorimetric 37°C
U/I 33 Roche Colorimetric 37°C
U/I 41 Randox Colorimetric 37°C
Lithium mmol/l 0.956 Ion selective electrode
mg/dl 0.664
mmol/l 0.963 Spectrophotometric
mg/dl 0.669
Magnesium mmol/l 0.884 Arsenazo III
mg/dl 2.15
mmol/l 1.00 Calmagite
mg/dl 2.43
mmol/l 0.920 Xylidyl Blue
mg/dl 2.24
mmol/l 0.900 Methylthymol blue
mg/dl 2.19
mmol/l 0.930 Chlorphosphonazo III
mg/dl 2.26
mmol/l 0.892 Enzymatic
mg/dl 2.17
Osmolality mOsm/kg 297 Calculated
mOsm/kg 303 Freezing point depression
Phosphate Inorganic mmol/l 1.51 Phosphomolybdate enzymatic
mg/dl 4.68
mmol/l 1.50 Phosphomolybdate UV
mg/dl 4.65
Potassium mmol/l 3.94 ISE method - direct
mmol/l 3.98 ISE method - indirect
mmol/l 4.17 Enzymatic
Protein Total g/l 59.0 Biuret reaction end point
g/dl 5.90
g/l 59.1 Biuret reaction kinetic
g/dl 5.91
Sodium mmol/l 140 ISE method - direct

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 2 (CAL 2)
METHOD Lot. No. 1590UN Cat. No. CAL2350
Size 20 x 5ml Expiry 2025-07-28
Analyte unit Target methods
Sodium mmol/l 142 ISE method - indirect
mmol/l 143 Enzymatic
TIBC µmol/l 43.7 Removal of excess free iron
µg/dl 244
µmol/l 43.9 FE+UIBC(saturation with iron)
µg/dl 245
µmol/l 48.0 Direct Colorimetric
µg/dl 268
µmol/l 47.6 Calculated from Transferrin
µg/dl 266
µmol/l 51.8 Randox Direct
µg/dl 290
Triglycerides mmol/l 1.11 Lipase/GPO-PAP no correction
mg/dl 98.2
mmol/l 1.11 Lipase/GPO-PAP 0.11mmol/l correction
mg/dl 98.2
mmol/l 1.10 L/G Kinase EP. no correction
mg/dl 97.4
mmol/l 1.09 L/G kinase EP. 0.11 mmol/l correction
mg/dl 96.5
mmol/l 1.11 Lipase/Glycerol Dehydrogenase
mg/dl 98.2
Urea mmol/l 7.56 Urease end point
mg/dl 45.4
mmol/l 7.57 Urease kinetic
mg/dl 45.5
mmol/l 7.57 BUN
mg/dl 21.2
Uric Acid (Urate) mmol/l 0.339 Uricase catalase 340nm
mg/dl 5.70
mmol/l 0.340 Uricase peroxidase with ascorbate oxidase
mg/dl 5.71
mmol/l 0.342 Uricase peroxidase no ascorbate oxidase
mg/dl 5.75
mmol/l 0.337 Spectrophotometric at 280-290
mg/dl 5.66
mmol/l 0.338 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 5.68
Zinc µmol/l 22.2 Atomic absorption
µg/dl 145
µmol/l 23.0 Colorimetric with deproteinisation
µg/dl 150

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