BIOLABO

www.biolabo.fr
MANUFACTURER:
BIOLABO MULTICALIBRATOR
BIOLABO SAS,
Les Hautes Rives
Multiparametric calibrator
02160, Maizy, France For clinical biochemistry analysis

REF 95015 R1 10 x 5 mL R2 1 x 60 mL

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TECHNICAL SUPPORT AND ORDERS
Tel : (33) 03 23 25 15 50
IVD IN VITRO DIAGNOSTIC
Fax: (33) 03 23 256 256

PRINCIPLE AND INTENTED USE STABILITY AND STORAGE

BIOLABO MULTICALIBRATOR is a calibrator for clinical chemistry analysis Store at 2 - 8°C, well recap in the original vial and away from light.
(substrates, electrolytes, lipids, enzymes and proteins) suitable for manual • Unopened, lyophilised serum (vial R1) and diluent (vial R2) are stable
procedure or automated instruments. until expiry date stated on the label stated on the label of the kit , when
stored and used as described in the insert.
REAGENTS
• Reconstituted serum: Transfer the requested quantity; tightly cap the vial
flacon R1 and store at 2-8°C. Under these conditions, analytes are usually stable
Lyophilised bovine serum
for:
flacon R2 8 hours at 15-25°C.
Diluent
7 days at 2-8°C.
MULTICALIBRATOR analytes are as follows: 30 days at –20°C. Aliquote and freeze once only.
Enzymes: ALT (GPT), AST (GOT), Amylase, Gamma-GT, Alkaline Shorter stabilities in reconstituted serum applies to:
Phosphatase, LDH. Alkaline phosphatase: increase 1 to 2 % / 24 hours at 2-8°C.
Electrolytes: increase of 1 % / hour at 15-25°C.
Calcium, Chloride, Iron, Magnesium, Inorganic Phosphorus,
Sodium, Kalium LDH, CK, Bilirubin, Acid phosphatase:
decrease 1 to 2 % / week at-20°C.
Proteins: Total protein, Albumin
Acid phosphatase, LDH: decrease 1 to 2 % / 24 hours at 2-8°C.
Lipids: Total Cholesterol, Triglycerides Acid Phosphatase: decrease 1 % / hour at 15-25°C.
Substrates: Bilirubin, Creatinine, Glucose, Urea, Uric acid. Phosphorus , Triglycerides: increase 1 to 2 % / 24 hours at 2-8°C.
Discard reconstituted serum if cloudy or if absorbance of diluted serum
Added enzymes are from animal origin.
(1+19) in saline solution measured at 600 nm > 0.060.
The concentrations/activities of each analyte are batch-specific.
Don’t use reconstituted serum after expiry date stated on the label of the
SAFETY CAUTIONS (1) (2) vial. Discard serum if cloudy or if the absobance of diluted serum (1+19) in
saline measured at 600 nm is > 0.060.
BIOLABO reagents are designated for professional, in vitro diagnostic use.
• This serum and all specimens should be handled as potentially infectious,
PROCEDURE
in accordance with good laboratory practices using appropriate
precautions. Respect legislation in force in the country. This multicalibrator should be used with reagents or kits referring to the
• Verify the integrity of the contents before use. same method in accordance with technical data sheet of the reagent in use.
• Use adequate protections (overall, gloves, glasses). BIOLABO MULTICALIBRATOR has to be handled as patient serum.
• Do not pipette by mouth.
• In the event of exposure the directive of the responsible health authorities QUALITY CONTROL
should be followed. BIOLABO EXATROL-N Level I REF 95010,
• Material Safety Data Sheet is available upon request. BIOLABO EXATROL-P Level II REF 95011,
Waste disposal: Respect legislation in force in the country. or other assayed control sera referring to the same method.
It is recommended to:
REAGENTS PREPARATION Participate to external quality control program.
1- Carefully open one bottle of vial R1 avoiding the loss of lyophilisate. Control with frequency stated in technical sheet of the reagent in use.
2- Pipette into vial R1 exactly 5 mL of diluent (vial R2). Validate Calibration values when using other reagents that BIOLABO
3- Carefully close the bottle. reagents.
4- Let stand at room temperature and away from light for 15-30 minutes.
5- Dissolve the contents by occasional gentle swirling (avoiding the CALIBRATION VALUES AND UNCERTAINTY (3)
formation of foam). Refer to indicated values. Calibration values were determinate in several
6- Lyophilisate should be completely dissolved before use. independent laboratories or in our laboratory using:
WARNING: Do not shake. Store away from light. • BIOLABO procedure and calibrator referring to international standards
(SRM: Standard Reference Material).
Notes:
• Recommended and validated statistical techniques.
• For CK determination, diluent with a temperature below 10°C should be
used. • Metrologically controlled instrument.
• For ALP determination, allow the reconstituted serum to stand for one Assigned value is the median of values obtained for each analyte.
hour at room temperature. Values in brackets indicate the composed uncertainty taking into account all
• CK and bilirubin are light-sensitive. the sources of error which may influence the result.

REFERENCES
MATERIAL REQUIRED BUT NOT PROVIDED
(1) Occupational Safety and Health Standards ; Bloodborne pathogens
1. Basic medical analysis laboratory equipment. (29CFR1910.1030) Federal Register July 1, (1998) ; 6, p.267-280
2. Reagents Kits and control sera. (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
INTERFERENCES (3) Data on file at BIOLABO Diagnostics
Factors which may influence results are bacterial contamination, precision
of the volume dispensed during reconstitution, respect of automated
instrument procedure, temperature control...

IVD REF LOT →

Manufacturer Use by In vitro diagnostic Temperature limitation Catalogue number See insert Batch number Store away from light sufficient for dilute with

Made in France Latest Revision : www.biolabo.fr Revision : 28/07/2011