CALIBRATION SERUM LEVEL 3 (CAL 3)
CAT. NO. CAL 2351 LOT NO. 1315UE
SIZE: 20 x 5ml EXPIRY: 2025-05-28
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 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 is stable for 3 days at 2 - 8°C and 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 for1 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.
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CAL2351 - Lot No. 1315UE
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. 16 May ’23 me
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