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435UE

435UE
435UE

RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY

Tel:Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912

Email Email: applications@https://www.wendangku.net/doc/a718549543.html, : applications@https://www.wendangku.net/doc/a718549543.html, : applications@https://www.wendangku.net/doc/a718549543.html, Website: https://www.wendangku.net/doc/a718549543.html, abc

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A CATALOGUE NO.CATALOGUE NO. CAL 2351 Calibration Serum Level 3 (CAL 3) DESCRIPTION Calibration Serum. 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 (HIV1, 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 AN

D 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 +25°C, 7 days at +4°C and 1 month 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 +20 to +25°C, 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 Cat No. CAL2351 20 x 5ml Level 3 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 (25-30μl) 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 +25°C, 2 days at +4°C and 1 month 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 +25°C before measurement. Bilirubin in the serum is light sensitive and it is recommended that the serum be stored in the dark. Stored in the dark it is stable for 1 day at +4°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. 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 Support, Northern Ireland, tel: (028) 9442 2413 or email Technical.Support@https://www.wendangku.net/doc/a718549543.html,

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 Revised 09 Feb ‘10 ne

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