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ACCUCARE®
BOVINE NORMAL CONTROL SERA |
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CHARACTERSTICS Bovine multi sera are lyophillised control sera based on bovine serum. Multi sera can be supplied as an assayed serum for control accuracy or as precision serum for control of reproducibility. Constituent concentration are in the low, normal and elevated ranges. ASSAYED CONTROL SERUM Each batch of assayed serum is submitted to approximately 1200 laboratories and the values are assigned from a consensus mean. With each batch a control range is provided for individual parameters and each parameter method and when available a value for automated analysers. The control range is equivalent to the assigned mean + 2 S.D. PRECISION CONTROL SERUM Each batch of precision control serum is submitted to selected laboratories and values are assigned from a consensus of results obtained by these laboratories PREPARATION Multi sera is sealed under vacuum. Open the vial carefully, avoiding any loss of material and reconstitute in the appropriate accurately measured volume of freshly distilled water at +20 to +25°C, Replace the rubber stopper, close vial and leave to stand for 30 minutes out of bright light before use. Ensure that contents are completely dissolved by swirling gently. After 30 minutes invert vial to ensure that all traces of dry material are dissolved. Do not shake the vial. The serum should only be reconstituted using this procedure. |
STABILITY The serum is stable upto the expiry date when store at a constant temperature 2-8°C. The expiry date is illustrated on the side of each pack. Once reconstituted the components of the serum are stable for 24 hours at +25°C, 7 days at 2-8°C, or at least 1 month when frozen once at -20°C. NOTES 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. For Total & Prostatic Acid Phosphatase the material should be stabilized by adding 1 drop (25-30 ml) of 0.7 M Acetic acid solution to 1 ml of serum. After stabilization the material is stable for at least 2 hours at +25°C, at least 2 days at 2-8°C and atleast 1 month at when frozen at -20°C. 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 at least 8 hours at 2-8°C. Do not store at +15°C - 25°C. do not freeze. Creatinine Kinase is the least stable of the enzymes and assays should be completed as soon as possible. The enzyme is stable in the serum for 12 hours at 2-8°C. The level of Creatinine Kinase obtained can also depend on the temperature of the distilled water used for reconstitution. We recommend water at +20-+25°C. Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components. SAFETY This control is manufactured from bovine serum. Human additives which include prostatic acid Phosphatase and prostrate specific antigen have been tested at donor level and found to be non reactive for HBsAg, HIV and HCV antibodies. However as no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as through capable of transmitting infectious disease. For IN VITRO diagnostics use only. |
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Lab
Care Diagnostics (India) Pvt. Ltd. 16-A, 'A' Wing , 1st Floor Sita Estate Mahul RoadAziz Baug, Chembur Mumbai 400 074. India Phone: 00 91 22 2554 2109/ 00 91 22 2554 1558 Fax: 00 91 22 2554 3541 E-mail : accucare@labcarediagnostics.com |