Abstract

SUAREZ BATISTA, Lilia et al. Cuban anti-A Hemo-CIM hemoclassifier monoclonal reagent: Stability study. Rev Cubana Hematol Inmunol Hemoter [online]. 1999, vol.15, n.2, pp. 132-136. ISSN 1561-2996.

The stability studies of the reactives obtained from monoclonal antibodies of murine origin are essential to attain adequate results in their practical application and are also an indispensable requirement for good production practices, which allow to establish the life of these products adequately. The hemagglutination methods were used to measure the biological activity of the anti-A Hemo-CIM product expressed in power, avidity and intesity against a set of erythrocytes of group A₁ and A₂B that was included due to its low antigen A expression to show more effectively any deterioration suffered by the reagent. It was determined that the useful life of the hemoclassifier produced at the Molecular Immunology Center is of 2 years and the product may be stored at a temperatura between 2 and 8 °C. Besides, the batches that were placed on the counter every day during 5 hours at 21 EC starting from month 0 and at 8,14 and 22 months after its production, simulating the conditions under which the users maintain these reagents, kept the quality required for their use, demostrating that one can work with this product under such conditions

Keywords : REAGEN KITS, DIAGNOSTIC; ABO BLOOD-GROUP SYSTEM [classification]; DRUG STABILITY; DRUG EXPIRATION; DRUG QUALITY; ANTIBODIES, MONOCLONAL.

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