Abstract

TRUJILLO ALFONSO, Maydelin et al. Validation of the Ultra Micro Elisa for certification of human placent as a source of pharmaceuticals and cosmetics. Rev Cubana Farm [online]. 2014, vol.48, n.2, pp.285-295. ISSN 0034-7515.

Introduction: the Viral Control Laboratory of the Placenta Derivatives Production Plant certifies the human placenta as pharmaceutical and cosmetic raw material by means of the microultra analytic system. Objective: to validate the Ultra Micro System for determination of hepatitis B surface antigen, antibodies to Hepatitis C Virus, and Immunodeficiency Human Virus Type 1 and 2 in umbilical cord serum samples. Methods: the qualification of the operation and the validation of the analytic performance of the UMELISA HBsAg Plus system, UMELISA HCV and UMELISA HIV 1+2 Recombinant using the Hepanostika HBsAg Unite-Form II, Hepanostika Ultra HCV and Vironostika HIV-unite-Form II Ag/Ab as reference systems. Results: the qualification of the operation for the three analytic techniques was satisfactory. The diagnostic and analytic specificities were 100 %; as well as the agreement with the reference techniques. The variation coefficient was lower than 10 % during the inter-assay precision study, below 20 % intra-assay and the robustness of the techniques was shown to manage small changes in the incubation temperature. Conclusions: the ELISA Ultra Micro Systems used as quality control methods of the human placenta were specific, precise and robust under the tested conditions, so they can be safely and reliably used.

Keywords : human placenta; diagnosticians; ELISA; validation; quality control.

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