Validation of serological and molecular methods for the viral certification of the raw material of HEBERTRANS ®

Abstract

Introduction: The selection and development of analytical methods has always been an important issue for testing laboratories. To adopt a method, it is necessary to validate it, since the objective of validation is to test its suitability, as well as the competence of the laboratory to perform a certain test. The Dialyzed Extract of Leukocytes constitutes the fundamental raw material in the manufacture of HEBERTRANS®. For its viral certification, the HIV Ab & Ag serological system (DIA.PRO, Italy), and two molecular systems developed in Cuba are used, based on qualitative polymerase chain reaction (PCR) for virus detection. of hepatitis C and human immunodeficiency type 1, which must be validated to demonstrate that they work with this type of samples. Objective: To validate the systems used in the viral certification of HEBERTRANS®. Methods: Studies of specificity, concordance, detection limit and robustness were performed, with the use of simulated positive and negative Leukocyte Dialyzed Extract samples. Results: The high rates of specificity and robustness, very good concordance with reference systems, as well as detection limits capable of detecting low concentrations of analyte, showed a good performance of the systems with samples of Dialyzed Leukocyte Extract. Conclusions: The results obtained demonstrated the feasibility of using these systems in the certification of the Leukocyte Dialyzed Extract as raw material for HEBERTRANS®.

Keywords

• diagnóstico
• métodos
• vih
• hepatits c
• reacción en cadena de la polimerasa.