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

Authors

Keywords:

diagnosis, methods, HIV, hepatitis C, polymerase chain reaction.

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®.

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Published

2023-05-15

How to Cite

1.
Romero Martínez K, Pérez Guevara MT, Blanco de Armas M, Machado Zaldívar LY, Fleites Vázquez A, Sánchez Diéguez E. Validation of serological and molecular methods for the viral certification of the raw material of HEBERTRANS ®. Rev Cubana Med Milit [Internet]. 2023 May 15 [cited 2024 Dec. 29];52(2):e02302494. Available from: https://revmedmilitar.sld.cu/index.php/mil/article/view/2494

Issue

Vol. 52 No. 2 (2023): April - June

Section

Research Article

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