Revalidation of the positive serological panel intended for the quality control of kits for HIV serological diagnosis

Authors

  • Yasmin Rosa Ribeiro Instituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil Author https://orcid.org/0000-0002-8840-4880
  • José Roberto Niemeyer de Castro Instituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil Author https://orcid.org/0000-0002-2975-9729
  • Helena Cristina Balthazar Guedes Borges Instituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil Author https://orcid.org/0000-0002-8197-4629
  • Danielle Copello Vigo Instituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil Author https://orcid.org/0000-0003-1460-6284
  • Danielle Custódio Deslandes Passo Instituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil Author https://orcid.org/0000-0001-7068-9585
  • Marli Melo da Silva Instituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil Author https://orcid.org/0000-0002-8408-3477
  • Gabriella Pires da Silva Macedo Instituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil Author https://orcid.org/0000-0002-1565-8695

DOI:

https://doi.org/10.22239/2317-269X.01570

Keywords:

HIV; Serological Panel; AIDS

Abstract

Introduction: Kits used in the diagnosis of the human immunodefciency virus (HIV) must meet the requirements of RDC No. 36, of August 26, 2015 for registration with the National Health Surveillance Agency and Law No. 6.360, of September 23 1976 for commercialization in the country. One of the registration steps corresponds to the previous laboratory analysis of the products with the highest risk class (class IV), carried out by the Laboratory of Blood and Blood Products (LSH). In the analysis of the products, serological panels consisting of true positive samples are used as the main tool in the  sensitivity assessment. Objective: To revalidate a true HIV positive serological panel for the evaluation of in vitro HIV diagnostic kits. Method: A  retrospective evaluation and selection of the panel results was performed against the kits that obtained satisfactory results and were received for prior analysis from January 2010 to December 2011. The reactivity of the panel samples in three immunoenzymatic assays (ELISA), in three  chemiluminescence assays (CLIA), in three immunochromatographic assays (rapid tests) and in three western blots was used as revalidation criterion; and reactivity in an enzyme-linked fluorescent enzyme assay (ELFA), in addition to a volume equal to or greater than 1 mL. Results: During the period, 73 kits for in vitro diagnosis of HIV  infection were received for analysis at the LSH, 47 (64.4%) of which were satisfactory, distributed as follows: 43.0% (20/47) ELISA, 34.0% (16/47) immunochromatographic assays, 13.0% (06/47) western blot, 2.0% (01/47) ELFA, 8.0% (04/47) chemiluminescence assays. After the evaluation, 77.0% (34/44) of the units were revalidated, and 23.0% (10/44) were excluded from the panel, as they did not meet the established criteria. Conclusions: The revalidated panel currently consists of 34 units of true positive samples, with consistent results, thus increasing the reliability and safety of the analyses carried out and of the tests marketed in the  country.


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Published

2022-02-28

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Articles

How to Cite

Revalidation of the positive serological panel intended for the quality control of kits for HIV serological diagnosis. (2022). Health Surveillance under Debate: Society, Science & Technology , 10(1), 40-43. https://doi.org/10.22239/2317-269X.01570

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