Revalidation of the serological panel report on the evaluation of Chagas disease diagnostic kits

• Autor(a) principal: Pires da Silva Macedo, Gabriella
• Data de Publicação: 2020
• Outros Autores: da Silva Ribeiro, Álvaro, Coelho Adati, Marisa, Balthazar Guedes Borges, Helena Cristina, Machado Passo, Roberto, Furtado de Mendonça, Valéria, Rosa Ribeiro, Yasmin, Niemeyer de Castro, José Roberto
• Tipo de documento: Artigo
• Idioma: por; eng
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1561
• topic: Chagas Disease; Revalidation; Serological Panel; Trypanosoma cruzi; Diagnosis; Doença de Chagas; Revalidação; Painel Sorológico; Trypanosoma cruzi; Diagnóstico

Introduction: Acute phase of Chagas disease is characterised by the presence of blood parasites while in the chronic phase, parasite titres decrease and antibodies increase.  According to RDC nº 36, of August 26, 2015, diagnostic tests for the disease belong to risk class IV, with mandatory registration with the National Health Surveillance Agency. The performance of these products is assessed in the laboratory analysis prior to registration, against serological panels composed of true positive and negative samples. Objective:  Revalidate the serological panel composed of true positive samples for Chagas disease  used in the analysis of in vitro diagnostic kits for the detection of specific antibodies against Trypanosoma cruzi. Method: Revalidation of the Chagas serological panel by retrospective analysis of results obtained in the methodologies: ELISA, Rapid Test, Immunofluorescence, Agglutination, Hemagglutination and Chemiluminescence, meeting the criteria of: positivity in 02 Rapid Tests; 03 Immunofluorescences; 01 Agglutination Test; 05 ELISAS, 02 Hemagglutination Tests, 03 Chemiluminescences and volume ≥ 10 mL. Results: 45 kits with a satisfactory report were selected, being 60.0% ELISA, 16.0% immunofluorescence, 11.0%  chemiluminescence, 7.0%  hemagglutination, 4.0% immunochromatographic test and 2.0% agglutination. 160 records were evaluated, 56.2% of which were destined for ELISA, 14.4% of chemiluminescence, 13.1% of immunoflurescence, 8.1% of hemagglutination, 5.6% of rapid tests and 2.5% of agglutination. A standardized spreadsheet was prepared to insert the data in Excel® and evaluate the samples against the methodologies. A total of 64 samples were revalidated. Conclusions: The revalidated Panel, composed of 64 samples, was characterized and its use guarantees reliable results, expanding the analytical capacity of the Laboratory of Blood and Blood Products in the quality control of diagnostic kits.