Revalidation of the positive serological panel for syphilis – a tool in the quality control of kits for syphilis diagnosis

• Autor(a) principal: Custódio Deslandes do Passo, Danielle
• Data de Publicação: 2020
• Outros Autores: Coelho Adati, Marisa, Copello Vigo, Danielle, da Silva Ribeiro, Álvaro, Machado Passo, Roberto, Pereira da Silva Zamith, Helena
• 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/1562
• topic: Sífilis; Painel Sorológico; Controle de Qualidade

Introduction: Syphilis is a slowly evolving infectious disease caused by a gram-negative bacterium in the group of spirochetes, exclusive to humans, called Treponema pallidum. In the fight against syphilis, an important tool is the laboratory analysis through products for in vitro diagnosis that allows the diagnosis of the disease. The effectiveness of these products is assessed against serological panels composed of true positive and negative samples. Objective: To reassess the reactivity of the 153 samples that make up the positive serological panel for  syphilis at the Laboratory of Blood and Blood Products (LSH) of the National Institute for Quality Control in Health (INCQS). Method: Revalidation of the serological panel for syphilis through retrospective analysis of LSH laboratory data from 2011 to 2015, meeting the positivity criteria in 5 different methodologies and sample volume ≥ 10 mL. Results: Of the 172 initial samples, 153 had stock volume ≥ 10 mL. In the proposed period, 46 syphilis diagnosis products were identified with a satisfactory report, comprising 5 different methodologies. The analytical results of the 153 samples belonging to the positive panel were analyzed in the protocols for recording the results of these products. After re-evaluating the reactivity of the 153 samples from the positive panel 130, they were revalidated as positive while 23 were considered to be indeterminate. Conclusions: The positive panel for revalidated syphilis will remain an essential instrument in the previous analysis for the purpose of regularizing kits for diagnosing the disease.