Monitoramento pós-mercado dos testes rápidos para COVID-19: enfrentamento da pandemia:

Introduction: In December 2019, the  first group of patients with symptoms of atypical pneumonia was discovered in Wuhan, China. On January 7, 2020, the etiologic agent was identified; it was a new betacoronavirus, genetically similar to SARS-CoV-1, consisting of a simple RNA strand, an enveloped virus of 50-200nm in diameter, which was called SARS-CoV-2. Soon after, the disease was named COVID-19. On January 30, WHO declared a Public Health Emergency of International Importance due to the spread of the coronavirus. Tests for serological detection of IgM and IgG antibodies are those that provide an estimate of the immune response to SARS-CoV-2, highlighting the Rapid Diagnostic Tests (RDT), simple and accessible with a result within 5-30 minutes, based on sensitization of antigens/antibodies conjugated to colloidal gold capturing specific proteins present in the infected serum, plasma or blood. Objective: This work aims to show the analysis carried out with RDT for COVID-19 diagnosis in compliance with the current legislation from 02.04 to 18.08.2020. Method: In March of 2020, 25 serum/plasma samples were donated, without any identification. These samples were the remaining samples of tests performed on individuals with a confirmed diagnosis of SARS-CoV-2 infection by the RT-PCR technique from health services (National Institute of Infectious Diseases Evandro Chagas – INI and State Institute of the Brain Paulo Niemeyer – IEC) located in the metropolitan region of the state of Rio de Janeiro. The samples obtained in order to become a serological panel were stored at -20ºC until the moment of use. Simultaneously, a panel of samples with confirmed reactivity for IgM and IgG antibodies from COVID-19 was being made, throughout the pandemic and the samples used were evaluated against three Rapid Tests, of different antigenic compositions or different brands; two ELISA tests for IgM and IgG; two chemiluminescence tests and when applicable, a molecular test. In order to assess the specificity of the products sent, surplus donation plasma samples were selected, known to be negative for HIV, HTLV, hepatitis b and c, chagas and syphilis, collected between 2013 and 2014, in the southern regions of the country, period in which SARS-CoV-2 was nonexistent in the world. In addition to True Positive (VP) and True Negative (VN) samples, interfering serum or plasma samples with reactivity for HIV, HCV, HTLV, HBsAg, chagas disease, syphilis and dengue were also included in the evaluation. Results:  Out of 178 TR lots, 74.1%, 132 lots were from China and 25.9%, 46 TR lots were from Brazil; Germany; South Korea; Canada; USA; Singapore; Ireland and Switzerland. The analytical result showed that 57.0%, 101 TR lots obtained a Satisfactory result and 43%, 77 lots had Unsatisfactory results, when compared to the Sensitivity and Specificity values declared by the manufacturer, in the Instructions for Use. Conclusions:The results obtained show the need for constant monitoring of TRs for COVID-19 with the primary purpose of guaranteeing the quality of products sold in the country, one of the National Health Surveillance System pillars of action.  Introdução: Em dezembro de 2019, foi descoberto na cidade de Wuhan, China, um primeiro grupo de pacientes com sintomas de uma pneumonia atípica. Em 7 de janeiro de 2020, o seu agente etiológico foi identificado: tratava-se de um novo betacoronavírus, geneticamente similar ao SARS-CoV-1, constituído defita simples de RNA, vírus envelopado de 50-200 nm de diâmetro designado como SARS-CoV-2, e a doença foi denominada COVID-19. Em 30 de janeiro, a Organização Mundial da Saúde declarou Emergência de Saúde Pública de Importância Internacional em razão da disseminação desse novo vírus. Os testes para detecção sorológica de anticorpos IgM e IgG fornecem uma estimativa da resposta imune ao SARS-CoV-2, com destaque para os Testes Rápidos (TR) que são simples e acessíveis fornecendo resultados em 5-30 min. Esses testes são sensibilizados com antígenos/anticorpos conjugados ao ouro coloidal, capturando proteínas específicas presentes no soro, plasma ou sangue de pacientes infectados. Objetivo: Demonstrar a análise efetuada nos TR para diagnóstico da COVID-19, em atendimento a legislação vigente, no período de 2 de abril a 18 de agosto de 2020. Método: Durante o mês de março de 2020, foram cedidas 25 amostras de soro/plasma, sem qualquer identificação, excedentes dos testes efetuados em indivíduos com diagnóstico confirmado de infecção pelo SARS-CoV-2 pela técnica de RT-PCR provenientes de serviços de saúde (InstitutoNacional de Infectologia Evandro Chagas – INI e Instituto Estadual do Cérebro Paulo Niemeyer – IEC) localizados na região metropolitana do estado do Rio de Janeiro. As amostras obtidas para a confecção de painel sorológico foram armazenadas a -20ºC até o momento do uso. Concomitantemente, um painel de amostras com reatividade confirmada para anticorpos IgM e IgG da COVID-19 foi sendo confeccionado ao longo da pandemia e as amostras utilizadas foram avaliadas frente a três TR, de diferentes composições antigênicas ou diferentes marcas; dois testes ELISA para IgM e IgG; dois testes de quimioluminescência e quando aplicável, um teste molecular. Para avaliação da especificidade dos produtos encaminhados, foram selecionadas amostras de plasma excedentes de doação, sabidamente negativas para HIV, HTLV, hepatite B e C, doença de chagas e sífilis coletadas nos anos de 2013 e 2014, na Região Sul do país, período no qual o SARS-CoV-2 era inexistente. Além de amostras Verdadeiro Positivas (VP) e Verdadeiro Negativas (VN), ainda foram incluídas na avaliação amostras de soro ou plasma interferentes com reatividade para HIV, HCV, HTLV, HBsAg, doença de chagas, sífilis e dengue. Resultados:  Dos 178 lotes de TR, 74,1% foram provenientes da China e 25,9%, do Brasil, da Alemanha, da Coreia do Sul, do Canadá, dos EUA, da Cingapura,da Irlanda e da Suíça. O resultado analítico demonstrou que 57,0% dos TR obtiveram resultados satisfatórios e 43,0%, resultados insatisfatórios, quando comparados aos valores de sensibilidade e especificidade declarados pelo fabricante na instrução de uso. Conclusões: Há necessidade de constante monitoramento dos TR para COVID-19, com finalidade precípua de garantir a qualidade dos produtos comercializados no país, um dos pilares das ações do Sistema Nacional de Vigilância Sanitária

Seroprevalence of Hantavirus among Manual Cane Cutters and Epidemiological Aspects of HPS in Central Brazil

Hantavirus pulmonary syndrome (HPS) is a rodent-borne zoonotic disease that is endemic throughout the Americas. Agricultural activities increase exposure to wild rodents, especially for sugarcane cutters. We carried out a survey of the epidemiological aspects of HPS and investigated the prevalence of hantavirus infection in the sugarcane cutter population from different localities in the Brazilian Midwest region. We conducted a retrospective study of all confirmed HPS cases in the state of Goiás reported to the National HPS surveillance system between 2007 and 2017, along with a seroepidemiological study in a population of sugarcane cutters working in Goiás state in 2016, using the anti-hantavirus (Andes) ELISA IgG. A total of 634 serum samples from cane cutters were tested for hantavirus antibodies, with 44 (6.9%) being IgG-reactive according to ELISA. The destination of garbage was the only statistically significant variable (p = 0.03) related to the detection of hantavirus IgG (p < 0.05). We described the epidemiological profile of reported hantavirus cases in Goiás—a highly endemic area for HPS, and where the seroepidemiological study was conducted. Our results increase our knowledge about hantavirus infections in Brazil and highlight the vulnerability of sugarcane cutters to a highly lethal disease that, to date, has no specific treatment or vaccination