A participação da universidade na produção de testes diagnósticos moleculares do novo coronavírus no Brasil: resposta aos desafios sanitários

Abstract

led to immediate and radical measures by public health agencies worldwide. By January 12, 2020, the viral genome sequences had been deposited in the Global Initiative for Sharing All Influenza Data (GISAID) 1 and became a priority for the development of diagnostic tests for the virus in networks of research centers and public laboratories. Community transmission was identified in various countries starting in February, with rapid and steady spread throughout Europe, the Americas, and Africa. The World Health Organization (WHO) declared COVID-19 a pandemic in early March. The first case in Brazil was reported on February 26.Based on the accumulated collaborative experience in the diagnosis of respiratory viruses with real-time polymerase chain reaction (RT-qPCR) in previous epidemics such as SARS-CoV in 2003, the process was defined and validated for RT-qPCR use in screening and diagnostic confirmation of the novel coronavirus (SARS-CoV-2) in respiratory secretions, even before access to the viral isolates. The methodology developed in this process became the official WHO protocol 1 . Surveys were conducted to assess the presence of the necessary expertise for molecular diagnosis of SARS-CoV-2 in specialized laboratories in 30 European countries, and 24 countries were prepared to perform the diagnostic test by January 29. However, the countries reported difficulties in access to inputs, positive controls for validation of the test, and trained and available human resources 2 .There are currently various protocols available for COVID-19 diagnosis in the world, proposed by official public health agencies and private companies. The techniques differ according to the reagents and genes detected by the tests, but they are based on the same protocol, infrastructure, and inputs. Development in Molecular Biology and its application to molecular diagnostic tests allowed the rapid definition of protocols 3 . However, this knowledge alone cannot guarantee tests with adequate sensitivity and specificity, with the necessary speed and in the required amounts. That is, the recommendation by the director of WHO and echoed by national leaders at the start of the pandemic, for mass testing in populations, was unattainable.This sparked concern among health professionals and especially among populations, due to the mass media focus on access to molecular tests as a tool for monitoring and controlling the pandemic. There was also enormous pressure on health authorities to perform large-scale molecular testing. Even

Experience of Implementing the Molecular Diagnosis of Covid-19 in the Regional Laboratory Center Instituto Adolfo Lutz De President Prudente

“…Among them, there is a lack of materials such as synthetic swabs (100% rayon) for collection, plastic materials (tips, cryotubes, reaction microplates, etc.) and supplies such as enzymes and probes used in real-time PCR (Silva et al, 2020).…”

Rapid response of a public health reference laboratory to the COVID-19 pandemic

“…The initiative included public, private and academic laboratories, providing human resources, equipment and inputs for testing. Before this network was created, the laboratories were accredited by the IAL to perform COVID-19 tests [28]. Other states in Brazil, such as Bahia, Minas Gerais and Pernambuco, also established laboratory networks for COVID-19 diagnosis coordinated by the public health reference laboratories of each state and composed of academic laboratories [29–31].…”

Paradigmas da gestão de imunizantes: o uso de métodos quantitativos como suporte à decisão em tempos de Covid-19 no estado do Rio de Janeiro

“…Nessa dinâmica, ressalta-se a importância da compreensão da sociedade acerca dos critérios de diagnósticos clínico-epidemiológicos implantados pelo MS para combate à covid-19. Um grande desafio para as ações de vigilância epidemiológica foi a dificuldade na importação de insumos necessários à realização do diagnóstico, cuja demanda crescente ensejou acirrada disputa entre grandes países (SILVA et al, 2020).…”