Analysis of COVID-19 diagnostic test implementation in Brazil: strategies in place at the beginning of the pandemic
Análise da implementação do teste diagnóstico da COVID-19 no Brasil: estratégias em vigor no início da pandemia
Palavras-chave:
COVID-19, Diagnostic, Public health, SARS-CoV-2, Point-of-careResumo
The World Health Organization considers the mass testing one of the main tools for controlling the COVID-19 pandemic. The aim of this study was to evaluate the strategies adopted by the Brazilian Federal Government to promote population testing and access to in vitro diagnostic products for COVID-19 within the Unified Health System. Thus, we analyzed the information collected in databases from ANVISA (Brazilian Health Regulatory Agency), the Ministry of Health and Our World in Data on regulatory flexibility for in vitro diagnostic products for COVID-19, the impacts of acquisition and distribution for tests and the pandemic indicators, respectively. Around 65% of the tests registered at ANVISA were from China, while only 17% were Brazilian tests. Of the 441 registered tests, 67.8% were rapid antibody tests. Brazil only carried out 20 million of the 46 million tests planned for 2020 by the Diagnosis to Care Program. The reduced mass testing and the use mainly of rapid tests for antibodies detection may contribute to the underreporting of the disease and to Brazil's position among the countries that test the least and with a high number of cases and deaths presented in the early years of the COVID-19 pandemic.
Downloads
Referências
BIGONI, A. et al. Brazil’s health system functionality amidst of the COVID-19 pandemic: An analysis of resilience. The Lancet Regional Health - Americas, v. 10, p. 100222, jun. 2022.
BOLISLIS, W. R. et al. Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities. Clinical Therapeutics Excerpta Medica Inc., 1 jan. 2021.
BRASIL, A. Vacinas, 2023.
BRASIL. ANVISA. RESOLUÇÃO RDC No 348, DE 17 DE MARÇO DE 2020 – RESOLUÇÃO.
BRASIL. ANVISA. Fila Completa de Produtos de Diagnóstico in vitro para COVID-19.
BRASIL. ANVISA. RESOLUÇÃO - RDC No 36, DE 26 DE AGOSTO DE 2015.
BRASIL. ANVISA. RESOLUÇÃO - RDC No 379, DE 30 DE ABRIL DE 2020.
BRASIL, M. DA S. Plano Nacional de Operacionalização da Vacinação contra a COVID-19. Brasília: [s.n.], 2020.
BRAZIL. MINISTÉRIO DA SAÚDE. Boletim epidemiológico Especial no40. 2020a.
BRAZIL. MINISTÉRIO DA SAÚDE. Boletim Especial no12: Especial Vigilância Epidemiológica. [s.l: s.n.].
BRASIL. MINISTÉRIO DA SAÚDE. Ciência e Tecnologia: Fiocruz firmará acordo para produzir vacina contra Covid-19 via Universidade de Oxford.
BRASIL. MINISTÉRIO DA SAÚDE. DOENÇA PELO CORONAVÍRUS 2019: Especial Vigilância Epidemiológica LaboratorialBoletim COE. [s.l: s.n.].
BRASIL. MINISTÉRIO DA SAÚDE. Painel de Testes.
BRAZIL. MINISTÉRIO DA SAÚDE. BOLETIM EPIDEMIOLÓGICO ESPECIAL N. 35.
BRASIL. PRESIDÊNCIA DA REPÚBLICA. LEI No 13.243, DE 11 DE JANEIRO DE 2016.
CNBC. U.S. agrees to pay Sanofi and GSK $2.1 billion for 100 million doses of coronavirus vaccine.
DEKA, S.; KALITA, D. Effectiveness of Sample Pooling Strategies for SARS-CoV-2 Mass Screening by RT-PCR: A Scoping Review. Journal of Laboratory Physicians, v. 12, n. 03, p. 212–218, dez. 2020.
FOLHA. Governo “recicla” plano de testagem e prevê diagnóstico clínico para Covid-19.
FRANÇ, E. B. et al. Measuring misclassification of Covid-19 as garbage codes: Results of investigating 1,365 deaths and implications for vital statistics in Brazil. PLOS Global Public Health, v. 2, n. 5, p. e0000199, maio 2022.
GADELHA, C. A. G.; DA COSTA BRAGA, P. S. Saúde e inovação: Dinâmica econômica e Estado de Bem-Estar Social no Brasil. Cadernos de Saude Publica, v. 32, p. 1–13, 2016.
GADELHA, C. A. G. O Complexo Econômico-Industrial da Saúde no Brasil hoje. Disponível em: <https://library.fes.de/pdf-files/bueros/brasilien/16202.pdf>. Acesso em: 11 abr. 2022.
GCDL. COVID-19 Data Explorer - Our World in Data.
GCDL. Coronavirus Pandemic (COVID-19) - Our World in Data - Tests.
GLOBO. Ministério da Saúde admite falta de testes no Brasil e prevê aumento da produção da Fiocruz.
GUGLIELMI, G. Fast coronavirus tests: what they can and can’t do. NatureNLM (Medline), , set. 2020.
HALLAL, P. C.; VICTORA, C. G. Overcoming Brazil’s monumental COVID-19 failure: an urgent call to action. Nature Medicine, v. 27, n. 6, p. 933–933, 6 jun. 2021.
KLEIN, K. et al. Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences? Therapeutic Innovation and Regulatory Science, v. 56, n. 2, p. 366–377, 1 mar. 2022.
KRÜTTGEN, A. et al. Comparison of the SARS-CoV-2 Rapid Antigen Test to the Real Star Sars-CoV-2 RT PCR Kit. Journal of Virological Methods, v. 288, n. October 2020, p. 114024, 2020.
KUZNETSOVA, L. COVID-19: The World Community Expects the World Health Organization to Play a Stronger Lead-ership and Coordination Role in Pandemics Control. Frontiers in Public Health, v. 8, 8 set. 2020.
LAI, C.-C. et al. In vitro diagnostics of coronavirus disease 2019: Technologies and application. Journal of Microbiology, Immunology and Infection, v. 54, n. 2, p. 164–174, 1 abr. 2021.
LAUREANO, A. F. S.; RIBOLDI, M. The different tests for the diagnosis of COVID-19 - A review in Brazil so far. JBRA Assisted Reproduction, v. 24, n. 3, p. 340
LEE, D.; LEE, J. Testing on the move: South Korea’s rapid response to the COVID-19 pandemic. Transportation Research Interdisciplinary Perspectives, v. 5, p. 100111, 1 maio 2020.
MARSON, F. A. L.; ORTEGA, M. M. COVID-19 in Brazil. Pulmonology, v. 26, n. 4, p. 241–244, jul. 2020.
NATIONAL AUDIT OFFICE. Investigation into preparations for potential COVID-19 vaccines A picture of the National Audit Office logo. Department for Business, Energy & Industrial Strategy, Department of Health & Social Care, NHS England and NHS Improvement, and Public Health England, p. 51, 2020.
RAMOS-CASALS, M.; BRITO-ZERÓN, P.; MARIETTE, X. Systemic and organ-specific immune-related manifestations of COVID-19. Nature Reviews Rheumatology, v. 17, n. 6, p. 315–332, 26 jun. 2021.
RAVI, N. et al. Diagnostics for SARS-CoV-2 detection: A comprehensive review of the FDA-EUA COVID-19 testing landscape. Biosensors and Bioelectronics, v. 165, n. April, p. 112454, out. 2020.
OMS. WHO Emergency Use Listing for In vitro diagnostics (IVDs) Detecting SARS-CoV-2.
OMS. Director-General’s opening remarks at the media briefing on COVID-19 - 16 March 2020. Disponível em: <https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---16-march-2020>. Acesso em: 20 out. 2020b.
ROGERS, R. et al. The COVID-19 Diagnostic Dilemma: a Clinician’s Perspective. Journal of Clinical Microbiology, v. 58, n. 8, p. e01287-20, 2020.
U.S DEPARTMENT OF DEFENSE. Trump Administration’s Operation Warp Speed Accelerates AstraZeneca COVID-19 Vaccine to be Available Beginning in October > U.S. Department of Defense > Release.
USAID, A. FOR I. D. Promoting the Quality of Medicines Plus (PQM+) A proposed model to build capacity for emer- gency use authorization for diagnostics: Guidance for national regulatory authorities. n. November, 2021a.
VARGAS, M. Governo federal pode ter de jogar fora 6,8 milhões de testes perto da validade. Disponível em: <https://www.cnnbrasil.com.br/saude/2020/11/22/governo-federal-pode-ter-de-jogar-fora-6-8-milhoes-de-testes-perto-da-validade>. Acesso em: 8 jan. 2021.
XU, M. et al. COVID‐19 diagnostic testing: Technology perspective. Clinical and Translational Medicine, v. 10, n. 4, p. 1–15, 2020.
WHO. Regulation and Prequalification.
WHO. Public health criteria to adjust public health and social measures in the context of COVID-19.
