Post-market monitoring of rapid test for COVID-19 antibody detection: Data analysis from the Microsoft ® Power Bi platform
Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02131 | Published on: 28/06/2024
DOI:
https://doi.org/10.22239/2317-269X.02131Keywords:
Serological Tests, SARS-CoV-2, Quality Control, Rapid TestAbstract
Introduction: The COVID-19 outbreak caused by a new type of coronavirus was confirmed by Chinese authorities on January 7, 2020, resulting in hundreds of deaths worldwide. Due to the rapid spread of the disease, the World Health Organization (WHO) declared a Public Health Emergency of International Concern on January 30, 2020, and later declared it a pandemic on March 11, 2020. In response to the public health emergency, the National Health Surveillance Agency (Anvisa) in Brazil published Collegiate Board Resolutions (RDCs) No. 379/2020 and RDC No. 445/2020. These regulations established the laboratory analysis of products for in vitro diagnosis by the National Institute for Quality Control in Health (INCQS). Objective: The purpose of this study was to evaluate the performance data of rapid tests for the detection (AcTR) of COVID-19 antibodies on the Microsoft ® Power Bi platform on the Anvisa portal. Method: The evaluation period was from April 6, 2020, to December 28, 2021. Results: Out of 293 batches of AcTR products evaluated, 55.3% were found to be compliant, while 44.7% were non-compliant according to the established analysis criteria. Conclusions: The main reason for non compliance was reduced sensitivity of the tests. Post-market monitoring was conducted to ensure the availability of quality, safe, and effective products in the Brazilian market and to support decision-making by Brazilian authorities.
Downloads
Author Biographies
-
Milena Glória Carvalho, Instituto Nacional de Controle de Qualidade em Saúde/Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil
-
Marisa Coelho Adati, Instituto Nacional de Controle de Qualidade em Saúde/Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil
-
Helena Cristina Balthazar Guedes Borges, Instituto Nacional de Controle de Qualidade em Saúde/Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil
Downloads
Published
Issue
Section
License
Copyright (c) 2024 Health Surveillance under Debate: Society, Science & Technology
This work is licensed under a Creative Commons Attribution 4.0 International License.
COPYRIGHT ALLOWANCE The author (s) hereinafter designated as the ASSIGNOR hereby assign and transfer, free of charge, the ownership of the copyrights related to this ARTICLE to the Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debate, represented by FUNDAÇÃO OSWALDO CRUZ, established at Av. Brasil, nº 4365, Manguinhos, Rio de Janeiro, RJ, Brazil, CEP 21045-900, under the conditions set out below: (a) The terms and conditions set forth in this Agreement shall apply to the following: 1. The ASSIGNOR declares that they s(he) is (are) the author (s) and owner (s) of the copyrighted property of the ARTICLE submitted. 2. The ASSIGNOR declares that the ARTICLE does not infringe the copyrights and / or other property rights of third parties, that the disclosure of images (if any) has been authorized and that they s(he) assume(s) full moral and / or property liability for its content, before third parties. 3. THE ASSIGNOR assigns and transfers all copyrights relating to the ARTICLE to the ASSIGNEE, especially the rights of editing, publication, translation into another language and reproduction by any process or technique. The ASSIGNEE becomes the exclusive owner of the rights related to the ARTICLE, and any reproduction, totally or partially, is prohibited in any other means of publicity, printed or electronic, without prior written authorization from the ASSIGNEE. 4. The assignment is free and, therefore, there will be no remuneration for the use of the ARTICLE by the ASSIGNEE.
