A Review on COVID-19 Diagnosis Tests Approved for Use in Brazil and the Impact on Pandemic Control

Abstract

With the COVID-19 pandemic, many diagnostic tests (molecular or immunological) were rapidly standardised, given the urgency of the situation, many are still in the process of being validated. The main objective of this study was to review the aspects of the diagnostic kits approved in Brazil and their application in the different federative units to gather epidemiological information. In order to achieve these objectives, a survey was carried out on the data available at the regulatory agency (ANVISA) and in the literature. The main countries that have registered products in Brazil are China (51.4%), Brazil (16.6%), South Korea (9.2%), USA (8.8%) and Germany (3.6%). The methodologies of these products are based on the detection of nucleic-acid (15.8%), antigen (13%) and antibody (71.2%). In the immunological tests, it was verified that the sensitivity ranged from 55 to 100% and the specificity from 80 to 100%. The percentage of cases in the samples tested in Brazil is elevated in almost all federative units since eight states showed 40% of positive cases in tested samples, while 18 states displayed between 20 and 40%. In conclusion, this review showed HIGHLIGHTS The main COVID-19 diagnostic methods in Brazil are updated.  More than 80% of the approved products are from other countries.  The tests are based on the detection of nucleic-acid (15.8%), antigen (13%) and antibody (71.2%).  The most of Brazilian federative units show an elevated percentage of cases per samples tested. 2 Vedova-Costa J.M.D.; et al.

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

“…In 2020, most of the tests for COVID-19 diagnosis waiting approval by ANVISA were serological tests. By mid-February 2021, 500 test submissions had already been approved by ANVISA, based on nucleic acid, antigen and antibody detection [9]. Among the nucleic acid detection tests approved by ANVISA for use in COVID-19 diagnosis, the majority were RT-qPCR, considered the gold standard in the detection of viral particles [9].…”

“…Spike glycoprotein contains two functional subunits, S1 and S2. S1 is responsible for binding the virus to cell receptors in the host and S2 is for fusing the viral membrane with the host cell membrane [7][8][9].…”

“…SARS-CoV-2 transmission occurs between people through respiratory droplets when in close contact [9,15]. The symptoms of COVID-19 usually appear between 5-6 days after infection and may begin 2-14 days after exposure.…”

“…Laboratory diagnosis of COVID-19 is based on the detection of SARS-CoV-2 RNA by real-time PCR after reverse transcription (RT-qPCR) and antigen testing [19,20], which are the reference tests recommended by the WHO. Several RT-qPCR protocols have been developed for the detection of SARS-CoV-2 in different biological materials such as nasopharyngeal and oropharyngeal swabs, bronchoalveolar lavage, gargling fluid, faeces, urine among others [9,[21][22][23]. Most of the molecular tests approved by ANVISA (Brazilian National Agency of Health Surveillance) for use in the diagnosis of COVID-19 in Brazil are based on RT-qPCR.…”

Nanotechnology on agent identification, diseases diagnosis and therapeutic approaches

“…This surface contains antibodies specific for the antibody associated with the nanoparticle, which retains them and allows visualization by colorimetric change (Raji et al, 2021). This association has shown to be a promising platform for outbreak elucidation and diagnosis of various agents (Bhattarakosol, et al, 2018;Chen et al, 2018;Chen et al, 2019;Elahi et al, 2019;Vedova-Costa et al, 2021), as well as monitoring the evolution of neurodegenerative diseases such as Alzheimer's and diabetes (Popli et al, 2018).…”