tetano
Editor, Senior Moderator
PLoS One
. 2022 Jun 16;17(6):e0269997.
doi: 10.1371/journal.pone.0269997. eCollection 2022.
Performance differences among commercially available antigen rapid tests for COVID-19 in Brazil
Mariana Lourenço Freire[SUP] 1 [/SUP], Lindicy Leidicy Alves[SUP] 1 [/SUP], Carolina Senra de Souza[SUP] 1 2 [/SUP], Juliana Wilke Saliba[SUP] 1 2 [/SUP], Verônica Faria[SUP] 1 [/SUP], Mariana Junqueira Pedras[SUP] 1 [/SUP], Nara de Oliveira Carvalho[SUP] 3 [/SUP], Gláucia Queiroz Andrade[SUP] 3 [/SUP], Ana Rabello[SUP] 1 [/SUP], Daniel Moreira Avelar[SUP] 1 [/SUP], Gláucia Cota[SUP] 1 [/SUP]
Affiliations
Abstract
A rapid and accurate diagnosis is a crucial strategy for containing the coronavirus disease (COVID-19) pandemic. Considering the obstacles to upscaling the use of RT-qPCR, rapid tests based on antigen detection (Ag-RDT) have become an alternative to enhance mass testing, reducing the time for a prompt diagnosis and virus spreading. However, the performances of several commercially available Ag-RDTs have not yet been evaluated in several countries. Here, we evaluate the performance of eight Ag-RDTs available in Brazil to diagnose COVID-19. Patients admitted to tertiary hospitals with moderate or mild COVID-19 symptoms and presenting risk factors for severe disease were included. The tests were performed using a masked protocol, strictly following the manufacturer's recommendations and were compared with RT-qPCR. The overall sensitivity of the tests ranged from 9.8 to 81.1%, and specificity greater than 83% was observed for all the evaluated tests. Overall, slight or fair agreement was observed between Ag-RDTs and RT-PCR, except for the Ag-RDT COVID-19 (Acro Biotech), in which moderate agreement was observed. Lower sensitivity of Ag-RDTs was observed for patients with cycle threshold > 25, indicating that the sensitivity was directly affected by viral load, whereas the effect of the disease duration was unclear. Despite the lower sensitivity of Ag-RDTs compared with RT-qPCR, its easy fulfillment and promptness still justify its use, even at hospital admission. However, the main advantage of Ag-RDTs seems to be the possibility of increasing access to the diagnosis of COVID-19 in patients with a high viral load, allowing immediate clinical management and reduction of infectivity and community transmission.
. 2022 Jun 16;17(6):e0269997.
doi: 10.1371/journal.pone.0269997. eCollection 2022.
Performance differences among commercially available antigen rapid tests for COVID-19 in Brazil
Mariana Lourenço Freire[SUP] 1 [/SUP], Lindicy Leidicy Alves[SUP] 1 [/SUP], Carolina Senra de Souza[SUP] 1 2 [/SUP], Juliana Wilke Saliba[SUP] 1 2 [/SUP], Verônica Faria[SUP] 1 [/SUP], Mariana Junqueira Pedras[SUP] 1 [/SUP], Nara de Oliveira Carvalho[SUP] 3 [/SUP], Gláucia Queiroz Andrade[SUP] 3 [/SUP], Ana Rabello[SUP] 1 [/SUP], Daniel Moreira Avelar[SUP] 1 [/SUP], Gláucia Cota[SUP] 1 [/SUP]
Affiliations
- PMID: 35709075
- DOI: 10.1371/journal.pone.0269997
Abstract
A rapid and accurate diagnosis is a crucial strategy for containing the coronavirus disease (COVID-19) pandemic. Considering the obstacles to upscaling the use of RT-qPCR, rapid tests based on antigen detection (Ag-RDT) have become an alternative to enhance mass testing, reducing the time for a prompt diagnosis and virus spreading. However, the performances of several commercially available Ag-RDTs have not yet been evaluated in several countries. Here, we evaluate the performance of eight Ag-RDTs available in Brazil to diagnose COVID-19. Patients admitted to tertiary hospitals with moderate or mild COVID-19 symptoms and presenting risk factors for severe disease were included. The tests were performed using a masked protocol, strictly following the manufacturer's recommendations and were compared with RT-qPCR. The overall sensitivity of the tests ranged from 9.8 to 81.1%, and specificity greater than 83% was observed for all the evaluated tests. Overall, slight or fair agreement was observed between Ag-RDTs and RT-PCR, except for the Ag-RDT COVID-19 (Acro Biotech), in which moderate agreement was observed. Lower sensitivity of Ag-RDTs was observed for patients with cycle threshold > 25, indicating that the sensitivity was directly affected by viral load, whereas the effect of the disease duration was unclear. Despite the lower sensitivity of Ag-RDTs compared with RT-qPCR, its easy fulfillment and promptness still justify its use, even at hospital admission. However, the main advantage of Ag-RDTs seems to be the possibility of increasing access to the diagnosis of COVID-19 in patients with a high viral load, allowing immediate clinical management and reduction of infectivity and community transmission.