Abstract
Since the emergence of a novel infection due to the SARS-CoV-2 virus (COVID-19), the World Health Organization has urged countries to develop diagnostic tests to combat the pandemic. Molecular assays were developed following the release of the gene sequence of the virus in January 2020. Reverse transcription-quantitative PCR (RT-qPCR) is taken as the gold standard for the diagnosis of COVID-19. However, due to its limitations, highly sensitive methods for detecting antigens (antigen rapid diagnostic tests) have been developed that would help in a timely and accurate diagnosis. Antigen rapid diagnostic tests (Ag-RDTs) can help guide patient management at the point of care by random screening, re-testing, and timely decision-making in the field of public health. When the affordability and validity of the diagnostic assay are involved, no assay can show 100% correct results. Further studies need to be done to better understand the response of the Ag-RDTs in different settings. Nevertheless, Ag-RDTs can play a complementary role in the response and case management of COVID-19.
Highlights
Coronavirus disease 2019, COVID-19, emerged from the Wuhan province of China at the end of 2019 [1], and the World Health Organization (WHO) declared it as a pandemic on March 11th, 2020 [2]
Whereas a study from Belgium reported that Coris COVID-19 Ag Respi-Strip rapid test showed a higher antigen detection rate that correlates with higher viral loads, but this study suggested that the test’s low sensitivity precludes its use as the first-line test for COVID-19 [11]
A study in Spain reported the overall sensitivity of 48.1% with the PanbioTM COVID-19 Antigen rapid diagnostic tests (Ag-RDTs) for the identification of SARS-CoV-2-infected individuals among asymptomatic close contacts of confirmed COVID-19 cases [15], which was similar to the data published by Linares et al (54.5%) [16], Fenollar et al (45.4%) [17], Bulilete et al (59.0%) [18]
Summary
Coronavirus disease 2019, COVID-19, emerged from the Wuhan province of China at the end of 2019 [1], and the World Health Organization (WHO) declared it as a pandemic on March 11th, 2020 [2]. This led to the need for highly sensitive immunological diagnostic methods, which detect on-site viral antigens in clinical specimens that would help in early and accurate diagnosis of COVID-19 [7]. As of March 2021, the rapid tests that received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) is shown in Table (2) [9].
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