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J Clin Virol . Evaluation of Rapid Antigen Test for Detection of SARS-CoV-2 Virus

tetano

Editor, Senior Moderator
J Clin Virol


. 2020 Jun 8;129:104500.
doi: 10.1016/j.jcv.2020.104500. Online ahead of print.
Evaluation of Rapid Antigen Test for Detection of SARS-CoV-2 Virus


Gannon Ck Mak[SUP] 1 [/SUP], Peter Kc Cheng[SUP] 2 [/SUP], Stephen Sy Lau[SUP] 2 [/SUP], Kitty Ky Wong[SUP] 2 [/SUP], C S Lau[SUP] 2 [/SUP], Edman Tk Lam[SUP] 2 [/SUP], Rickjason Cw Chan[SUP] 2 [/SUP], Dominic Nc Tsang[SUP] 2 [/SUP]



Affiliations

Abstract

Background: The rapid diagnosis of Coronavirus Disease 2019 (COVID-19) patients is essential to reduce the disease spread. Rapid antigen detection (RAD) tests are available, however, there is scanty data on the performance of RAD tests.
Objective: To evaluate the performance of the commercially available BIOCREDIT COVID-19 Ag test and compare it with RT-PCR for detecting Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus. Analytical sensitivity for the detection of SARS-CoV-2 virus was determined for the RAD test using viral culture and RT-PCR as reference methods. The RAD test was further evaluated using respiratory samples collected from confirmed COVID-19 patients. The results were compared with RT-PCR test.
Results: The detection limits between RAD test, viral culture and RT-PCR varied hugely. RAD was 10[SUP]3[/SUP] fold less sensitive than viral culture while RAD was 10[SUP]5[/SUP] fold less sensitive than RT-PCR. The RAD test detected between 11.1 % and 45.7 % of RT-PCR-positive samples from COVID-19 patients.
Conclusions: This study demonstrated that the RAD test serves only as adjunct to RT-PCR test because of potential for false-negative results.

Keywords: 2019 novel coronavirus; COVID-19; RT-PCR; Rapid antigen detection; SARS-CoV-2; Viral culture.
 
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