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J Clin Lab Anal . Performance evaluation of four rapid antibody tests for the detection of severe acute respiratory syndrome coronavirus 2

tetano

Editor, Senior Moderator
J Clin Lab Anal


. 2022 Apr 21;e24374.
doi: 10.1002/jcla.24374. Online ahead of print.
Performance evaluation of four rapid antibody tests for the detection of severe acute respiratory syndrome coronavirus 2


Jae Kyung Kim[SUP] 1 [/SUP], Sook Won Ryu[SUP] 2 [/SUP], Jae Soo Kim[SUP] 3 [/SUP], Bo Kyeung Jung[SUP] 4 [/SUP]



Affiliations

Abstract

Background: The prompt detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is important in the therapeutic management of infected patients. Rapid diagnostic tests are widely used for this purpose. This study aimed to evaluate the clinical performance of four SARS-CoV-2 immunoglobulin IgG/IgM rapid diagnostic tests in the detection of SARS-CoV-2.
Methods: Nasopharyngeal and oropharyngeal swabs and/or sputum were collected from 30 patients infected with SARS-CoV-2 and 30 healthy volunteers. All specimens were tested using four SARS-CoV-2 IgG/IgM rapid diagnostic tests and real-time polymerase chain reaction. We assessed the clinical sensitivity and specificity of the tests.
Results: The clinical sensitivity of FREND™, SsmarTest™, BIOCREDIT™, and IVDLAB™ was 96.67%, 100.00%, 100.00%, and 96.67%, respectively, compared to real-time polymerase chain reaction. The clinical specificity was 96.67%, 100.00%, 86.67%, and 96.67%, respectively.
Conclusion: These findings could expedite the detection of SARS-CoV-2 and thus reduce the risk of further transmission of the virus.

Keywords: SARS-CoV-2; SARS-CoV-2 IgG/IgM antibody; rapid antibody test; rapid diagnostic test; sensitivity; specificity.
 
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