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J Clin Virol . Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus

tetano

Editor, Senior Moderator
J Clin Virol


. 2020 Oct 29;133:104684.
doi: 10.1016/j.jcv.2020.104684. Online ahead of print.
Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus


Gannon Ck Mak[SUP] 1 [/SUP], Stephen Sy Lau[SUP] 2 [/SUP], Kitty Ky Wong[SUP] 2 [/SUP], Nancy Ls Chow[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: Numerous rapid antigen detection (RAD) kits for diagnosing COVID-19 patients are available in the market recently.
Objective: To compare analytical sensitivity and clinical sensitivity for the three commercially available RAD kits.
Study design: Analytical sensitivity for the detection of SARS-CoV-2 virus was determined by limit of detection (LOD) using RT-PCR as a reference method. Clinical sensitivity was evaluated by using respiratory specimens collected from confirmed COVID-19 patients.
Results: The LOD results showed that the three RAD kits varied from 10[SUP]2[/SUP]-10[SUP]5[/SUP] fold less sensitive than RT-PCR. Clinical sensitivity of RAD kits ranged from 22.9 %-71.4 % for detecting specimens from COVID-19 patients.
Conclusions: Although RAD kits were less sensitive than RT-PCR, understanding the clinical characteristics of different RAD kits can guide us to obtain suitable specimens for testing. The likelihood of positive results for RAD kits will be higher.

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