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


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 102-105 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.

SUBMITTER: Mak GC 

PROVIDER: S-EPMC7598567 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

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

Mak Gannon Ck GC   Lau Stephen Sy SS   Wong Kitty Ky KK   Chow Nancy Ls NL   Lau C S CS   Lam Edman Tk ET   Chan Rickjason Cw RC   Tsang Dominic Nc DN  

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology 20201029


<h4>Background</h4>Numerous rapid antigen detection (RAD) kits for diagnosing COVID-19 patients are available in the market recently.<h4>Objective</h4>To compare analytical sensitivity and clinical sensitivity for the three commercially available RAD kits.<h4>Study design</h4>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 co  ...[more]

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