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Comparative Study
. 2020 Nov 13;17(1):177.
doi: 10.1186/s12985-020-01452-5.

Rapid SARS-CoV-2 antigen detection assay in comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in Thailand

Chutikarn Chaimayo  1 , Bualan Kaewnaphan  1 , Nattaya Tanlieng  1 , Niracha Athipanyasilp  1 , Rujipas Sirijatuphat  2 , Methee Chayakulkeeree  2 , Nasikarn Angkasekwinai  2 , Ruengpung Sutthent  1 , Nattawut Puangpunngam  3 , Theerawoot Tharmviboonsri  4 , Orawan Pongraweewan  5 , Suebwong Chuthapisith  3 , Yongyut Sirivatanauksorn  3 , Wannee Kantakamalakul  1 , Navin Horthongkham  6
Affiliations
Comparative Study

Rapid SARS-CoV-2 antigen detection assay in comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in Thailand

Chutikarn Chaimayo et al. Virol J. .

Abstract

Background: The Coronavirus disease 2019 (COVID-19) pandemic continues to spread across the world. Hence, there is an urgent need for rapid, simple, and accurate tests to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Performance characteristics of the rapid SARS-CoV-2 antigen detection test should be evaluated and compared with the gold standard real-time reverse transcription-polymerase chain reaction (RT-PCR) test for diagnosis of COVID-19 cases.

Methods: The rapid SARS-CoV-2 antigen detection test, Standard™ Q COVID-19 Ag kit (SD Biosensor®, Republic of Korea), was compared with the real-time RT-PCR test, Allplex™ 2019-nCoV Assay (Seegene®, Korea) for detection of SARS-CoV-2 in respiratory specimens. Four hundred fifty-four respiratory samples (mainly nasopharyngeal and throat swabs) were obtained from COVID-19 suspected cases and contact individuals, including pre-operative patients at Siriraj Hospital, Bangkok, Thailand during March-May 2020.

Results: Of 454 respiratory samples, 60 (13.2%) were positive, and 394 (86.8%) were negative for SARS-CoV-2 RNA by real-time RT-PCR assay. The duration from onset to laboratory test in COVID-19 suspected cases and contact individuals ranged from 0 to 14 days with a median of 3 days. The rapid SARS-CoV-2 antigen detection test's sensitivity and specificity were 98.33% (95% CI, 91.06-99.96%) and 98.73% (95% CI, 97.06-99.59%), respectively. One false negative test result was from a sample with a high real-time RT-PCR cycle threshold (Ct), while five false positive test results were from specimens of pre-operative patients.

Conclusions: The rapid assay for SARS-CoV-2 antigen detection showed comparable sensitivity and specificity with the real-time RT-PCR assay. Thus, there is a potential use of this rapid and simple SARS-CoV-2 antigen detection test as a screening assay.

Keywords: COVID-19; RT-PCR; Rapid antigen; SARS-CoV-2; Thailand.

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Conflict of interest statement

All authors declared no conflict of interest. There is no involvement from the companies Seegene or SD Biosensor.

Figures

Fig. 1
Fig. 1
Interpretation of rapid SARS-CoV-2 antigen detection assay (Standard Q COVID-19 Ag Test). Demonstration of a a test strip for viral transport media control, b a test strip, which was interpreted as negative SARS-CoV-2 antigen, c a test strip, which was interpreted as (weakly) positive SARS-CoV-2 antigen, and d a test strip, which was interpreted as positive SARS-CoV-2 antigen. The results were interpreted as positive when both control (c) and SARS-CoV-2 antigen (T) lines appeared within 30 min
See this image and copyright information in PMC

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