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Rapid SARS-CoV-2 antigen detection assay in comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in Thailand.
Chaimayo, Chutikarn; Kaewnaphan, Bualan; Tanlieng, Nattaya; Athipanyasilp, Niracha; Sirijatuphat, Rujipas; Chayakulkeeree, Methee; Angkasekwinai, Nasikarn; Sutthent, Ruengpung; Puangpunngam, Nattawut; Tharmviboonsri, Theerawoot; Pongraweewan, Orawan; Chuthapisith, Suebwong; Sirivatanauksorn, Yongyut; Kantakamalakul, Wannee; Horthongkham, Navin.
  • Chaimayo C; Department of Microbiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
  • Kaewnaphan B; Department of Microbiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
  • Tanlieng N; Department of Microbiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
  • Athipanyasilp N; Department of Microbiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
  • Sirijatuphat R; Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
  • Chayakulkeeree M; Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
  • Angkasekwinai N; Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
  • Sutthent R; Department of Microbiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
  • Puangpunngam N; Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
  • Tharmviboonsri T; Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
  • Pongraweewan O; Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
  • Chuthapisith S; Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
  • Sirivatanauksorn Y; Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
  • Kantakamalakul W; Department of Microbiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
  • Horthongkham N; Department of Microbiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. navin.hor@mahidol.ac.th.
Virol J ; 17(1): 177, 2020 11 13.
Article in English | MEDLINE | ID: covidwho-926411
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Nucleic Acid Testing / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study Limits: Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: Asia Language: English Journal: Virol J Journal subject: Virology Year: 2020 Document Type: Article Affiliation country: S12985-020-01452-5

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Nucleic Acid Testing / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study Limits: Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: Asia Language: English Journal: Virol J Journal subject: Virology Year: 2020 Document Type: Article Affiliation country: S12985-020-01452-5