J Korean Med Sci.  2021 Apr;36(14):e101. 10.3346/jkms.2021.36.e101.

Clinical Application of the Standard Q COVID-19 Ag Test for the Detection of SARS-CoV-2 Infection

Affiliations
  • 1Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea
  • 2Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Korea
  • 3Department of Emergency Medicine, Seoul National University College of Medicine, Seoul, Korea

Abstract

We evaluated the Standard Q COVID-19 Ag test for the diagnosis of coronavirus disease 2019 (COVID-19) compared to the reverse transcription-polymerase chain reaction (RT-PCR) test. We applied both tests to patients who were about to be hospitalized, had visited an emergency room, or had been admitted due to COVID-19 confirmed by RT-PCR. Two nasopharyngeal swabs were obtained; one was tested by RT-PCR and the other by the Standard Q COVID-19 Ag test. A total of 118 pairs of tests from 98 patients were performed between January 5 and 11, 2021. The overall sensitivity and specificity for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for the Standard Q COVID-19 Ag test compared to RT-PCR were 17.5% (95% confidence interval [CI], 8.8–32.0%) and 100% (95% CI, 95.3–100.0%). Analysis of the results using RT-PCR cycle thresholds of ≤ 30 or ≤ 25 increased the sensitivity to 26.9% (95% CI, 13.7–46.1%), and 41.1% (95% CI, 21.6–64.0%), respectively.

Keyword

SARS-CoV-2; COVID-19; Antigen Test
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