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

J Korean Med Sci. 2021 Apr 12;36(14):e101. doi: 10.3346/jkms.2021.36.e101.

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.

Keywords: Antigen Test; COVID-19; SARS-CoV-2.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Antigens, Viral / immunology*
  • COVID-19 / diagnosis*
  • COVID-19 / immunology*
  • COVID-19 Testing*
  • Emergency Service, Hospital
  • False Positive Reactions
  • Humans
  • Nasopharynx / virology
  • Predictive Value of Tests
  • Probability
  • Reference Standards
  • Reproducibility of Results
  • Reverse Transcriptase Polymerase Chain Reaction
  • Sensitivity and Specificity

Substances

  • Antigens, Viral