Validation of the STANDARD Q COVID-19 antigen test in Vojvodina, Serbia

PLoS One. 2021 Feb 22;16(2):e0247606. doi: 10.1371/journal.pone.0247606. eCollection 2021.

Abstract

Background: Since COVID-19 pandemic is a global crisis, tests with high sensitivity and specificity are crucial for the identification and management of COVID-19 patients. There is an urgent need for low-cost rapid antigen COVID-19 test with a good diagnostic performance. Although various antigen rapid detection tests are widely available, strong evidence of their usefulness in clinical practice are still limited. Therefore, our aim was to evaluate clinical performance of STANDARD Q COVID-19 Ag Test (SD Biosensor, Gyeonggi-do, South Korea).

Methods: The performance of the STANDARD Q COVID-19 Ag Test for the detection of SARS-CoV-2 antigen was evaluated in comparison to RT-qPCR results in 120 symptomatic patients (median age 49, IQR 36-70) who presented to health care facility in Novi Sad, Vojvodina, Serbia.

Results: Twenty five out of 120 samples have been tested positive using STANDARD Q COVID-19 Ag Test, and all of them were also positive on RT-qPCR. Overall, the STANDARD Q COVID-19 Ag Test showed sensitivity of 58.1% (95% CI 42.1-73.0) but it was higher in the early days of disease, when the highest viral loads were detected. During the first five days after the symptom onset, the sensitivity ranged from 66.7% to 100% and the pooled accuracy and Kappa values were high (0.92 and 0.852).

Conclusions: A strong agreement between performance of STANDARD Q COVID-19 Ag Test and RT-qPCR was observed during the first five days of illness, suggesting that this rapid antigenic test can be very useful for COVID-19 diagnosis in the early phase of disease.

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Antigens, Viral / analysis*
  • COVID-19 / diagnosis*
  • COVID-19 Serological Testing / methods*
  • Early Diagnosis
  • Humans
  • Middle Aged
  • Nasopharynx* / immunology
  • Nasopharynx* / virology
  • SARS-CoV-2 / isolation & purification*
  • Sensitivity and Specificity
  • Serbia / epidemiology

Substances

  • Antigens, Viral

Grant support

This work is a part of the research that was supported by Provincial Secretariat for Higher Education and Scientific Research grant number 142-451-3072/2020-03. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.