Lab Med Qual Assur.  2024 Dec;46(4):208-213. 10.15263/jlmqa.2024.46.4.208.

Clinical Performance Evaluation of the Ag Test for Detecting SARS-CoV-2 and Influenza A/B Viruses Using Nasopharyngeal Swabs

• Yoou MS
• Jeong JH
• Choi EH
• Kim Y
• Ihm C

• KMID: 2563492
• DOI: http://doi.org/10.15263/jlmqa.2024.46.4.208

Abstract

Background
Rapid antigen tests (RATs) are widely used in clinical settings, aiding in the prevention of infectious diseases. However, there is a lack of research on the performance of RATs that can simultaneously diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and Influenza A/B viruses. In this study, we aimed to evaluate the performance of a newly developed RAT that can detect all three pathogens at once, to assess its potential for clinical application.
Methods
Clinical performance testing was conducted using 436 nasopharyngeal swab samples collected from patients with suspected respiratory infections. The newly developed RAT was compared with realtime reverse transcription-polymerase chain reaction (rRT-PCR) results to evaluate clinical sensitivity and specificity. Additionally, concordance with two previously approved products was assessed.
Results
For patients who tested positive with rRT-PCR, the detection sensitivity of the newly developed INCLIX TRF COVID-19 & Flu A/B Ag test was 90.91% for SARS-CoV-2, 97.75% for Influenza A, and 93.00% for Influenza B, with a specificity of 100% for all three pathogens. In the concordance assessment with the existing RATs, the agreement was 99.76% (κ=0.9922) for SARS-CoV-2, 99.76% (κ=0.9927) for Influenza A, and 99.76% (κ=0.9930) for Influenza B. Compared to the existing RATs, all showed a concordance with κ >0.8.
Conclusions
The INCLIX TRF COVID-19 & Flu A/B Ag test efficiently detected antigens of SARS-CoV-2 and Influenza A/B viruses simultaneously within a short testing time of 15 minutes. Therefore, this test method, with its high sensitivity and specificity, will be highly useful for diagnosing viral infections in clinical settings.

Keyword

SARS-CoV-2; Influenza A; Influenza B; Rapid antigen test