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

Year: 2024

Type: article

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.

Source: Imsang byeong'ri wa jeongdo gwanri/Journal of laboratory medicine and quality assurance

DOI: 10.15263/jlmqa.2024.46.4.208

Authors: Myoung-Schook Yoou, Ji Hun Jeong, Eun-Hye Choi, Yuri Kim, Chunhwa Ihm

Institutions: Eulji University, Daejeon Eulji Medical Center, Eulji University

Language: English

Topic: SARS-CoV-2 detection and testing

Subfield: Infectious Diseases

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: diamond

Funders: Ministry of Trade, Industry and Energy, Ministry of Food and Drug Safety, Ministry of Health and Welfare, Ministry of Science and ICT, South Korea