EVALUATION OF THE DIAGNOSTIC PERFORMANCE OF COVID-19 RAPID ANTIGEN TEST IN COMPARISON TO SARS-COV-2 REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION

Authors : Ezgi Gülten, Duygu Öcal, Elif Mukime Sarıcaoğlu, İrem Akdemir Kalkan, Güle Çınar, Zeynep Ceren Karahan, Ebru Evren, Ebru Us, Alpay Azap, Atilla Halil Elhan

Pages : 197-202

Doi:10.24938/kutfd.1702068

View : 40 | Download : 25

Publication Date : 2025-08-25

Article Type : Research Paper

Abstract :Objective: The World Health Organization recommends reverse transcriptase polymerase chain reaction (RT-PCR) as the reference method for COVID-19 diagnosis. However, it is time- consuming, costly, and requires specialized equipment and trained personnel. Therefore, rapid antigen tests (RATs), which provide results within 15–30 minutes, have emerged as a potential alternative. The aim of the current study was to assess the diagnostic performance of the SARS-CoV-2 Rapid Antigen Test (Ref No: 9901-NCOV-01G, Roche Diagnostics) compared to RT-PCR in adult patients with COVID-19-related symptoms. Material and Methods: In this prospective observational study, 492 symptomatic adult patients, aged ≥ 18 years, were tested using simultaneous oro-nasopharyngeal swabs for RAT and RT- PCR. Diagnostic metrics were calculated, and the impact of cycle threshold (Ct) values and symptom duration on RAT performance was analyzed. Results: In total, 167 (33.9%) of 492 patients’ oro- nasopharyngeal swab samples tested by RT-PCR result were positive. Compared to RT-PCR, the sensitivity, specificity, positive and negative predictive value of RAT were 90.4% [95% confidence interval (CI): 85%-94%], 98.8% (95% CI: 96.9%-99.5%), 97.4% (95% CI: 93.6%-99%) and 95.3% (95% CI: 92.4%-97.1%), respectively. The Ct values of samples with false-negative RAT results were higher than the samples that tested positive by RAT and RT-PCR [23.93±4.40) vs. 18.42±4.56), p 26 groups, respectively. Furthermore, as Ct values increased, RAT was less likely to detect SARS-CoV-2 infection (p<0.001). Conclusion: The SARS-CoV-2 RAT exhibited high diagnostic performance in symptomatic patients and exceeded the minimum sensitivity and specificity thresholds recommended by the World Health Organization. Although its sensitivity decreases with higher Ct values, which may reflect lower viral loads, RAT remains a valuable point-of-care tool for early detection and isolation of COVID-19 cases. Confirmatory RT- PCR testing should be considered in symptomatic patients with negative RAT results.
Keywords : COVID-19, tanısal doğruluk, hızlı antijen testi, SARS-CoV-2

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