TY  - JOUR
T1  - EVALUATION OF THE DIAGNOSTIC PERFORMANCE OF COVID-19 RAPID ANTIGEN TEST IN COMPARISON TO SARS-COV-2 REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION
TT  - COVID-19 Hızlı Antijen Testinin Sars-Cov-2 Reverz Transkriptaz Polimeraz Zincir Reaksiyonu İle Karşılaştırmalı Tanısal Performansının Değerlendirilmesi
AU  - Gülten, Ezgi
AU  - Öcal, Duygu
AU  - Sarıcaoğlu, Elif Mukime
AU  - Akdemir Kalkan, İrem
AU  - Çınar, Güle
AU  - Karahan, Zeynep Ceren
AU  - Evren, Ebru
AU  - Us, Ebru
AU  - Azap, Alpay
AU  - Elhan, Atilla Halil
PY  - 2025
DA  - August
Y2  - 2025
DO  - 10.24938/kutfd.1702068
JF  - The Journal of Kırıkkale University Faculty of Medicine
JO  - Kırıkkale Uni Med J
PB  - Kırıkkale Üniversitesi
WT  - DergiPark
SN  - 2148-9645
SP  - 197
EP  - 202
VL  - 27
IS  - 2
LA  - en
AB  - 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
KW  - COVID-19
KW  - diagnostic accuracy
KW  - rapid antigen test
KW  - SARS-CoV-2
N2  - Amaç: Dünya Sağlık Örgütü, COVID-19 tanısında referans yöntem olarak reverz transkriptaz polimeraz zincir reaksiyonunu (RT-PZR) önermektedir. Ancak bu yöntem; zaman alıcı ve maliyetli olup özel donanım ve eğitimli personel gerektirmektedir. Bu nedenle, hızlı antijen testleri (HAT) potansiyel bir alternatif olarak öne çıkmıştır. Bu çalışmanın amacı, COVID-19 ile ilişkili semptomları olan erişkin hastalarda SARS-CoV-2 Hızlı Antijen Testi'nin (Ref No: 9901- NCOV-01G, Roche Diagnostics) RT-PZR ile karşılaştırmalı tanısal performansını değerlendirmektir. Gereç ve Yöntemler: Bu prospektif gözlemsel çalışmada, 492 semptomatik erişkin hastadan eş zamanlı olarak alınan oro- nazofarengeal sürüntüler HAT ve RT-PZR yöntemleriyle test edilmiştir. Tanısal ölçütler hesaplanmış ve döngü eşiği (Ct) değerlerinin ve semptom süresinin HAT performansı üzerindeki etkisi analiz edilmiştir. Bulgular: RT-PZR ile test edilen 492 hastanın 167’sinde (%33,9) oro-nazofarengeal sürüntü örnekleri pozitif bulunmuştur. RT-PZR ile karşılaştırıldığında, HAT’in duyarlılığı %90,4 [güven aralığı (GA) %95: %85–%94], özgüllüğü %98,8 (GA %95: %96,9–%99,5), pozitif prediktif değeri %97,4 (GA %95: %93,6–%99) ve negatif prediktif değeri %95,3 (GA %95: %92,4–%97,1) olarak hesaplanmıştır. Yanlış negatif HAT sonuçlarına sahip örneklerin Ct değerleri, her iki yöntemle de pozitif saptanan örneklere kıyasla daha yüksek bulunmuştur [23,93±4,40) vs. 18,42±4,56), p
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UR  - https://doi.org/10.24938/kutfd.1702068
L1  - https://dergipark.org.tr/tr/download/article-file/4882390
ER  -