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. 2023 Feb;51(1):91-96.
doi: 10.1007/s15010-022-01832-9. Epub 2022 May 5.

Comparison of a novel antigen detection test with reverse transcription polymerase chain reaction assay for laboratory diagnosis of SARS-CoV-2 infection

Osman Sezer Cirit  1 , Esvet Mutlu  2 , Banu Sancak  3 , Tanil Kocagöz  4 , Özge Can  5 , Candan Çicek  6 , Ayca Arzu Sayiner  7 , Özgür Appak  7 , Neval Yurttutan Uyar  8 , Canan Külah  9 , Aysegül Çopur Çiçek  10 , Osman Birol Özgümüs  10 , Yasemin Ay Altintop  11 , Esma Saatçi  11 , Tekin Karsligil  12 , Yasemin Zer  12 , Nevgün Sepin Özen  13 , Yesim Çekin  13 , Zeynep Ceren Karahan  14 , Ebru Evren  14 , Ayse Esra Karakoç  15 , Sultan Gülbahçe Orhan  15 , Derya Mutlu  3 , Tugba Bozdemir  3 , Yeliz Tanriverdi Çayci  16 , Canberk Çinar  16 , Meltem Tasbakan  17 , Merve Mert  17 , Ece Çinar  18 , Oya Özlem Eren Kutsoylu  19 , Sesin Kocagöz  20 , Ayse Ertürk  21 , Ilhami Çelik  22 , Ayse Özlem Mete  23 , Müge Günalp Eneyli  24 , Irem Akdemir  25 , Taliha Karakök  26 , Dilara Inan  27 , Aynur Atilla  28 , Şevket Onur Taflan  29 , Kağan Etka Yörük  29
Affiliations

Comparison of a novel antigen detection test with reverse transcription polymerase chain reaction assay for laboratory diagnosis of SARS-CoV-2 infection

Osman Sezer Cirit et al. Infection. 2023 Feb.

Abstract

Molecular diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by real-time reverse transcription polymerase chain reaction (RT-PCR) in respiratory specimens is considered the gold standard method. This method is highly sensitive and specific but it has some limitations such as being expensive and requiring special laboratory equipment and skilled personnel. RapidFor™ Antigen Rapid Test Kit is a commercially available Ag-RDT which is produced in Turkey and designed to detect the nucleocapsid antigen of SARS-CoV-2 in nasopharyngeal swab samples. The aim of this study was to evaluate the performance of this novel SARS-CoV-2 antigen detection considering the RT-PCR method as the gold standard. Four hundred forty-four nasopharyngeal swab samples which were collected from the patients who met clinical criteria of COVID-19 from ten centers in Turkey between September 2020 and February 2021 were included in the study. All the nasopharyngeal swab samples were tested for SARS-CoV-2 RNA using commercial RT-PCR kits (Bioeksen and A1 Lifesciences, İstanbul, Turkey) according to the manufacturer's instructions. Viral loads were assessed according to the cycle threshold (Ct) values. RapidFor™ SARS-CoV-2 antigen test (Vitrosens Biotechnology, Istanbul, Turkey) was used to investigate the presence of SARS-CoV-2 antigen in all samples following the manufacturer's instructions. Out of 444 nasopharyngeal swab samples tested, 346 (77.9%) were positive and 98 (22.1%) were negative for SARS-CoV-2 RNA by RTPCR. Overall sensitivity of the RapidFor™. Antigen Rapid Test Kit was 80.3% whereas specificity was found to be 87.8%. Positivity rate of rapid antigen test in samples with Ct values over 25 and below 30 was 82.7%, while it increased to 95.7% in samples 20 ≤ Ct < 25 and reached 100% in samples with Ct values below 20. RapidFor™ SARS-CoV-2 Ag test might be a good choice in the screening of symptomatic and asymptomatic patients and their contacts for taking isolation measures early, with advantages over RT-PCR as being rapid, easy and being applicable in every laboratory and even at point of care.

Keywords: COVID-19; Nasopharyngeal swab samples; RT-PCR; Rapid antigen test; SARS-CoV-2.

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Conflict of interest statement

No conflict of interest is declared by the authors.

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