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

Autor: Cirit OS; Gaziantep Dr. Ersin Arslan Training and Research Hospital Medical Microbiology Laboratory, Gaziantep, Turkey. osmancirit@yahoo.com., Mutlu E; Faculty of Medicine Department of Medical Microbiology, Akdeniz University, Antalya, Turkey., Sancak B; Faculty of Medicine Department of Medical Microbiology, Hacettepe University, Ankara, Turkey., Kocagöz T; School of Medicine Department of Medical Microbiology and Medical Biotechnology, Acibadem University, Istanbul, Turkey., Can Ö; Acibadem University School of Medical Engineering, Istanbul, Turkey., Çicek C; Faculty of Medicine Department of Medical Microbiology, Ege University, Izmir, Turkey., Arzu Sayiner A; Dokuz Eylül University Faculty of Medicine Department of Medical Microbiology, Izmir, Turkey., Appak Ö; Dokuz Eylül University Faculty of Medicine Department of Medical Microbiology, Izmir, Turkey., Uyar NY; School of Medicine Department of Medical Microbiology, Acibadem University, Istanbul, Turkey., Külah C; Acibadem Labmed, Istanbul, Turkey., Çiçek AÇ; Faculty of Medicine Department of Medical Microbiology, Recep Tayyip Erdogan University, Rize, Turkey., Özgümüs OB; Faculty of Medicine Department of Medical Microbiology, Recep Tayyip Erdogan University, Rize, Turkey., Ay Altintop Y; Kayseri City Training and Research Hospital Medical Microbiology Laboratory, Kayseri, Turkey., Saatçi E; Kayseri City Training and Research Hospital Medical Microbiology Laboratory, Kayseri, Turkey., Karsligil T; Faculty of Medicine Department of Medical Microbiology, Gaziantep University, Gaziantep, Turkey., Zer Y; Faculty of Medicine Department of Medical Microbiology, Gaziantep University, Gaziantep, Turkey., Özen NS; University of Health Sciences Antalya Training and Research Hospital Medical Microbiology Laboratory, Antalya, Turkey., Çekin Y; University of Health Sciences Antalya Training and Research Hospital Medical Microbiology Laboratory, Antalya, Turkey., Karahan ZC; Faculty of Medicine Department of Medical Microbiology, Ankara University, Ankara, Turkey., Evren E; Faculty of Medicine Department of Medical Microbiology, Ankara University, Ankara, Turkey., Karakoç AE; University of Health Sciences Ankara Training and Research Hospital Medical Microbiology Laboratory, Ankara, Turkey., Orhan SG; University of Health Sciences Ankara Training and Research Hospital Medical Microbiology Laboratory, Ankara, Turkey., Mutlu D; Faculty of Medicine Department of Medical Microbiology, Hacettepe University, Ankara, Turkey., Bozdemir T; Faculty of Medicine Department of Medical Microbiology, Hacettepe University, Ankara, Turkey., Çayci YT; Faculty of Medicine Department of Medical Microbiology, Ondokuz Mayis University, Samsun, Turkey., Çinar C; Faculty of Medicine Department of Medical Microbiology, Ondokuz Mayis University, Samsun, Turkey., Tasbakan M; Faculty of Medicine Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, Turkey., Mert M; Faculty of Medicine Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, Turkey., Çinar E; Faculty of Medicine Department of Physical Medicine and Rehabilitation, Ege University, Izmir, Turkey., Kutsoylu OÖE; Dokuz Eylül University Faculty of Medicine Department of Infectious Diseases and Clinical Microbiology, Izmir, Turkey., Kocagöz S; Department of Infectious Diseases and Clinical Microbiology, Acibadem University School of Medicine, Istanbul, Turkey., Ertürk A; Faculty of Medicine Department of Infectious Diseases and Clinical Microbiology, Recep Tayyip Erdogan University, Rize, Turkey., Çelik I; Diseases and Clinical Microbiology Department, Kayseri City Training and Research Hospital Infectious, Kayseri, Turkey., Mete AÖ; Faculty of Medicine Department of Infectious Diseases and Clinical Microbiology, Gaziantep University, Gaziantep, Turkey., Günalp Eneyli M; Faculty of Medicine Department of Emergency Medicine, Ankara University, Ankara, Turkey., Akdemir I; Faculty of Medicine Department of Infectious Diseases and Clinical Microbiology, Ankara University, Ankara, Turkey., Karakök T; Diseases and Clinical Microbiology Department, University of Health Sciences Ankara Training and Research Hospital Infectious, Ankara, Turkey., Inan D; Faculty of Medicine Department of Infectious Diseases and Clinical Microbiology, Akdeniz University, Antalya, Turkey., Atilla A; Faculty of Medicine Department of Infectious Diseases and Clinical Microbiology, Ondokuz Mayis University, Samsun, Turkey., Taflan ŞO; Vitrosens Biotechnology, Istanbul, Turkey., Yörük KE; Vitrosens Biotechnology, Istanbul, Turkey.
Jazyk: angličtina
Zdroj: Infection [Infection] 2023 Feb; Vol. 51 (1), pp. 91-96. Date of Electronic Publication: 2022 May 05.
DOI: 10.1007/s15010-022-01832-9
Abstrakt: 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.
(© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)
Databáze: MEDLINE
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