Gaziantep Dr. Ersin Arslan Training and Research Hospital Medical Microbiology Laboratory, Gaziantep, Turkey.
Faculty of Medicine Department of Medical Microbiology, Akdeniz University, Antalya, Turkey.
Infection. 2023 Feb;51(1):91-96. doi: 10.1007/s15010-022-01832-9. Epub 2022 May 5.
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.
实时逆转录聚合酶链反应（RT-PCR）检测呼吸道标本中严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的分子诊断被认为是金标准方法。该方法高度敏感且特异，但也存在一些局限性，如昂贵、需要特殊的实验室设备和熟练的人员。RapidFor™抗原快速检测试剂盒是一种商业化的 Ag-RDT，由土耳其生产，旨在检测鼻咽拭子样本中 SARS-CoV-2 的核衣壳抗原。本研究旨在评估该新型 SARS-CoV-2 抗原检测方法的性能，以 RT-PCR 方法为金标准。2020 年 9 月至 2021 年 2 月期间，从土耳其 10 个中心符合 COVID-19 临床标准的患者中收集了 444 份鼻咽拭子样本，纳入本研究。所有鼻咽拭子样本均根据制造商的说明使用商业 RT-PCR 试剂盒（Bioeksen 和 A1 Lifesciences，伊斯坦布尔，土耳其）检测 SARS-CoV-2 RNA。根据 Ct 值评估病毒载量。按照制造商的说明，使用 RapidFor™SARS-CoV-2 抗原检测试剂盒（Vitrosens Biotechnology，伊斯坦布尔，土耳其）检测所有样本中 SARS-CoV-2 抗原的存在。在 444 份鼻咽拭子样本中，346 份（77.9%）通过 RT-PCR 检测为 SARS-CoV-2 RNA 阳性，98 份（22.1%）为阴性。RapidFor™抗原快速检测试剂盒的总体敏感性为 80.3%，特异性为 87.8%。Ct 值超过 25 且低于 30 的样本中快速抗原检测的阳性率为 82.7%，而 Ct 值为 20≤且<25 的样本中阳性率增加至 95.7%，Ct 值低于 20 的样本中阳性率达到 100%。RapidFor™SARS-CoV-2 Ag 检测可能是对症状性和无症状性患者及其接触者进行早期隔离措施筛查的一个不错选择，其优势在于比 RT-PCR 更快速、简便，并且适用于每个实验室，甚至在护理点。
