An evaluation of rapid antigen tests diagnostic performance in the detection of SARS-CoV-2 infection

A. M. Res, G. Bayram, Harun Gulbudak, Taylan Bozok, G. Aslan
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Abstract

Aim: The study aimed simultaneously compare the diagnostic performance of the rapid antigen test (CoVard COVID-19 Rapid Antigen Test Kit, Turkey) and the RT-PCR test used in the detection of SARS-CoV-2 infection. Materials and Methods: In this study, the results of rapid antigen tests and RT-PCR tests applied simultaneously to the diagnosis of SARS-CoV-2 infection on nasopharyngeal swab specimens taken from patients applying to the …… University Hospital Emergency Unit with various symptoms were retrospectively analyzed. The study included 308 patients with or without respiratory tract infection symptoms who underwent COVID-19 rapid antigen and RT-PCR testing. Results: It was observed that 157 (51.0%) of the patients had symptoms related to COVID-19. A total of 50 (16.2%; 95%CI: 12.0-20.5%) of the patients' rapid antigen test and 97 (31.5%; 95%CI: 26.3-37.0) of the patients' RT-PCR test were positive. The rapid antigen test for 41 (42.3%; 95%CI: 32.0-52.9) out of 97 specimens with a positive RT-PCR test was also positive. The rapid antigen test was positive in nine (18%; 95%CI: 8.6-28.6) specimens while the RT-PCR test was negative. The concordance between the rapid antigen test and the RT-PCR was intermediate (k=0.437, p<0.0005). Conclusion: Compared to nucleic acid-based tests, rapid antigen tests are practical and fast, as well as not requiring experienced personnel and special laboratory infrastructure. It was concluded that the use of rapid antigen tests will help provide rapid triage in emergency services, especially during the times when cases with COVID-19 are on the rise.
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快速抗原试验在检测SARS-CoV-2感染中的诊断效果评价
目的:本研究旨在同时比较快速抗原检测(CoVard COVID-19快速抗原检测试剂盒,土耳其)和RT-PCR检测在SARS-CoV-2感染中的诊断性能。材料与方法:回顾性分析在......大学医院急诊科就诊的不同症状患者鼻咽拭子标本中同时应用快速抗原检测和RT-PCR检测诊断SARS-CoV-2感染的结果。该研究包括308名有或无呼吸道感染症状的患者,他们接受了COVID-19快速抗原和RT-PCR检测。结果:157例(51.0%)患者出现新冠肺炎相关症状。共50例(16.2%;95%CI: 12.0 ~ 20.5%), 97% (31.5%;95%CI: 26.3 ~ 37.0)的患者RT-PCR检测呈阳性。快速抗原检测41例(42.3%);95%CI: 32.0-52.9)在97例RT-PCR检测阳性的标本中也呈阳性。快速抗原试验阳性9例(18%;95%CI: 8.6-28.6), RT-PCR检测为阴性。快速抗原检测结果与RT-PCR结果的一致性为中等(k=0.437, p<0.0005)。结论:与核酸检测相比,抗原快速检测实用、快捷,且不需要经验丰富的人员和专门的实验室基础设施。结论是,使用快速抗原检测将有助于在紧急服务中提供快速分诊,特别是在COVID-19病例呈上升趋势的时期。
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