Forensic Medicine and Toxicology Department, University of Tripoli, Tripoli, Libya.
Genetic Engineering Department, Biotechnology Research Center, Tripoli, Libya.
J Med Virol. 2021 Dec;93(12):6512-6518. doi: 10.1002/jmv.27186. Epub 2021 Jul 28.
There is a great demand for more rapid tests for SARS-CoV-2 detection to reduce waiting time, boost public health strategies for combating disease, decrease costs, and prevent overwhelming laboratory capacities. This study was conducted to assess the performance of 10 lateral flow device viral antigen immunoassays for the detection of SARS-CoV-2 in nasopharyngeal swab specimens. We analyzed 231 nasopharyngeal samples collected from October 2020 to December 2020, from suspected COVID-19 cases and contacts of positive cases at Biotechnology Research Center laboratories, Tripoli, Libya. The performance of 10 COVID-19 Antigen (Ag) rapid test devices for the detection of SARS-CoV-2 antigen was compared to a quantitative reverse transcription-polymerase chain reaction (RT-qPCR). In this study, 161 cases had symptoms consistent with COVID-19. The mean duration from symptom onset was 6.6 ± 4.3 days. The median cycle threshold (C ) of positive samples was 25. Among the 108 positive samples detected by RT-qPCR, the COVID-19 antigen (Ag) tests detected 83 cases correctly. All rapid Ag test devices used in this study showed 100% specificity. While tests from six manufacturers had an overall sensitivity range from 75% to 100%, the remaining four tests had a sensitivity of 50%-71.43%. Sensitivity during the first 6 days of symptoms and in samples with high viral loads (C < 25), was 100% in all but two of the test platforms. False-negative samples had a median C of 34 and an average duration of onset of symptoms of 11.3 days (range = 5-20 days). Antigen test diagnosis has high sensitivity and specificity in early disease when patients present less than 7 days of symptom onset. Patients are encouraged to test as soon as they get COVID-19-related symptoms within 1 week and to seek medical advice within 24 h if they develop disturbed smell/taste. The use of rapid antigen tests is important for controlling the COVID-19 pandemic and reducing the burden on molecular diagnostic laboratories.
目前,人们迫切需要更快速的 SARS-CoV-2 检测方法,以缩短检测等待时间,助力疾病防控策略,降低成本,并防止实验室检测能力过载。本研究旨在评估 10 种侧向流动设备病毒抗原免疫测定法在检测鼻咽拭子样本中 SARS-CoV-2 的性能。我们分析了 2020 年 10 月至 12 月期间在利比亚的黎波里生物技术研究中心实验室收集的 231 份来自疑似 COVID-19 病例和阳性病例接触者的鼻咽样本。将 10 种 COVID-19 抗原(Ag)快速检测设备用于检测 SARS-CoV-2 抗原的性能与定量逆转录-聚合酶链反应(RT-qPCR)进行了比较。在这项研究中,161 例患者出现了符合 COVID-19 的症状。从症状出现到就诊的平均时间为 6.6±4.3 天。阳性样本的中位循环阈值(C)为 25。在通过 RT-qPCR 检测到的 108 个阳性样本中,COVID-19 抗原(Ag)检测正确检测到 83 个病例。本研究中使用的所有快速 Ag 检测试剂盒均具有 100%的特异性。虽然来自 6 家制造商的检测试剂盒的总体敏感性范围为 75%-100%,但其余 4 种检测试剂盒的敏感性为 50%-71.43%。在症状出现的前 6 天以及在病毒载量较高(C<25)的样本中,所有检测平台的敏感性均为 100%,除了两个平台之外。假阴性样本的中位 C 值为 34,症状出现的平均时间为 11.3 天(范围为 5-20 天)。在患者出现症状不足 7 天的早期疾病中,抗原检测具有较高的敏感性和特异性。鼓励患者在出现 COVID-19 相关症状后 1 周内尽快进行检测,如果出现嗅觉/味觉障碍,则在 24 小时内寻求医疗建议。快速抗原检测对于控制 COVID-19 大流行和减轻分子诊断实验室的负担非常重要。