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口咽拭子标本用于 SARS-CoV-2 检测的快速床边侧向流动抗原检测的诊断性能。

Diagnostic performance of oral swab specimen for SARS-CoV-2 detection with rapid point-of-care lateral flow antigen test.

机构信息

Division of Microbiology, ICMR-National AIDS Research Institute, 73, G block, MIDC, Bhosari, Pune, Maharashtra, India.

Old Bhosari Hospital, Bhosari, Pune, Maharashtra, India.

出版信息

Sci Rep. 2022 May 5;12(1):7355. doi: 10.1038/s41598-022-11284-8.

Abstract

We evaluated the performance of oral swab specimen both health-care worker (HCW) collected and self-collected for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) detection with rapid antigen test (RAT) as compared to reverse transcriptase polymerase chain reaction (RT-PCR). Of the 529 participants enrolled, 121 (22.8%) were RT-PCR positive. Among the RT-PCR positives, 62 (51.2%) were RAT positive using oral swab. When compared with RT-PCR, RAT with oral swab had sensitivity and specificity of 63.3 and 96.8% respectively among symptomatic individuals. No statistically significant difference was observed in RAT positivity with HCW collection and self-collection, p = 0.606. Ct values were significantly lower in RT-PCR and RAT positive samples (ORF gene: 18.85 ± 4.36; E gene: 18.72 ± 4.84) as compared to RT-PCR positive and RAT negative samples (ORF gene: 26.98 ± 7.09; E gene: 26.97 ± 7.07), p < 0.0001. Our study demonstrated moderate sensitivity of RAT with oral swab in symptomatic individuals. Oral swab was the preferred sampling by almost all participants in terms of convenience and comfort as compared to nasopharyngeal swab. Oral swabs have utility for SARS-CoV-2 antigen detection among symptomatic individuals residing in remote rural areas and can serve as an initial screening tool during COVID-19 spikes when cases rise exponentially and laboratory capacities for RT-PCR testing become overwhelmed.

摘要

我们评估了医护人员(HCW)采集和自我采集的口咽拭子标本在使用快速抗原检测(RAT)与逆转录聚合酶链反应(RT-PCR)检测严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2)方面的性能。在纳入的 529 名参与者中,有 121 名(22.8%)RT-PCR 阳性。在 RT-PCR 阳性者中,62 名(51.2%)使用口咽拭子的 RAT 阳性。与 RT-PCR 相比,在有症状者中,RAT 与口咽拭子的敏感性和特异性分别为 63.3%和 96.8%。在 HCW 采集和自我采集的 RAT 阳性率方面,差异无统计学意义(p=0.606)。与 RT-PCR 和 RAT 阴性样本相比,RT-PCR 和 RAT 阳性样本的 Ct 值显著降低(ORF 基因:18.85±4.36;E 基因:18.72±4.84),p<0.0001。我们的研究表明,在有症状者中,RAT 与口咽拭子的敏感性为中等。与鼻咽拭子相比,口咽拭子在便利性和舒适性方面几乎得到了所有参与者的青睐。在 COVID-19 病例呈指数级增长且 RT-PCR 检测能力不堪重负时,对于居住在偏远农村地区的有症状者,口咽拭子可作为 SARS-CoV-2 抗原检测的一种有效手段,作为初始筛查工具。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6339/9072408/a35bdb33bd41/41598_2022_11284_Fig1_HTML.jpg

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