Virology Unit (UNVIR-CONICET), Centro de Educación Médica e Investigaciones Clínicas (CEMIC) University Hospital, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Virology Laboratory, Centro de Educación Médica e Investigaciones Clínicas (CEMIC) University Hospital, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
J Med Virol. 2021 May;93(5):3268-3272. doi: 10.1002/jmv.26839. Epub 2021 Feb 23.
Current diagnostic standards involve severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection in nasopharyngeal swabs (NPS), but saliva is an attractive and noninvasive option for diagnosis. The objectives were to determine the performance of saliva in comparison with NPS for detecting SARS-CoV-2 and to compare the optimized home brew reverse-transcription polymerase chain reaction (RT-PCR) with a commercial RT-PCR. Paired NPS and saliva specimens were prospectively collected and tested by RT-PCR from patients presenting at an emergency room with signs and symptoms compatible with coronavirus disease-2019. A total of 348 samples from 174 patients were tested by RT-PCR assays. Among 174 patients with symptoms, 63 (36%) were SARS-CoV-2 positive in NPS using the optimized home-brew PCR. Of these 63 patients, 61 (98%) were also positive in saliva. An additional positive SARS-CoV-2 saliva was detected in a patient with pneumonia. Kappa Cohen's coefficient agreement between NPS and saliva was 0.96 (95% confidence interval [CI], 0.90-0.99). Median Ct values in NPS versus saliva were 18.88 (interquartile range [IQR], 15.60-23.58; range, 11.97-38.10) versus 26.10 (IQR, 22.75-30.06; range, 13.78-39.22), respectively (p < .0001). The optimized home-brew RT-PCR demonstrated higher analytical and clinical sensitivity compared with the commercial RT-PCR assay. A high sensitivity (98%) and agreement (kappa 0.96) in saliva samples compared to NPS was demonstrated when using an optimized home-brew PCR even when the viral load in saliva was lower than in NPS. This noninvasive sample is easy to collect, requires less consumable and avoids discomfort to patients. Importantly, self-collection of saliva can diminish exposure to healthcare personnel.
目前的诊断标准包括在鼻咽拭子(NPS)中检测严重急性呼吸综合征冠状病毒 2(SARS-CoV-2),但唾液是一种有吸引力且非侵入性的诊断选择。目的是确定唾液在检测 SARS-CoV-2 方面与 NPS 的性能,并比较优化的家用逆转录聚合酶链反应(RT-PCR)与商业 RT-PCR。前瞻性收集了来自因符合 2019 年冠状病毒病症状和体征而到急诊室就诊的患者的配对 NPS 和唾液标本,并通过 RT-PCR 进行检测。共对 174 例有症状患者的 348 份样本进行了 RT-PCR 检测。在 174 例有症状患者中,63 例(36%)在 NPS 中使用优化的家用 PCR 检测呈 SARS-CoV-2 阳性。在这 63 例患者中,61 例(98%)在唾液中也呈阳性。在一位患有肺炎的患者中还检测到了另一个阳性 SARS-CoV-2 唾液样本。NPS 和唾液之间的 Cohen Kappa 系数一致性为 0.96(95%置信区间 [CI],0.90-0.99)。NPS 与唾液中的中位数 Ct 值分别为 18.88(四分位距 [IQR],15.60-23.58;范围,11.97-38.10)和 26.10(IQR,22.75-30.06;范围,13.78-39.22)(p<0.0001)。与商业 RT-PCR 检测相比,优化的家用 RT-PCR 显示出更高的分析和临床灵敏度。当使用优化的家用 PCR 时,唾液样本的灵敏度(98%)和一致性(kappa 0.96)均高于 NPS,即使唾液中的病毒载量低于 NPS。这种非侵入性样本易于采集,所需耗材更少,且不会给患者带来不适。重要的是,患者自行采集唾液可以减少对医护人员的暴露。