We assessed the performance, stability, and user acceptability of swab-independent self-collected saliva and saline mouth rinse/gargle sample types for the molecular detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults and school-aged children. Outpatients who had recently been diagnosed with COVID-19 or were presenting with suspected COVID-19 were asked to have a nasopharyngeal (NP) swab collected and provide at least one self-collected sample type. Participants were also asked about sample acceptability using a five-point Likert scale. For those previously diagnosed with COVID-19, all samples underwent real-time PCR testing using a lab-developed assay, and the majority were also tested using an FDA-authorized assay. For those presenting with suspected COVID-19, only those with a positive nasopharyngeal swab sample went on to have other samples tested. Saline mouth rinse/gargle and saliva samples were tested daily at time zero, day 1, and day 2 to assess nucleic acid stability at room temperature. Fifty participants (aged 4 to 71 years) were included; of these, 40 had at least one positive sample and were included in the primary sample yield analysis. Saline mouth rinse/gargle samples had a sensitivity of 98% (39/40), while saliva samples had a sensitivity of 79% (26/33). Both saline mouth rinse/gargle and saliva samples showed stable viral RNA detection after 2 days of room temperature storage. Mouth rinse/gargle samples had the highest (mean, 4.9) and health care worker (HCW)-collected NP swabs had the lowest acceptability scores (mean, 3.1). In conclusion, saline mouth rinse/gargle samples demonstrated higher combined user acceptability ratings and analytical performance than saliva and HCW-collected NP swabs. This sample type is a promising swab-independent option, particularly for outpatient self-collection in adults and school-aged children.

中文翻译：

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自收集的盐水含漱液样本可替代医护人员收集的鼻咽拭子，用于门诊患者的COVID-19诊断

我们评估了独立于拭子的唾液和盐水漱口/含漱液样本类型的性能，稳定性和用户可接受性，用于成人和学龄期严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的分子检测孩子们。要求最近被诊断出患有COVID-19或出现疑似COVID-19的门诊患者收集鼻咽（NP）拭子，并提供至少一种自我收集的样本类型。还使用五点李克特量表向参与者询问了样品的可接受性。对于先前被诊断为COVID-19的患者，所有样品均使用实验室开发的测定法进行了实时PCR测试，并且大多数样品也使用了FDA授权的测定法进行了测试。对于那些怀疑带有COVID-19的人，只有那些鼻咽拭子样本为阳性的人才继续进行其他样本的测试。每天在零时，第1天和第2天每天测试盐水漱口水/漱口水和唾液样品，以评估室温下的核酸稳定性。包括五十名参与者（年龄在4至71岁之间）；其中，有40个样品至少有一个阳性样品，并包含在初级样品产率分析中。盐水漱口/含漱液样本的灵敏度为98％（39/40），而唾液样本的灵敏度为79％（26/33）。室温保存2天后，盐水漱口水/漱口水和唾液样品均显示出稳定的病毒RNA检测。漱口/含漱液样本的最高（平均值为4.9），卫生保健工作者（HCW）收集的NP拭子的可接受性得分最低（平均值为3.1）。综上所述，盐水漱口/含漱液样本的唾液和HCW收集的NP棉签显示出更高的综合用户可接受性等级和分析性能。这种样本类型是一种有前途的拭子独立选择，特别是对于成年人和学龄儿童的门诊自我采集。