Dan Med J. 2021 Apr 7;68(5):A01210087.
The reference test to evaluate patients with suspected respiratory virus infection is a real-time reverse transcription-polymerase chain reaction (RT-PCR) from a nasopharyngeal swab (NPS). However, other specimen collection methods such as an oropharyngeal swab (OPS) or saliva specimen are also used for SARS-CoV-2 testing during the ongoing COVID-19 pandemic. However, it remains unclear if rates of SARS-CoV-2 detection differ between sampling methods. This study will compare the rates of SARS-CoV-2 detection by saliva, OPS, and NPS sampling in a public setting.
Individuals referred for outpatient SARS-CoV-2 testing will be invited to participate in a prospective clinical study. They will have saliva, OPS and NPS specimens collected that will be analysed separately for SARS-CoV-2 RNA by RT-PCR. The rate of SARS-CoV-2 detection in saliva, OPS and NPS will be compared using a logistic regression mixed-effect model analysis. A sample of 19,110 participants is required at an expected 1.5% test-positive rate in order to detect a 25.6% difference. The total sample size will be adjusted as the test-positive rate changes.
This study will provide evidence for the optimal site of specimen collection to detect SARS-CoV-2. The results may help guide the health authorities.
This is an investigator-initiated trial based on an unrestricted grant from the Novo Nordisk Foundation and the Aage og Johanne Louis-Hansens Fond. The foundations have had no say in the decisions on study design or reporting.
ClinicalTrials.gov (ID: NCT04715607).
评估疑似呼吸道病毒感染患者的参考检测方法是对鼻咽拭子（NPS）进行实时逆转录聚合酶链反应（RT-PCR）。然而，在当前的 COVID-19 大流行期间，也使用其他标本采集方法，如口咽拭子（OPS）或唾液标本，用于 SARS-CoV-2 检测。然而，目前尚不清楚不同采样方法检测 SARS-CoV-2 的检出率是否存在差异。本研究将比较唾液、OPS 和 NPS 采样方法在公共场所检测 SARS-CoV-2 的检出率。
将邀请因门诊 SARS-CoV-2 检测而转介的个体参加一项前瞻性临床研究。将采集唾液、OPS 和 NPS 标本，分别通过 RT-PCR 分析 SARS-CoV-2 RNA。使用逻辑回归混合效应模型分析比较唾液、OPS 和 NPS 中 SARS-CoV-2 的检出率。预计检测阳性率为 1.5%，需要 19,110 名参与者的样本，以检测出 25.6%的差异。总样本量将根据检测阳性率的变化进行调整。
本研究将为检测 SARS-CoV-2 提供最佳标本采集部位的证据。研究结果可能有助于指导卫生当局。
这是一项基于诺和诺德基金会和 Aage og Johanne Louis-Hansens 基金会的一项不受限制赠款的研究者发起的试验。这两个基金会对研究设计或报告的决策没有发言权。
ClinicalTrials.gov（编号：NCT04715607）。
