Department of Laboratory Medicine and Pathology, Mayo Clinic, Jacksonville, FL, USA.
Division of Community, Internal Medicine, Mayo Clinic, Jacksonville, FL, USA.
Lab Med. 2022 Nov 3;53(6):580-584. doi: 10.1093/labmed/lmac051.
Using a US Food and Drug Administration (FDA) emergency use authorization (EUA) reverse transcription polymerase chain reaction (RT-PCR) method, we examined the analytic performance accuracy of saliva specimens as compared to nasopharyngeal (NP) specimens in symptomatic patients. Correlation between test results and symptoms was also evaluated.
Over a 5-week period in 2020, 89 matched saliva and nasopharyngeal swabs were collected from individuals exhibiting symptoms consistent with SARS-CoV-2. Specimens were tested with an FDA EUA-approved RT-PCR method, and performance characteristics were compared.
The concordance rate between saliva and nasopharyngeal testing was 93.26%. The mean cycle threshold value of saliva when compared to the NP specimen was 3.56 cycles higher. As compared to NP swab, saliva testing demonstrates acceptable agreement but lower sensitivity.
When compared to a reference method using NP swabs, the use of saliva testing proved to be a reliable method. Self-collected saliva testing for SARS-CoV-2 allows for a viable option when trained staff or collection materials are in short supply.
使用美国食品和药物管理局（FDA）紧急使用授权（EUA）逆转录聚合酶链反应（RT-PCR）方法，我们比较了唾液标本与鼻咽（NP）标本在有症状患者中的分析性能准确性。还评估了检测结果与症状之间的相关性。
在 2020 年的 5 周期间，从表现出与 SARS-CoV-2 一致症状的个体中采集了 89 对匹配的唾液和鼻咽拭子。使用 FDA EUA 批准的 RT-PCR 方法对标本进行检测，并比较了性能特征。
唾液和鼻咽检测之间的符合率为 93.26%。与 NP 标本相比，唾液的平均循环阈值高 3.56 个循环。与 NP 拭子相比，唾液检测具有可接受的一致性，但敏感性较低。
与使用 NP 拭子的参考方法相比，唾液检测被证明是一种可靠的方法。当训练有素的工作人员或采集材料短缺时，自我采集的唾液检测是一种可行的选择。
