Abstract
Objective: 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.
Methods: 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.
Results: 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.
Conclusion: 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.
Keywords: SARS-CoV-2; cycle threshold; nasopharyngeal swab; saliva; self-collection; sensitivity.
【저자키워드】 SARS-CoV-2, Saliva, Nasopharyngeal swab, self-collection, cycle threshold, Sensitivity., 【초록키워드】 Symptom, drug, RT-PCR, FDA, Emergency use authorization, EUA, sensitivity, Symptomatic patients, Characteristics, Accuracy, nasopharyngeal, reverse transcription, NP swab, food, Cycle threshold value, individual, specimen, reference method, concordance rate, NP swabs, over, polymerase chain, tested, collected, examined, evaluated, exhibiting, saliva specimen, 【제목키워드】 detection, Sample,