A direct, real-time reverse transcriptase PCR test on pooled saliva was validated in 2,786 participants against oropharyngeal swabs. Among asymptomatic/pre-symptomatic participants, the test was found to be in 99.21% agreement and 45% more sensitive than contemporaneous oropharyngeal swabs. The test was then used for surveillance testing on 44,242 saliva samples from asymptomatic participants. Those whose saliva showed evidence of SARS-CoV-2 within 50 cycles of amplification were referred for confirmatory testing, with 87% of those tested by nasal swab within 72 hours receiving a positive diagnostic result on Abbott ID NOW or real-time PCR platforms. Median Ct values on the saliva PCR for those with a positive and negative confirmatory tests was 30.67 and 35.92 respectively, however, binary logistic regression analysis of the saliva Ct values indicates that Ct thresholds as high as 47 may be useful in a surveillance setting. Overall, data indicate that direct RT-PCR testing of pooled saliva samples is an effective method of SARS-CoV-2 surveillance.
【초록키워드】 SARS-CoV-2, Saliva, diagnostic, amplification, PCR, Asymptomatic, Surveillance, Real-time PCR, nasal swab, PCR test, Evidence, SARS-CoV-2 surveillance, Ct values, Abbott, evidence of, reverse transcriptase, Logistic regression analysis, Participants, RT-PCR testing, oropharyngeal swabs, participant, saliva samples, positive, surveillance testing, confirmatory tests, effective, binary logistic regression analysis, real-time reverse transcriptase, tested, receiving, indicate, Ct threshold, 【제목키워드】 COVID-19, validation, real-time RT-PCR test,