tetano
Editor, Senior Moderator
J Mol Diagn
. 2020 Nov 17;S1525-1578(20)30541-9.
doi: 10.1016/j.jmoldx.2020.10.018. Online ahead of print.
Performance of SARS-CoV-2 Real-time RT-PCR Tests on Oral Rinses and Saliva Samples
N Esther Babady[SUP] 1 [/SUP], Tracy McMillen[SUP] 2 [/SUP], Krupa Jani[SUP] 2 [/SUP], Agnes Viale[SUP] 3 [/SUP], Elizabeth V Robilotti[SUP] 4 [/SUP], Anoshe Aslam[SUP] 4 [/SUP], Maureen Diver[SUP] 5 [/SUP], Desiree Sokoli[SUP] 5 [/SUP], Greg Mason[SUP] 4 [/SUP], Monika K Shah[SUP] 4 [/SUP], Deborah Korenstein[SUP] 4 [/SUP], Mini Kamboj[SUP] 4 [/SUP]
Affiliations
Abstract
Access to rapid and accurate detection of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA is essential for controlling the current global pandemic of Coronavirus Disease 2019 (COVID-19). In this study, the use of oral rinses and posterior oropharyngeal saliva as an alternative to swab collection methods from symptomatic and asymptomatic healthcare workers for the detection of SARS-CoV-2 RNA by RT-PCR was evaluated. For saliva samples, the overall agreement with oropharyngeal swabs (OPS) was 93% (Ƙ=0.84) with a sensitivity of 96.7% (95%CI:83.3-99.8%). The agreement between saliva and nasopharyngeal swabs was 97.7% (Ƙ=0.93) with a sensitivity of 94.1% (95% CI:73.0-99.7%). Oral rinses were compared with NPS only, with an overall agreement of 85.7% (Ƙ=0.65), and a sensitivity of 63% (95% CI:46.6-77.8%). The agreement between a laboratory-developed test based on the CDC RT-PCR and two commercial assays, the Xpert Xpress SARS-CoV-2 and the Cobas SARS-CoV-2 was also evaluated. The overall agreement was higher than 90%. Finally, SARS-CoV-2 RNA in saliva samples was shown to be stable, with no changes in viral loads over 24 hours at both room temperature and 4?C. While the dilution of SARS-CoV-2 in oral rinses precluded its acceptability as a sample type, posterior oropharyngeal saliva was an acceptable alternative sample type for SARS-CoV-2 RNA detection.
. 2020 Nov 17;S1525-1578(20)30541-9.
doi: 10.1016/j.jmoldx.2020.10.018. Online ahead of print.
Performance of SARS-CoV-2 Real-time RT-PCR Tests on Oral Rinses and Saliva Samples
N Esther Babady[SUP] 1 [/SUP], Tracy McMillen[SUP] 2 [/SUP], Krupa Jani[SUP] 2 [/SUP], Agnes Viale[SUP] 3 [/SUP], Elizabeth V Robilotti[SUP] 4 [/SUP], Anoshe Aslam[SUP] 4 [/SUP], Maureen Diver[SUP] 5 [/SUP], Desiree Sokoli[SUP] 5 [/SUP], Greg Mason[SUP] 4 [/SUP], Monika K Shah[SUP] 4 [/SUP], Deborah Korenstein[SUP] 4 [/SUP], Mini Kamboj[SUP] 4 [/SUP]
Affiliations
- PMID: 33217552
- PMCID: PMC7670901
- DOI: 10.1016/j.jmoldx.2020.10.018
Abstract
Access to rapid and accurate detection of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA is essential for controlling the current global pandemic of Coronavirus Disease 2019 (COVID-19). In this study, the use of oral rinses and posterior oropharyngeal saliva as an alternative to swab collection methods from symptomatic and asymptomatic healthcare workers for the detection of SARS-CoV-2 RNA by RT-PCR was evaluated. For saliva samples, the overall agreement with oropharyngeal swabs (OPS) was 93% (Ƙ=0.84) with a sensitivity of 96.7% (95%CI:83.3-99.8%). The agreement between saliva and nasopharyngeal swabs was 97.7% (Ƙ=0.93) with a sensitivity of 94.1% (95% CI:73.0-99.7%). Oral rinses were compared with NPS only, with an overall agreement of 85.7% (Ƙ=0.65), and a sensitivity of 63% (95% CI:46.6-77.8%). The agreement between a laboratory-developed test based on the CDC RT-PCR and two commercial assays, the Xpert Xpress SARS-CoV-2 and the Cobas SARS-CoV-2 was also evaluated. The overall agreement was higher than 90%. Finally, SARS-CoV-2 RNA in saliva samples was shown to be stable, with no changes in viral loads over 24 hours at both room temperature and 4?C. While the dilution of SARS-CoV-2 in oral rinses precluded its acceptability as a sample type, posterior oropharyngeal saliva was an acceptable alternative sample type for SARS-CoV-2 RNA detection.