The Use of Saliva as a Diagnostic Specimen for SARS CoV-2 Molecular Diagnostic Testing for Pediatric Patients

Meghan Delaney, Joelle Simpson, Bobbe Thomas, Christal Ralph, Michael Evangalista, Mahdi Moshgriz, Joyce Granados, Mark McGuire, Roberta DeBiasi, Joseph Campos
2021 Acta Scientific Medical Sciences  
Testing children for COVID-19 via sensitive molecular methods is important, although collecting nasopharyngeal (NP) specimens can be challenging. A less invasive specimen collection approach that yields test results comparable to those from NP specimens would be beneficial to simplify sample collection. Methods: To demonstrate that saliva is a suitable specimen for testing children, the clinical usability and the analytic performance of saliva were compared to NP specimens suspended in viral
more » ... nsport medium. Four different FDA EUA-approved molecular assays and one EUA approved saliva collection device were investigated. Results: There were 526 patients aged 3 and 61 years, 461 (88%) were <18 years, 425 were asymptomatic (81.1%), 92 were symptomatic (17.6%). Saliva mixed with stabilizing buffer was found to yield comparable sensitivity to NP specimens when tested on the AllPlex SARS-CoV-2 molecular test (Seegene Inc). The analytic sensitivity of the AllPlex assay with SpectrumDNA saliva stabilizer was found to be 250 genomic copies/mL. Conclusions: Of the four SARS-CoV-2 assays studied, we found the AllPlex assay to be best suited for testing saliva collected from children 5 years of age or older. The sensitivity of viral detection was equivalent to NP specimens when saliva specimens were mixed with the saliva stabilizer.
doi:10.31080/asmi.2021.04.0798 fatcat:dadouqwxczatdldmiyy2hcch2m