Multiplatform Assessment of Saliva for SARS-CoV-2 Molecular Detection in Symptomatic Healthcare Personnel and Patients Presenting to the Emergency Department.

Robert F Potter, Eric M Ransom, Meghan A Wallace, Caitlin Johnson, Jennie H Kwon, Hilary M Babcock, Charles S Eby, Neil W Anderson, Bijal A Parikh, Carey-Ann D Burnham
Author Information
  1. Robert F Potter: Department of Pathology & Immunology, Washington University School of Medicine, St. Louis, MO, USA.
  2. Eric M Ransom: Department of Pathology & Immunology, Washington University School of Medicine, St. Louis, MO, USA.
  3. Meghan A Wallace: Department of Pathology & Immunology, Washington University School of Medicine, St. Louis, MO, USA.
  4. Caitlin Johnson: Department of Pathology & Immunology, Washington University School of Medicine, St. Louis, MO, USA.
  5. Jennie H Kwon: Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
  6. Hilary M Babcock: Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
  7. Charles S Eby: Department of Pathology & Immunology, Washington University School of Medicine, St. Louis, MO, USA.
  8. Neil W Anderson: Department of Pathology & Immunology, Washington University School of Medicine, St. Louis, MO, USA.
  9. Bijal A Parikh: Department of Pathology & Immunology, Washington University School of Medicine, St. Louis, MO, USA.
  10. Carey-Ann D Burnham: Department of Pathology & Immunology, Washington University School of Medicine, St. Louis, MO, USA.

Abstract

BACKGROUND: Saliva has garnered great interest as an alternative specimen type for molecular detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Data are limited on the relative performance of different molecular methods using saliva specimens and the relative sensitivity of saliva to nasopharyngeal (NP) swabs.
METHODS: To address the gap in knowledge, we enrolled symptomatic healthcare personnel (n = 250) from Barnes-Jewish Hospital/Washington University Medical Center and patients presenting to the Emergency Department with clinical symptoms compatible with coronavirus disease 2019 (COVID-19; n = 292). We collected paired saliva specimens and NP swabs. The Lyra SARS-CoV-2 assay (Quidel) was evaluated on paired saliva and NP samples. Subsequently we compared the Simplexa COVID-19 Direct Kit (Diasorin) and a modified SalivaDirect (Yale) assay on a subset of positive and negative saliva specimens.
RESULTS: The positive percent agreement (PPA) between saliva and NP samples using the Lyra SARS-CoV-2 assay was 63.2%. Saliva samples had higher SARS-CoV-2 cycle threshold values compared to NP swabs (P < 0.0001). We found a 76.47% (26/34) PPA for Simplexa COVID-19 Direct Kit on saliva and a 67.6% (23/34) PPA for SalivaDirect compared to NP swab results.
CONCLUSION: These data demonstrate molecular assays have variability in performance for detection of SARS-CoV-2 in saliva.

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MeSH Term

COVID-19
Delivery of Health Care
Emergency Service, Hospital
Humans
Nasopharynx
SARS-CoV-2
Saliva
Specimen Handling

Word Cloud

Created with Highcharts 10.0.0salivaNPSARS-CoV-2SalivamolecularspecimensswabsCOVID-19assaysamplescomparedPPAdetectioncoronavirusrelativeperformanceusingEmergencyDepartmentpairedLyraSimplexaDirectKitSalivaDirectpositiveBACKGROUND:garneredgreatinterestalternativespecimentypesevereacuterespiratorysyndrome2DatalimiteddifferentmethodssensitivitynasopharyngealMETHODS:addressgapknowledgeenrolledsymptomatichealthcarepersonneln = 250Barnes-JewishHospital/WashingtonUniversityMedicalCenterpatientspresentingclinicalsymptomscompatibledisease2019n = 292collectedQuidelevaluatedSubsequentlyDiasorinmodifiedYalesubsetnegativeRESULTS:percentagreement632%higherSARS-CoV-2 cyclethresholdvaluesP < 00001found7647%26/34676%23/34swabresultsCONCLUSION:datademonstrateassaysvariabilityMultiplatformAssessmentMolecularDetectionSymptomaticHealthcarePersonnelPatientsPresenting

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