Suitability and Sufficiency of Telehealth Clinician-Observed, Participant-Collected Samples for SARS-CoV-2 Testing: The iCollect Cohort Pilot Study

• DOI: 10.2196/19731
• Publication Date: 2020-05-29T17:07:32Z
• Authors: Jodie L Guest; Patrick S Sullivan; Mariah Valentine-...; Rachel Valencia; Elizabeth Adam; Nicole Luisi; Mariko Nakano; Jeannette Guarner; Carlos del Rio; Charles Sailey; Zoe Goedecke; Aaron J Siegler; Travis H Sanchez
• Keywords: Telehealth

Background The severe acute respiratory coronavirus 2 (SARS-CoV-2) pandemic calls for expanded opportunities testing, including novel testing strategies such as home-collected specimens. Objective We aimed to understand whether oropharyngeal swab (OPS), saliva, and dried blood spot (DBS) specimens collected by participants at home mailed a laboratory were sufficient use in diagnostic serology tests of SARS-CoV-2. Methods Eligible consented online participant-collection kit support collection three SARS-CoV-2 testing: OPS, DBS. Participants performed the specimen procedures during telehealth video appointment while clinical observers watched documented suitability collection. biological sufficiency detection reverse transcriptase–polymerase chain reaction was assessed laboratorians using visual inspection quantification nucleic acid contents samples ribonuclease P (RNase P) measurements. Results Of enrolled participants,153/159 (96.2%) returned their kits, which included this analysis. All these attended appointments. Clinical that collected, 147/153 (96.1%) saliva samples, 146/151 (96.7%) 135/145 (93.1%) DBS quality submission testing; 100% OPS 98% had cycle threshold values RNase <30, indicating contained RNA-PCR Conclusions These pilot data indicate most participant-collected are suitable RNA serology. rated quantitative assessment indicated biologically sufficient. utility mailed-in testing. International Registered Report Identifier (IRRID) RR2-10.2196/19054