Suitability and Sufficiency of telehealth clinician-observed participant-collected samples for SARS-CoV2 testing: the iCollect Cohort Pilot Study

BACKGROUND: The SARS-CoV-2 pandemic calls for expanded opportunities for testing, including novel testing strategies like participant-collected specimens OBJECTIVE: We aimed to understand whether oropharyngeal swab (OPS), saliva and dried blood spot (DBS) specimens participant-collected at home and mailed to a laboratory were sufficient for use in diagnostic and serology tests METHODS: Eligible participants were consented online and mailed a participant-collection kit to support collection of three specimens for SARS-CoV-2 testing;saliva, OPS, and DBS Participants performed specimen collection while clinical observers watched through a telehealth video appointment and documented the suitability of the collection The biological sufficiency of specimens for detection of SARS-CoV-2 by RT-PCR and serology testing was assessed by laboratorians using visual inspection and quantification of nucleic acid content of samples by RNase P measurements RESULTS: One hundred and fifty-three participants returned their kits and are included in this analysis (out of 159 enrolled (96%) All attended their video appointments Clinical observers assessed that, of the samples collected, 96% of saliva, 97% of OPS and 93% of the DBS samples were of sufficient quality for submission for laboratory testing;100% OPS and 99% of saliva had Ct values RNase P l30, indicating sufficient nucleic acid for RNA-PCR testing for SARS-CoV-2 CONCLUSIONS: These pilot data indicate that most participant-collected OPS, saliva and DBS specimens are suitable and sufficient for testing for SARS-CoV-2 RNA and serology Clinical observers rated the collection of specimens as suitable for testing and visual and quantitative laboratory assessment indicated that specimens were biologically sufficient These data support the utility of participant-collected and mailed-in specimens for SARS-CoV-2 INTERNATIONAL REGISTERED REPORT: RR2-10 2196/19054