Accepted for/Published in: JMIR Public Health and Surveillance
Date Submitted: May 4, 2020
Date Accepted: May 29, 2020
Date Submitted to PubMed: Jun 1, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Suitability and Sufficiency of telehealth clinician-observed participant-collected samples for SARS-CoV2 testing: the iCollect Cohort Pilot Study
ABSTRACT
Background:
The SARS-CoV-2 pandemic calls for expanded opportunities for testing, including novel testing strategies like participant-collected specimens. 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.
Objective:
To assess the suitability (by clinician observation) and sufficiency (by laboratory assessment of specimens) of participant-collected samples to be analyzed for SARS-CoV-2 RNA and serology.
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 clinicians observed through a telehealth video meeting 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. All attended their video session. Clinicians assessed that 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 <30, 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. Observing clinicians 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.
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