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

• Published in: JMIR public health and surveillance Vol. 6; no. 2; p. e19731
• Main Authors: Guest, Jodie L, Sullivan, Patrick S, Valentine-Graves, Mariah, Valencia, Rachel, Adam, Elizabeth, Luisi, Nicole, Nakano, Mariko, Guarner, Jeannette, Del Rio, Carlos, Sailey, Charles, Goedecke, Zoe, Siegler, Aaron J, Sanchez, Travis H
• Format: Journal Article
• Language: English
• Published: Canada JMIR Publications 25.06.2020
• Subjects: Adolescent; Adult; Aged; Clinical Laboratory Techniques - methods; Cohort Studies; Coronavirus Infections - diagnosis; Coronavirus Infections - epidemiology; COVID-19; COVID-19 Testing; Dried Blood Spot Testing; Female; Health Services Research; Humans; Male; Middle Aged; Original Paper; Oropharynx - virology; Pandemics; Pilot Projects; Pneumonia, Viral - diagnosis; Pneumonia, Viral - epidemiology; Saliva - virology; Specimen Handling - methods; Telemedicine; Young Adult; COVID-19; pilot study; telehealth; testing; diagnosis; home testing; diagnostic
• ISSN: 2369-2960; 2369-2960
• DOI: 10.2196/19731

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