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

Abstract

Background 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. Objective 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. Methods 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. Results 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. 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 the specimens were biologically sufficient. These data support the utility of participant-collected and mailed-in specimens for SARS-CoV-2 testing. International Registered Report Identifier (IRRID) RR2-10.2196/19054

At-home self-collection of saliva, oropharyngeal swabs and dried blood spots for SARS-CoV-2 diagnosis and serology: Post-collection acceptability of specimen collection process and patient confidence in specimens

“…The feedback of the participants is interpreted in light of the evaluation of the specimen quality by clinicians and laboratorians. [13] The specimens collected by these same participants were judged by clinicians to be suitable for laboratory testing (saliva: 97%; throat swab: 96%) and were found to have adequate nucleic acid for RNA PCR diagnostic testing (saliva: 100%; throat swab: 99%). [13].…”

“…[13] The specimens collected by these same participants were judged by clinicians to be suitable for laboratory testing (saliva: 97%; throat swab: 96%) and were found to have adequate nucleic acid for RNA PCR diagnostic testing (saliva: 100%; throat swab: 99%). [13]. Comparing the three measures in terms of the assessment of sufficiency of specimen collection, participants had the lowest confidence in the adequacy of their specimen collections; healthcare providers observing the collection and laboratorians processing the specimens were more confident in the sufficiency of the specimens.…”

“…The iCollect study recruited 159 US adults for a study of the acceptability and sufficiency of at-home self-collected samples for SARS-CoV-2 PCR and immune response testing. We have previously documented the study protocol [9] and demonstrated that specimens collected at home are considered suitable by telehealth clinicians and sufficient by laboratorians [13].After participants self-collected specimens, we asked them to rate the acceptability of the self-collection process, and of packaging and shipping specimens, and we asked participants for recommendations on how to improve the specimen self-collection process. Here, we describe the participant-reported acceptability of self-specimen collection and participant suggestions to improve the self-collection and shipping process.…”

Nucleic Acid and Immunological Diagnostics for SARS-CoV-2: Processes, Platforms and Pitfalls

“…In this study more than 96% of the saliva and OPS samples had sufficient quality for laboratory testing. One hundred percent of the OPS samples and 98% of the saliva samples had RNAse P threshold cycle (Ct) values greater than 30, indicating sufficient nucleic acid in the sample for SARS-CoV-2 PCR testing [ 19 ].…”

Misinterpretation of viral load in COVID-19

“…The copyright holder for this this version posted October 8, 2020. ; https://doi.org/10.1101/2020.10.06.20208009 doi: medRxiv preprint However, the amount of biological material retrieved by a swab could vary depending on the quality of the collection, thus a normalization attempt could prove useful when interpreting results (12). In the present work, we compared tracheal aspirate excluding the possibility of false negative due to the presence of eventual inhibitors or the quality and integrity of RNA samples (12). However, all human cells have a singlecopy of the RNase P gene that encodes the mRNA moiety for the RNAse P enzyme.…”