Comparison of a Blood Self-Collection System with Routine Phlebotomy for SARS-CoV-2 Antibody Testing

Abstract

The Coronavirus Disease 2019 (COVID-19) pandemic forced researchers to reconsider in-person assessments due to transmission risk. We conducted a pilot study to evaluate the feasibility of using the Tasso-SST (Tasso, Inc, Seattle, Washington) device for blood self-collection for use in SARS-CoV-2 antibody testing in an ongoing COVID-19 prevalence and immunity research study. 100 participants were recruited between January and March 2021 from a previously identified sub-cohort of the Cabarrus County COVID-19 Prevalence and Immunity (C3PI) Study who were under-going bimonthly COVID-19 antibody testing. Participants were given a Tasso-SST kit and asked to self-collect blood during a scheduled visit where trained laboratory personnel performed routine phlebotomy. All participants completed an after-visit survey about their experience. Overall, 70.0% of participants were able to collect an adequate sample for testing using the device. Among those with an adequate sample, there was a high concordance in results between the Tasso-SST and phlebotomy blood collection methods (Cohen’s kappa coefficient = 0.88, Interclass correlation coefficient 0.98 [0.97, 0.99], p < 0.0001). The device received a high-level (90.0%) of acceptance among all participants. Overall, the Tasso-SST could prove to be a valuable tool for seroprevalence testing. However, future studies in larger, diverse populations over longer periods may provide a better understanding of device usability and acceptance among older participants and those with comorbidities in various use scenarios.

Feasibility, acceptability, and safety of a novel device for self-collecting capillary blood samples in clinical trials in the context of the pandemic and beyond

“…In line with recent studies, [ 9 , 33 , 36 – 38 ]. an overwhelming majority of participants had a positive experience with the device for capillary self-sampling.…”

“…Still, some parents preferred venous sampling, perhaps due to discomfort about being responsible for the procedure instead of medical personnel. Overall, all participants expressed their willingness to use the device again, consistent with previous studies conducted on adults and children [ 33 , 34 , 36 , 38 ]. The median duration of sampling using the device was comparable to a prior study that employed the TASSO-SST device [ 8 ].…”

Comparison of Capillary Blood Self-Collection using the Tasso-SST Device with Venous Phlebotomy for anti-SARS-CoV-2 Antibody Measurement

“…We identified three previous studies that have evaluated the performance of the Tasso self-collection kit as compared to venous phlebotomy, and overall, our findings were consistent (6)(7)(8). One such study evaluated Tasso's performance under several conditions: supervised collection of the Tasso device by a healthcare professional and unsupervised at-home self-collection with simulated winter and summer stressors after receipt by the testing laboratory (6). The authors note a good correlation between Tasso and venous phlebotomy collection methods regardless of condition.…”

“…However, future studies should also address logistical challenges that could impact test results, including those tested in Hendelman, et al (8). Second, previous studies have used the Abbott Alinity nucleocapsid IgG antibody assay (6,7) and the EuroImmun anti-SARS-CoV-2 IgG assay targeting the S1 domain of the spike protein (8). We add to this evidence base by replicating the high correlation between venous blood and Tasso serum when measuring different types of antibodies (both total Ig and IgG antibodies to the receptor binding domain of the spike protein) on another ELISA platform (an assay developed and validated at UNC) (11).…”

“…Furthermore, the cost of the Tasso devices is likely comparable to or less than standard phlebotomy, therefore potentially saving time and money for study staff as well as providing a more comfortable and convenient experience for participants. However, research comparing the Tasso device with phlebotomy for any blood analyte is currently limited (6)(7)(8). Given the ongoing COVID-19 pandemic, we assessed the accuracy and precision of antibody measurements of SARS-CoV-2-specific antibodies using the Tasso device as compared to standard venous phlebotomy.…”