Abstract
BackgroundEfforts to minimize COVID-19 exposure during the current SARS-CoV-2 pandemic have led to limitations in access to medical care and testing. The Tasso-SST kit includes all of the components necessary for remote, capillary blood self-collection. In this study, we sought to investigate the accuracy and reliability of the Tasso-SST device as a self-collection device for measurement of SARS-CoV-2 IgG antibodies.MethodsCapillary blood was obtained via unsupervised and supervised application of the Tasso-SST device, and venous blood was collected by standard venipuncture. Unsupervised self-collected blood samples underwent either extreme summer or winter-simulated shipping conditions prior to testing. Sera obtained by all three methods were tested concurrently using the EuroImmun anti-SARS-CoV-2 S1 IgG assay in a CLIA-certified clinical laboratory.ResultsSuccessful Tasso-SST capillary blood collection by unsupervised and supervised administration was completed by 93.4% and 94.5% of participants, respectively. Sera from 56 participants, 55 with documented (PCR+) COVID-19, and 33 healthy controls were then tested for anti-SARS-CoV-2 IgG antibodies. Compared to venous blood results, Tasso-SST-collected (unstressed) and the summer- and winter-stressed blood samples demonstrated Deming regression slopes of 1.00 (95% CI: 0.99–1.02), 1.00 (95% CI: 0.98–1.01), and 0.99 (95% CI: 0.97–1.01), respectively, with an overall accuracy of 98.9%.ConclusionsCapillary blood self-collection using the Tasso-SST device had a high success rate. Moreover, excellent concordance was found for anti-SARS-CoV-2 IgG results between Tasso-SST capillary and standard venous blood-derived sera. The Tasso-SST device should enable widespread collection of capillary blood for testing without medical supervision, facilitating epidemiologic studies.
Highlights
The global SARS-CoV-2 pandemic has forced large numbers of people into various degrees of physical isolation and quarantine, increasing barriers to health care, laboratory testing, and epidemiological surveillance [1]
Sera from 56 participants, 55 with documented (PCR+) COVID-19, and 33 healthy controls were tested for anti-SARS-CoV-2 IgG antibodies
Compared to venous blood results, Tasso-SST-collected and the summer- and winter-stressed blood samples demonstrated Deming regression slopes of 1.00, 1.00, and 0.99, respectively, with an overall accuracy of 98.9%
Summary
The global SARS-CoV-2 pandemic has forced large numbers of people into various degrees of physical isolation and quarantine, increasing barriers to health care, laboratory testing, and epidemiological surveillance [1]. In this context, we sought to investigate the feasibility and performance of an in-home capillary blood collection device, Tasso-SST, for anti-SARS-CoV2 IgG serological testing at a CLIA-certified clinical laboratory. The Tasso-SST kit contains all the necessary components for an in-home capillary blood draw, including instructions, shipping materials, and a self-use blood collection device. We sought to investigate the accuracy and reliability of the Tasso-SST device as a self-collection device for measurement of SARS-CoV-2 IgG antibodies
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