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Comparison of a Blood Self-Collection System with Routine Phlebotomy for SARS-CoV-2 Antibody Testing.
Wixted, Douglas; Neighbors, Coralei E; Pieper, Carl F; Wu, Angie; Kingsbury, Carla; Register, Heidi; Petzold, Elizabeth; Newby, L Kristin; Woods, Christopher W.
  • Wixted D; Duke Clinical and Translational Science Institute, Duke University, Durham, NC 27701, USA.
  • Neighbors CE; Duke Global Health Institute, Duke University, Durham, NC 27710, USA.
  • Pieper CF; Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC 27710, USA.
  • Wu A; Department of Clinical Research, Cytel Inc., Waltham, MA 02451, USA.
  • Kingsbury C; Duke Clinical Research Institute, Duke University, Durham, NC 27715, USA.
  • Register H; Duke Clinical and Translational Science Institute, Duke University, Durham, NC 27701, USA.
  • Petzold E; Duke Human Vaccine Institute, Duke University, Durham, NC 27710, USA.
  • Newby LK; Center for Applied Genomics and Precision Medicine, Duke University Medical Center, Durham, NC 27708, USA.
  • Woods CW; Duke Clinical and Translational Science Institute, Duke University, Durham, NC 27701, USA.
Diagnostics (Basel) ; 12(8)2022 Jul 31.
Article in English | MEDLINE | ID: covidwho-1969137
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.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study Language: English Year: 2022 Document Type: Article Affiliation country: Diagnostics12081857

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study Language: English Year: 2022 Document Type: Article Affiliation country: Diagnostics12081857