Abstract: PUB088
Pilot Study of a Remote Blood Self-Collection Device in Cure Glomerulonephropathy (CureGN)
Session Information
Category: Bioengineering
- 400 Bioengineering
Authors
- Hill-Horowitz, Taylor Addison, Cohen Children's Medical Center, Queens, New York, United States
- Vento, Suzanne, Cohen Children's Medical Center, Queens, New York, United States
- Holzman, Lawrence B., Penn Medicine, Philadelphia, Pennsylvania, United States
- Sethna, Christine B., Cohen Children's Medical Center, Queens, New York, United States
Group or Team Name
- On behalf of CureGN Investigators.
Background
Long-term biospecimen collection is a challenge in longitudinal cohort studies, especially for participants not actively followed clinically. TAP Micro Select is an FDA 510(k) cleared device that uses microneedles and a vacuum mechanism for self-collection of blood, allowing participants to provide biosamples remotely. This study aimed to determine the feasibility, reliability, and tolerability of the TAP device for remote blood collection for routine labs in the longitudinal CureGN study of primary glomerular disease.
Methods
Active participants at select CureGN sites were eligible. Participants were mailed materials for using the TAP device for at-home blood collection. Participants returned biosamples in a pre-paid shipper. Blood was processed for serum creatinine, albumin, and cystatin-C. In addition, samples from healthy controls were drawn both by venipuncture and TAP device. Control TAP samples were held at ambient temperatures for 24-72 hours (h) to simulate participant shipping. Outcomes were percent enrolled of those approached, time to receive samples, lab completion rate, participant satisfaction, and concordance of TAP samples with venipuncture.
Results
Of 47 participants approached, 39 (ages 14-85 years, 69% male) consented to the study (83% recruitment). The primary reason for declining was “dislike of handling blood.” Of the 22 who completed the blood draw, participants shipped their collected samples a median of 4.4 days [IQR 0.2-15.6] after receiving materials. Median time in transit was 27h [IQR 24-29]. Labs were successfully resulted for 91% (N=20/22) of samples (2 QNS). Satisfaction surveys show that 20/22 rated discomfort 1-2 of 10, 13/18 would choose TAP over venipuncture, and 12/16 said the option of TAP would increase their likelihood of research participation. Main participant concerns were the force needed to push the activation lever and difficulty obtaining enough blood. For 17 healthy controls, analyses comparing samples obtained by TAP vs venipuncture did not vary by assay or time (ICC >0.98).
Conclusion
Self-collection of blood with the TAP device was well-tolerated and strongly correlated with venipuncture under study conditions. Thus, remote blood collection with the TAP device is a feasible alternative to venipuncture and may improve collection of biosamples in longitudinal studies.
Funding
- NIDDK Support