Feasibility and validity of in-home self-collected capillary blood spot screening for type 1 diabetes risk

Sing, A; Naselli, G; Huang, D; Watson, K; Colman, PG; Harrison, L; Wentworth, J

Author(s): Sing, A; Naselli, G; Huang, D; Watson, K; Colman, PG; Harrison, L; Wentworth, J;
Details: Publication Year 2024-11-17,Volume 26,Issue #2,Page 87-94
Journal Title: Diabetes Technology & Therapeutics
Abstract: Aims Self-collection of a blood sample for autoantibody testing has potential to facilitate screening for type 1 diabetes risk. We sought to determine the feasibility and acceptability of this approach and the performance of downstream antibody assays. Methods People living with type 1 diabetes and their family members (N=97) provided paired capillary blood spot and serum samples collected, respectively, by themselves and a health worker. They provided feedback on the ease, convenience and painfulness of blood spot collection. Islet antibodies were measured in blood spots by Antibody Detection by Agglutination PCR (ADAP) or multiplex enzyme-linked immunoassay (ELISA), and in serum by radioimmunoassay (RIA) or ELISA. Results Using serum RIA and ELISA to define antibody status, 50 antibody-negative (Abneg) and 47 antibody-positive (Abpos) participants enrolled, of whom 43 and 47 respectively returned testable blood spot samples. The majority indicated self-collection was easier, more convenient and less painful than formal venesection. The sensitivity and specificity for detection of Abpos by blood spot was, respectively, 85% and 98% for ADAP and 87% and 100% for multiplex ELISA. The specificities by ADAP for each of four antigen specificities ranged from 98% to 100% and areas under the receiver operator curve from 0.841 to 0.986. Conclusions Self-collected blood spot sampling is preferred over venesection by research participants. ADAP and multiplex ELISA are highly specific assays for islet antibodies in blood spots with acceptable performance for use alone or in combination to facilitate screening for type 1 diabetes risk.
Publisher: Mary Ann Liebert
Keywords: Humans; *Diabetes Mellitus, Type 1; Feasibility Studies; Mass Screening; Autoantibodies; Sensitivity and Specificity; Autoantibody screening; Capillary blood spot; Feasibility; Sensitivity; Specificity; Type 1 diabetes
Research Division(s): Population Health And Immunity
PubMed ID: 37976038
Publisher's Version: https://doi.org/10.1089/dia.2023.0345
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2023-11-20 03:33:00

Last Modified: 2024-06-28 03:14:56