Remote self-collection of capillary blood using upper arm devices for autoantibody analysis in patients with immune-mediated inflammatory rheumatic diseases

• Published in: Rheumatic & musculoskeletal diseases open Vol. 8; no. 2; p. e002641
• Main Authors: Zarbl, Joshua, Eimer, Ekaterina, Gigg, Camilla, Bendzuck, Gerlinde, Korinth, Marianne, Elling-Audersch, Corinna, Kleyer, Arnd, Simon, David, Boeltz, Sebastian, Krusche, Martin, Mucke, Johanna, Muehlensiepen, Felix, Vuillerme, Nicolas, Krönke, Gerhard, Schett, Georg, Knitza, Johannes
• Format: Journal Article
• Language: English
• Published: London EULAR 01.09.2022; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Studies in Health Technology and Informatics
• Subjects: Accuracy; Antibodies, Anticardiolipin; Autoimmune Diseases; Biomarkers; Blood; C-reactive protein; Connective Tissue Diseases; Glycoproteins; Health services research; Life Sciences; Pain; Patients; Proteins; Questionnaires; Rheumatic diseases; Rheumatology; Usability; United States > US; Germany
• ISSN: 2056-5933; 2056-5933
• DOI: 10.1136/rmdopen-2022-002641

ObjectivesTo evaluate the feasibility, accuracy, usability and acceptability of two upper arm self-sampling devices for measurement of autoantibodies and C reactive protein (CRP) levels in patients with immune-mediated rheumatic diseases (IMRDs).Methods70 consecutive patients with IMRD with previously documented autoantibodies were assigned to supervised and unsupervised self-collection of capillary blood with the Tasso+ or TAP II device. Interchangeability of 17 biomarkers with standard venesection was assessed by: concordance, correlation, paired sample hypothesis testing and Bland-Altman plots. Patients completed an evaluation questionnaire, including the System Usability Scale (SUS) and Net Promoter Score (NPS).ResultsWhile 80.0% and 77.0% were able to safely and successfully collect capillary blood using the Tasso+ and TAP II within the first attempt, 69 of 70 (98.6%) patients were successful in collecting capillary blood within two attempts. Concordance between venous and capillary samples was high; 94.7% and 99.5% for positive and negative samples, respectively. For connective tissue disease screen, anti-Ro52 and anti-proteinase 3 autoantibody levels, no significant differences were observed. Self-sampling was less painful than standard venesection for the majority of patients (Tasso+: 71%; TAP II: 63%). Both devices were well accepted (NPS; both: +28%), usability was perceived as excellent (SUS; Tasso+: 88.6 of 100; TAP II: 86.0 of 100) and 48.6 %/62.9% of patients would prefer to use the Tasso+/TAP II, respectively, instead of a traditional venous blood collection.ConclusionsRemote self-collection of capillary blood using upper arm-based devices for autoantibody and CRP analysis in patients with autoimmune rheumatic diseases is feasible, accurate and well accepted among patients.Trial registration numberWHO International Clinical Trials Registry (DRKS00024925).