Remote self-collection of capillary blood using upper arm devices for autoantibody analysis in patients with immune-mediated inflammatory rheumatic diseases
Georg Schett,
Johannes Knitza,
Martin Krusche,
Johanna Mucke,
Arnd Kleyer,
Nicolas Vuillerme,
Felix Muehlensiepen,
Gerlinde Bendzuck,
Gerhard Krönke,
Sebastian Boeltz,
David Simon,
Joshua Zarbl,
Ekaterina Eimer,
Camilla Gigg,
Marianne Korinth,
Corinna Elling-Audersch
Affiliations
Georg Schett
4 Department of Internal Medicine 3 – Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany
Johannes Knitza
Department of Internal Medicine 3 – Rheumatology and Immunology, Friedrich-Alexander University Erlangen-Nuremberg and Universiätsklinikum Erlangen, Erlangen, Germany
Martin Krusche
Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
Johanna Mucke
Policlinic and Hiller Research Unit, Heinrich Heine University Düsseldorf, Dusseldorf, Nordrhein-Westfalen, Germany
Arnd Kleyer
Department of Internal Medicine 3 – Rheumatology and Immunology, Friedrich-Alexander University Erlangen-Nuremberg and Universiätsklinikum Erlangen, Erlangen, Germany
Nicolas Vuillerme
1 AGEIS, University Grenoble Alpes, Grenoble, France
Felix Muehlensiepen
1 Center for Health Services Research, Faculty of Health Sciences, Brandenburg Medical School Theodor Fontane, Neuruppin, Brandenburg, Germany
Gerlinde Bendzuck
5 Deutsche Rheuma-Liga Bundesverband e.V, Berlin, Germany
Gerhard Krönke
Department of Internal Medicine 3 – Rheumatology and Immunology, Friedrich-Alexander University Erlangen-Nuremberg and Universiätsklinikum Erlangen, Erlangen, Germany
Sebastian Boeltz
3 Department of Internal Medicine 3, Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Universitätsklinikum Erlangen, Erlangen, Germany
David Simon
Department of Internal Medicine 3 – Rheumatology and Immunology, Friedrich-Alexander University Erlangen-Nuremberg and Universiätsklinikum Erlangen, Erlangen, Germany
Joshua Zarbl
Department of Internal Medicine 3, Rheumatology and Immunology, Friedrich-Alexander University Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany
Ekaterina Eimer
Thermo Fisher Scientific, Freiburg, Germany
Camilla Gigg
Thermo Fisher Scientific, Freiburg, Germany
Marianne Korinth
Deutsche Rheuma-Liga Bundesverband e.V, Bonn, Germany
Corinna Elling-Audersch
Deutsche Rheuma-Liga Bundesverband e.V, Bonn, Germany
Objectives To 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).Methods 70 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).Results While 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.Conclusions Remote 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 number WHO International Clinical Trials Registry (DRKS00024925).
