Search

Additional file 1. Supplementary materials: Materials S1. Flow cytometry studies in blood.

Additional file 3. Supplementary materials: Materials S2. IFN-γ ELISPOT (enzyme-linked immunospot) assay. Materials S3. Additional methods: Histological analysis. Intraepithelial lymphogram. Supplementary results: Table S1. Median (IQR) of the studied CD8+ (percentage at day 6 and ratio day 6/day 0) and TCRγδ+ (percentage at day 6) T cell populations in the different groups of participants (in bold) and adjusted p values of the comparisons between groups obtained using a Dunn’s test following a significant Kruskal-Wallis test. Table S2. Global VAS score and VAS of individual clinical symptoms reported by the participants during the six days of the study (mean intensity ± SE and number and percentage of patients reporting the symptom).

Table S1 Indication for colonoscopy in both study phases. (DOCX 12 kb)

Figure S1. Tumour localization and staging in both study phases. (DOCX 11 kb)

Table S2 Description of patients included in study phase 1 and 2. (DOCX 22 kb)

Study protocol. (DOCX 201 kb)

Supplementary statistical methods. (DOCX 12 kb)

FIT performance. (DOCX 12 kb)

Tripod checklist. (DOCX 16 kb)

Background: An on-site, rapid, fingertip, whole-blood point-of-care test (POCT) is attractive for active case-finding of coeliac disease (CD) in primary care because of its simplicity. Aim: The aim of this article is to assess the usefulness and cost-effectiveness of adult case-finding using a POCT based on deamidated gliadin peptide antibodies (IgA/IgG-DGP) in primary care for CD diagnosis. Methods: A case-finding study for CD was conducted by using an easy-to-use, on-site, whole-blood for IgA/IgG-DGP-based fingertip POCT compared with tTG2 in 350 individuals. Sample size was calculated based on 0.28% prevalence in the reference population. Duodenal biopsies for histology, intraepithelial lymphocytes and in situ deposition of tTG2 were obtained if tTG2 and/or POCT were positive. Accuracy and cost-effectiveness of strategies using serology or POCT were calculated. Results: Prevalence of CD was 1.14% (95% CI, 0.3-3.4), almost double what was previously observed. Four patients were diagnosed with CD. tTG2 was positive in three (0.85%) and POCT in 29 (8.2%). Sensitivity of POCT for CD was 100%, specificity 93%, PPV 14%, and NPV 100%. POCT followed by duodenal biopsy was the most cost-effective approach in our setting (standard diagnosis: E13,033/case; POCT þ duodenal biopsy: E7360/case). Conclusions: A negative POCT allows ruling out CD in primary care, making it suitable for case-finding. POCT strategy was the most cost effective.