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. 2018 Jul;6(6):855-865.
doi: 10.1177/2050640618761700. Epub 2018 Feb 20.

Case-finding in primary care for coeliac disease: Accuracy and cost-effectiveness of a rapid point-of-care test

Maria Esteve  1   2 , Mercè Rosinach  1   2 , Montserrat Llordés  3 , Judit Calpe  3 , Glòria Montserrat  3 , Mar Pujals  1 , Abel Cela  3 , Anna Carrasco  1   2 , Montserrat Ibarra  1 , Pablo Ruiz-Ramirez  1 , Eva Tristán  1   2 , Beatriz Arau  1 , Carme Ferrer  3 , Meritxell Mariné  1   2 , Josepa Ribes  4 , Fernando Fernández-Bañares  1   2
Affiliations

Case-finding in primary care for coeliac disease: Accuracy and cost-effectiveness of a rapid point-of-care test

Maria Esteve et al. United European Gastroenterol J. 2018 Jul.

Abstract

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: €13,033/case; POCT + duodenal biopsy: €7360/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.

Keywords: Coeliac disease; diagnosis; point-of-care test; serology.

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Figures

Figure 1.
Figure 1.
Flowchart of the study procedures. CD: coeliac disease; IEL: intraepithelial lymphocyte; IgA: immunoglobulin A; PCP: primary care physician; POCT: point-of-care test; anti-tTG2: anti-transglutaminase 2 antibodies.
Figure 2.
Figure 2.
(a) Point-of-care test (Simtomax®). CT: control line; line A: IgA/IgG deamidated gliadin peptide; line B: total IgA. (b) Results of the present study. CD: coeliac disease; IgA: immunoglobulin A; IgG: immunoglobulin G.
Figure 3.
Figure 3.
Total costs and detailed procedures of the three diagnostic strategies. anti-tTG2: anti-transglutaminase 2 antibodies; POCT: point-of-care test. Tariffs of the National Health Services of the Catalan Government are provided in Table A.1 (Appendix 3).
Figure A1.
Figure A1.
Frequency of the clinical enrollment criteria.
See this image and copyright information in PMC

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