Diagnostic Accuracy of a Point-of-Care Test for Celiac Disease Antibody Screening among Infertile Patients.
Celiac disease
Early detection
Gluten intolerance
Rapid test
Screening
Journal
Inflammatory intestinal diseases
ISSN: 2296-9365
Titre abrégé: Inflamm Intest Dis
Pays: Switzerland
ID NLM: 101677990
Informations de publication
Date de publication:
Aug 2019
Aug 2019
Historique:
received:
26
04
2019
accepted:
17
06
2019
entrez:
28
9
2019
pubmed:
29
9
2019
medline:
29
9
2019
Statut:
ppublish
Résumé
Screening for celiac disease among infertile patients has been suggested. Several rapid point-of-care (POC) tests aimed at detecting celiac disease antibodies have been developed. It has been suggested that these POC tests can be implemented as a replacement for standard laboratory tests. To evaluate the diagnostic accuracy of a POC test (Simtomax®) that detects celiac disease antibodies compared with standard laboratory tests when screening for celiac disease among patients referred for fertility treatment in 2 Danish fertility clinics. Serum samples were analyzed for IgA anti-tissue transglutaminase (TGA) as the reference standard test with a cutoff of ≥7 kU/L and by the index POC test based on IgA and IgG antibodies against deamidated gliadin peptides (DGP). In IgA deficiency, the reference standard test was IgG DGP with a cutoff of ≥7 kU/L. Participants answered a questionnaire on gluten intake, symptoms, and risk factors. Diagnostic confirmation was made by duodenal biopsies. IgA TGA/IgG DGP were used as the reference standard to calculate positive and negative predictive values. A total of 622 men and women (51.6%) were enrolled during 2015. The reference standard IgA TGA/IgG DGP was positive in 7 participants (1.1% [95% CI 0.5-2.3]) and the POC test was positive in 84 participants (13.5% [95% CI 10.9-16.4]), 3 of whom also had positive reference standard tests. This yields a sensitivity of the index POC test of 42.9% (95% CI 9.9-81.6) and a specificity of 86.8% (95% CI 83.9-89.4). Positive and negative predictive values were 3.57% (95% CI 0.7-10.1) and 99.3% (95% CI 98.1-99.8). The sensitivity of the POC test was low; however, the specificity was moderately good. The POC test had a high negative predictive value in this low prevalent population but missed 1 patient with biopsy-confirmed celiac disease. However, because of many false-positive tests, it cannot be recommended as replacement for standard laboratory tests but rather as a triage test to decide if the standard serology tests should be performed.
Sections du résumé
BACKGROUND
BACKGROUND
Screening for celiac disease among infertile patients has been suggested. Several rapid point-of-care (POC) tests aimed at detecting celiac disease antibodies have been developed. It has been suggested that these POC tests can be implemented as a replacement for standard laboratory tests.
OBJECTIVE
OBJECTIVE
To evaluate the diagnostic accuracy of a POC test (Simtomax®) that detects celiac disease antibodies compared with standard laboratory tests when screening for celiac disease among patients referred for fertility treatment in 2 Danish fertility clinics.
METHODS
METHODS
Serum samples were analyzed for IgA anti-tissue transglutaminase (TGA) as the reference standard test with a cutoff of ≥7 kU/L and by the index POC test based on IgA and IgG antibodies against deamidated gliadin peptides (DGP). In IgA deficiency, the reference standard test was IgG DGP with a cutoff of ≥7 kU/L. Participants answered a questionnaire on gluten intake, symptoms, and risk factors. Diagnostic confirmation was made by duodenal biopsies. IgA TGA/IgG DGP were used as the reference standard to calculate positive and negative predictive values.
RESULTS
RESULTS
A total of 622 men and women (51.6%) were enrolled during 2015. The reference standard IgA TGA/IgG DGP was positive in 7 participants (1.1% [95% CI 0.5-2.3]) and the POC test was positive in 84 participants (13.5% [95% CI 10.9-16.4]), 3 of whom also had positive reference standard tests. This yields a sensitivity of the index POC test of 42.9% (95% CI 9.9-81.6) and a specificity of 86.8% (95% CI 83.9-89.4). Positive and negative predictive values were 3.57% (95% CI 0.7-10.1) and 99.3% (95% CI 98.1-99.8).
CONCLUSION
CONCLUSIONS
The sensitivity of the POC test was low; however, the specificity was moderately good. The POC test had a high negative predictive value in this low prevalent population but missed 1 patient with biopsy-confirmed celiac disease. However, because of many false-positive tests, it cannot be recommended as replacement for standard laboratory tests but rather as a triage test to decide if the standard serology tests should be performed.
Identifiants
pubmed: 31559264
doi: 10.1159/000501520
pii: iid-0004-0123
pmc: PMC6751420
doi:
Types de publication
Journal Article
Langues
eng
Pagination
123-130Déclaration de conflit d'intérêts
The authors have no conflict of interest to declare.
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