A SYSTEMATIC REVIEW OF THE DIAGNOSTIC ACCURACY OF SEROLOGIC TESTS IN THE DIAGNOSIS OF CELIAC DISEASE

Author(s)

Costa V1, Chandra KM2, McCurdy B3, Ieraci L4, Levin L31Ministry of Health and Long-Term Care, Toronto, ON, Canada, 2McMaster University, Hamilton, ON, Canada, 3Ontario Ministry of Health and Long-term Care, Toronto, ON, Canada, 4Toronto Health Economics and Technology Assessment (THETA) Collaborative, Toronto, ON, Canada

OBJECTIVES: To evaluate the diagnostic accuracy of IgA (immunoglobulin A) and IgG serologic tests in the diagnosis of celiac disease including anti-tissue transglutaminase (tTG) antibody,  anti-deamidated gliadin peptide antibody (DGP), anti-endomysial antibody (EMA), and anti-gliadin antibodies (AGA). METHODS: A systematic review of the peer-reviewed literature was conducted to identify studies that evaluated the sensitivity and specificity of serologic celiac disease tests using small bowel biopsy as the gold standard. The patient population consisted of untreated, undiagnosed subjects with symptoms consistent with the disease. Pooled estimates of sensitivity and specificity were calculated using a bivariate, binomial generalized linear mixed model (SAS 9.2) which takes into account the negative correlation between sensitivity and specificity. Statistical significance was defined by p-values less than 0.05, where “false discovery rate” adjustments were made for multiple hypothesis testing. RESULTS: In total, 17 studies were eligible for the analysis. The pooled analysis showed that IgA tTG has a sensitivity of 92.1% (95% CI 88.0, 96.3), compared to 89.2% (83.3, 95.1, p=0.12) for IgA DGP, 85.1% (79.5, 94.4, p=0.07) for IgA EMA, 74.9% (63.6, 86.2, p=0.0003) for IgA AGA. Combining more than one serologic test slightly increased the sensitivity, 95.1% (92.2, 98%, p=0.039 vs. IgA tTG). The pooled sensitivity of IgG DGP was 88.4% (95% CI: 82.1, 94.6), 44.7% (30.3, 59.2, p=0.0003) for IgG tTG, and 69.1% (56.0, 82.2, p=0.34) for IgG AGA. Specificity ranged from 90.1% to 93.9% and was similar among the different tests. The quality of the evidence according to the GRADE Working Group criteria was considered “moderate” for IgA tTG and EMA, “low” for IgA DGP and test combinations, and “very low” for IgA AGA.  CONCLUSIONS: The evidence available suggests that IgA tTG has a higher accuracy than other serologic tests. Combining more than one serologic test contributes little to the diagnostic accuracy.

Conference/Value in Health Info

2010-11, ISPOR Europe 2010, Prague, Czech Republic

Value in Health, Vol. 13, No. 7 (November 2010)

Code

PGI1

Topic

Clinical Outcomes, Epidemiology & Public Health

Topic Subcategory

Comparative Effectiveness or Efficacy, Disease Classification & Coding

Disease

Gastrointestinal Disorders

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