Diagnostic Accuracy of Ten Second-Generation (Human) Tissue Transglutaminase Antibody Assays in Celiac Disease

Abstract

Background: Anti-tissue transglutaminase (tTG) assays that use human tTG as antigen have recently become available. We evaluated commercially available assays with human tTG antigen to estimate their diagnostic accuracies and to determine whether they agree sufficiently to be used interchangeably. Methods: Ten commercially available second-generation anti-tTG assays were evaluated. The following populations were studied: celiac disease (CD) patients at the time of diagnosis without (n ‫؍‬ 70) or with (n ‫؍‬ 5) IgA deficiency; diseased controls (n ‫؍‬ 70); and CD patients without (n ‫؍‬ 28) or with (n ‫؍‬ 2) IgA deficiency during follow-up. All individuals included in the study underwent intestinal biopsy. Technical performance (linearity, interference, precision, correlation, and agreement) and diagnostic accuracy (sensitivity and specificity) were compared. Anti-gliadin and anti-endomysium antibodies were also measured. Results: IgA anti-tTG results correlated well overall, but numerical values differed. Diagnostic sensitivity ranged between 91% and 97% and specificity between 96% and 100%. These were higher than the sensitivity and specificity of the IgA endomysium assay and the IgA gliadin assay. Generally, IgG anti-tTG was less sensitive but more specific than IgG anti-gliadin for the diagnosis of CD in the small group of IgA-deficient patients. Conclusions: Overall diagnostic performance of IgA tTG assays is acceptable and comparable among the

Diagnostic efficacy of the ELISA test for the detection of deamidated anti‐gliadin peptide antibodies in the diagnosis and monitoring of celiac disease

“…The excellent diagnostic performance of tests for antitTG and EMA antibodies has enabled the hidden part of the celiac iceberg to be identified in recent years (20,21). The current prevalence of CD in the Western countries is estimated at between 1:80 and 1:100 (16,(20)(21)(22)(23)(24).…”

“…The current prevalence of CD in the Western countries is estimated at between 1:80 and 1:100 (16,(20)(21)(22)(23)(24). Identification of anti-tTG and EMA antibodies as a marker for CD has caused AGA to lose the diagnostic role they had held since the early 80s (25).…”

“…Patients with an IgA deficiency (total IgA o0.5 mg/L) are known to have a significantly higher risk than the normal population of developing CD and, in the absence of IgA, it is necessary to test for class IgG antibodies. However, recent studies report unfavorable data relating to the performance of commercial anti-tTG IgG tests in terms of both sensitivity and specificity (21). The possibility of combining the antitTG IgG test with a sensitive, specific AGA IgG test may therefore prove very useful in diagnostic practice (30).…”

The old and new tests for celiac disease: which is the best test combination to diagnose celiac disease in pediatric patients?

“…However, discordant data between adults and children have been reported as the anti-tTG assay is less accurate in very young patients and autoantibody levels can fluctuate (9)(10)(11). In fact, the reported sensitivity for IgA anti-tTG, including all ages, ranges between 67% and 100%, with a specificity between 96% and 100% (5,(11)(12)(13)(14)(15)(16)(17)(18)(19), while in very young patients the sensitivity is lower, with a value ranging from 67% to 83% (11,17,18).…”

Celiac disease diagnosis and gluten-free food analytical control

“…Van Meensel [79] and colleagues evaluated 10 different commercially available second-generation IgA anti-tTG ELISA kits, and showed that most of these assays presented excellent performance, with good linear ranges. According to the optimal receiver operating characteristics (ROC) curve cutoff employed, the sensitivity values ranged from 91 to 97% and the specificity ranged between 96 and 100%.…”