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Point-of-care celiac disease test exhibited low sensitivity
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The performance of a rapid point-of-care celiac disease test used in endoscopy showed poor rates of agreement with standard serology results and cannot yet be recommended for use in endoscopy units, according to researchers in the UK.
Investigators recruited 576 patients (mean age, 49.7 years; 63.5% women), including 53 seeking reassessment for known celiac disease (CD), 117 with newly diagnosed CD and 82 positively identified by the rapid point-of-care test (POCT; Biocard Celiac Test; Ani Biotech Oy, Vantaa, Finland).
All patients were serologically tested for immunoglobulin A tissue transglutaminase (IgA TTG), endomysial antibody (EMA), plus total IgA level. All patients also were tested by POCT. The Biocard reported 82 positive test results from the 117 new CD cases.
Researchers reported 14 false-positive test results among controls (n=406), yielding:
- Sensitivity: 70.1%
- Specificity: 96.6%
- Positive predictive value: 85.4%
- Negative predictive value: 91.8%
By comparison, TTG and EMA performed better than POCT, yielding:
- TTG sensitivity: 91%
- TTG specificity: 83.5%
- EMA sensitivity: 83.8%
- EMA specificity: 97.5%
POCT results were positive in 61.5% of patients with known CD seeking reassessment; 26 had villous atrophy.
“Despite the presence of serology-negative CD, the high pretest probability of CD within our cohort would be expected to overestimate the performance of the POCT,” the investigators wrote. “Bearing this in mind, we find the results particularly disappointing.”
Disclosure: Funding was provided by BHR Pharmaceuticals, suppliers of the Biocard test.
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