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Point-of-care testing for celiac disease has a low sensitivity in endoscopy
Peter D Mooney1, Matthew Kurien1, Kate E Evans1
1Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom.
Insights
A point-of-care test (POCT) for celiac disease (CD) showed disappointing performance. The immunoglobulin A tissue transglutaminase (TTG) POCT is not recommended for endoscopy units due to poor agreement with standard serology.
Area of Science:
- Gastroenterology
- Immunology
- Diagnostics
Background:
- Celiac disease (CD) is a prevalent condition often diagnosed late.
- Rapid point-of-care tests (POCTs) could improve diagnostic timelines for CD.
- Assessing novel diagnostic tools is crucial for timely CD management.
Purpose of the Study:
- To evaluate the clinical utility of an immunoglobulin (Ig) A tissue transglutaminase (TTG) antibody POCT.
- To compare the POCT performance against standard serological tests and histology in an endoscopic setting.
Main Methods:
- Prospective observational study conducted in a UK university hospital.
- Recruited 576 patients with suspected or known CD undergoing endoscopy.
- Utilized POCT, serum TTG, endomysial antibody (EMA) testing, and duodenal biopsies for comparison.
Main Results:
- The POCT demonstrated a sensitivity of 70.1% and specificity of 96.6%.
- Standard TTG and EMA tests showed significantly better performance than the POCT.
- Poor agreement was observed between the POCT and standard serological methods.
Conclusions:
- The evaluated POCT's performance was unsatisfactory compared to established serological tests.
- The current POCT is not recommended for use within endoscopy units for celiac disease diagnosis.
- Further development is needed to improve POCT accuracy for celiac disease.
Background:
Celiac disease (CD) is a common but underdiagnosed condition. A rapid point-of-care test (POCT) could reduce lead times and missed diagnoses.
Objective:
To assess the utility of an immunoglobulin (Ig) A tissue transglutaminase (TTG) antibody POCT in an endoscopic setting.
Design:
Prospective observational study.
Setting:
A single UK university hospital.
Patients:
Patients presenting with suspected CD, known CD, and routine endoscopy for upper GI symptoms.
Interventions:
All patients were tested with POCT, serum TTG, endomysial antibody (EMA), and upper GI endoscopy with duodenal biopsies at the same visit.
Main Outcome Measurements:
Comparison was made with histology in all cases, with villous atrophy regarded as diagnostic of CD.
Results:
A total of 576 patients (63.5% female, mean [± standard deviation] age 49.7 years [± 17.6 years]) were recruited. A total of 523 patients had no prior diagnosis of CD, and 53 patients had known CD coming for reassessment. A total of 117 patients were newly diagnosed with CD, and 82 were positively identified by the POCT. Sensitivity, specificity, positive predictive value, and negative predictive value were 70.1%, 96.6%, 85.4%, and 91.8%, respectively. In comparison, TTG and EMA both performed significantly better than the POCT. Sensitivity and specificity of TTG were 91.0% and 83.5%, respectively, and EMA were 83.8% and 97.5%, respectively. Of patients with known CD coming for reassessment, 26 had villous atrophy, and POCT results were positive in 16 (61.5%). There was poor agreement between POCT and standard serology.
Limitations:
High pre-test probability of CD.
Conclusion:
The performance of this POCT was disappointing compared with standard serology and cannot at present be recommended within the context of an endoscopy unit.
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