Diagnostic properties of expired and reused negative expired ASAN® Helicobacter Test

Abstract

OBJECTIVE

To evaluate the efficacy of expired ASAN® Helicobacter Test (CLO test) and a color-changing property of negative expired CLO test.

METHODS

This cross-sectional diagnostic study was conducted at Kalasin Hospital, Thailand. The negative expired CLO test pellets were obtained from the patients undergoing endoscopy from December 2017 to March 2018. Gastric mucosa from positive expired CLO test pellets was reinserted into the negative expired CLO test pellets. Color changing, the interval after expiration and the interval from the first use were recorded. Pathological examination was used as a gold standard.

RESULTS

We test the diagnostic property of 20 negative reused expired CLO test pellets. It yielded 92.9% sensitivity, 76.5%s specificity, 62.0% positive predictive value, 96% negative predictive value, and 81.3% accuracy. All test pellets had a color changing from yellow to magenta within 1 to 4 hours after reinsertion with the positive CLO test gastric mucosa. The median interval from the first use was 15 days (interquartile range (IQR), 5 to 28), the median expired interval was 139 days (IQR, 9 to 191).

CONCLUSION

This was the first study that tried to confirm the diagnostic property of the expired CLO test. Its color-changing property of negative expired CLO test remained with high sensitivity and high negative predictive value.