THE PYLORITEK TEST AND THE CLO TEST - ACCURACY AND INCREMENTAL COST-ANALYSIS

Objective: The aim of this study was to compare the Pyloritek test (a 1-h rapid urease test) to the widely used CLO test, Methods: Seventy-o ne patients undergoing upper endoscopy were studied. All patients gave informed consent. A single antral biopsy specimen was obtained for th e CLO test, and another was obtained for the Pyloritek test, Additiona l specimens were obtained for culture and professed in the event of a discordant result. The Pyloritek assay was read at 1 h by one observer . The CLO test was read at 24 h by an observer blinded to the results of the Pyloritek assay. Results: These were 18 males and 53 females, a nd the mean age (+/-SEM) was 53 +/- 17 yr. Thirty-two patients had a p ositive result on the CLO test, and 39 had a negative lest result, Of the 32 patients with a positive CLO test result at 24 h, 31 were posit ive by the Pyloritek test at 1 h. All 39 patients with negative CLO te st results had negative Pyloritek test results as well. There was one discordant result, a negative Pyloritek test result and a positive CLO test result. Culture demonstrated growth of Helicobacter pylori. The kappa value, a measure of the reliability of the Pyloritek test compar ed with the CLO test, was 0.972 (SE, 0.0284; 95% confidence interval, 0.925-1). Marginal cost-effectiveness analysis favored the Pyloritek t est, Conclusions: Results of the Pyloritek test at 1 h and the CLO tes t at 24 h are comparable in terms of detection of urease activity.