Twenty‐minute 50 mg ¹³C‐urea breath test without test meal for the diagnosis of Helicobacter pylori infection in Chinese

Abstract

Background: We have previously shown that the 75 mg 13C‐urea breath test without citrate test meal is highly accurate for the diagnosis of Helicobacter pylori infection in Chinese subjects. A lower dose 50 mg 13C‐urea breath test protocol with a sampling time at 20 min has not been validated previously. Aim: To investigate the accuracy of a 20‐min 50 mg 13C‐urea breath test protocol in Chinese subjects. Methods: Consecutive dyspeptic patients referred for upper endoscopy were recruited. 13C‐urea breath test was performed using (a) 75 mg and 50 mg of 13C‐urea on two separate days without a test meal, and (b) 50 mg of 13C‐urea with 2.4 g citrate as test meal, and compared with the gold standard [rapid urease test (CLO test) and histology]. Baseline, 20‐min and 30‐min breath samples were collected in all cases. Results: Two hundred and six patients were tested. The accuracy of the 50 mg 13C‐urea breath test (no citrate) at 20 min and 30 min was 98%, comparable to that of the 50 mg 13C‐urea breath test with citrate (99.1%) and the 75 mg 13C‐urea breath test without citrate (100%). Conclusions: A 20‐min 50 mg 13C‐urea breath test without citrate produced highly accurate results for the diagnosis of Helicobacter pylori infection and is more economical and convenient for the Chinese population.

An optimized13C-urea breath test for the diagnosis ofH pyloriinfection

“…From each study, the protocol with the best diagnostic performance was selected . Of these, 12 (30%) yielded sensitivities and specificities of 100% [33,37,43,45,47,56,61,63,65,[67][68][69] . Based on the results after reviewing the literature, the present study introduced several variations to simplify even further the technique and make it more cost-efficient, without compromising the high standards of sensitivity, specificity, positive and negative predictive values of the test.…”

“…Later on, doses of 125 [35,72] and 100 mg [36,40,47,48,51,54,57,60,62,65,[73][74][75][76][77][78][79][80][81][82][83] were validated by several American, European and Asian groups, and more recently 75 mg [32,37,[43][44][45]49,50,55,72,[84][85][86][87][88][89][90][91][92][93] , 50 mg [52,56,58,94,95] , 38 mg [96] , 25 mg and even 10 mg [69] of 13 C-urea have proved to be sufficient.…”

“…As shown in Table 3, the majority of the test meals have provided reliable results. Even the complete absence of a test meal has shown little, if any, variation in the diagnostic performance of the assay [35,40,47,53,56,59,60,102,104] .…”

“…The conventional European 13 C-UTB protocol used in our region is sensitive and specific enough (values close to 100%), but it takes 40-45 min to complete and is performed using 100 mg of 13 C-urea. For the present study we decided to use 50 mg of 13 C-urea to reduce the cost of the assays by half, a dose that has proved to be as accurate as higher doses [52,56,58,61,63,68] . The 13 C-urea was administered diluted in 10 mL of water and taken as a single swallow, to try to avoid cross-contamination with urease-producing oropharyngeal bacteria.…”

Accuracy of breath tests using low doses of 13C-urea to diagnose Helicobacter pylori infection: a randomised controlled trial

“…Three other trials involving more than 300 patients studied in the pretreatment setting indicated that a dose of 50 mg of 13 C-urea, dispensed as a liquid solution or as a solid capsule, had sensitivity and specificity values greater than 95%. [8][9][10] One of these studies also evaluated the performance of 50 mg in the post-treatment setting, reporting sensitivity and specificity values of 100%. 10 In this study, we first evaluated the sensitivity and specificity of three breath tests, using 25, 15, and 10 mg of 13 C-urea, respectively, before eradication of H pylori.…”