OBJECTIVE: This review aims to evaluate the 13C-UBT diagnostic accuracy studies conducted among Asian population and validate its use for the Asian population.
METHODS: Original articles were systematically searched in PubMed, Scopus, and Google Scholar using the PICOS strategy by applying relevant keywords. Only studies published in English and conducted in Asia were included. Our search returned 276 articles. After assessment, 11 articles which answered our research question and met the criteria set for systematic review and meta-analysis were accepted. A total of 15 study protocols were extracted from the 11 accepted articles.
FINDINGS: Majority of the studies were conducted in Hong Kong (six), followed by Taiwan (five), Japan (two), and one each in Singapore and Israel. All studies had used histology as part of its gold standard of reference. All but one study was performed on adult populations. The summary estimate for sensitivity was 97% (95% CI: 96, 98%), and specificity was 96% (95% CI: 95, 97%), with significant heterogeneity between studies. Adjusting for the dose (50 mg) and breath sample collection time (20 minutes) had improved both accuracy estimates and significantly reduced heterogeneity.
CONCLUSION: This review supports the test-and-treat strategy for H. pylori infection management. Prevalence and cost-effectiveness studies are mandatory for health authorities to adopt this strategy into national policy.
OBJECTIVE: To compare the accuracy and reaction time of a new biopsy urease test, Pronto Dry (Medical Instruments Corporation, Solothurn, Switzerland) and the CLO test in the diagnosis of H. pylori infection.
METHODS: Consecutive patients presenting with dyspepsia to the endoscopy unit, University of Malaya Medical Centre were recruited for the study. Patients who were previously treated for H. pylori infection or who had received antibiotics, proton pump inhibitors or bismuth compounds in the preceding 4 weeks were excluded. H. pylori diagnosis was made based on the ultra rapid urease test and histological examination of gastric biopsies. Four antral and four corpus biopsies were taken for this purpose from all patients. A diagnosis of H. pylori infection was made when both the ultra rapid urease test and histology were positive in either the antral or corpus biopsies. A negative diagnosis of H. pylori was made when both tests from antral and corpus biopsies were all negative. Another four antral and four corpus biopsies (two each) were taken for the Pronto Dry and CLO tests. The Pronto Dry and CLO tests were stored and performed according to the manufacturer's instruction.
RESULTS: Two hundred and eight patients were recruited in the study. Eighty-six of the patients were males and 122 were females. The mean age was 46.3 years with a range of 15-82 years. The results for both the Pronto Dry and the CLO tests were completely concordant with sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of 98.1%, 100%, 100%, 98.1% and 99%, respectively. The Pronto Dry test showed a faster reaction time to positive compared with the CLO test, with 96.2% positive reaction by 30 min versus 70.8% and 100% positive reaction time by 55 min versus 83%. The colorimetric change was also more distinct with the Pronto Dry test compared with the CLO test.
CONCLUSIONS: Both the Pronto Dry and the CLO tests were highly accurate for the diagnosis of H. pylori infection. The Pronto Dry test showed a quicker positive reaction time and the positive colour change was more distinct.
MATERIALS AND METHODS: This prospective study was conducted between July 2012 and December 2013. Stool samples of 59 dyspeptic patients who underwent upper endoscopy were evaluated for H. pylori stool antigen.
RESULTS: From the 59 patients who participated in this study, there were 36 (61%) males and 23 (39%) females. H. pylori was diagnosed in 24 (40.7%) gastric biopsies, 22 (91.7 %) of these being positive for the Atlas H. pylori antigen test. The sensitivity, specificity, PPV, NPV and accuracy were 91.7%, 100%, 100%, 94.6% and 96.6% respectively.
CONCLUSIONS: The Atlas H. pylori antigen test is a new non-invasive method which is simple to perform and avails reliable results in a few minutes. Thus it can be the best option for the diagnosis of H. pylori infection due to its high sensitivity and specificity.
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