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World J Gastroenterol. Nov 7, 2007; 13(41): 5454-5464
Published online Nov 7, 2007. doi: 10.3748/wjg.v13.i41.5454
An optimized 13C-urea breath test for the diagnosis of H pylori infection
Germán Campuzano-Maya
Germán Campuzano-Maya, Professor, Ad honorem, School of Medicine, University of Antioquia, Medellín, Colombia; Medical Director, Laboratorio Clínico Hematológico®, Medellín, Colombia
Author contributions: All authors contributed equally to the work.
Correspondence to: Dr. Germán Campuzano-Maya, Laboratorio Clínico Hematológico, Carrera 43C No. 5-33, Medellín, Colombia. gcampuzano@hematologico.com
Telephone: +574-4444200 Fax: +574-3128232
Received: June 27, 2007
Revised: August 17, 2007
Accepted: August 29, 2007
Published online: November 7, 2007
Abstract

AIM: To validate an optimized 13C-urea breath test (13C-UBT) protocol for the diagnosis of H pylori infection that is cost-efficient and maintains excellent diagnostic accuracy.

METHODS: 70 healthy volunteers were tested with two simplified 13C-UBT protocols, with test meal (Protocol 2) and without test meal (Protocol 1). Breath samples were collected at 10, 20 and 30 min after ingestion of 50 mg 13C-urea dissolved in 10 mL of water, taken as a single swallow, followed by 200 mL of water (pH 6.0) and a circular motion around the waistline to homogenize the urea solution. Performance of both protocols was analyzed at various cut-off values. Results were validated against the European protocol.

RESULTS: According to the reference protocol, 65.7% individuals were positive for H pylori infection and 34.3% were negative. There were no significant differences in the ability of both protocols to correctly identify positive and negative H pylori individuals. However, only Protocol 1 with no test meal achieved accuracy, sensitivity, specificity, positive and negative predictive values of 100%. The highest values achieved by Protocol 2 were 98.57%, 97.83%, 100%, 100% and 100%, respectively.

CONCLUSION: A 10 min, 50 mg 13C-UBT with no test meal using a cut-off value of 2-2.5 is a highly accurate test for the diagnosis of H pylori infection at a reduced cost.

Keywords: H pylori; 13C-urea breath test; Diagnosis; Accuracy; Cost