VALIDATION OF A NOVEL REAL TIME 13 C UREA BREATH TEST FOR RAPID EVALUATION OF HELICOBACTER PYLORI IN CHILDREN AND ADOLESCENTS ARIE LEVINE, MD, ORIT SHEVAH, BSc, TAMIR MILOH, MD, EYTAN WINE, MD, YARON NIV, MD, YORAM BUJANOVER, MD, YONA AVNI, MD, AND HAIM SHIRIN, MD We prospectively evaluated a 13 C urea breath test (UBT) that involves passive continuous sampling for diagnosis of Helicobacter pylori in 72 children. Results were obtained within 10 minutes in 96% of patients. The test is rapid, user-friendly, and has 100% concordance with conventional diagnostic methods. (J Pediatr 2004;145:112-4) I dentification of Helicobacter pylori infection, a risk factor for duodenal ulcers and gastritis in children, 1-3 can be achieved by a variety of methods. Like the more invasive tests currently available, such as endoscopy and biopsy, urea breath tests (UBT) can detect active infection with high sensitivity and specificity. Therefore, the UBT may be considered the preferred method for epidemiological studies and for screening patients with dyspeptic symptoms. It also is the preferred method at present for monitoring eradication or recurrence of the infection. 4-5 Conventional 13 C UBT also requires 13 CO 2 analysis. This demands collecting, storing, and transporting the samples to isotope ratio mass spectrometer (IRMS) or gas chromatography laboratories. The test also requires active compliance, which can occasionally be problematic in children. 5 An immediate result can be obtained if the sampling method is altered. One such option includes continuous sampling real time (CRT) 13 C UBT technology. A device utilizing this technology (BreathID, Oridion, Israel) has been validated previously in adults. 6 This office-based system offers several advantages over conventional mass spectrometry-based UBTs, including an immediate test result, standardized test meal, and a sampling method that does not require active cooperation. The IDcircuit (Oridion), a nasal passive breath sampling device, continuously transports the breath sample from the patient to the BreathID device. Based on molecular correlation spectrometry, the BreathID continuously measures 13 CO 2 and 12 CO 2 concentrations from the patient’s breath and establishes the 13 CO 2 / 12 CO 2 ratio, which is displayed onscreen, within 10 to 20 minutes. Because an apparatus of this type conceivably could be easier to use in the pediatric population and in ambulatory settings, we initiated a prospective study to evaluate the accuracy of CRT 13 C UBT in children and adolescents. METHODS Consecutive children and adolescents aged 5 to 18 years who were referred for gastroscopy or for 13 C UBT served as the study population. Outpatients referred by pediatricians for UBT were not required to undergo endoscopy. Indications for isolated 13 C UBT testing were persistent epigastric pain or verification of eradication after treatment of H pylori. Exclusion criteria included use of antibiotics, histamine-2 receptor antagonists, or proton pump inhibitors over the proceeding 7 days. Patients consumed a standard test drink, containing 75 mg 13 C urea and 4.5 gm granulated citric acid-based power dissolved in 200 mL water. All patients performed CRT 13 C UBT for up to 20 minutes using the Oridion BreathID. In parallel, simultaneous breath samples at baseline and at the end of the CRT 13 C UBT were collected and sent for isotope ratio analysis by previously validated IRMS (IRMS, Micromass, UK) 1 to Israel’s largest central laboratory. The researchers were blinded to the results of IRMS testing. The determination of positive or negative results was based on a device algorithm, with From the Pediatric Gastroenterology Unit, Department of Gastroenterol- ogy, The E. Wolfson Medical Center, Holon, Tel-Aviv University, Tel-Aviv; the Department of Gastroenterology, Rabin Medical Center, Petach Tiqva; and the Department of Pediatrics, Sheba Medical Center, Ramat-Gan, Israel. Submitted for publication Oct 9, 2003; last revision received Jan 10, 2004; accepted Mar 16, 2004. Reprint requests: Arie Levine, MD, Pediatric Gastroenterology Service, E. Wolfson Medical Center, POB 5 Holon 58100, Israel. E-mail: a-levine@ inter.net.il; alevine@wolfson.health. gov.il. 0022-3476/$ - see front matter Copyright ª 2004 Elsevier Inc. All rights reserved. 10.1016/j.jpeds.2004.03.025 CRT Continuous sampling real time IRMS Isotope ratio mass spectrometer UBT Urea breath test 112