Applicability of a short/rapid 13C-urea breath test for Helicobacter pylori: retrospective multicenter chart review study

Abstract

BackgroundCarbon labeled urea breath tests usually entail a two point sampling with a 20 to 30-minute gap. Our aim was to evaluate the duration of time needed for diagnosing Helicobacter pylori by the BreathID® System.MethodsThis is a retrospective multicenter chart review study. Test location, date, delta over baseline, and duration of the entire test were recorded. Consecutively 13C urea breath tests results were extracted from the files over a nine year period.ResultsOf the 12,791 tests results, 35.1% were positively diagnosed and only 0.1% were inconclusive. A statistically significant difference in prevalence among the countries was found: Germany showing the lowest, 13.3%, and Israel the highest, 44.1%. Significant differences were found in time to diagnosis: a positive diagnosis had the shortest and an inconclusive result had the longest. Overall test duration averaged 15.1 minutes in Germany versus approximately 13 minutes in other countries. Diagnosis was achieved after approximately 9 minutes in Israel, Italy and Switzerland, but after 10 on average in the others. The mean delta over baseline value for a negative diagnosis was 1.03 ± 0.86, (range, 0.9 - 5), versus 20.2 ± 18.9, (range, 5.1 - 159.4) for a positive one.ConclusionsThe BreathID® System used in diagnosing Helicobacter pylori can safely shorten test duration on average of 10-13 minutes without any loss of sensitivity or specificity and with no test lasting more than 21 minutes.

The validity of breath collection bags method in detecting Helicobacter pylori using the novel BreathID®Hp Lab System: a multicenter clinical study in 257 subjects

“…Moreover, test results are available in real time for decision-making at the point of care. 11,12 A user-friendly interface for operation and point-of-care testing is another advantage.…”

Meta-analysis of Association between Helicobacter pylori Infection and Epilepsy

“…13 C-UBT reveals the active (present) infection, whereas the serology can reveal the past infection. However, it may be impossible to directly compare the 13 C-UBT results due to the difference in UBT protocols across different clinical centers generated differences in breath sample collection times and intervals, as well as influences on delaying gastric emptying [21,22].…”

Epidemiology and Diagnosis of Helicobacter pylori Infection

“…Schmilovitz-Weiss et al [50] in a retrospective multicenter chart review study established that the Breath ID System (Exalenz, Modi'in, Israel) used in diagnosing H. pylori infection can safely shorten the test duration by an average of 10-13 minutes without a loss in sensitivity or specificity.…”