Gastroenterology Unit, Hasharon Hospital, Rabin Medical Center, Petach Tikva, Tel-Aviv University, Tel Aviv, Israel.
BMC Gastroenterol. 2012 Jan 19;12:8. doi: 10.1186/1471-230X-12-8.
Carbon 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.
This 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.
Of 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.
The 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.
碳标记尿素呼气试验通常需要在 20 至 30 分钟的时间间隔内进行两点采样。我们的目的是评估 BreathID®系统诊断幽门螺杆菌所需的时间。
这是一项回顾性多中心图表回顾研究。记录了测试地点、日期、与基线的差值和整个测试的持续时间。在 9 年期间，从文件中提取了连续的 13C 尿素呼气试验结果。
在 12791 次测试结果中，35.1%被阳性诊断，只有 0.1%为不确定。发现各国之间的患病率存在统计学显著差异：德国最低，为 13.3%，以色列最高，为 44.1%。在诊断时间方面存在显著差异：阳性诊断最短，不确定结果最长。德国的总测试持续时间平均为 15.1 分钟，而其他国家约为 13 分钟。在以色列、意大利和瑞士，诊断在大约 9 分钟后完成，但在其他国家平均需要 10 分钟。阴性诊断的平均基线差值为 1.03 ± 0.86（范围 0.9-5），阳性诊断的平均基线差值为 20.2 ± 18.9（范围 5.1-159.4）。
BreathID®系统用于诊断幽门螺杆菌，可以安全地将测试持续时间平均缩短 10-13 分钟，而不会降低敏感性或特异性，并且没有测试持续时间超过 21 分钟。
