Campuzano-Maya Germán
School of Medicine, University of Antioquia, Medellín, Colombia.
World J Gastroenterol. 2007 Nov 7;13(41):5454-64. doi: 10.3748/wjg.v13.i41.5454.
To validate an optimized (13)C-urea breath test ((13)C-UBT) protocol for the diagnosis of H pylori infection that is cost-efficient and maintains excellent diagnostic accuracy.
70 healthy volunteers were tested with two simplified (13)C-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 (13)C-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.
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.
A 10 min, 50 mg (13)C-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.
验证一种优化的用于诊断幽门螺杆菌感染的(13)C - 尿素呼气试验((13)C - UBT)方案,该方案具有成本效益且保持出色的诊断准确性。
70名健康志愿者采用两种简化的(13)C - UBT方案进行检测,一种有试餐(方案2),另一种无试餐(方案1)。在摄入溶解于10 mL水中的50 mg(13)C - 尿素后,单次咽下,随后饮用200 mL水(pH 6.0)并围绕腰围做圆周运动以使尿素溶液均匀化,分别在摄入后10、20和30分钟采集呼气样本。分析两种方案在不同临界值下的性能。结果与欧洲方案进行验证。
根据参考方案,65.7%的个体幽门螺杆菌感染呈阳性,34.3%呈阴性。两种方案正确识别幽门螺杆菌阳性和阴性个体的能力无显著差异。然而,只有无试餐的方案1实现了100%的准确性、敏感性、特异性、阳性预测值和阴性预测值。方案2所达到的最高值分别为98.57%、97.83%、100%、100%和100%。
一种10分钟、50 mg无试餐的(13)C - UBT,使用2 - 2.5的临界值,是一种成本降低的用于诊断幽门螺杆菌感染的高度准确的检测方法。