^13C呼气试验与幽门螺杆菌抗体检测的比较研究

Comparative study on ^13C breath test and helicobaeter pylori antibody detection methods

目的利用^13C呼气试验对两种幽门螺杆菌抗体检测试剂进行比较和评价。方法选取我院消化科门诊和住院部共41例因消化道症状而初次就诊的患者为研究对象，所有患者进行^13C呼气试验、同时用两种幽门螺杆菌抗体试剂检测患者的血清幽门螺杆菌抗体。以^13C呼气试验结果为标准，根据CLSIEP12-A2文件推荐方法，计算两种幽门螺杆菌抗体检测试剂的灵敏度和特异性的95％可信区间以及两种试剂灵敏度和特异性差值的95％可信区间。结果试剂1的灵敏度和特异性的95％可信区间分别是[26．8％，73．2％]和[87．5％，100％]；试剂2的灵敏度和特异性的95％可信区间分别是[38．7％，83．6％]和[71．9％，96．1％]。两种试剂灵敏度和特异性差值的95％可信区间是[-33．7％，7．7％]和[-3．3％，28．1％]。结论两种幽门螺杆菌抗体检测试剂的灵敏度和特异性差异无统计学意义，均可用于临床幽门螺杆菌感染的筛查和流行病学调查。

Objective To compare and value two kinds of helicobacter pylori （Hp） antibody detection reagents by using 13C breath test. Methods 41 patients with digestive tract symptoms underwent 13C breath test, at the same time, all of them were test for helicobacter pylori by 2 kinds of antibody detection reagents. Taking 13C breath test as standard, EP12-A2 made by CLSI was used to calculate 95% confidence interval （CI） for the sensitivity or specificity, and 95% confidence interval for the difference between paired sensitivities and specificities of two Hp antibody detection reagents mentioned above. Results 95% confidence interval for the sensitivity or specificity of reagent 1 were [26.8%, 73.2%] and [87.5%, 100%] respectively, while those of reagent 2 were [38.7%, 83.6%] and [71.9%, 96.1%] respectively. In addition, 95% confidence interval for the difference between paired sensitivities of above two reagents was [-33.7%, 7.7%], while that for the difference between paired specificities was [-3.3%, 28.1%]. Conclusion There are no statistically significant differences in the sensitivity and specificity of two Hp antibody detection reagents, and both of them can be used for the detection and epidemiological investigation of Hp infection in clinic.