幽门螺杆菌抗原和抗体试验的诊断效能评估

Evaluation of the clinical diagnostic efficiency of helicobacter pylori antigen assay and antibody assay

目的通过对三种试验评估,以期为临床提供一种方便、可靠的幽门螺杆菌(Hp)检测方法。方法分别以13CUBT、胃镜快速尿素酶试验(RUT)结果作为参考,评估粪便Hp抗原试验1(HpSA1)、粪便Hp抗原试验2(Hp SA2)、血Hp IgG抗体试验(Hp-IgG)的灵敏度、特异性、阳性预测值和阴性预测值等。结果以13C-UBT作为参考,Hp SA1、Hp SA2和Hp-IgG的灵敏度分别为0.9677、0.9355和0.9737,特异性分别为0.5455、0.8182和0.6552,ROC曲线下面积分别为0.745、0.882和0.832。以RUT作为参考,Hp SA1和Hp SA2的灵敏度分别为0.9487、0.8974,特异性分别为0.6053、0.9474,ROC曲线下面积分别为0.777、0.922。当HpSA2Hp-IgG联合使用时,特异为0.9373,灵敏度为0.9109。结论 Hp SA2的特异高,Hp-IgG的检测灵敏度高,二者联合使用,可达更好的临床诊断效能,适用于Hp的快速筛查。

Objective Based on the assessment of detection efficiency of three helicobacter pylori（ Hp） detection methods,in order to provide a convenient and reliable method for detection of helicobacter pylori. Methods As reference methods,13C-UBT and rapid urease test（ RUT） were used to evaluate the sensitivity,specificity,negative predictive value and positive predictive value of Hp stool antigen 1 assay（ Hp SA 1）,Hp stool antigen 2 assay（ Hp SA 2） and Hp blood IgG antibody assay（ Hp- IgG）. Results With13C- UBT as the reference method,the sensitivities of Hp SA1,Hp SA2 and Hp- IgG were 0. 9677,0. 9355 and 0. 9737 respectively; the specificities were 0. 5455,0. 8182 and 0. 6552 respectively; the areas under the ROC curve were 0. 745,0. 882 and 0. 832 respectively. With the RUT as the reference method,the sensitivities of Hp SA1 and Hp SA2 were 0. 9487 and 0. 8974 respectively,the specificities were 0. 6053 and 0. 9474 respectively,the areas under the ROC curve were 0. 777and 0. 922 respectively. When Hp SA2 was combined with Hp- IgG,the specificity of united test was 0. 9373,the sensitivity was 0. 9109. Conclusion The specificity of Hp SA2 is high,and the sensitivity of Hp- IgG is high. Combining Hp SA2 and Hp- IgG can obtain better diagnostic efficacy,which is applicable to the rapid screening of helicobacter pylori.