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目的建立并评价幽门螺杆菌(Hp)尿素酶B亚单位(UreB)特异性抗体的检测方法。方法应用纯化的重组HpUreB作为包被抗原,建立检测HpUreB特异性抗体的ELISA间接法。以Hp抗体Western blot检测作为“金标准”,评价所建立方法的真实性和可靠性。结果检测血清特异性IgG的灵敏度为100·0%,特异度为97·7%,阳性预测值为97·2%,阴性预测值为100·0%,约登指数为0·977,符合率为98·7%,试验的一致率为98·5%;检测血清中总的特异性Ig灵敏度为97·1%,特异度为95·3%,阳性预测值为94·4%,阴性预测值为97·6%,约登指数为0·925,符合率为96·2%,试验的一致率为97·8%;检测唾液中特异性sIgA的灵敏度为96·2%,特异度为94·5%,阳性预测值为89·3%,阴性预测值为98·1%,约登指数为0·907,符合率为95·1%,试验的一致率为97·5%;检测粪便标本中的特异性sIgA的灵敏度为92·0%,特异度为90·2%,阳性预测值为85·2%,阴性预测值为94·9%,约登指数为0·822,符合率为90·9%,试验的一致率为98·6%,CV值均小于15%。结论该检测方法真实性、可靠性、重复性良好,能满足临床标本检测的要求。
Objective To establish and evaluate the detection method of UreB specific antibody of Helicobacter pylori (Hp). Methods The purified recombinant HpUreB was used as coating antigen to establish ELISA indirect method for detecting HpUreB specific antibodies. Hp antibody Western blot detection as a “gold standard” to evaluate the authenticity and reliability of the established method. Results The sensitivity of serum specific IgG was 100.0%, the specificity was 97.7%, the positive predictive value was 97.2%, the negative predictive value was 100.0%, the Youden index was 0.977, and the coincidence rate 98.7%. The agreement rate of the test was 98.5%. The total specific Ig in serum was 97.1%, the specificity was 95.3%, the positive predictive value was 94.4%, the negative predictive value The value of 97.6%, the Youden index of 0. 925, the compliance rate of 96.2%, the test was 97.8% concordance; detection of saliva specific sIgA sensitivity was 96.2%, the specificity was 94.5%, the positive predictive value was 89.3%, the negative predictive value was 98.1%, the Youden index was 0.907, the coincidence rate was 95.1%, and the consistent rate of the test was 97.5% The specificity of sIgA in stool specimens was 92.0% with a specificity of 90.2%, a positive predictive value of 85.2%, a negative predictive value of 94.9%, and a Youden index of 0.822, in agreement with The rate of 90.9%, the test of 98.6% consistency, CV values were less than 15%. Conclusion The method has the advantages of authenticity, reliability and repeatability, which can meet the requirements of clinical specimen testing.