三种结核抗体试剂盒在结核病诊断中的应用评价

Evaluation of three tuberculosis antibody kits in tuberculosis diagnosis

目的 评价3种结核抗体试剂盒在结核病诊断中的应用价值。方法 收集2015年1—12月解放军第三〇九医院病理科应用聚合酶链反应反向斑点杂交法（polymerase chain reaction-reverse dot blot,PCR-RDB）进行组织标本分枝杆菌菌种鉴定（以下称“分子病理”）的601例患者资料,排除不符合纳入标准的患者,最终纳入205例患者。通过病案检索获得3种结核抗体试剂盒（TB-IgG、SD Rapid TB、TB-DOT）检测外周血结核抗体的结果。应用SPSS 20.0统计学软件,分析3种结核抗体相较于分子病理学检测的敏感度、特异度等检测效能,采用McNemar 检验和Kappa值分析检测结果的差异性和一致性。结果 以分子病理检查结果为标准,TB-IgG、SD Rapid TB、TB-DOT 试剂盒的敏感度分别为26.6%（34/128）、20.3%（26/128）、97.7%（125/128）;特异度分别为90.9%（70/77）、98.7%（76/77）、3.9%（3/77）;阳性预测值分别为82.9%（34/41）、96.3%（26/27）、62.8%（125/199）;阴性预测值分别为42.7%（70/164）、42.7%（76/178）、50.0%（3/6）;正确指数分别为0.18、0.19、0.02。TB-IgG、SD Rapid TB 试剂盒检测结果分别与分子病理检查相比较,诊断差异均有统计学意义（χ2配对=9.17,P〈0.001;矫正χ2配对=13.58,P〈0.001）,且与分子病理检测存在微弱一致性（Kappa值分别为0.14、0.15,P值均〈0.001）;而TB-DOT与分子病理的诊断差异无统计学意义（矫正χ2配对=0.04,P=0.833）,不能肯定与分子病理检测存在一致性（Kappa值=0.02,P=0.523）。结论 3种结核抗体试剂盒检测结果存在一定差异,SD Rapid TB在3种检测方法中相对较好;多种抗原联合检测可以提高检测的敏感度和特异度,对结核病诊断具有辅助价值。

Objective To evaluate the application value of three tuberculosis （TB） antibody kits in tuberculosis diagnosis. Methods Of 601 patients treated by PCR-reverse dot blot hybridization （PCR-RDB） to identify the tissue species mycobacteria strains （referred to as molecular pathology） at Department of Pathology, the 309th Hospital of PLA between January 2015 and December 2015, the patients who did not meet inclusion criteria were excluded. Finally, 205 cases were included, and the results of peripheral blood tuberculosis antibody by three TB antibody kits were detected from records. The McNemar test and Kappa test results were used to decide the difference and consistency by SPSS 20.0. Results Compared with molecular pathological results, the sensitivities of TB-IgG, SD Rapid TB, TB-DOT were 26.6% （34/128）, 20.3% （26/128）, 97.7% （125/128）; the specificities were 90.9% （70/77）, 98.7% （76/77）, 3.9% （3/77）; the positive predictive values were 82.9% （34/41）, 96.3% （26/27）, 62.8% （125/199）; the negative predictive values were 42.7% （70/164）, 42.7% （76/178）, 50.0% （3/6）; the jaden indexes were 0.18, 0.19, 0.02, respectively. Compared with the molecular pathology group, diagnosis differences in TB-IgG and SD Rapid TB kits groups were statistically significant （χ2=9.17, P〈0.001; χ2Correct=13.58, P〈0.001）. TB-IgG and SD Rapid TB kits were found weak consistency with the molecular pathology （Kappa=0.14, 0.15, Ps〈0.001）;while diagnosis difference between the molecular pathology and TB-DOT kit was not statistically significant （χ2=0.04, P=0.833）, and consistency was not sure （Kappa=0.02, P=0.523）. Conclusion The detection results of three TB antibody kits were different to some extent; SD Rapid TB was relatively better than the other two; multiple antigen detection could improve sensitivity and specificity, and might be assist to the diagnosis of tuberculosis.