结核分枝杆菌特异性蛋白（TB-SA）抗体检测试剂在结核病诊断中的应用研究

目的 评价结核分枝杆菌特异性蛋白(tuberculosis specific antigen, TB-SA)抗体检测试剂在结核病中的应用价值。 方法 以天津市和平区结核病控制中心、山东省烟台芝罘区肺科医院和河南省南阳市卧龙区结核病防治中心为研究现场，连续纳入2012年4月至10月门诊就诊的所有肺结核疑似患者944例，同时纳入110名健康志愿者作为对照。对所有纳入患者及健康志愿者进行痰涂片、培养、结核菌素试验（PPD）和胸部X线检查，签署知情同意书后留取血清进行TB-SA抗体检测。痰涂片采用萋-尼（Ziehl-Neelsen）染色法，培养采用接种酸性罗氏固体培养基培养。现场数据由双人录入，在国家结核病参比实验室统一整理分析。 结果755例确诊的活动性结核病患者，TB-SA抗体检测法阳性率为74.8% (565/755，95%CI＝71.7%～77.9%)，远高于涂片阳性率25.6%（193/755）(χ²=366.59，P<0.0001) 和培养阳性率39.6%（299/755）(χ²=190.12，P<0.0001)。在培养阳性结核病患者中，TB-SA抗体检查敏感度为88.5% (255/288，95%CI＝84.8%～92.2%)。在菌阴活动性结核病患者中，TB-SA抗体检查敏感度为68.0% (310/456，95%CI＝63.7%～72.3%)。TB-SA抗体检测法在活动性结核病患者中的阳性预测值为92.3% (565/612，95%CI＝90.2%～94.4%)，在健康人群中检测特异度为97.3% (95%CI＝94.3%～100.3%)。 结论TB-SA抗体检测法在结核病患者中阳性检出率显著高于涂片和培养，适用于结核病，特别是菌阴结核病的诊断；TB-SA抗体检测法诊断结核病的特异度高，可用于人群健康体检。

The application research of tuberculosis specific antigen (TB-SA) antibody detection kit in the diagnosis of tuberculosis

Objective To evaluate the value of tuberculosis specific antigen （TB-SA） antibody detection kit in the diagnosis of tuberculosis. Methods Nine hundred and forty-four pulmonary tuberculosis suspects were conti- nually recruited from April 2012 to October 2012 in 3 district＇s TB centers from Tianjin city, Shandong province and Henan province, respectively, 110 healthy people were enrolled at the same time. Sputum and serum specimen from all cases were collected for Ziehl-Neelsen staining smear, traditional mycobacterium culture and TB-SA antibody test. PPD skin test and chest X-ray were also examined to all cases. The data were entered separately by 2 people in sites and analyzed by national TB reference laboratory. Results Among 755 active TB patients, the positive rate of TPrSA antibody test were 74.8% （565/755, 95%0CI： 71.7%-77.9%）, significantly higher than smear （25.6%0, 193/755,X^2=366.59, P〈0. 0001） and culture （39.6%, 299/755, X^2=190. 12, P〈0. 0001）; its specificity and positive predictive value were 97.3% （95%CI： 94. 3%-100.3%） and 92.3% （95%CI; 90.2%-94. 4%）, re- spectively. Among culture-positive TB patients, the sensitivity of TB-SA antibody test was 88. 5%（95% CI： 84. 8%-92.2%）. However, the sensitivity of TB-SA antibody test was 68. 0% （95%CI： 63.7%-72.3%） among smear- and culture-negative TB patients. Conclusion TB-SA antibody test has significantly higher positive rate than smear and conventional culture, and can be used for the diagnosis of TB patient especially smear- and culture- negative TB patients. In addition, it can be used for healthy screening examination.