Wang Y, Lu B, Liu J, Xiao T, Wan K, Guan C
Department of Physiology, Xiangya School of Medicine, Central South University, Changsha, Hunan, 410078, China,
Eur J Clin Microbiol Infect Dis. 2014 Nov;33(11):1989-94. doi: 10.1007/s10096-014-2150-7. Epub 2014 Jun 10.
A specific immunoassay method with the colloidal gold labeling technique has been developed more and more for tuberculosis (TB) diagnosis. The aim of this multicenter clinical evaluation was to evaluate the performance of a new serological diagnostic kit (the Trustline TB IgG/IgM Rapid Test kit) for the detection of Mycobacterium tuberculosis infection in China, with the Aupu TB Ab (IgG) Colloidal Gold Test kit being used as a control. A total of 1,009 specimens were collected from three TB hospitals, including 628 patients with TB, and 219 non-TB and 162 healthy patients as negative controls. According to the clinical diagnostic results, the sensitivities of the Trustline kit and the Aupu kit were 61.3 % and 53.7 %, respectively. Using the bacteriological test results as the "gold standard" to compare the results of the two kits, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and Youden index (YI) were 77.60 %, 79.8 %, 73.31 %, 81.50 %, and 0.574 by the Trustline kit, and 67.86 %, 88.9 %, 83.27 %, 77.40 %, and 0.568 by the Aupu kit, respectively. Further, the sensitivity of the Trustline kit and the Aupu kit for the smear staining and the bacterial culture being positive was 75.6 %, 76.6 % and 65.6 %, 66.5 %, and for the negative result, it was 53.8 %, 50.9 % and 47.5 %, 45.0 %, respectively. Additionally, 35 specimens were IgM-positive by the Trustline kit; of these, 30 (4.8 %) were from patients with TB and 5 (1.3 %) were from individuals without TB. The results showed that the experimental test had a much higher sensitivity than the other commercial test and exhibited a good detection rate for M. tuberculosis infection. Therefore, this kit can be used in the supplementary diagnosis and screening of TB.
一种采用胶体金标记技术的特异性免疫测定方法已越来越多地用于结核病（TB）诊断。这项多中心临床评估的目的是，在中国评估一种新型血清学诊断试剂盒（信镛TB IgG/IgM快速检测试剂盒）检测结核分枝杆菌感染的性能，以澳普TB抗体（IgG）胶体金检测试剂盒作为对照。共从三家结核病医院收集了1009份标本，其中包括628例结核病患者，以及219例非结核病患者和162例健康患者作为阴性对照。根据临床诊断结果，信镛试剂盒和澳普试剂盒的灵敏度分别为61.3%和53.7%。以细菌学检测结果作为“金标准”来比较两种试剂盒的结果，信镛试剂盒的灵敏度、特异性、阳性预测值（PPV）、阴性预测值（NPV）和尤登指数（YI）分别为77.60%、79.8%、73.31%、81.50%和0.574，澳普试剂盒分别为67.86%、88.9%、83.27%、77.40%和0.568。此外，信镛试剂盒检测出35份标本IgM呈阳性；其中，30份（4.8%）来自结核病患者，5份（1.3%）来自非结核病个体。结果表明，该实验检测方法比其他商业检测方法具有更高的灵敏度，对结核分枝杆菌感染具有良好的检出率。因此，该试剂盒可用于结核病的辅助诊断和筛查。
