Reddy J R, Kwang J, Lechtenberg K F, Khan N C, Prasad Reddy B, Chengappa M M
JN-International, Inc., Oakland, NE 68045, USA.
Comp Immunol Microbiol Infect Dis. 2002 Jan;25(1):21-7. doi: 10.1016/s0147-9571(01)00016-9.
A rapid serological test for tuberculosis (TB) infection was designed using antigens specific to Mycobacterium tuberculosis. Tuberculosis infection, TB vaccination and exposure to environmental Mycobacteria cannot be distinguished using skin tests based on tuberculin protein derivatives. The standard diagnostic techniques such as skin tests, X-rays and DNA techniques are time consuming, expensive, and not practical for screening large populations. We used the 38, 63, 64, 14, 59-kDa antigens of M. tuberculosis to develop a rapid immunochromatographic test kit. This study evaluates the diagnostic potential of the rapid test kit using TB positive and TB negative serum samples from various hospitals in India. The samples were obtained from patients infected with or exposed to bacteria and viral pathogens. The results demonstrated that the combination of antigens improved the diagnostic specificity and sensitivity. The specificity of the test was 99.42% with sensitivity of 98.52% (n = 241). In case of multiple infections, the specificity was 93.15% with a low sensitivity of 73.52% n = 141). The test kit may offer an improved alternative to purified protein derivative (PPD). This rapid TB test kit may be a useful tool for first-line testing of suspected cases, epidemiological studies and in designing a quality health system to reduce health hazards in resource-poor countries.
利用结核分枝杆菌特异性抗原设计了一种快速结核（TB）感染血清学检测方法。基于结核菌素蛋白衍生物的皮肤试验无法区分结核感染、卡介苗接种和环境分枝杆菌暴露情况。诸如皮肤试验、X射线和DNA技术等标准诊断技术耗时、昂贵，且不适用于大规模人群筛查。我们使用结核分枝杆菌的38、63、64、14、59-kDa抗原开发了一种快速免疫层析检测试剂盒。本研究使用来自印度各医院的TB阳性和TB阴性血清样本评估了该快速检测试剂盒的诊断潜力。样本取自感染或接触细菌及病毒病原体的患者。结果表明，抗原组合提高了诊断特异性和敏感性。该检测的特异性为99.42%，敏感性为98.52%（n = 241）。在多重感染情况下，特异性为93.15%，敏感性较低，为73.52%（n = 141）。该检测试剂盒可能是纯化蛋白衍生物（PPD）的一种改进替代品。这种快速结核检测试剂盒可能是疑似病例一线检测、流行病学研究以及设计优质卫生系统以减少资源匮乏国家健康危害方面的有用工具。
