Department of Health Services, University of Washington School of Public Health, Seattle, WA 98195-7660, USA.
Indian J Med Res. 2012 May;135(5):695-702.
Diagnostic tests for active tuberculosis (TB) based on the detection of antibodies (serological tests) have been commercially available for decades, although no international guidelines have recommended their use. An estimated 1.5 million serological TB tests, mainly enzyme-linked immunosorbent assays, are performed in India alone every year, mostly in the private sector. The cost of serological tests in India is conservatively estimated at US $15 million (`825 million) per year. Findings from systematic reviews on the diagnostic accuracy of serological tests for both pulmonary and extra-pulmonary TB suggest that these tests are inaccurate and imprecise. A cost-effectiveness modelling study suggests that, if used as a replacement test for sputum microscopy, serology would increase costs to the Indian TB control sector approximately 4-fold and result in fewer disability-adjusted life years averted and more false-positive diagnoses. After considering all available evidence, the World Health Organization issued a strong recommendation against the use of currently available commercial serological tests for the diagnosis of TB disease. The expanding evidence base continues to demonstrate that the harms/risks of serological tests far outweigh the benefits. Greater engagement of the private sector is needed to discontinue the use of serological tests and to replace these tests with WHO-endorsed new diagnostics in India. The recent ban on import or sale of TB serological tests by the Indian health ministry is a welcome step in the right direction.
基于抗体检测（血清学检测）的活动性肺结核（TB）诊断检测已商业化数十年，但尚无国际指南推荐使用这些检测。仅在印度，每年就进行估计 150 万次血清学 TB 检测，主要是酶联免疫吸附测定，其中大部分在私营部门进行。印度血清学检测的费用估计每年保守估计为 1500 万美元（8.25 亿卢比）。针对肺内和肺外 TB 的血清学检测诊断准确性的系统评价结果表明，这些检测不准确且不精确。一项成本效益建模研究表明，如果将其用作痰显微镜检查的替代检测方法，那么血清学检测将使印度结核病控制部门的成本增加约 4 倍，并导致更少的残疾调整生命年被避免和更多的假阳性诊断。在考虑了所有现有证据后，世界卫生组织强烈建议不使用目前市售的商业血清学检测方法来诊断结核病。不断扩大的证据基础继续表明，血清学检测的危害/风险远远超过其益处。需要私营部门的更大参与，以停止使用血清学检测，并在印度用世界卫生组织认可的新诊断方法取代这些检测。印度卫生部最近禁止进口或销售结核病血清学检测，这是朝着正确方向迈出的可喜一步。
