TB Centre, London School of Hygiene & Tropical Medicine, London, UK.
Sequella, Inc, Rockville, Maryland, USA.
Int J Tuberc Lung Dis. 2018 Jun 1;22(6):622-627. doi: 10.5588/ijtld.17.0716.
There remains a lack of effective and inexpensive diagnostic tools for active tuberculosis (TB) disease. Testing immune responses to proteins secreted by Mycobacterium tuberculosis, such as MPT64, may be a diagnostic option.
To evaluate the sensitivity and specificity of a patch test using MPT64 for the diagnosis of active TB disease.
This randomised, double-blind, placebo-controlled, prospective study in Lima, Peru, involved 55 healthy controls and 457 symptomatic individuals referred for routine TB testing by the National TB Control Programme. All subjects underwent a comprehensive diagnostic workup, and received an active patch on one arm and a placebo patch on the opposite arm, which were read after 4 days.
Eighty-one (18%) of the symptomatic participants were classified as having definite TB, while an additional 98 (21%) had probable TB. The patch tests performed the same in both groups, with a sensitivity of 27% and specificity of 74%. The area under the receiver operating characteristic curve was 0.495 (95%CI 0.425-0.565).
Contrary to existing literature, the MPT64 patch was not sensitive and specific to detect active TB. Given the potential of the test, understanding possible differences in the protein source or underlying genetic factors should be explored further.
目前仍缺乏有效且廉价的工具来诊断活动性结核病（TB）。检测针对结核分枝杆菌分泌的蛋白（如 MPT64）的免疫反应可能是一种诊断选择。
评估 MPT64 贴皮试验在诊断活动性 TB 疾病中的敏感性和特异性。
这是一项在秘鲁利马进行的随机、双盲、安慰剂对照、前瞻性研究，纳入了 55 名健康对照者和 457 名因国家结核病控制规划常规 TB 检测而就诊的有症状个体。所有参与者均接受了全面的诊断评估，并在一侧手臂上接受了活性贴剂，在对侧手臂上接受了安慰剂贴剂，在 4 天后进行了读取。
81 名（18%）有症状的参与者被归类为患有明确的 TB，而另外 98 名（21%）患有可能的 TB。两组的贴皮试验结果相同，敏感性为 27%，特异性为 74%。受试者工作特征曲线下面积为 0.495（95%CI 0.425-0.565）。
与现有文献相反，MPT64 贴皮试验对检测活动性 TB 既不敏感也不特异。鉴于该检测的潜力，应进一步探索其蛋白来源或潜在遗传因素的差异。
