The objective was to evaluate the sensitivity and specificity of a novel prototype test, TB REaD™, a reporter enzyme fluorescence-based assay, for pulmonary tuberculosis and to determine the optimal threshold for test positivity. This blinded, prospective study enrolled 250 patients, of which 23.2% were Mycobacterium tuberculosis complex (MTB) culture-positive. At the manufacturer-set threshold, sensitivity of the assay was 93.1% (95% confidence interval [CI] 83.3-98.1) and specificity was 8.9% (95% CI 5.2-13.8). The highest accuracy was seen at a higher threshold: sensitivity 58.6% (95% CI 44.9-71.4), specificity 59.4% (95% CI 52.1%-66.4%), with sensitivity by smear status being 40.0% (95% CI 21.1-61.3) for smear-negative and 72.7% (95% CI 54.5-86.7) for smear-positive. This study demonstrated limited accuracy of the TB REaD™ prototype for detection of pulmonary TB. Further improvements are necessary, potentially exploring probes that are more specific to MTB.

中文翻译：

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对原型检测进行首次临床评估，以检测β-内酰胺酶作为肺结核标记物的酶活性。

目的是评估针对肺结核的新型原型检测TB REaD™（基于报告酶荧光的检测方法）的敏感性和特异性，并确定检测阳性的最佳阈值。这项盲目的前瞻性研究招募了250名患者，其中23.2％为结核分枝杆菌复合物（MTB）培养阳性。在制造商设定的阈值下，测定的灵敏度为93.1％（95％置信区间[CI] 83.3-98.1），特异性为8.9％（95％CI 5.2-13.8）。在较高的阈值处观察到最高的准确性：灵敏度58.6％（95％CI 44.9-71.4），特异性59.4％（95％CI 52.1％-66.4％），涂片状态灵敏度为40.0％（95％CI 21.1）。涂片阴性为61.3），涂片阳性为72.7％（95％CI 54.5-86.7）。这项研究表明，TB REaD™原型检测肺结核的准确性有限。有必要进行进一步的改进，从而有可能探索更特定于MTB的探针。