FIND, Chemin des Mines 9, 1202, Geneva, Switzerland.
Division of Infectious Diseases, Beth Israel Deaconess Medical Center, 330 Brookline Ave, 02215, Boston, USA.
Diagn Microbiol Infect Dis. 2020 Jun;97(2):115026. doi: 10.1016/j.diagmicrobio.2020.115026. Epub 2020 Feb 19.
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.
目的是评估一种新型原型检测方法——TB REaD™（一种基于报告酶荧光的检测方法）对肺结核的灵敏度和特异性，并确定检测阳性的最佳阈值。这项盲法、前瞻性研究纳入了 250 名患者，其中 23.2%为结核分枝杆菌复合体（MTB）培养阳性。在制造商设定的阈值下，该检测方法的灵敏度为 93.1%（95%置信区间[CI]83.3-98.1），特异性为 8.9%（95% CI 5.2-13.8）。在较高的阈值下，检测的准确性最高：灵敏度为 58.6%（95% CI 44.9-71.4），特异性为 59.4%（95% CI 52.1%-66.4%），其中根据涂片状态的灵敏度为 40.0%（95% CI 21.1-61.3）对于涂片阴性，72.7%（95% CI 54.5-86.7）对于涂片阳性。本研究表明，TB REaD™原型检测方法对肺结核的检测准确性有限。需要进一步改进，可能需要探索更特异针对 MTB 的探针。
