用于诊断肺结核的 Truenat™ MTB Plus 的准确性。
Accuracy of Truenat™ MTB Plus for the diagnosis of pulmonary TB.
作者信息
Melo M C M, Silveira A K, Dalvi A P R, Silva J, Printes V S, Anselmo L, da Silva T I, Oliveira M M, Conceição C, Lopes A, Bollela V, Cordeiro-Santos M, Bhering M, Moreira A S R, Carvalho A C C, Kritski A L
机构信息
Institute of Thoracic Diseases, Medical School, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.
Molecular Mycobacteriology Laboratory, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.
出版信息
IJTLD Open. 2025 Apr 9;2(4):199-207. doi: 10.5588/ijtldopen.24.0561. eCollection 2025 Apr.
BACKGROUND
Truenat™ is a WHO-recommended rapid molecular test for diagnosing TB and detecting rifampicin resistance, whose performance has been evaluated in a few high TB burden countries.
METHODS
A prospective multicentre study was conducted in Brazil to estimate the sensitivity and specificity of Truenat MTB Plus compared to Xpert MTB/RIF Ultra for detecting pulmonary TB. Liquid culture for and drug susceptibility testing were used as reference.
RESULTS
Among 283 participants, 112 (39.6%) had culture-positive pulmonary TB. The sensitivity and specificity of Truenat MTB Plus were respectively 72.7% (95% CI 63.41-80.78) and 99.4% (95% CI 96.71-99.98), compared to 78.4% (95% CI 69.56-85.63) and 99.4% (95% CI 96.67-99.98) for Xpert MTB/RIF Ultra. In 89 people living with HIV (PLHIV), Truenat MTB Plus showed a sensitivity of 45.0% (95% CI 23.06-68.47) and specificity of 100.0% (95% CI 95.64-100.00). Among 71 patients previously treated for TB, Truenat MTB Plus showed sensitivity and specificity of respectively 79.3% (95% CI 60.28-92.01) and 97.5% (95% CI 86.84-99.94). Xpert MTB/RIF Ultra detected rifampicin resistance in 11/88 samples (12.5%) vs 9/72 (12.5%) with Truenat MTB Plus.
CONCLUSION
The Truenat MTB Plus performance was comparable to Xpert MTB/RIF Ultra. Both tests demonstrated lower sensitivity in PLHIV.
背景
Truenat™是世界卫生组织推荐的用于诊断结核病和检测利福平耐药性的快速分子检测方法，其性能已在一些结核病高负担国家进行了评估。
方法
在巴西进行了一项前瞻性多中心研究，以评估与Xpert MTB/RIF Ultra相比，Truenat MTB Plus检测肺结核的敏感性和特异性。以液体培养和药敏试验作为参考标准。
结果
在283名参与者中，112人（39.6%）痰培养确诊为肺结核。Truenat MTB Plus的敏感性和特异性分别为72.7%（95%可信区间63.41 - 80.78）和99.4%（95%可信区间96.71 - 99.98），而Xpert MTB/RIF Ultra的敏感性和特异性分别为78.4%（95%可信区间69.56 - 85.63）和99.4%（95%可信区间96.67 - 99.98）。在89名艾滋病毒感染者（PLHIV）中，Truenat MTB Plus的敏感性为45.0%（95%可信区间23.06 - 68.47），特异性为100.0%（95%可信区间95.64 - 100.00）。在71名既往接受过抗结核治疗的患者中，Truenat MTB Plus的敏感性和特异性分别为79.3%（95%可信区间60.28 - 92.01）和97.5%（95%可信区间86.84 - 99.94）。Xpert MTB/RIF Ultra在88份样本中检测出11份（12.5%）利福平耐药，而Truenat MTB Plus在72份样本中检测出9份（12.5%）。
结论
Truenat MTB Plus的性能与Xpert MTB/RIF Ultra相当。两种检测方法在艾滋病毒感染者中的敏感性均较低。
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