Accuracy of Truenat™ MTB Plus for the diagnosis of pulmonary TB.

IJTLD open Pub Date : 2025-04-09 eCollection Date: 2025-04-01 DOI:10.5588/ijtldopen.24.0561

M C M Melo, A K Silveira, A P R Dalvi, J Silva, V S Printes, L Anselmo, T I da Silva, M M Oliveira, C Conceição, A Lopes, V Bollela, M Cordeiro-Santos, M Bhering, A S R Moreira, A C C Carvalho, A L Kritski

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Abstract

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 Mycobacterium tuberculosis 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.

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Truenat™MTB Plus诊断肺结核的准确性

背景：Truenat™是世卫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Truenat MTB Plus与Xpert®MTB/RIF Ultra在检测肺结核方面的敏感性和特异性。以结核分枝杆菌液体培养和药敏试验为参考。结果：283名参与者中，112名（39.6%）患有培养阳性肺结核。Truenat MTB Plus的敏感性和特异性分别为72.7% （95% CI 63.41 ~ 80.78）和99.4% (95% CI 96.71 ~ 99.98)，而Xpert MTB/RIF Ultra的敏感性和特异性分别为78.4% （95% CI 69.56 ~ 85.63）和99.4% （95% CI 96.67 ~ 99.98）。在89例HIV感染者（PLHIV）中，Truenat MTB Plus的敏感性为45.0% (95% CI 23.06-68.47)，特异性为100.0% （95% CI 95.64-100.00）。在71例既往接受过结核病治疗的患者中，Truenat MTB Plus的敏感性和特异性分别为79.3% （95% CI 60.28-92.01）和97.5% （95% CI 86.84-99.94）。Xpert MTB/RIF Ultra检测到11/88份样本（12.5%）对利福平耐药，而Truenat MTB Plus检测到9/72份（12.5%）耐药。结论：Truenat MTB Plus的性能与Xpert MTB/RIF Ultra相当。两项检测均显示对PLHIV的敏感性较低。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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IJTLD open

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