Diagnostic performance of the Cobas MTB and Logix Smart MTB for diagnosing pulmonary and extrapulmonary tuberculosis: a cross-sectional study of diagnostic tests.

IF 3.4 Q2 INFECTIOUS DISEASES Therapeutic Advances in Infectious Disease Pub Date : 2024-12-14 eCollection Date: 2024-01-01 DOI:10.1177/20499361241304516

Miguel Hueda-Zavaleta, Juan Carlos Gomez de la Torre, Diana Minchón-Vizconde, Claudia Barletta-Carrillo, Cesar Copaja-Corzo, Gustavo Tapia-Sequeiros, Cinthya Flores, Cristian Piscoche, Cecilia Miranda, Ada Mendoza, Vicente A Benites-Zapata

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Abstract

Background: Molecular tests have contributed to reducing the mortality rate through early and accurate diagnosis of tuberculosis (TB). This is due to their low processing complexity and diagnostic accuracy superior to conventional methods.

Objective: To evaluate the diagnostic performance of Cobas MTB and Logix Smart MTB compared to Xpert MTB/RIF Ultra for pulmonary tuberculosis (PTB) and extrapulmonary tuberculosis (EPTB).

Design: A cross-sectional study of diagnostic tests was carried out in a clinical laboratory in Lima, Peru.

Methods: All pulmonary and extrapulmonary samples from patients with presumptive TB who had been subjected to smear microscopy, Xpert MTB/RIF Ultra, Cobas MTB, Logix Smart MTB, and mycobacteria culture were included to determine their diagnostic performance.

Results: A total of 175 samples were included, 102 (58.3%) of pulmonary origin and 73 (41.7%) of extrapulmonary origin. Among the total samples, 19 (10.9%) had positive cultures (all were pulmonary samples), 48 (27.4%) had positive Xpert MTB/RIF Ultra results, 45 (25.7%) had positive Cobas MTB results, and 36 (20.6%) had positive Logix Smart MTB results. The agreement between Cobas MTB and Logix Smart with the Xpert MTB/RIF Ultra was 97.1% and 93.8%, respectively. Compared to Xpert MTB/RIF Ultra, the area under the curve/receiver operating characteristic and sensitivity of the Cobas MTB and Logix Smart methods were 0.95 and 91.7%, and 0.90 and 81.0%, respectively.

Conclusion: Cobas MTB and Logix Smart presented adequate performance for diagnosing pulmonary and extrapulmonary tuberculosis comparable to the Xpert MTB/RIF Ultra.

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Cobas MTB和Logix Smart MTB诊断肺结核和肺外肺结核的诊断性能：诊断试验的横断面研究。

背景：分子检测通过早期准确诊断结核病（TB），为降低死亡率做出了贡献。这是因为分子检验的处理复杂性低，诊断准确性优于传统方法：与 Xpert MTB/RIF Ultra 相比，评估 Cobas MTB 和 Logix Smart MTB 对肺结核（PTB）和肺外结核（EPTB）的诊断性能：设计：在秘鲁利马的一家临床实验室开展了一项诊断测试横断面研究：方法：纳入所有经过涂片显微镜检查、Xpert MTB/RIF Ultra、Cobas MTB、Logix Smart MTB 和分枝杆菌培养的推定肺结核患者的肺部和肺外样本，以确定其诊断性能：结果：共纳入 175 份样本，其中 102 份（58.3%）来自肺部，73 份（41.7%）来自肺外。在所有样本中，19 份样本（10.9%）的培养结果呈阳性（均为肺部样本），48 份样本（27.4%）的 Xpert MTB/RIF Ultra 结果呈阳性，45 份样本（25.7%）的 Cobas MTB 结果呈阳性，36 份样本（20.6%）的 Logix Smart MTB 结果呈阳性。Cobas MTB 和 Logix Smart 与 Xpert MTB/RIF Ultra 的一致性分别为 97.1%和 93.8%。与 Xpert MTB/RIF Ultra 相比，Cobas MTB 和 Logix Smart 方法的曲线下面积/接收器工作特征和灵敏度分别为 0.95% 和 91.7%，以及 0.90% 和 81.0%：Cobas MTB 和 Logix Smart 在诊断肺部和肺外结核病方面的性能足以媲美 Xpert MTB/RIF Ultra。

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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