Hueda-Zavaleta Miguel, Gomez de la Torre Juan Carlos, Minchón-Vizconde Diana, Barletta-Carrillo Claudia, Copaja-Corzo Cesar, Tapia-Sequeiros Gustavo, Flores Cinthya, Piscoche Cristian, Miranda Cecilia, Mendoza Ada, Benites-Zapata Vicente A
Diagnóstico, tratamiento e investigación de enfermedades infecciosas y tropicales, Universidad Privada de Tacna, Tacna, Peru.
Laboratorio clínico Roe, Lima, Peru.
Ther Adv Infect Dis. 2024 Dec 14;11:20499361241304516. doi: 10.1177/20499361241304516. eCollection 2024 Jan-Dec.
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.
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).
A cross-sectional study of diagnostic tests was carried out in a clinical laboratory in Lima, Peru.
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.
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.
Cobas MTB and Logix Smart presented adequate performance for diagnosing pulmonary and extrapulmonary tuberculosis comparable to the Xpert MTB/RIF Ultra.
分子检测通过对结核病（TB）的早期准确诊断，有助于降低死亡率。这得益于其较低的操作复杂性以及优于传统方法的诊断准确性。
评估Cobas MTB和Logix Smart MTB相较于Xpert MTB/RIF Ultra用于肺结核（PTB）和肺外结核（EPTB）的诊断性能。
在秘鲁利马的一家临床实验室开展了一项诊断检测的横断面研究。
纳入所有疑似结核病患者的肺和肺外样本，这些样本均接受了涂片显微镜检查、Xpert MTB/RIF Ultra、Cobas MTB、Logix Smart MTB以及分枝杆菌培养，以确定它们的诊断性能。
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（10.9%）培养结果呈阳性（均为肺部样本），48份（27.4%）Xpert MTB/RIF Ultra检测结果呈阳性，45份（25.7%）Cobas MTB检测结果呈阳性，36份（20.6%）Logix Smart MTB检测结果呈阳性。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/受试者工作特征曲线及灵敏度分别为0.95和91.7%，以及0.90和81.0%。
Cobas MTB和Logix Smart在诊断肺结核和肺外结核方面表现出与Xpert MTB/RIF Ultra相当的性能。
