Accuracy of Xpert MTB/RIF Ultra for the diagnosis of tuberculosis in adult patients: a retrospective cohort study.

Chintan Kaswala, Yvonne Schmiedel, Debasree Kundu, Mithun Mohan George, Divya Dayanand, Emily Devasagayam, Abi Manesh S, Selwyn Selva Kumar, Joy S Michael, Marilyn M Ninan, Geeta Chacko, Anand Zachariah, Sowmya Sathyendra, Samuel George Hansdak, Ramya Iyadurai, Devasahayam Jesudas Christopher, Richa Gupta, Rajiv Karthik, Ooriapadickal Cherian Abraham, George M Varghese
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引用次数: 4

Abstract

Objectives: The value of the "trace" result in Xpert Ultra for diagnosing active tuberculosis (TB) remains unclear. Our study evaluated the diagnostic accuracy of Xpert MTB/RIF Ultra (Xpert Ultra) (Cepheid, Sunnyvale, USA) over Xpert MTB/RIF (Xpert) (Cepheid, Sunnyvale, USA) and mycobacterial culture when compared with a composite reference standard (CRS).

Methods: A retrospective single-center observational study was conducted in a tertiary care hospital in South India. Over three months, patients (aged ≥15 years) data on Xpert Ultra tests and mycobacterial culture of pulmonary and extrapulmonary samples were extracted from their electronic medical records. Patients were defined as TB cases based on the CRS criteria. Sensitivity, specificity, positive and negative predictive values of diagnostic tests were calculated by comparing them to the CRS.

Results: Xpert Ultra was more sensitive (87.8%) than Xpert (72.1%) and culture (44.1%). The specificity of Xpert Ultra was lower (98.1%) than those of Xpert (100%) and culture (100%). The sensitivity (92%) and specificity (100%) of Xpert Ultra were highest when performed on pus samples.

Conclusions: Xpert Ultra with the trace category is superior to the conventional Xpert, and mycobacterial culture in identifying TB.

Xpert MTB/RIF Ultra诊断成人结核病的准确性:一项回顾性队列研究。
目的:Xpert Ultra“微量”结果在诊断活动性肺结核(TB)中的价值尚不清楚。我们的研究评估了Xpert MTB/RIF Ultra (Xpert Ultra) (Cepheid, Sunnyvale, USA)对Xpert MTB/RIF (Xpert) (Cepheid, Sunnyvale, USA)和分枝杆菌培养的诊断准确性,并与复合参考标准(CRS)进行了比较。方法:在印度南部一家三级医院进行回顾性单中心观察性研究。在三个月的时间里,从患者的电子病历中提取Xpert Ultra试验数据和肺及肺外样本分枝杆菌培养数据。根据CRS标准将患者定义为结核病例。通过与CRS比较,计算诊断试验的敏感性、特异性、阳性预测值和阴性预测值。结果:Xpert Ultra的敏感性(87.8%)高于Xpert(72.1%)和培养(44.1%)。Xpert Ultra的特异性(98.1%)低于Xpert(100%)和培养(100%)。Xpert Ultra的灵敏度(92%)和特异性(100%)在脓样本中最高。结论:微量类别的Xpert Ultra在鉴别结核方面优于常规的Xpert和分枝杆菌培养。
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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