Diagnostic Efficacy of New Xpert Ultra for Extrapulmonary Tuberculosis Using Culture and Composite Reference Standard.

IF 0.8 Q3 MEDICINE, GENERAL & INTERNAL
Jyoti Chaudhary, Divjot Singh Chawla, Veenu Gupta, Akashdeep Singh, Manisha Aggarwal
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Abstract

Introduction: Xpert Ultra (Cepheid, USA) is recently introduced with an extra category of trace-positive results and higher sensitivity for tuberculosis (TB) diagnosis.

Objective: The objective of the study was to assess the diagnostic accuracy of Xpert Ultra for extrapulmonary samples using culture and composite reference standard (CRS) as the gold standard.

Materials and methods: In a 1-year (March 2021-22) prospective observational study, samples of suspected extrapulmonary TB (EPTB) patients were subjected to Ziehl-Neelsen staining, culture, and Xpert Ultra (Cepheid, Sunnyvale, CA) tests. Relevant clinical and treatment information was noted. The diagnostic accuracy of Xpert Ultra compared with culture and CRS was calculated.

Results: Out of 1720 suspected patients of EPTB, 223 (13%), predominantly males 135 (60%), with a mean age of 41.46 ± 19.81 years, were diagnosed as TB positive following CRS criteria. The maximum cases were of pleural TB (35.4%), followed by central nervous system TB (17.9%), gastrointestinal TB (17.5%), and lymph node TB (12.1%). Of all samples, 150 (8.7%) were microbiologically confirmed, including 141 detected by Xpert ultra, 67 culture positive, and only 16 smear positive. Among the Xpert Ultra-positive samples, 35 showed trace results, including six false-positive results. Considering culture and CRS as the gold standard, the sensitivity (86.57%, 59.64%) and specificity (94.98%, 99.47%) of Xpert Ultra were calculated, respectively. Rifampicin resistance was detected in 1 (0.70%) sample.

Conclusion: Diagnosis of EPTB is a challenge and Xpert Ultra may detect TB at a very early stage. However, it is essential to rule out false-positive results. Additional studies are needed on Xpert Ultra to interpret trace results better.

新型 Xpert Ultra 使用培养和复合参考标准对肺结核的诊断效果。
简介:Xpert Ultra(美国 Cepheid 公司)是最近推出的一种用于肺结核(TB)诊断的新技术:Xpert Ultra(美国Cepheid公司)是最近推出的一种肺结核诊断试剂盒,它具有额外的微量阳性结果类别和更高的灵敏度:研究目的:以培养和复合参考标准(CRS)为金标准,评估 Xpert Ultra 对肺外样本的诊断准确性:在一项为期 1 年(2021 年 3 月至 2022 年 3 月)的前瞻性观察研究中,对肺外结核(EPTB)疑似患者样本进行了齐氏-奈尔森染色、培养和 Xpert Ultra(Cepheid,Sunnyvale,CA)检测。并记录了相关的临床和治疗信息。计算了 Xpert Ultra 与培养和 CRS 相比的诊断准确率:在 1720 名 EPTB 疑似患者中,有 223 人(13%)根据 CRS 标准被诊断为肺结核阳性,其中 135 人(60%)为男性,平均年龄(41.46±19.81)岁。最多的病例是胸膜结核(35.4%),其次是中枢神经系统结核(17.9%)、胃肠道结核(17.5%)和淋巴结结核(12.1%)。在所有样本中,有 150 个样本(8.7%)经微生物学确诊,其中 141 个样本经 Xpert Ultra 检测,67 个样本培养阳性,只有 16 个样本涂片阳性。在 Xpert Ultra 检测呈阳性的样本中,有 35 份显示微量结果,包括 6 份假阳性结果。以培养和 CRS 为金标准,计算出 Xpert Ultra 的灵敏度(86.57%,59.64%)和特异度(94.98%,99.47%)。在 1 个样本(0.70%)中检测到了利福平耐药性:结论:EPTB 的诊断是一项挑战,而 Xpert Ultra 可以在早期发现结核病。结论:诊断 EPTB 是一项挑战,Xpert Ultra 可在早期阶段检测出结核病,但必须排除假阳性结果。需要对 Xpert Ultra 进行更多的研究,以便更好地解释微量结果。
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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