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首页> 外文期刊>Journal of Clinical Microbiology >Same-Day Tools, Including Xpert Ultra and IRISA-TB, for Rapid Diagnosis of Pleural Tuberculosis: a Prospective Observational Study
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Same-Day Tools, Including Xpert Ultra and IRISA-TB, for Rapid Diagnosis of Pleural Tuberculosis: a Prospective Observational Study

机译：包括Xpert Ultra和IRISA-TB在内的即日工具，用于快速诊断胸膜结核：一项前瞻性观察研究

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The diagnosis of pleural tuberculosis (TB) is problematic. The comparative performance of newer same-day tools for pleural TB, including Xpert MTB/RIF Ultra (ULTRA), has hitherto not been comprehensively studied. Adenosine deaminase (ADA), IRISA-TB (interferon gamma ultrasensitive rapid immunosuspension assay), Xpert MTB/RIF, and ULTRA performance outcomes were evaluated in pleural fluid samples from 149 patients with suspected pleural TB. ABSTRACT The diagnosis of pleural tuberculosis (TB) is problematic. The comparative performance of newer same-day tools for pleural TB, including Xpert MTB/RIF Ultra (ULTRA), has hitherto not been comprehensively studied. Adenosine deaminase (ADA), IRISA-TB (interferon gamma ultrasensitive rapid immunosuspension assay), Xpert MTB/RIF, and ULTRA performance outcomes were evaluated in pleural fluid samples from 149 patients with suspected pleural TB. The reference standard was culture positivity (fluid, biopsy specimen, or sputum) and/or pleural biopsy histopathology (termed definite TB). Those designated as having non-TB were negative by microbiological testing and were not initiated on anti-TB treatment. To determine the effect of sample concentration, 65 samples underwent pelleting by centrifugation, followed by conventional Xpert MTB/RIF and ULTRA. Of the 149 patients, 49 had definite TB, 16 had probable TB (not definite but treated for TB), and 84 had non-TB. ULTRA sensitivity and specificity (95% confidence intervals [CI]) were similar to those of Xpert MTB/RIF [sensitivity, 37.5% (25.3 to 51.2) versus 28.6% (15.9 to 41.2), respectively; specificity, 98.8% (96.5 to 100) versus 98.8% (96.5 to 100), respectively]. Centrifugation did not significantly improve ULTRA sensitivity (29.5% versus 31.3%, respectively). Adenosine deaminase and IRISA-TB sensitivity were 84.4% (73.9 to 95.0) and 89.8% (81.3 to 98.3), respectively. However, IRISA-TB demonstrated significantly better specificity (96.4% versus 87.5% [ P = 0.034]), positive predictive value (93.6% versus 80.9 [ P = 0.028]), and positive likelihood ratio (25.1 versus 6.8 [ P = 0.032]) than ADA. In summary, Xpert ULTRA has poor sensitivity for the diagnosis of pleural TB. Alternative assays (ADA and IRISA-TB) are significantly more sensitive, with IRISA-TB demonstrating a higher specificity and rule-in value than ADA in this high-TB-burden setting where HIV is endemic.
机译：胸膜结核（TB）的诊断存在问题。迄今为止，尚未对Xpert MTB / RIF Ultra（ULTRA）等新型胸膜结核工具的比较性能进行全面研究。在149例疑似胸膜结核患者的胸水样本中评估了腺苷脱氨酶（ADA），IRISA-TB（干扰素γ超敏感快速免疫悬浮试验），Xpert MTB / RIF和ULTRA表现结果。摘要胸膜结核（TB）的诊断存在问题。迄今为止，尚未对Xpert MTB / RIF Ultra（ULTRA）等新型胸膜结核工具的比较性能进行全面研究。在149例疑似胸膜结核患者的胸水样本中评估了腺苷脱氨酶（ADA），IRISA-TB（干扰素γ超敏感快速免疫悬浮试验），Xpert MTB / RIF和ULTRA表现结果。参考标准是培养阳性（流体，活检标本或痰液）和/或胸膜活检组织病理学（称为确定性结核病）。通过微生物学测试被指定为非结核病的患者呈阴性，并且未开始接受抗结核病治疗。为了确定样品浓度的影响，先对65个样品进行离心沉淀，然后再进行常规Xpert MTB / RIF和ULTRA。在149例患者中，有49例确诊为结核病，有16例可能为结核病（未确定但已接受结核病治疗），有84例为非结核病。 ULTRA的敏感性和特异性（95％置信区间[CI]）与Xpert MTB / RIF相似[敏感性分别为37.5％（25.3至51.2）和28.6％（15.9至41.2）;特异性分别为98.8％（96.5至100）和98.8％（96.5至100）]。离心没有显着提高ULTRA灵敏度（分别为29.5％和31.3％）。腺苷脱氨酶和IRISA-TB敏感性分别为84.4％（73.9至95.0）和89.8％（81.3至98.3）。然而，IRISA-TB的特异性明显更好（96.4％比87.5％[P = 0.034]），阳性预测值（93.6％比80.9 [P = 0.028]）和阳性似然比（25.1比6.8 [P = 0.032]） ）比ADA。总之，Xpert ULTRA诊断胸膜结核的敏感性较差。替代检测（ADA和IRISA-TB）的敏感性要高得多，在这种HIV流行的高结核病负担地区，IRISA-TB表现出比ADA更高的特异性和规则价值。

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