論文No2312
Accuracy of Xpert MTB/RIF Ultra for the Diagnosis of Pleural TB in a Multicenter Cohort Study
Guirong Wang, Shuqi Wang, Xinting Yang, Qing Sun, Guanglu Jiang, Mailing Huang, Fengmin Huo, Yifeng Ma, Xiaoyou Chen, Hairong Huang
CHEST, February 2020, Volume 157, Issue 2, Pages 268–275.
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＜背景＞
Xpert MTB/RIF (Xpert)アッセイは結核診断を大いに改善させ、リファンピシン(RIF)への耐性の同定に役立っている。
しかし、Xpertの感度は胸水に関して不明である。
この研究では新しい次世代Xpert MTB/RIF Ultra(Xpert Ultra)を、胸水の結核診断に関してXpertと比較した。
＜方法＞
結核性胸膜炎が疑われた患者を４つの病院から登録し、胸水を塗抹、培養、Xpertの検査に回した。
凍結(−80°C)させた胸水をXpert Ultraで検査した。
分離された菌にたいして感受性試験(DST)を行った。
＜結果＞
全体で317名の結核性胸膜炎疑いの患者が登録され、
208名が臨床、生化学、組織、放射線検査の特徴、12か月以上のフォローアップデータにもとづき、結核性胸膜炎と診断された。
結核の診断に関する直接比較ではXpert Ultra (44.23%, 92 of 208)は、
培養(26.44%, 55 of 208, P < .001)、Xpert (19.23%, 40 of 208, P < .001)、
塗抹 (1.44%, three of 208, P < .001)よりも感度が高かった。
Xpert Ultraのアウトカムが統合されると、結核性胸膜炎の確定診断率は56.25% (117 of 208) から 64.90% (135 of 208)に改善した。
塗抹、培養、Xpert、Xpert Ultraの特異度は100% (84 of 84), 100% (84 of 84), 98.67% (83 of 84), and 98.67% (83 of 84)であった。
Xpert Ultraはリファンピシン耐性に関してDSTが100%一致した。
＜感想＞
Xpert Ultraを使うと胸水からの結核性胸膜炎の診断感度が改善したようです。
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Background
The Xpert MTB/RIF (Xpert) assay has greatly improved the diagnosis of TB and identification of resistance to rifampicin (RIF). However, sensitivity of Xpert remains poor for pleural fluid detection. This study evaluated the performance of the novel next-generation Xpert MTB/RIF Ultra (Xpert Ultra) in comparison with Xpert for pleural TB diagnosis.
Methods
Patients with suspected pleural TB were enrolled consecutively in four hospitals, and pleural fluids were subjected to smear, culture, and Xpert. Defrosted pleural fluid (−80°C) was examined using Xpert Ultra. Drug susceptibility testing (DST) was conducted for all of the recovered isolates.
Results
In total, 317 individuals with suspected pleural TB were recruited; 208 of them were diagnosed with pleural TB according to the composite reference standard, which was composed of clinical, laboratory, histopathologic, and radiologic examination features and ≥ 12 months of follow-up data. The direct head-to-head comparison for Mycobacterium tuberculosis detection showed that Xpert Ultra (44.23%, 92 of 208) produced a higher sensitivity than culture (26.44%, 55 of 208, P < .001), Xpert (19.23%, 40 of 208, P < .001), and smear (1.44%, three of 208, P < .001). When Xpert Ultra outcomes were integrated, the percentage of definite pleural TB cases increased from 56.25% (117 of 208) to 64.90% (135 of 208). The specificities of smear, culture, Xpert, and Xpert Ultra were 100% (84 of 84), 100% (84 of 84), 98.67% (83 of 84), and 98.67% (83 of 84), respectively. Xpert Ultra was 100% concordant with phenotype DST for the detection of RIF resistance.
Conclusions
Xpert Ultra has great potential in diagnosis of pleural TB and its RIF resistance, which could speed up the initiation of appropriate treatment.