Zhejiang Tuberculosis Diagnosis and Treatment Center, Affiliated Hangzhou Chest Hospital, Zhejiang University School of Medicine, PR China.
Zhejiang Tuberculosis Diagnosis and Treatment Center, Affiliated Hangzhou Chest Hospital, Zhejiang University School of Medicine, PR China.
Tuberculosis (Edinb). 2023 May;140:102349. doi: 10.1016/j.tube.2023.102349. Epub 2023 May 2.
To evaluate the tuberculosis diagnostic performance of the InnowaveDx MTB-RIF assay (InnowaveDx test) in bronchoalveolar lavage fluid (BALF).
A total of 213 BALF samples from suspected PTB patients were analyzed. AFB smear, culture, Xpert, Innowavedx test, CapitalBio test and simultaneous amplification and testing (SAT) were performed.
Of the 213 patients included in the study, 163 were diagnosed with PTB, and 50 were TB negative. Using the final clinical diagnosis as the reference, the sensitivity of InnowaveDx assay was 70.6%, which was significantly higher than the values achieved using the other methods (P < 0.05), and the specificity was 88.0%, which was comparable with other methods (P > 0.05). Among the 83 PTB cases with negative culture results, the detection rate of InnowaveDx assay was significantly higher than those of AFB smear, Xpert, CapitalBio test and SAT (P < 0.05). Kappa analysis was used to compare the agreement of InnowaveDx and Xpert in detecting RIF sensitivity, and the result showed the Kappa value was 0.78.
The InnowaveDx test is a sensitive, rapid and cost-effective tool for PTB diagnosis. In addition, the sensitivity of InnowaveDx to RIF in samples with low TB load should be interpreted with caution in light of other clinical data.
评估 InnowaveDx MTB-RIF 检测（InnowaveDx 检测）在支气管肺泡灌洗液（BALF）中对结核病的诊断性能。
分析了 213 例疑似肺结核患者的 BALF 样本。进行了 AFB 涂片、培养、Xpert、Innowavedx 检测、CapitalBio 检测和同步扩增和检测（SAT）。
在纳入研究的 213 例患者中，163 例被诊断为肺结核，50 例为结核阴性。以最终临床诊断为参考，InnowaveDx 检测的灵敏度为 70.6%，明显高于其他方法（P<0.05），特异性为 88.0%，与其他方法相当（P>0.05）。在 83 例培养结果阴性的肺结核病例中，InnowaveDx 检测的检出率明显高于 AFB 涂片、Xpert、CapitalBio 检测和 SAT（P<0.05）。使用 Kappa 分析比较 InnowaveDx 和 Xpert 检测 rif 敏感性的一致性，结果显示 Kappa 值为 0.78。
InnowaveDx 检测是一种敏感、快速且具有成本效益的肺结核诊断工具。此外，鉴于其他临床数据，应谨慎解释 InnowaveDx 对低结核负荷样本中 rif 敏感性的检测。
