Validation of a commercial serodiagnostic kit for diagnosing pulmonary Mycobacterium avium complex disease
Validation of a commercial serodiagnostic kit for diagnosing pulmonary Mycobacterium avium complex disease
复制标题
DOI：
10.5588/ijtld.14.0564
复制
发表时间：
2015-01-01
影响因子：
4
通讯作者：
Kobayashi, K.
中科院分区：
文献类型：
--
作者：
Kitada, S.;Yoshimura, K.;Kobayashi, K.
背景：用于诊断鸟分枝杆菌复合体 (MAC-PD) 引起的肺部疾病的商业血清诊断试剂盒于 2011 年在日本开发并上市。目的：评估该试剂盒在常规临床环境中的性能。方法：在这项回顾性单中心研究中，获得了抗糖肽脂 (GPL) 核心 IgA 抗体 (U/ml) 血清水平的数据。 使用该试剂盒对根据美国胸科协会标准诊断为 MAC-PD 的患者、肺结核 (PTB) 或堪萨斯分枝杆菌肺病患者以及健康志愿者进行了分析。结果：MAC-PD 患者 (n = 485) 血清中抗 GPL 核心 IgA 抗体水平显着高于 (P < 0.0001) MAC-PD 患者 (n = 485) 显着高于 PTB 患者 (n = 485) = 133）或堪萨斯分枝杆菌肺病（n = 23）或健康受试者（n = 265）。当截止水平设定为0.7 U/ml时，敏感性和特异性分别为78.6%和96.9%。胸部计算机断层扫描显示疾病范围较大的患者抗体水平较高（P < 0.0001）。结论：血清诊断试剂盒显示出良好的敏感性和特异性。抗体水平可以反映疾病活动性。需要做更多的工作来确定该诊断测定是否可以与当前的诊断标准结合使用以改善 MAC-PD 的诊断。
SETTING: A commercial serodiagnostic kit for diagnosing pulmonary disease due to Mycobacterium avium complex (MAC-PD) was developed and launched in Japan in 2011.OBJECTIVE: To evaluate the performance of this kit in routine clinical settings.METHODS: In this retrospective single-centre study, data on serum levels of anti-glycopeptidolipid (GPL) core IgA antibody (U/ml) measured using the kit were analysed in patients diagnosed with MAC-PD according to American Thoracic Society criteria, in those with pulmonary tuberculosis (PTB) or pulmonary M. kansasii disease and in healthy volunteers.RESULTS: The anti-GPL-core IgA antibody levels of serum were significantly higher (P < 0.0001) in patients with MAC-PD (n = 485) than in those with PTB (n = 133) or pulmonary M. kansasii disease (n = 23) or in healthy subjects (n = 265). When the cut-off level was set at 0.7 U/ml, the sensitivity and specificity were respectively 78.6% and 96.9%. Higher antibody levels were observed in patients with greater extent of disease on chest computed tomography (P < 0.0001).CONCLUSIONS: The serodiagnostic kit revealed good sensitivity and specificity. The antibody levels may reflect disease activity. Additional work is needed to determine whether the diagnostic assay could be used in conjunction with current diagnostic criteria to improve the diagnosis of MAC-PD.