Kitada S, Yoshimura K, Miki K, Miki M, Hashimoto H, Matsui H, Kuroyama M, Ageshio F, Kagawa H, Mori M, Maekura R, Kobayashi K
Department of Respiratory Medicine, National Hospital Organization, National Toneyama Hospital, Osaka, Japan.
Sakai City Institute of Public Health, Osaka, Japan.
Int J Tuberc Lung Dis. 2015 Jan;19(1):97-103. doi: 10.5588/ijtld.14.0564.
A commercial serodiagnostic kit for diagnosing pulmonary disease due to Mycobacterium avium complex (MAC-PD) was developed and launched in Japan in 2011.
To evaluate the performance of this kit in routine clinical settings.
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.
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).
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.
一种用于诊断鸟分枝杆菌复合群所致肺部疾病（MAC-PD）的商业血清学诊断试剂盒于2011年在日本研发并推出。
评估该试剂盒在常规临床环境中的性能。
在这项回顾性单中心研究中，对根据美国胸科学会标准诊断为MAC-PD的患者、肺结核（PTB）患者、堪萨斯分枝杆菌肺部疾病患者以及健康志愿者，分析使用该试剂盒测得的血清抗糖脂肽（GPL）核心IgA抗体水平（U/ml）的数据。
MAC-PD患者（n = 485）血清中的抗GPL核心IgA抗体水平显著高于PTB患者（n = 133）、堪萨斯分枝杆菌肺部疾病患者（n = 23）或健康受试者（n = 265）（P < 0.0001）。当临界值设定为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越大的患者抗体水平越高（P < 0.0001）。
该血清学诊断试剂盒显示出良好的敏感性和特异性。抗体水平可能反映疾病活动度。需要进一步研究以确定该诊断检测方法是否可与当前诊断标准结合使用，以改善MAC-PD的诊断。
