Objective: To evaluate the diagnosis of interferon gamma release assay (IGRA) combined with tumor marker carbohydrate antigen-125 (CA-125) in active pulmonary tuberculosis (PTB). Methods: One hundred and three patients with active PTB (48 definite and 55 clinical diagnosed), 646 patients with non-PTB pulmonary disease and 60 normal controls hospitalized in Beijing Tongren Hospital, Capital Medical University between January 2014 and December 2016 were retrospectively investigated. Blood samples were collected to determine the IGRA and CA-125 level by enzyme-linked immunosorbent assay and electrochemiluminescence, respectively. The CA-125 level of patients with active PTB, non-PTB pulmonary disease and normal controls were compared. Subsequently, the best cut-off value of CA-125 for diagnosing PTB was calculated based on 60 active PTB cases and 60 normal controls. Methodological evaluation of IGRA, CA-125 and combination of these two tests (both positive) for active PTB diagnosing were performed based on 43 active PTB cases and all the non-PTB pulmonary disease cases. Results: The median values of CA-125 among definite and clinical diagnosis groups of active PTB were 55.00 (25.35, 156.90) U/ml and 81.50 (39.40, 138.00) U/ml, respectively. There was no difference between the two groups (U=1 093.00, P>0.05). And the CA-125 level of male and female PTB patients were also undifferentiated (U=1 124.00, P>0.05). There were statistically significant differences in CA-125 levels between the active PTB group and all other non-PTB groups (all P<0.001), including those who had ever closely contacted with TB patients. The area under the ROC curve constructed by CA-125 for diagnosing active PTB was 0.933. And the best cut-off value of CA-125 was 22.00 U/ml. Based on this cut-off value, the accuracy, sensitivity and specificity of CA-125 for diagnosing active PTB were 70.5% (486/689), 86.0% (37/43) and 69.5% (449/646). The accuracy, sensitivity and specificity of IGRA for diagnosing active PTB were 73.3% (480/689), 90.7% (39/43) and 68.3%(441/64). The accuracy, sensitivity and specificity of IGRA combined with CA-125 for diagnosing active PTB were 90.6% (624/689), 76.7% (33/43), 91.5% (591/646). Both of the accuracy and the false positive ratio of this combinational method (8.5%, 55/646) were significantly lower than two indexes individually used (χ(2)=94.461, 88.261, P<0.001). However, the false negative ratio was increased to 23.3% (10/43) by combinational method. Conclusion: IGRA combined with CA-125 has a certain clinical value in diagnosis of active PTB, especially when the evidences of bacterial is not available.
目的： 探讨γ-干扰素释放试验（IGRA）联合肿瘤标志物糖类抗原-125（CA-125）在活动性肺结核（PTB）诊断中的价值。 方法： 回顾性入组2014年1月至2016年12月就诊于首都医科大学附属北京同仁医院的103例活动性PTB患者（包括48例确诊及55例临床诊断患者）、646例非PTB肺部疾病患者及60名健康对照者，分别通过酶联免疫吸附法及电化学发光法进行全血IGRA及血清CA-125检测。比较活动期PTB患者与各类非PTB肺部疾病患者、健康对照者CA-125水平差异，并通过活动性PTB患者及健康对照者各60例计算CA-125单独诊断活动性PTB的最佳cut-off值。而后通过剩余43例活动性PTB及所有非PTB肺部疾病患者进行CA-125、IGRA单独诊断及二者联合（即均为阳性）诊断活动性PTB的方法学评价。 结果： 活动性PTB确诊组与临床诊断组CA-125水平分别为55.00（25.35，156.90）、81.50（39.40，138.00）U/ml，差异无统计学意义（U=1 093.00，P>0.05）；男性与女性活动性PTB患者CA-125水平分别为69.15（29.43，125.28）、77.60（35.50，185.70）U/ml，差异无统计学意义（U=1 124.00，P>0.05）。活动性PTB组与其他各非PTB组间CA-125水平差异均具有统计学意义（均P<0.001）。CA-125诊断活动性PTB的受试者工作特征曲线（ROC曲线）的曲线下面积为0.933，诊断活动性PTB的最佳cut-off值为22.00 U/ml。将其单独用于活动性PTB诊断，准确率为70.5%（486/689）、敏感度为86.0%（37/43）、特异度为69.5%（449/646）。IGRA单独用于活动性PTB诊断的准确率为73.3%（480/689）、敏感度为90.7%（39/43）、特异度为68.3%（441/64）。IGRA联合CA-125用于活动性PTB诊断的准确率达90.6%（624/689）、敏感度为76.7%（33/43）、特异度为91.5%（591/646）。其准确率及假阳性率（8.5%，55/646）均明显低于IGRA、CA-125的单独应用（χ(2)=94.461、88.261，均P<0.001），但假阴性率为23.3%（10/43）。 结论： 对于活动性PTB，尤其是无法获得病原学证据时，IGRA与CA-125的联合应用具有一定诊断意义。.
Keywords: Antigens, tumor-associated, carbohydrate; Diagnosis; Tuberculosis, pulmonary; γ-IFN Release assays.