Sun Y F, Zhang M X, Sui W J, Yuan L, Tong X J, Wang S L, Wang M, Huang Y F, Lu X X
Department of Laboratory Medicine, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.
Zhonghua Yi Xue Za Zhi. 2019 Feb 26;99(8):599-604. doi: 10.3760/cma.j.issn.0376-2491.2019.08.007.
To evaluate the diagnosis of interferon gamma release assay (IGRA) combined with tumor marker carbohydrate antigen-125 (CA-125) in active pulmonary tuberculosis (PTB). 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. 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 (=1 093.00, 0.05). And the CA-125 level of male and female PTB patients were also undifferentiated (=1 124.00, 0.05). There were statistically significant differences in CA-125 levels between the active PTB group and all other non-PTB groups (all 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, 0.001). However, the false negative ratio was increased to 23.3% (10/43) by combinational method. IGRA combined with CA-125 has a certain clinical value in diagnosis of active PTB, especially when the evidences of bacterial is not available.
评估干扰素γ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。回顾性调查2014年1月至2016年12月在北京同仁医院住院的103例活动性PTB患者(48例确诊和55例临床诊断)、646例非PTB肺部疾病患者及60例正常对照者。分别采集血样,采用酶联免疫吸附试验和电化学发光法检测IGRA和CA-125水平。比较活动性PTB患者、非PTB肺部疾病患者及正常对照者的CA-125水平。随后,根据60例活动性PTB病例和60例正常对照者计算诊断PTB的CA-125最佳截断值。基于43例活动性PTB病例和所有非PTB肺部疾病病例,对IGRA、CA-125及两者联合检测(均为阳性)诊断活动性PTB进行方法学评价。活动性PTB确诊组和临床诊断组的CA-125中位数分别为55.00(25.35,156.90)U/ml和81.50(39.40,138.00)U/ml,两组间差异无统计学意义(=1 093.00,0.05)。男性和女性PTB患者的CA-125水平也无差异(=1 124.00,0.05)。活动性PTB组与所有其他非PTB组(包括曾密切接触结核病患者的人群)的CA-125水平差异有统计学意义(均为0.001)。CA-125诊断活动性PTB的ROC曲线下面积为0.933。CA-125的最佳截断值为22.00 U/ml。基于该截断值,CA-125诊断活动性PTB的准确性、敏感性和特异性分别为70.5%(486/689)、86.0%(37/43)和69.5%(449/646)。IGRA诊断活动性PTB的准确性、敏感性和特异性分别为73.3%(480/689)、90.7%(39/43)和68.3%(441/64)。IGRA联合CA-125诊断活动性PTB的准确性、敏感性和特异性分别为90.6%(624/689)、76.7%(33/43)、91.5%(591/646)。该联合方法的准确性和假阳性率(8.5%,55/646)均显著低于单独使用的两项指标(χ(2)=94.461,88.261,0.001)。然而,联合方法的假阴性率增至23.3%(10/43)。IGRA联合CA-125在活动性PTB诊断中具有一定临床价值,尤其在缺乏细菌学证据时。