3种抗棘球蚴抗体检测试剂盒用于棘球蚴病血清学诊断效果评价

摘要/Abstract

摘要： 目的　评价我国3种商品化抗棘球蚴抗体检测试剂盒用于棘球蚴病血清学诊断的效能。方法　收集142份细粒棘球蚴病、89份多房棘球蚴病确诊患者及39份健康对照者血清标本，分别采用试剂盒A[酶联免疫吸附试验（ELISA法）]、B（ELISA法）、C（胶体金法）检测，比较细粒棘球蚴病和多房棘球蚴病患者血常规和生化指标差异，分析采用试剂盒A和B检测的棘球蚴病患者血清特异性抗体吸光度值（A值）与血常规及生化指标的相关性，评价3种试剂盒检测棘球蚴病的效果。结果　细粒棘球蚴病和多房棘球蚴病患者白细胞计数（WBC）、中性粒细胞计数（NEU）、单核细胞计数（MONO）、嗜碱性粒细胞计数（BASO）、丙氨酸氨基转移酶（ALT）和天门冬氨酸氨基转移酶（AST）、总胆红素（TBIL）、直接胆红素（DBIL）、间接胆红素（IBIL）中位数差异无统计学意义（P均 > 0.05），细粒棘球蚴病患者淋巴细胞计数（LYM）和白蛋白（ALB）中位数显著高于多房棘球蚴病患者（P均< 0.05），而多房棘球蚴病患者嗜酸性粒细胞计数（EOS）中位数显著高于细粒棘球蚴病患者（P < 0.01）。采用试剂盒A检测的棘球蚴病患者血清特异性抗体A值与患者WBC（rs = 0.153，P < 0.05）、EOS（rs = 0.174，P < 0.05）呈线性正相关，与TBIL（rs = -0.134，P < 0.05）、IBIL（rs = -0.146，P < 0.05）呈线性负相关。采用试剂盒B检测的棘球蚴病患者血清特异性抗体A值与WBC（rs = 0.257，P < 0.01）、NEU（rs = 0.203，P < 0.01）、MONO（rs = 0.159，P < 0.05）、EOS（rs = 0.330，P < 0.01）、ALT（rs = 0.171，P < 0.01）、AST（rs = 0.160，P < 0.05）呈线性正相关，与ALB呈线性负相关（rs = -0.168，P < 0.05）。试剂盒A、B和C诊断棘球蚴病患者的总符合率分别为86.30%、69.63%和91.48%，敏感度分别为84.42%、64.94%和92.21%，特异度分别为97.44%、97.44%和87.18%，约登指数分别为0.82、0.62和0.79，Kappa值分别为0.600、0.337和0.750。试剂盒A、B和C诊断细粒棘球蚴病患者的总符合率分别为84.54%、64.64%和71.82%，敏感度分别为80.99%、55.63%和68.31%，特异度分别为97.44%、97.44%和87.18%，约登指数分别为0.78、0.53和0.56；试剂盒A、B和C诊断多房棘球蚴病患者的总符合率分别为92.19%、85.16%和85.16%，敏感度分别为89.89%、79.78%和84.27%，特异度分别为97.44%、97.44%和87.18%，约登指数分别为0.87、0.77和0.72。试剂盒C在诊断细粒和多房棘球蚴病时存在交叉反应。试剂盒A和B用于诊断棘球蚴病的受试者工作特征曲线（receiver operating characteristic curve，ROC）曲线下面积分别为0.970和0.948，差异无统计学意义（Z = 1.618，P > 0.05），试剂盒A和B诊断棘球蚴病结果具有较好一致性（Kappa = 0.585，P < 0.01）。结论　3种抗棘球蚴抗体检测试剂盒对多房棘球蚴病血清学诊断效果均优于细粒棘球蚴病。试剂盒A诊断棘球蚴病具有较高敏感性和特异性，检测性能相对稳定、干扰因素相对较少，适合用于棘球蚴病术前初步诊断和术后患者血清抗体随访监测；试剂盒C诊断棘球蚴病具有较高敏感性和特异性，操作方便、报告率高，适用于棘球蚴病初步筛查。

关键词: 棘球蚴病, 抗体检测, 血清学诊断, 诊断效能

Abstract: Objective　To evaluate the efficiency of three Chinese commercial anti?Echinococcus antibody?based assays for the serodiagnosis of echinococcosis. Methods　A total of 142 sera from cystic echinococcosis patients, 89 sera from alveolar echinococcosis and 39 sera from healthy controls were sampled, and detected by kits A (ELISA), B (ELISA) and C (colloidal gold immunoassay). The routine blood testing results and biochemical parameters were compared between the cystic and alveolar echinococcosis patients, and the associations of the absorbance (A value) of the serum specific antibody detected by A and B kits with the routine blood testing results and biochemical parameters were examined in echinococcosis patients. In addition, the performance of these three assays for the serodiagnosis of echinococcosis was evaluated. Results　There were no significant differences between the cystic and alveolar echinococcosis patients in terms of the median white blood cell count (WBC), neutrophil count (NEU), monocyte count (MONO), basophil count (BASO), alanine aminotransferase concentration (ALT), aspirate aminotransferase concentration (AST), total bilirubin (TBIL), direct bilirubin (DBIL), indirect bilirubin (IBIL) (all P values > 0.05), and higher median lymphocyte count (LYM) and albumin levels (ALB) were detected in cystic echinococcosis patients than in alveolar echinococcosis patients (both P values < 0.05), while the median eosinophil count (EOS) was greater in the alveolar echinococcosis patients than in the cystic echinococcosis patients (P < 0.01). The A value of the serum specific antibody detected by kit A showed a linear positive correlation with WBC (rs = 0.153, P < 0.05) and EOS (rs = 0.174, P < 0.05), and a linear negative correlation with TBIL (rs = -0.134, P < 0.05) and IBIL (rs = -0.146, P < 0.05), while the A value of the serum specific antibody detected by kit B showed a linear positive correlation with WBC (rs = 0.257, P < 0.01), NEU (rs = 0.203, P < 0.01), MONO (rs = 0.159, P < 0.05), EOS (rs = 0.330, P < 0.01), ALT (rs = 0.171, P < 0.01) and AST (rs = 0.160, P < 0.05), and a linear negative correlation with ALB (rs = -0.168, P < 0.05). The overall coincidence rate, sensitivity, specificity, Youden’s index and Kappa value of A, B and C kits were 86.30%, 69.63% and 91.48%; 84.42%, 64.94% and 92.21%; 97.44%, 97.44% and 87.18%; 0.82, 0.62 and 0.79; and 0.600, 0.337 and 0.750 for the diagnosis of echinococcosis, respectively. The overall coincidence rate, sensitivity, specificity and Youden’s index of A, B and C kits were 84.54%, 64.64% and 71.82%; 80.99%, 55.63% and 68.31%; 97.44%, 97.44% and 87.18%; and 0.78, 0.53 and 0.56 for the diagnosis of cystic echinococcosis, respectively, while the overall coincidence rate, sensitivity, specificity and Youden’s index of A, B and C kits were 92.19%, 85.16% and 85.16%; 89.89%, 79.78% and 84.27%; 97.44%, 97.44% and 87.18%; and 0.87, 0.77 and 0.72 for the diagnosis of alveolar echinococcosis, respectively. The C kit showed cross?reactions in the serodiagnosis of cystic echinococcosis and alveolar echinococcosis. There were no significant difference in the area under the receiver operating characteristic curve (ROC) between A and B kits for the diagnosis of echinococcosis (0.970 vs. 0.948, Z = 1.618, P > 0.05), and there was a high agreement between A and B kits in the diagnosis of echinococcosis (Kappa = 0.585, P < 0.01). Conclusions　The three commercial anti?Echinococcus antibody?based kits exhibit a higher serodiagnostic efficiency for alveolar echinococcosis than for cystic echinococcosis. The A kit shows a high sensitivity and specificity for the diagnosis of echinococcosis, and has a relatively stable diagnostic performance and fewer influencing factors, which is suitable for the pre?surgical preliminary diagnosis and post?surgical follow?up monitoring of serum anti?Echinococcus antibody, while the C kit shows a high sensitivity and specificity for the diagnosis of echinococcosis, and is easy to perform and high in reporting rate, which is feasible for initial screening of echinococcosis.

Key words: Echinococcosis, Antibody detection, Serodiagnosis, Diagnostic efficiency

中图分类号:

R532.32

杨智勇，田丰源，蔡其刚，朱文君，韩秀敏. 3种抗棘球蚴抗体检测试剂盒用于棘球蚴病血清学诊断效果评价[J]. 中国血吸虫病防治杂志, 2020, 32(6): 605-.

YANG Zhi-Yong, TIAN Feng-Yuan, CAI Qi-Gang, ZHU Wen-Jun, HAN Xiu-Min. Evaluation of the diagnostic efficiency of three anti-Echinococcus antibody?based assays for the serodiagnosis of echinococcosis[J]. Chin J Schisto Control, 2020, 32(6): 605-.

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3种抗棘球蚴抗体检测试剂盒用于棘球蚴病血清学诊断效果评价

Evaluation of the diagnostic efficiency of three anti-Echinococcus antibody?based assays for the serodiagnosis of echinococcosis

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