化学发光免疫法在甲状腺肿瘤患者中的鉴别诊断效能

Differential diagnostic efficiency of chemiluminescence immunoassay in patients with thyroid tumors

目的:分析化学发光免疫法(CLIA)在甲状腺肿瘤患者中的鉴别诊断效能。方法:选取2021年4月至2023年4月该院收治的120例甲状腺肿瘤患者进行前瞻性研究。所有患者均采用CLIA、免疫放射法(RIA)检测血清甲状腺球蛋白(Tg)、甲状腺球蛋白抗体(TgAb)水平。以病理结果为金标准,比较CLIA检测与RIA检测Tg、TgAb水平、对甲状腺肿瘤的鉴别诊断效能,并采用Kappa检验分析CLIA检测、RIA检测与病理检查诊断结果的一致性。结果:CLIA检测TgAb水平与RIA检测比较,差异无统计学意义(P>0.05);CLIA检测Tg水平高于RIA检测,差异有统计学意义(P<0.05);金标准结果显示,120例甲状腺肿瘤患者中,恶性78例,良性42例;CLIA检测结果显示,恶性74例,良性46例;RIA检测结果显示,恶性70例,良性50例;CLIA检测诊断甲状腺癌的准确度、灵敏度、特异度、阳性预测值、阴性预测值均高于RIA检测,误诊率、漏诊率低于RIA检测,差异均有统计学意义(P<0.05);Kappa检验结果显示,CLIA检测与病理检查诊断甲状腺肿瘤的一致性较好(Kappa=0.785,P=0.000);RIA检测与病理检查诊断甲状腺肿瘤的一致性尚可(Kappa=0.474,P=0.000);CLIA检测与病理检查诊断甲状腺肿瘤的一致性高于RIA检测。结论:CLIA检测诊断甲状腺癌的准确度、灵敏度、特异度、阳性预测值、阴性预测值均高于RIA检测,误诊率、漏诊率低于RIA检测,CLIA检测与病理检查诊断甲状腺肿瘤的一致性高于RIA检测。

Objective:To analyze differential diagnostic efficiency of chemiluminescent immunoassay(CLIA)in patients with thyroid tumors.Methods:A prospective study was conducted on 120 patients with thyroid tumors admitted to this hospital from April 2021 to April 2023.The serum thyroglobulin(Tg)and thyroglobulin antibody(TgAb)levels were detected by CLIA and immunoradiometric assay(RIA)in all patients.Using the pathological results as the gold standard,the results CLIA detection and RIA detection for the Tg and TgAb levels and the efficiencies in the differential diagnosis of thyroid tumors were compared.Kappa test was used to analyze the consistencies of CLIA detection,RIA detection and pathological examination.Results:There was no significant difference in the TgAb level between CLIA and RIA detection(P>0.05).The Tg level detected by CLIA was higher than that detected by RIA,and the difference was statistically significant(P<0.05).The gold standard showed that among the 120 patients with thyroid tumors,78 were benign and 42 were malignan;CLIA test results showed that 74 cases were benign and 46 cases were malignan;RIA test results showed that 70 cases were benign and 50 cases were malignan.The accuracy,sensitivity,specificity,benign predictive value and malignan predictive value of CLIA in the diagnosis of thyroid cancer were higher than those of RIA,the misdiagnosis rate and missed diagnosis rate were lower than those of RIA,and the differences were statistically significant(P<0.05).Kappa test results showed that CLIA detection and pathological examination had good consistency in the diagnosis of thyroid tumors(Kappa=0.785,P=0.000);the consistency of RIA detection and pathological examination in the diagnosis of thyroid tumors was acceptable(Kappa=0.474,P=0.000).The consistency of CLIA detection and pathological examination in the diagnosis of thyroid tumors was higher than that of RIA detection.Conclusions:The accuracy,sensitivity,specificity,benign predictive value and malignan predictive value of CLIA in the diagnosis of thyroid cancer are higher than those of RIA;while the misdiagnosis rate and missed diagnosis rate are lower than those of RIA.Further,the consistency between CLIA and pathological examination in the diagnosis of thyroid tumors is higher than that of RIA.