化学发光免疫检测在甲胎蛋白检验中的应用准确性评价及其性能分析
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摘要
目的:探讨化学发光免疫分析(CLIA)法检测血清甲胎蛋白(AFP)的准确性及临床价值。方法:选取40例在医院就诊的肝癌患者纳入肝癌组,同期选取接受正常体检的30名健康体检者纳入健康组;将两组血清样本分别采用时间分辨荧光免疫分析(TRFIA)法和CLIA法检测血清样本中的AFP含量,对比分析两种检测方法的准确性。结果:肝癌组采用两种检测方法测定血清样本中AFP含量均显著高于健康组,其差异有统计学意义(t=28.300,t=28.516;P<0.05);TRFIA法和CLIA法分别测定两组AFP含量比较,差异均无统计学意义(t=0.039,t=0.054;P>0.05)。高浓度AFP标准品血清中AFP表达量明显高于中、低浓度AFP标准品血清,其差异有统计学意义(t=29.330,P<0.05),且变异系数(CV)值明显低于中、低浓度AFP标准品血清,其差异有统计学意义(t=8.501,P<0.05);TRFIA法与CLIA法测定结果比较差异无统计学意义(t=0.521,P>0.05);CLIA法测定两组AFP回收量比较差异无统计学意义(t=0.694,P>0.05),且两组AFP回收率比较差异无统计学意义(x~2=0.016,P>0.05)。结论:TRFIA法和CLIA法应用于血清AFP检验中,均能取得较高的准确性,临床应用时可根据实际情况选择检验方法。
Objective: To investigate the accuracy and clinical value of chemiluminescence immunoassay(CLIA) in detecting serum alpha-fetoprotein(AFP). Methods: Forty patients with hepatocellular carcinoma were enrolled in hepatocellular carcinoma group, and 30 healthy peoples who were confirmed by normal physical examination were enrolled in the health group at the same time. Time-resolved fluorescence immunoassay(TRFIA) and CLIA were used to detect the content of serum AFP of the two groups, respectively. And the accuracies of the two methods were further compared and analyzed. Results: The levels of serum AFP that were detected by two detection methods of hepatocellular carcinoma group were significantly higher than those of healthy group(t=28.300, t=28.516, P<0.05), respectively. The difference of serum AFP between TRFIA and CLIA in each group was no significant(t=0.039, t=0.054, P>0.05). The AFP expression of serum AFP standard of high concentration was significantly higher than that in serum AFP standard of medium and low concentration(t=29.330, P<0.05). And the coefficient of variation(CV) value of serum AFP standard of high concentration was significantly lower than that of serum AFP standard of medium and low concentration(t=8.501, P<0.05). The difference of detection result between TRFIA and CLIA was no significant(t=0.521, P>0.05). And the difference of recovery amount about AFP between two groups was no significant(t=0.694, P>0.05), and the difference of recovery rate about AFP between two groups was no significant(x2=0.016, P>0.05). Conclusion: Both of TRFIA method and CLIA method can obtain high accuracy in serum AFP test. In clinical application, which be selected should depend on the actual situation.
Objective: To investigate the accuracy and clinical value of chemiluminescence immunoassay(CLIA) in detecting serum alpha-fetoprotein(AFP). Methods: Forty patients with hepatocellular carcinoma were enrolled in hepatocellular carcinoma group, and 30 healthy peoples who were confirmed by normal physical examination were enrolled in the health group at the same time. Time-resolved fluorescence immunoassay(TRFIA) and CLIA were used to detect the content of serum AFP of the two groups, respectively. And the accuracies of the two methods were further compared and analyzed. Results: The levels of serum AFP that were detected by two detection methods of hepatocellular carcinoma group were significantly higher than those of healthy group(t=28.300, t=28.516, P<0.05), respectively. The difference of serum AFP between TRFIA and CLIA in each group was no significant(t=0.039, t=0.054, P>0.05). The AFP expression of serum AFP standard of high concentration was significantly higher than that in serum AFP standard of medium and low concentration(t=29.330, P<0.05). And the coefficient of variation(CV) value of serum AFP standard of high concentration was significantly lower than that of serum AFP standard of medium and low concentration(t=8.501, P<0.05). The difference of detection result between TRFIA and CLIA was no significant(t=0.521, P>0.05). And the difference of recovery amount about AFP between two groups was no significant(t=0.694, P>0.05), and the difference of recovery rate about AFP between two groups was no significant(x2=0.016, P>0.05). Conclusion: Both of TRFIA method and CLIA method can obtain high accuracy in serum AFP test. In clinical application, which be selected should depend on the actual situation.
引文
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[11]袁星星,姜菲菲,贾泳梅,等.血清铁蛋白和甲胎蛋白及甲胎蛋白异质体-L3单项与联合检测对原发性肝癌辅助诊断的临床应用价值[J].中华检验医学杂志,2016,39(8):604-608.
[12]邹长进.原发性肝癌患者血清前白蛋白、特异性生长因子、甲胎蛋白含量分析[J].中国卫生检验杂志,2016(15):2214-2215.
[13]Yao M,ZhaoJ,LuF.Alpha-fetoprotein still is a valuable diagnostic and prognosis predicting biomarker in hepatitis B virus infection-related hepatocellular carcinoma[J].Oncotarget,2016,7(4):3702-3708.
[14]Ota?A,Hazar M,Ota??,et al.Effect of increasing maximal aerobic exercise on serum gonadal hormones and alpha-fetoprotein in the luteal phase of professional female soccer players[J].JPhys Ther Sci,2016,28(3):807-810.
[15]龚信建,林晓春.电化学发光法检测消化道肿瘤5项标志物的诊断试验与评价[J].检验医学与临床,2017,14(17):2565-2567.
[2]Bittner T,Zetterberg H,Teunissen CE,et al.Technical performance of a novel,fully automated electrochemiluminescence immunoassay for the quantitation ofβ-amyloid(1-42)in human cerebrospinal fluid[J].Alzheimers Dement,2016,12(5):517-526.
[3]王婷婷,单凤玲,陆汉魁.不同化学发光免疫分析系统检测亚临床甲状腺功能减退症血清促甲状腺激素的结果对比[J].中华核医学与分子影像杂志,2017,37(6):342-345.
[4]赵锐,戴雯,徐万州,等.循环酶法检测血清同型半胱氨酸方法学评价及其在肿瘤诊断中的应用[J].检验医学与临床,2016,13(24):3437-3439.
[5]中国抗癌协会肝癌专业委员会.原发性肝癌诊断标准[J].中华肝脏病杂志,2000,8(3):135-135.
[6]张淑艳,杨永昌,常帅,等.不同化学发光检测系统测定甲状腺球蛋白抗体的比较研究[J].中国急救复苏与灾害医学杂志,2017,13(8):741-743.
[7]倪颖,李瀚旻.甲胎蛋白联合异常凝血酶原检测对原发性肝癌诊断价值的Meta分析[J].中西医结合肝病杂志,2017,27(5):303-307.
[8]Yang JD,Dai J,Singal AG,et al.Improved Performance of Serum Alpha-Fetoprotein for Hepatocellular Carcinoma Diagnosis in HCV cirrhosis with Normal Alanine Transaminase[J].Cancer Epidemiol Biomarkers Prev,2017,26(7):1085-1092.
[9]孔丽.糖类抗原19-9、糖链抗原72-4、癌胚抗原和甲胎蛋白联合检测对胃癌的诊断价值分析-基于非参数检验和二项Logistic回归模型[J].中国卫生检验杂志,2018,9(14):12-16.
[10]Chudecka-G?az A,Cymbaluk-P?oska A,LuterekPuszyńska K,et al.Diagnostic usefulness of the Risk of Ovarian Malignancy Algorithm using the electrochemiluminescence immunoassay for HE4 and the chemiluminescence microparticle immunoassay for CA125[J].Oncol Lett,2016,12(5):3101-3114.
[11]袁星星,姜菲菲,贾泳梅,等.血清铁蛋白和甲胎蛋白及甲胎蛋白异质体-L3单项与联合检测对原发性肝癌辅助诊断的临床应用价值[J].中华检验医学杂志,2016,39(8):604-608.
[12]邹长进.原发性肝癌患者血清前白蛋白、特异性生长因子、甲胎蛋白含量分析[J].中国卫生检验杂志,2016(15):2214-2215.
[13]Yao M,ZhaoJ,LuF.Alpha-fetoprotein still is a valuable diagnostic and prognosis predicting biomarker in hepatitis B virus infection-related hepatocellular carcinoma[J].Oncotarget,2016,7(4):3702-3708.
[14]Ota?A,Hazar M,Ota??,et al.Effect of increasing maximal aerobic exercise on serum gonadal hormones and alpha-fetoprotein in the luteal phase of professional female soccer players[J].JPhys Ther Sci,2016,28(3):807-810.
[15]龚信建,林晓春.电化学发光法检测消化道肿瘤5项标志物的诊断试验与评价[J].检验医学与临床,2017,14(17):2565-2567.