化学发光与酶联免疫法检测优生五项抗体IgM及IgG的临床应用评价
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摘要
目的探讨化学发光法与酶联免疫法在优生五项抗体IgM和IgG检测中阳性率的准确度差异。方法选取2017年7月～2018年5月间来我院进行产前检查的91例健康适龄孕妇作为研究对象,分别采用化学发光法和酶联免疫法同时检测血清优生五项抗体IgM和IgG,分别比较两种方法测定优生五项抗体IgM及IgG的阳性例数、阳性率、假阳性率和单次检测平均成本。结果 91例受检者的优生五项抗体使用ELISA法和化学发光检测法检测结果均差异无统计学意义,可见两种方法检测准确率基本相当。但化学发光法假阳性率低于ELISA法,差异有统计学意义(χ2=4.741,P <0.05);化学发光法检测优生五项的平均成本明显高于ELISA法。结论从本研究有限的实验数例结果来看,化学发光法与酶联免疫法检测TORCH抗体IgM和IgG准确性没有大的差别,基本都能满足临床普通的检查要求,理论上化学发光法检测敏感性要高于酶联免疫法,且操作简便,但酶联免疫法环境要求及检测成本相对要低,两种检测方法各有优劣,因此在选择TORCH抗体检测方法时应根据医院自身的实际情况合理选择。
Objective To explore the difference in the accuracy of chemiluminescence and enzyme-linked immuno sorbent assay(ELISA)in the detection of eugenic five antibodies IgM and IgG. Methods Ninety-one healthy pregnant women who came to our hospital for prenatal examination from July 2017 to May 2018 were selected as subjects of study.IgM and IgG were detected by chemiluminescence and ELISA respectively,and the number of positive cases,positive rate,false positive rate and average cost of single test were compared between the two methods for the determination of IgM and IgG. Results There were no significant differences in the detection results of the five antibodies of 91 subjects using ELISA and chemiluminescence detection,indicating that the detection accuracy of the two methods was basically the same.However,the false positive rate of chemiluminescence method was lower than ELISA method,and the difference was significant(χ2=4.741,P < 0.05).The average cost of chemiluminescence was significantly higher than ELISA. Conclusion The results of several experimental cases showed that the accuracy of chemiluminescence and enzyme-linked immunoassay in detecting IgM and IgG of TORCH antibody are not significantly different,which can satisfy clinical common examination requirement basically.In theory,the sensitivity of chemiluminescence assay is higher than that of elisa,and the operation is simple,but the environmental requirements and detection cost of ELISA are relatively low.The two methods have their own advantages and disadvantages,so the selection of TORCH antibody detection method should be based on the actual situation of the hospital.
Objective To explore the difference in the accuracy of chemiluminescence and enzyme-linked immuno sorbent assay(ELISA)in the detection of eugenic five antibodies IgM and IgG. Methods Ninety-one healthy pregnant women who came to our hospital for prenatal examination from July 2017 to May 2018 were selected as subjects of study.IgM and IgG were detected by chemiluminescence and ELISA respectively,and the number of positive cases,positive rate,false positive rate and average cost of single test were compared between the two methods for the determination of IgM and IgG. Results There were no significant differences in the detection results of the five antibodies of 91 subjects using ELISA and chemiluminescence detection,indicating that the detection accuracy of the two methods was basically the same.However,the false positive rate of chemiluminescence method was lower than ELISA method,and the difference was significant(χ2=4.741,P < 0.05).The average cost of chemiluminescence was significantly higher than ELISA. Conclusion The results of several experimental cases showed that the accuracy of chemiluminescence and enzyme-linked immunoassay in detecting IgM and IgG of TORCH antibody are not significantly different,which can satisfy clinical common examination requirement basically.In theory,the sensitivity of chemiluminescence assay is higher than that of elisa,and the operation is simple,but the environmental requirements and detection cost of ELISA are relatively low.The two methods have their own advantages and disadvantages,so the selection of TORCH antibody detection method should be based on the actual situation of the hospital.
引文
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[7]安静娜,李冬冬,陈其霞,等.电化学发光免疫法与酶联免疫吸附法检测乙型肝炎病毒血清标志物的结果分析[J].中国输血杂志,2015,28(4):374-376.
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[10]王燕,尹秋霞,窦恒利.化学发光法和酶联免疫法作为筛选试验测定丙肝抗体的评价[J].标记免疫分析与临床,2013,20(4):246-250.
[11]张敏娜,胡燕,侯俊,等.化学发光法检测抗HEV IgG试剂盒的研制和评价[J].细胞与分子免疫学杂志,2015,31(5):648-651.
[12]付小国,王燕华,秦加巍.电化学发光免疫分析法和酶联免疫吸附法检测人类免疫缺陷病毒抗体效果评价[J].临床和实验医学杂志,2009,8(4):77-78.
[13]Wu D,Wu Y,Wang L,et al.Evaluation of a Novel ArrayBased Toxoplasma,Rubella,Cytomegalovirus,and Herpes Simplex Virus IgG Enzyme Linked Immunosorbent Assay and Its Comparison with Virion/Serion Enzyme Linked Immunosorbent Assays[J].Annals of Laboratory Medicine,2014,34(1):38-42.
[14]Mi HC,Chan O S,Lee J.TORCH(toxoplasmosis,rubella,cytomegalovirus,and herpes simplex virus)screening of small for gestational age and intrauterine growth restricted neonates:efficacy study in a single institute in Korea[J].Korean Journal of Pediatrics,2018,61(4):114-120.
[15]Yamamoto R,Ishii K,Shimada M,et al.Significance of maternal screening for toxoplasmosis,rubella,cytomegalovirus and herpes simplex virus infection in cases of fetal growth restriction[J].Journal of Obstetrics&Gynaecology Research,2013,39(3):653-657.
[2]王海宁.酶联免疫吸附试验、胶体金法和化学发光法检测孕妇人巨细胞病毒感染的对比研究[J].陕西医学杂志,2016,45(10):1390-1391.
[3]侯俊,胡燕,邬顺全,等.化学发光法检测HCV IgG抗体方法的建立和初步应用[J].中华检验医学杂志,2015,38(3):159-162.
[4]巫翠云,邱梅花.不良妊娠与HSV2 IgM IgG抗体检测结果分析[J].海南医学,2015,26(1):133-134.
[5]Gogate PM,Sahasrabudhe M,Shah M,et al.Long term outcomes of bilateral congenital and developmental cataracts operated in Maharashtra,India.Miraj pediatric cataract study III[J].Indian Journal of Ophthalmology,2014,62(2):186-195.
[6]覃慧群,刘棣华.TORCH五项检测对计生中心免费孕前优生健康检查者的作用效果探讨[J].中国卫生标准管理,2017,8(12):106-108.
[7]安静娜,李冬冬,陈其霞,等.电化学发光免疫法与酶联免疫吸附法检测乙型肝炎病毒血清标志物的结果分析[J].中国输血杂志,2015,28(4):374-376.
[8]Khanna RC,Foster A,Krishnaiah S,et al.Visual outcomes of bilateral congenital and developmental cataracts in young children in south India and causes of poor outcome[J].Indian Journal of Ophthalmology,2013,61(2):65-70.
[9]Mochida GH,Ganesh VS,Felie JM,et al.A homozygous mutation in the tight-junction protein JAM3 causes hemorrhagic destruction of the brain,subependymal calcification,and congenital cataracts[J].American Journal of Human Genetics,2010,87(6):882-889.
[10]王燕,尹秋霞,窦恒利.化学发光法和酶联免疫法作为筛选试验测定丙肝抗体的评价[J].标记免疫分析与临床,2013,20(4):246-250.
[11]张敏娜,胡燕,侯俊,等.化学发光法检测抗HEV IgG试剂盒的研制和评价[J].细胞与分子免疫学杂志,2015,31(5):648-651.
[12]付小国,王燕华,秦加巍.电化学发光免疫分析法和酶联免疫吸附法检测人类免疫缺陷病毒抗体效果评价[J].临床和实验医学杂志,2009,8(4):77-78.
[13]Wu D,Wu Y,Wang L,et al.Evaluation of a Novel ArrayBased Toxoplasma,Rubella,Cytomegalovirus,and Herpes Simplex Virus IgG Enzyme Linked Immunosorbent Assay and Its Comparison with Virion/Serion Enzyme Linked Immunosorbent Assays[J].Annals of Laboratory Medicine,2014,34(1):38-42.
[14]Mi HC,Chan O S,Lee J.TORCH(toxoplasmosis,rubella,cytomegalovirus,and herpes simplex virus)screening of small for gestational age and intrauterine growth restricted neonates:efficacy study in a single institute in Korea[J].Korean Journal of Pediatrics,2018,61(4):114-120.
[15]Yamamoto R,Ishii K,Shimada M,et al.Significance of maternal screening for toxoplasmosis,rubella,cytomegalovirus and herpes simplex virus infection in cases of fetal growth restriction[J].Journal of Obstetrics&Gynaecology Research,2013,39(3):653-657.