电化学发光免疫法与ELISA法检验性能比较
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摘要
目的:比较电化学发光免疫分析仪(HISCL-5000)与酶联免疫吸附试验(ELISA)的检验性能,为临床检验工作提供参考。方法:用HISCL-5000与ELISA法2种方法同时检测HISCL-5000配套的HBsAg校准品、质控品、临床样本以及2017年省免疫学HBsAg室间质评质控品,比较2种方法的线性范围、精密度和准确度。结果:HISCL-5000线性范围远大于ELISA法,HISCL-5000精密度和准确度均高于ELISA法,2种方法的差异有统计学意义(P<0.05)。结论:ELISA法线性范围较窄、精密度和准确度在手工操作过程中较差,易产生漏诊和误诊;而HISCL-5000具有高精密度、高准确度及良好线性范围的优点,可以替代ELISA法。
Objective:To compare the test performance of electrochemiluminescence immunoassay(HISCL-5000)and ELISA,so as to provide reference for clinical laboratory work.Method:Two methods of HISCL-5000 and ELISA were used to detect the HBsAg calibration materials,quality control materials,clinical samples and the quality control materials of province immunology EQA(external quality assessment)of 2017,and the linear range,precision and accuracy of the two methods were compared.Result:The linear range of HISCL-5000 was far greater than that of ELISA,and the precision and accuracy of HISCL-5000 were both higher than those of ELISA,and the differences of the two methods were statistically significant(P<0.05).Conclusion:The linear range of ELISA was narrow,and its precision and accuracy were poor in manual operation,so it was easy to produce miss diagnosis and misdiagnosis.The electrochemiluminescence immunoanalyzer(HISCL-5000)might have the advantages of high precision,high accuracy and good linear range,which could completely replace ELISA.
Objective:To compare the test performance of electrochemiluminescence immunoassay(HISCL-5000)and ELISA,so as to provide reference for clinical laboratory work.Method:Two methods of HISCL-5000 and ELISA were used to detect the HBsAg calibration materials,quality control materials,clinical samples and the quality control materials of province immunology EQA(external quality assessment)of 2017,and the linear range,precision and accuracy of the two methods were compared.Result:The linear range of HISCL-5000 was far greater than that of ELISA,and the precision and accuracy of HISCL-5000 were both higher than those of ELISA,and the differences of the two methods were statistically significant(P<0.05).Conclusion:The linear range of ELISA was narrow,and its precision and accuracy were poor in manual operation,so it was easy to produce miss diagnosis and misdiagnosis.The electrochemiluminescence immunoanalyzer(HISCL-5000)might have the advantages of high precision,high accuracy and good linear range,which could completely replace ELISA.
引文
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[8] Zhang X,Zhou D,Sheng S,et al.Electrochemical immunoassay for the cancer marker LMP-1(EpsteinBarr virus-derived latent membrane protein 1)using a glassy carbon electrode modified with Pd@Pt nanoparticles and a nanocomposite consisting of graphene sheets and MWCNTs[J].Microchimica Acta,2016,183:2055-2062.
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[10]Ohne K,Kani S,Ohashi M,et al.Clinical evaluation of a newly developed high-sensitive detection of hepatitis B virus surface antigen by a semi-automated immune complex transfer chemiluminescent enzyme immunoassay[J].Rinsho Byori,2013,61:787-794.
[11]Nakamura E,Kakuda H,Matsuura K,et al.Quantitative analysis of hepatitis B surface antigen as a clinical marker[J].Rinsho Byori,2011,59:838-843.
[2] Akbar SM,Al-Mahtab M,Khan SI,et al.Current trends in hepatitis B vaccination[J].Future Virol,2016,11:369-378.
[3] Liu C,Chen T,Lin J,et al.Evaluation of the performance of four methods for detection of hepatitis B surface antigen and their application for testing 116,455specimens[J].J Virol Methods,2014,196:174-178.
[4] Gish RG,Chang TT,Lai CL.Quantitative hepatitis B surface antigen analysis in hepatitis B e antigen-positive nucleoside-naive patients treated with entecavir[J].Antiviral therapy,2013,18:691-698.
[5] Li L,Cai B,Tao C,et al.Performance Evaluation of CLIA for Treponema Pallidum Specific Antibodies Detection in Comparison with ELISA[J/OL].J Clin Lab Anal,2016,30:216-222.
[6] Long A,Call DR,Cain KD.Comparison of quantitative PCR and ELISA for detection and quantification of Flavobacterium psychrophilum in salmonid broodstock[J].Dis Aquat Organ,2015,115:139-146.
[7] Liu C,Chen T,Lin J,et al.Evaluation of the performance of four methods for detection of hepatitis B surface antigen and their application for testing 116455specimens[J].J Virol Methods,2014,196:174-178.
[8] Zhang X,Zhou D,Sheng S,et al.Electrochemical immunoassay for the cancer marker LMP-1(EpsteinBarr virus-derived latent membrane protein 1)using a glassy carbon electrode modified with Pd@Pt nanoparticles and a nanocomposite consisting of graphene sheets and MWCNTs[J].Microchimica Acta,2016,183:2055-2062.
[9] Feng S,Wei B,Rao C,et al.Clinical Evaluation of the Newly Developed HISCL-5000Analyzer on Detection of Hepatitis B Virus Markers in West China Hospital[J].Clin Lab,2016,62:1053-1060.
[10]Ohne K,Kani S,Ohashi M,et al.Clinical evaluation of a newly developed high-sensitive detection of hepatitis B virus surface antigen by a semi-automated immune complex transfer chemiluminescent enzyme immunoassay[J].Rinsho Byori,2013,61:787-794.
[11]Nakamura E,Kakuda H,Matsuura K,et al.Quantitative analysis of hepatitis B surface antigen as a clinical marker[J].Rinsho Byori,2011,59:838-843.