IV胶原检测试剂盒性能评价
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摘要
目的建立IV胶原磁微粒化学发光免疫检测方法。方法采用夹心法,IV包被抗体包被于顺磁微粒上作为固相抗原,样本中的抗原和磁微粒上的抗体特异性结合,再加入酶标抗体形成夹心复合物。结果本试剂盒的线性范围为50-1000ng/mL;空白限(LOB)为0.671ng/mL,检出限(LOD)为2.49ng/mL,功能灵敏度(FS)为4.8ng/mL;分析内精密度<4.6%,天间精密度<5.8%;总不精密度<7.1%;样品的回收率在94.10～103.40%之间。与25种临床治疗药物对检测结果无干扰。结论建立的IV胶原磁微粒化学发光定量免疫分析方法灵敏度高、测定速度快、准确度高及特异性强,利于临床研究的开展,应用和推广前景巨大。
Objective To establish magnetic particlesquantitativechemiluminescence immunoassay Analysis method for IVcollagen. Methods As solid-phase antigen, IVantibody which coated on themagneticparticles.TheIVcollagen in the sample is specifically bound toantibody on themagnetic particles. Results The linear range of the test kit was50 to 1000 ng/mL; LOB was0.671 ng/mL; LOD was 2.49 ng/mL; FS was 4.8 ng/mL. The CV between a day was<4.6%; the CV between days was <5.8%,the total CV was <7.1%. The recovery rate of the samples was from 94.10% to 103.40%.IVcollagen has no cross-reactivity with 25 kinds of clinical therapeutic drugs. Conclusion This method of high sensitivity, fast detection speed, high accuracy and specificity cholylglycine is good for clinical research,which has great application and promotion prospects.
Objective To establish magnetic particlesquantitativechemiluminescence immunoassay Analysis method for IVcollagen. Methods As solid-phase antigen, IVantibody which coated on themagneticparticles.TheIVcollagen in the sample is specifically bound toantibody on themagnetic particles. Results The linear range of the test kit was50 to 1000 ng/mL; LOB was0.671 ng/mL; LOD was 2.49 ng/mL; FS was 4.8 ng/mL. The CV between a day was<4.6%; the CV between days was <5.8%,the total CV was <7.1%. The recovery rate of the samples was from 94.10% to 103.40%.IVcollagen has no cross-reactivity with 25 kinds of clinical therapeutic drugs. Conclusion This method of high sensitivity, fast detection speed, high accuracy and specificity cholylglycine is good for clinical research,which has great application and promotion prospects.
引文
[1]陈洁,程艳杰,王晶.血清IV型胶原测定在肝硬化诊断中的应用[J].大连医科大学学报,2002,6(24):142.
[2]李小维,苌新明.血清IV型胶原在肝纤维化诊断中的意义[J].西安医科大学学报,2000,21(5):432.
[3]NCCLS.Method comparison and bias estimation using patient samples;approved guideline[J].EP9-A2,NCCLS,2002.
[4]Clinical And Laboratory Standards Institute.User verification ofperformance for precision and trueness;approved guideline.2nd ed[J].EP15-A2,CLSI,2005.
[5]NCCLS.EP5-A2 Evaluation of precision performance of quantitative measurementmethods;approved guideline-second edition[S].Wayne,PA:NCCLS,2004.
[6]NCCLS.Evaluationofthe linearity of quantitative measurement procedur es:AstatisticalApproach;ApprovedguidelineNCCLS document EP6-A[S].Wayne,PA:NCCLS,2003.
[7]NCCLS.C28-A2.How to define and determine reference intervals in the clinical laboratory Approved[J].guideline-secondedition,2000.
[8]薛建元,林言箴,尹浩然,等.IV型胶原纤维及其酶在胃癌浸润转移中的作用[J].中国肿瘤临床,1995:241.
[2]李小维,苌新明.血清IV型胶原在肝纤维化诊断中的意义[J].西安医科大学学报,2000,21(5):432.
[3]NCCLS.Method comparison and bias estimation using patient samples;approved guideline[J].EP9-A2,NCCLS,2002.
[4]Clinical And Laboratory Standards Institute.User verification ofperformance for precision and trueness;approved guideline.2nd ed[J].EP15-A2,CLSI,2005.
[5]NCCLS.EP5-A2 Evaluation of precision performance of quantitative measurementmethods;approved guideline-second edition[S].Wayne,PA:NCCLS,2004.
[6]NCCLS.Evaluationofthe linearity of quantitative measurement procedur es:AstatisticalApproach;ApprovedguidelineNCCLS document EP6-A[S].Wayne,PA:NCCLS,2003.
[7]NCCLS.C28-A2.How to define and determine reference intervals in the clinical laboratory Approved[J].guideline-secondedition,2000.
[8]薛建元,林言箴,尹浩然,等.IV型胶原纤维及其酶在胃癌浸润转移中的作用[J].中国肿瘤临床,1995:241.