电化学发光测定血清总Ⅰ型前胶原氨基端前肽的分析性能评价  

Evaluation of a automated electrochemiluminescence system for serum total N-terminal propeptide of type I collagen assay

作　　者：甘洁民[1] 缪应新[1] 张蓉[1] 施泓[1] 

机构地区：[1]复旦大学附属华东医院,上海200040

出　　处：《实验与检验医学》2014年第4期389-391,共3页Experimental and Laboratory Medicine

摘　　要：目的：按美国病理家学会（CAP）的要求，验证电化学发光免疫测定人血清I型前胶原氨基端前肽（tP1NP）的各项分析性能，建立本实验室的参考范围。方法选取低值和高值2个水平的质控品，每天检测一次，连续20次，统计日间变异；用6种不同浓度的低值血清连续检测10d,检测功能灵敏度；将高值和低值血清按一定比例混合，检测其浓度，回归分析验证测量范围；选取138名健康体检人群检测tP1NP，建立本实验室的参考范围。结果日间CV分别4.7%和2.4%；功能灵敏度为6.60ng/ml；分析验证测量范围（AMR）在6.8-1020.2ng/ml；本实验室tP1NP的参考范围为17.8～55.8ml。结论用电化学发光免疫法测定血清I型前胶原氨基端前肽，灵敏度高，稳定性好,本系统的各项性能符合CAP要求。Objective To evaluate automated electrochemiluminescence system for assay of serum total N-terminal propep-tide of type I collagen（tP1NP） and establish the reference value in our laboratory. Methods Serum tP1NP was measured on Elec-sys 2010 automated analyzer（Roche）. The between-run coefficient of variation （CV） was calculated with the tested values of high and low lever controls. The functional sensitivity was analyzed with a series tested results of low lever serum. The analytic measure-ment range （AMR） was determined with the results of mixed serum. The reference range of serum tP1NP in our laboratory was es-tablished with the detected results of 138 normal subjects. Results The between-run CVs were 4.7% and 2.4%. The functional sensitivity was 6.60 ng/ml. AMR was 6.8-1020.2ng/ml. The reference range was 17.8-55.8 ng/ml. Conclusion The ECLIA method has good performance for detecting tP1NP level.

关 键 词：血清I型前胶原氨基端前肽(tP1NP) 电化学发光免疫 方法学评价 

分 类 号：R446.11[医药卫生—诊断学]