评估Advia Centaur全自动化学发光免疫分析法测定血浆总同型半胱氨酸的性能。

Evaluation of Advia Centaur automated chemiluminescence immunoassay for determining total homocysteine in plasma.

作者信息

Demuth Karine, Ducros Véronique, Michelsohn Samantha, Paul Jean-Louis

机构信息

Laboratoire de Biochimie Cardiovasculaire, Hôpital Européen Georges Pompidou, AP-HP, 75015 Paris, France.

出版信息

Clin Chim Acta. 2004 Nov;349(1-2):113-20. doi: 10.1016/j.cccn.2004.06.012.

DOI:10.1016/j.cccn.2004.06.012

PMID:15469863

Abstract

BACKGROUND

A lot of methods are now available for total plasma homocysteine (tHcy) determination. HPLC with fluorescence detection were the most widely used methods until recently but immunoassays, easier to use, currently supplant in-house laboratory methods.

METHODS

The latest commercial automated chemiluminescence immunoassay (ICL) for tHcy, developed on the ADVIA Centaur analyzer (Bayer Diagnostics), was fully evaluated and compared with a current HPLC method.

RESULTS

The ICL-ADVIA Centaur method had a detection limit <0.9 micromol/l and was linear for tHcy between 2.4 and 58.8 micromol/l. The within- and between assay imprecision was <6% and <7%, respectively. The analytical recovery ranged from 93.5% to 109.7%. The comparison of 168 clinical plasma specimens indicated a good correlation between the two methods (r=0.96, p<0.0001) but a systematic positive bias for ICL-ADVIA Centaur method (mean difference=3.0 micromol/l).

CONCLUSIONS

The ADVIA Centaur method is a useful and practicable alternative to HPLC methods for tHcy determination. The ICL method is even more convenient than chromatographic methods for routine use because of its significantly higher throughput (200 samples/h vs. 40 per 24 h). However, the agreement among methods is insufficient to allow them to be used interchangeably.

摘要

背景

目前有多种方法可用于测定血浆总同型半胱氨酸（tHcy）。直到最近，带有荧光检测的高效液相色谱法（HPLC）是最广泛使用的方法，但免疫测定法使用更简便，目前已取代了内部实验室方法。

方法

对在ADVIA Centaur分析仪（拜耳诊断公司）上开发的最新商用tHcy自动化化学发光免疫测定法（ICL）进行了全面评估，并与当前的HPLC方法进行了比较。

结果

ICL-ADVIA Centaur方法的检测限<0.9微摩尔/升，tHcy在2.4至58.8微摩尔/升之间呈线性。批内和批间不精密度分别<6%和<7%。分析回收率在93.5%至109.7%之间。对168份临床血浆标本的比较表明，两种方法之间具有良好的相关性（r=0.96，p<0.0001），但ICL-ADVIA Centaur方法存在系统性正偏差（平均差异=3.0微摩尔/升）。