Evaluation of an automated chemiluminescent immunoassay for complexed PSA on the Bayer ACS:180™ system

被引:2
作者
Datta, P
Dasgupta, A
机构
[1] Bayer Corp, Div Diagnost, Tarrytown, NY 10591 USA
[2] Univ Texas, Sch Med, Dept Pathol & Lab Med, Houston, TX 77030 USA
关键词
automated chemiluminescent immunoassay; complexed PSA; ACS : 180 (TM) methods; ACCESS methods; evaluation;
D O I
10.1002/jcla.10089
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
Prostate-specific antigen (PSA), the most important tumor marker for the detection of prostate cancer, exists in serum in a free, uncomplexed form (free PSA [fPSA]), and as bound to protease inhibitors (mainly alpha1-antichymotrypsin [ACT]). The measurement of complexed PSA (cPSA) concentration in serum has been shown to have better sensitivity and specificity than serum total PSA concentration. A new chemiluminescent immunoassay for cPSA for use on the Bayer ACS:180(TM) fully automated system (Bayer Corp., Tarrytown, NY) has been developed and evaluated. The precision of the new assay was <3.9% (within-run coefficient of variation [CV]) and <5.0% (total CV). The analytical sensitivity (95% upper limit of noise at zero calibrator) was <0.03 ng/mL. A comparison of the ACS:180(TM) cPSA results with the cPSA concentrations calculated from the ACCESS (Beckman-Coulter) PSA and fPSA assays yielded the following regression equation: ACS:180(TM) cPSA = 0.93* (calculated ACCESS cPSA) +0.43, R = 0.993, n = 95. The mean dilution and spike recovery for five samples were both 98%. No interference was observed from hemoglobin, triglyceride, or bilirubin (NCCLS protocol). These results indicate that the ACS:180(TM) cPSA assay is precise, and compares well with the calculated cPSA from ACCESS total and free-PSA results.
引用
收藏
页码:174 / 178
页数:5
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