Evaluation of an automated chemiluminescent immunoassay for complexed PSA on the Bayer ACS:180™ system
✍ Scribed by Pradip Datta; Amitava Dasgupta
- Publisher
- John Wiley and Sons
- Year
- 2003
- Tongue
- English
- Weight
- 95 KB
- Volume
- 17
- Category
- Article
- ISSN
- 0887-8013
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✦ Synopsis
Abstract
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 α1‐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™ 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™ cPSA results with the cPSA concentrations calculated from the ACCESS (Beckman‐Coulter) PSA and fPSA assays yielded the following regression equation: ACS:180™ 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™ cPSA assay is precise, and compares well with the calculated cPSA from ACCESS total and free‐PSA results. J. Clin. Lab. Anal. 17:174–178, 2003. © 2003 Wiley‐Liss, Inc.