De Keukeleire Steven, Wauters Annick, Luyts Dave, Chandler Candice, Piqueur Marian
Department Clinical Chemistry, ZNA Hospitals, Antwerp, Belgium.
Department Clinical Chemistry, ZNA Hospitals, Antwerp, Belgium.
Clin Biochem. 2014 Sep;47(13-14):1323-5. doi: 10.1016/j.clinbiochem.2014.06.006. Epub 2014 Jun 15.
To assess the precision and the performance of the VITROS(®) total PSA II (tPSA) and free PSA (fPSA) assays on the VITROS(®) ECi/ECiQ Immunodiagnostic system.
The precision of the tPSA and fPSA assays was evaluated following the Clinical and Laboratory Standards Institute (CLSI)-guideline EP5-A2. During a 20-day period, 2 runs of 5 quality control (QC) samples were performed daily. Results of tPSA (n=292) and fPSA (n=289) were compared between VITROS(®) ECi/ECiQ Immunodiagnostic system and Roche Cobas 8000 e602 system (Cobas tPSA and fPSA assays). A modified CLSI-guideline EP9-A2 was used to correlate the results based on a Deming regression correlation study.
A within-run and within-calibration imprecision of ≤2% was obtained for all 5 QC concentration levels for both tPSA and fPSA. Method comparison revealed a constant bias of 17% for tPSA and 6% for fPSA. These values are within the desirable bias of 18.7% suggested by the Westgard Biological Variation Database Specifications. A high agreement was found between the two methods, with correlation coefficients of 0.997 and 0.993 for tPSA and fPSA respectively.
The VITROS(®) tPSA and fPSA assays showed an excellent precision and bias and a good correlation with the Roche method.
评估VITROS®总前列腺特异性抗原II（tPSA）和游离前列腺特异性抗原（fPSA）检测在VITROS® ECi/ECiQ免疫诊断系统上的精密度和性能。
按照临床和实验室标准协会（CLSI）指南EP5-A2评估tPSA和fPSA检测的精密度。在20天内，每天进行2次，每次检测5个质量控制（QC）样本。比较VITROS® ECi/ECiQ免疫诊断系统与罗氏Cobas 8000 e602系统（Cobas tPSA和fPSA检测）的tPSA（n = 292）和fPSA（n = 289）检测结果。基于Deming回归相关性研究，使用改良的CLSI指南EP9-A2对结果进行相关性分析。
tPSA和fPSA的所有5个QC浓度水平的批内和批内校准不精密度均≤2%。方法比较显示，tPSA的恒定偏差为17%，fPSA为6%。这些值在韦斯特加德生物变异数据库规范建议的18.7%的理想偏差范围内。两种方法之间具有高度一致性，tPSA和fPSA的相关系数分别为0.997和0.993。
VITROS® tPSA和fPSA检测显示出优异的精密度和偏差，并且与罗氏方法具有良好的相关性。
