Oesterling J E, Moyad M A, Wright G L, Beck G R
Michigan Prostate Institute, University of Michigan, Ann Arbor 48109, USA.
Urology. 1995 Oct;46(4):524-32. doi: 10.1016/S0090-4295(99)80266-0.
To compare the similarity of individual prostate-specific antigen (PSA) results when using the Tandem-R PSA assay, the Tandem-E PSA assay, or the IMx PSA assay; to assess the lot-to-lot variation within (intra-assay interlot) and between (interassay interlot) the Tandem-R, Tandem-E, and IMx PSA assays; and to evaluate the individual and overall potential lot-to-lot bias of the Tandem-R, Tandem-E, and IMx PSA assays.
Forty-nine serum samples (PSA values from 0 to 85 ng/mL) were each tested by three separate lots (manufacturer's reagent materials) of Tandem-R, Tandem-E, and IMx PSA assays. Therefore, a total of nine different lots were utilized per patient sample in this investigation. Analyses primarily focused on three ranges: 0 to 10 ng/mL (low), 10 to 85 ng/mL (high), and 0 to 85 ng/mL (overall).
In the 0 to 10 ng/mL range, 93% of the assay comparisons yielded an actual difference of less than 1 ng/mL. All three assays demonstrated excellent correlation within and between their three respective lots, within all three ranges. The 95% confidence intervals around the percent coefficient of variation (CV) demonstrated similar results for each assay (CV range, 3.2% to 6.0%). All lots demonstrated an average actual PSA bias of less than +/- 1 ng/mL. The average percent PSA bias was also similar between all three assay systems. All lots demonstrated a less than +/- 4% bias.
Overall, the Tandem-R and IMx PSA assays yielded slightly lower results than the Tandem-E PSA assay. However, these differences were not statistically significant. In addition, the overall lot-to-lot variation (intra-assay and interassay) was not statistically significant, and the actual or percent PSA bias was minimal with these three assays. Therefore, a clinician can feel confident that a patient's serum sample should yield a similar and interchangeable result, whether it is determined by the Tandem-R, Tandem-E, or IMx PSA assay system.
比较使用串联 - R PSA检测法、串联 - E PSA检测法或IMx PSA检测法时个体前列腺特异性抗原（PSA）结果的相似性；评估串联 - R、串联 - E和IMx PSA检测法内部（批内批间）以及之间（批间批间）的批间差异；并评估串联 - R、串联 - E和IMx PSA检测法的个体及总体潜在批间偏差。
49份血清样本（PSA值为0至85 ng/mL）分别用串联 - R、串联 - E和IMx PSA检测法的三个不同批次（制造商的试剂材料）进行检测。因此，在本研究中，每个患者样本总共使用了九个不同批次。分析主要集中在三个范围：0至10 ng/mL（低）、10至85 ng/mL（高）和0至85 ng/mL（总体）。
在0至10 ng/mL范围内，93%的检测比较得出的实际差异小于1 ng/mL。在所有三个范围内，所有三种检测法在各自的三个批次内部和之间均显示出极好的相关性。变异系数（CV）百分比周围的95%置信区间显示，每种检测法的结果相似（CV范围为3.2%至6.0%）。所有批次的平均实际PSA偏差均小于±1 ng/mL。所有三种检测系统之间的平均PSA偏差百分比也相似。所有批次的偏差均小于±4%。
总体而言，串联 - R和IMx PSA检测法得出的结果略低于串联 - E PSA检测法。然而，这些差异无统计学意义。此外，总体批间差异（批内和批间）无统计学意义，并且这三种检测法的实际或PSA偏差百分比极小。因此，临床医生可以放心，无论患者的血清样本是通过串联 - R、串联 - E还是IMx PSA检测系统测定，都应得出相似且可互换的结果。
