Morris D L, Dillon P W, Very D L, Ng P, Kish L, Goldblatt J L, Bruzek D J, Chan D W, Ahmed M S, Witek D, Fritsche H A, Smith C, Schwartz D, Schwartz M K, Noteboom J L, Vessella R L, Yeung K K, Allard W J
Business Group Diagnostics, Bayer Corporation, Tarrytown, New York 10591, USA.
J Clin Lab Anal. 1998;12(1):65-74. doi: 10.1002/(SICI)1098-2825(1998)12:1<65::AID-JCLA11>3.0.CO;2-M.
The Bayer Immuno 1 PSA Assay measures total PSA in human serum and demonstrates excellent performance with an interassay CV < or = 3.4% and a biological detection limit of 0.03 microgram/L. No significant interference from common hormonal and chemotherapeutic drugs, kallikrein, prostatic acid phosphatase, and trypsin, or elevated levels of total bilirubin, hemoglobin, triglycerides, and IgG was observed. The 95th percentile values for healthy individuals increased with age from 3.0 micrograms/L for males 50-59 years and 3.3 micrograms/L for males 60-69 years, to 4.6 micrograms/L for males > or = 70 years. Clinical studies with retrospective samples demonstrated correspondence between serial measurements of PSA and clinical outcome for 98% of 159 prostate cancer patients. Clinical sensitivity for patients with clinical evidence of disease, untreated at the time of specimen draw, increased with increasing stage from 77.5-100%. Specificity of 60-70% for BPH and other benign urogenital diseases was consistent with previous findings. Bayer Immuno 1 PSA Assay values for 2131 specimens from healthy subjects and patients with prostate cancer, BPH, and other malignant and nonmalignant diseases correlated well with the Abbott IMx PSA Assay over the range 0.0-6,238 micrograms/L (Y = 1.10 x + 0.02). The Bayer Immuno 1 PSA Assay provides automated ultrasensitive, precise, and equimolar measurement of total PSA in human serum.
拜耳免疫1 PSA检测法可测定人血清中的总PSA，批间变异系数≤3.4%，生物学检测限为0.03微克/升，表现优异。未观察到常见激素和化疗药物、激肽释放酶、前列腺酸性磷酸酶及胰蛋白酶产生显著干扰，总胆红素、血红蛋白、甘油三酯及IgG水平升高也未产生干扰。健康个体的第95百分位数随年龄增长而升高，50 - 59岁男性为3.0微克/升，60 - 69岁男性为3.3微克/升，≥70岁男性为4.6微克/升。对159例前列腺癌患者的回顾性样本进行的临床研究表明，PSA的系列测量值与临床结局的对应率为98%。对于在采集标本时未接受治疗的有疾病临床证据的患者，临床敏感性随疾病分期增加从77.5%升至100%。良性前列腺增生（BPH）和其他良性泌尿生殖系统疾病的特异性为60 - 70%，与先前研究结果一致。来自健康受试者以及前列腺癌、BPH和其他恶性及非恶性疾病患者的2131份标本的拜耳免疫1 PSA检测值，在0.0 - 6238微克/升范围内与雅培IMx PSA检测法相关性良好（Y = 1.10x + 0.02）。拜耳免疫1 PSA检测法可对人血清中的总PSA进行自动化超灵敏、精确且等摩尔的测量。
