Rock R C, Chan D W, Bruzek D, Waldron C, Oesterling J, Walsh P
Department of Laboratory Medicine, Johns Hopkins Hospital, Baltimore, MD 21205.
Clin Chem. 1987 Dec;33(12):2257-61.
We evaluated the analytical performance of a new monoclonal immunoradiometric assay ("M-PSA") for prostate-specific antigen ("Tandem"; Hybritech Inc.) in comparison with a monoclonal immunoradiometric assay ("M-PAP") for mass measurement of prostatic acid phosphatase ("Tandem") and with a conventional enzyme-activity assay ("E-PAP") for prostatic acid phosphatase (EC 3.1.3.2). For M-PSA, the CVs were 1.3-3.0% within-run and 3.0-4.9% between-run. The minimum detectable mass concentration was 0.10 microgram/L, and linearity extended to 100 micrograms/L. The reference interval for M-PSA in 178 healthy men was 0-2.8 micrograms/L. Serum specimens from men with prostatic disease (primarily prostatic carcinoma and benign prostatic hypertrophy) were assayed by the three methods. Correlation was best between mass measurement (M-PAP) and enzyme activity (E-PAP) for prostatic acid phosphatase (r = 0.958). Results for PSA did not correlate well with those for either M-PAP (r = 0.629) or E-PAP (r = 0.387). PSA was increased in a higher percentage of specimens from men with earlier (clinical stage B) prostatic carcinoma than were results from either assay for PAP.
我们评估了一种用于前列腺特异性抗原的新型单克隆免疫放射分析方法（“M-PSA”，产品名为“Tandem”，由Hybritech公司生产）的分析性能，并将其与用于前列腺酸性磷酸酶质量测定的单克隆免疫放射分析方法（“M-PAP”，产品名为“Tandem”）以及用于前列腺酸性磷酸酶（EC 3.1.3.2）的传统酶活性分析方法（“E-PAP”）进行了比较。对于M-PSA，批内变异系数为1.3 - 3.0%，批间变异系数为3.0 - 4.9%。最低可检测质量浓度为0.10微克/升，线性范围扩展至100微克/升。178名健康男性的M-PSA参考区间为0 - 2.8微克/升。采用这三种方法对患有前列腺疾病（主要是前列腺癌和良性前列腺增生）男性的血清标本进行了检测。前列腺酸性磷酸酶的质量测定（M-PAP）与酶活性（E-PAP）之间的相关性最佳（r = 0.958）。PSA的检测结果与M-PAP（r = 0.629）或E-PAP（r = 0.387）的结果相关性均不佳。与两种PAP检测方法相比，患有早期（临床分期B）前列腺癌男性的标本中，PSA升高的比例更高。
