前立腺癌における前立腺特異抗原測定キットの比較

Abstract

1985年8月以降2年5ヵ月間受診した未治療33例, 既治療63例の前立腺癌および15例の前立腺肥大症を対象として, DPC, 大日本製薬よび栄研キットのPA 3キット間の比較検討を行った.1)未治療前立腺癌の診断効率は, 大日本製薬>DPC=栄研キットの順に良好であった.2) PA 3キット間の相関性は良好であったが, 個々の値は大きく相違し, 大日本製薬キットにおける測定値が最も低かった.3)標準値の設定が3キットとも大きく相違しており, 大日本製薬キットによる診断効率が高い理由は同キットにおける標準値が3キット中最も低値に設定されていることによる

The serum prostate specific antigen (PA) of the patients with prostatic cancer were determined with 3 assay kits, the Diagnostic Products Cooperation (DPC) kit, the Eiken kit and the Dainippon Pharmaceutical Co. (MARKIT F) kit. The first 2 assay kits involve radioimmunoassay and the latter EIA. For comparison, prostatic acid phosphatase (PAP) and gamma-seminoprotein (gamma-Sm) were determined using an Eiken kit and Chugai kit. Efficiency of the DPC kit, Eiken kit and the MARKIT F kit for untreated prostatic cancer was 26, 25 and 36%, respectively. The PA level measured using the Eiken kit and the MARKIT F kit both well correlated to the PAP level, but with the DPC kit correlation was slightly low. The PA level measured using the 3 different kits correlated poorly with the gamma-Sm level. The PA values obtained with 3 different assays from patients with prostatic cancer were highly correlated, but showed great differences in the values measured. When the standards used in the DPC kit were analyzed by the Eiken kit, the DPC standards as measured by the Eiken kit had only about half of their assigned values. The same standards were analyzed by the MARKIT F kit, the standards yielded measured values about one third of their assigned values. When the standards used in the MARKIT F kit were analyzed by the Eiken kit, the MARKIT F standards yielded measured values about 2.5 fold of their assigned values. The differences between the values obtained with the 3 assay kits presented a serious problem in clinical use of PA. Standardization of these assay kits will be awaited.