ユーロピウム(Europium)を標識物質としたDelfia PAPキットを用いた血清前立腺性酸性ホスファターゼ測定の検討

Abstract

1)測定検出感度は, 0.2ng/mlであった。2) 46歳以上の男子成人の平均値+2SDは1.41ng/mlであったので, 男子成人の正常上限値は1.5ng/mlとした。3)前立腺癌および前立腺肥大症より, 診断効率, ROC曲線をえて, 両者の鑑別が最も良好な2.5ng/mlを本キットのcut offとした。この結果, 男子成人, 前立腺癌, 前立腺肥大症および前立腺癌以外の泌尿器科癌での異常値出現率は, それぞれ0.7%, 65%, 20%および10%であった。4)前立腺癌の病期別の検出率は, 病期A2, B2, C, D1+D2それぞれ0%, 0%, 64%および83%であった。5)マーキットMPAキット(R)によるPSAと本PAPにて, 前立腺癌および前立腺肥大症を測定した。Delfia PAPキット(R)およびマーキットMPAキット(R)の診断効率は前者が52%, 後者が71%と, 後者が約20%高かった。正診率でも, 前者が69%, 後者が84%と, 後者が優れていた

Fundamental and clinical studies of serum prostatic acid phosphatase (PAP) detected by a Delfia PAP kit were performed. The system is a time-resolved fluoroimmunoassay using europium as a tracer. The lower limit of detection was 0.2 ng/ml. Sera from 54 patients with prostate cancer, 20 with benign prostatic hypertrophy, 20 with urological malignancies other than prostate cancer and 140 adult males over 46 years old were determined. From the mean + 2 S.D. of serum PAP values obtained on the adult males, 1.5 ng/ml was considered as the upper normal level of adult males. By calculating the efficiency and ROC curve using the PAP values of prostate cancer and benign prostatic cancer, 2.5 ng/ml was decided as a cut-off value of this kit. The positive rates of adult males, prostate cancer, benign prostatic cancer and urological malignancies other than prostate cancer were 0.7%, 65%, 20% and 10%, respectively. The sensitivity of stage A2, B2, C and D1 + D2 was, 0%, 0%, 64% and 83%, respectively. The efficiency of the Delfia PAP kit was 52% and that of the Markit M PA kit was 71%. The correlation between the values assayed with the Delfia PAP kit and the Dinabot PAP kit was very high; the value obtained with the Delfia PAP kit was about 80% of that obtained with the Dinabot PAP kit.