No21Vol1.indd

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1 ( ): - PSA Shojiro Kano Head, Working Group of PSA Testing Standardization Committee (PSA) PSA PSA JCCLS PSA A PSA B PSA PSA Wang PSA FDA Hybritech Tandem-R PSA

2 PSA PSA PSA - (ACT) - (AMG) ACT (PSA-ACT) PSA PSA (Free PSA) PSA-ACT, PSA-ACT PSA PSA-ACT Free PSA PSA (Total PSA) PSA PSA PSA Stanford NCCLS PSA PSA PSA PSA PSA-ACT PSA-ACT PSA-ACT Free PSA : : standard WHO IFCC (primary standard) NIBSC PSA PSA Tandem-R PSA PSA Free PSA (skewed response) PSA Free PSA PSA-ACT (equimolar response) PSA PSA ( )

3 Stanford Free PSA PSA- ACT Free PSA PSA-ACT Free PSA PSA-ACT PSA ad hoc ( ) Free PSA PSA-ACT - ) PSA ( ) PSA : standard ( ) (JCCLS) PSA ( ) PSA - ) PSA PSA PSA PSA AMG AMG Zn Hybritech ( ) Free PSA AMG ph. M NaOH ph. M HCl

4 ph.. mm - ) ( ) PSA Free PSA PSA-ACT consensus method PSA - ) ( ) C ( ) ( ) Stanford Free PSA PSA-ACT.. ng/ml ( ) (Free PSA PSA-ACT ) ( ). ( ) ( ) PSA (Free PSA PSA- ACT) ( ) ( ) ( )

5 PSA PSA-ACT Free PSA PSA-ACT Free PSA PSA-ACT - ) ELISA ( : standard) PSA AMG PSA PSA WHO PSA WHO PSA

6 PSA PSA PSA PSA Free PSA PSA-ACT PSA SR ( ) ( ) ( ) ( ) ( SR ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) Lilja H, Christensson A, Dahlen U, et al: Prostate-specifi c antigen in serum occurs predominantly in complex with a -antichymotrypsin Clin Chem., : -,. Stenman UH, Leinonen J, Alfthan H, et al: A complex between prostate specifi c antigen and a -antichymotrypsin is the major form of prostate specifi c antigen in serum of patients with prostatic cancer: assay of the complex improves clinical sensitivity for cancer Cancer Res., : -,. NCCLS Primary Reference Preparations Used to Standardize Calibration of Immunochemical Assays for Serum Prostate Specifi c Antigen (PSA); Approved Guideline NCCLS document I/LA -A NCCLS, Pennsylvania, USA,. PSA, : -,. PSA PSA ad hoc, : -,. PSA PSA

7 , ( ): -,. S Kano, M Ishibashi, K Kuwa, Y Itoh, W Tani, K Shimazu, K Abe, K Fujihashi and T Yoshikai: Successful Preparation of Serum-Based Secondary Reference Material for Standardization of Total Prostate-Specific Antigen (PSA) Immunoassays Proceeding of th European Congress of Clinical Chemistry and Laboratory Medicine, -,. PSA, (S ), -,. A PSA ) ) ) ( SR ( SR ) B:PSA WG JCCLS WG Dr. Harry G. Rittenhouse (Beckman Coulter, Inc) ICCC Kyoto Luncheon seminar

8 PSA standardization; biochemical & analytical implication WG ICCC Kyoto Dr. Robert M. Nakamura (Scripps Clinic) JCCLS WG JCCLS WG Dr. Sephen D. Mikolajczyk (Hybritech; Beckman Coulter Inc) prostatespecific antigen (total PSA) ( ) PSA Dr. Peter Bialk (Roche Diagnostics GmbH) WG EuroMedLab Barcelona Successful preparation of serumbased secondary reference material for standardization of total prostate-specifi c antigen (PSA) immunoassays WG WG WG WG Survey

9 WG WG Survey WG WG JCCLS WG WG WG C. PSA. Survey. Survey. Survey..... Base Buffer Base Serum... Free PSA PSA-ACT. Free PSA (A) (B, B')... Free PSA (A).. (,,,, ) (C ). (C) (C ) (C C ). Outlyer (C ) (C C ). Precision Profile. Precision Profile Outlyer

: / FDA HBsAg HIV 1/2 HCV : QMS : 3.5% IgM () 1.0% H317 - H334 - : : :: : QMS Everolimus : 6.4% (II) H400 - H % SDS QMS EDTA (K 3 ) EDTA (K 2 )

: / FDA HBsAg HIV 1/2 HCV : QMS : 3.5% IgM () 1.0% H317 - H334 - : : :: : QMS Everolimus : 6.4% (II) H400 - H % SDS QMS EDTA (K 3 ) EDTA (K 2 ) QMS (EVER) 0373852 (QMS) QMS QMS X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X