検査値の標準化について - saturingi.gr.jp

1 3 International Organization for Standardization; ISO calibration hierarchy 1-A 1-B ERM * E-mail: TEL/ FAX.

2 011-706-5710/ 011-716-3048 3 4 3 3 HP ISO ERM IFCC CRM470/RPPHS 1-C ERM A B C CRM JSCC CRM ERM IFCC CRM470 1 HECTEF HECTEF 1 TP NIST

3 SRM927b BUN CRE UA GLU HECTEF Na K Cl HECTEF Ca HECTEF o-CPC MXB T-CHO TG HECTEF HDL-C HECTEF NIST: National Institute of Standards and Technology HECTEF: ERM ERM ERM ERM ERM JSCC JCCLS JSCC JSCC ERM ERM JSCC HP JCCLS JSCC HECTEF ERM NIST ERM ERM

4 CRM470 IFCC CRM470 JCCLS 14 1980 JSCC 1989 6 1996 ERM dispersion precision repeatability within-day precision 1 between-day precision

5 Intra-laboratory precision error systematic error proportional systematic error constant systematic error random error bias; B 3 3 trueness trueness uncertainty uncertainty of measured; Cm 95 95% B s t t s/ n Cm Cm B B t s/ n allowance limit allowance limit of error accuracy standard deviation of biological intra-individual variation; Sp 1 SD standard deviation of within-subject biological variation.

6 SDw medical decision level z NEQAS National External Quality Assessment Scheme ( 3 3 4 standarization standard correction calibration calibration transferability traceability reference material.)

7 RM 1 NIST SRM (NIST Standard Reference Material) SRM NIST 120 SRM CRM470 Certified Reference Material IFCC 1993 1997 11 JCCLS HECTEF HECTEF (Health Care Technology Foundation ) JSCC (JC)ERM enzyme reference material JSCC 37 C 3 1 JCCLS ERM Km ERM ERM ERM JSCC ERM certified reference material.

8 CRM 1 certificate 1 primary reference material secondary reference material matrix reference material simulated reference material surrogate reference material serum reference material traceable definitive method reference method consensus method JSCC IFCC 30 C 37 C field method selected method recommended method quality assurance.

9 QA WHO Quality assurance related to health laboratory technology (internal quality control) (external quality control) JSCC, The Japanese Society of Clinical Chemistry JAMT, Japanese Association of Medical Technologists IFCC, International Federation of Clinical Chemistry and Laboratory Medicine ( ) JCCLS, Japan Committee for Clinical Laboratory Standards HECTEF, Health Care Technology Foundation NIST, National Institute of Standards and Technology HP X-R z (SD) (CV)

10 (SD CV) (SDW) 1/2 CV5