Transcription of 甲状腺ホルモン検査の 国際標準化 - jslm.org
1 1. ifcc ( international Federation of Clinical Chemistry and Laboratory Medicine). Committee for Standardization of Thyroid Function Tests (C-STFT). 2. 3. 4.. CV . 26 . 48 . CV CV. FT4 TSH 5. 26 . 48 . 6.. 7.. (2016). (TSH) . 64(4): 375-379. 2013 . 1688 . 677 TSH. 308 TSH. 155 TSH . 118 E TOSOH TSH 8. 9. 10. ifcc : C-STFT. FT4 TSH.. (standardization). (harmonization).. (RMP: Reference (ED ID-LC/tandem MS: (APTM: all-procedure trimmed Measurement Procedure) equilibrium dialysis isotope mean). dilution-liquid chromatography/. tandem mass spectrometry). (CRM: Certified IRMM468/469 WHO IRP80/558 & 81/565. Reference Material). TSH . 11. 12. ifcc conventional RMP listed in the Joint Committee On Traceability in Laboratory Medicine (JCTLM).
2 13. Reference services by ISO 17025 & 15195. accredited lab listed in the JCTLM database 14. TSH . : TSH 1 . 2 .. / .. 15. TSH . WHO IRP 80/558 & 81/565 . TSH . IU . Surrogate Reference Method Procedure RMP).. all-procedure trimmed mean (APTM). 16. I: . II: .. III: .. IV: . FT4 ED ID-LC/tandemMS . 4~202pmol/L 100 : standardization (n = 91) and follow-up panel (n = 95). TSH APTM ~193mIU/L. 100 : harmonization (n = 101) and 1st follow-up panel (n = 95)17. 18. IVD manufacturer Platform Immunoassay (FT4/TSH). Siemens Healthineers (USA) Advia Centaur XP. Abbott Diagnostics (USA) Architect i2000. Shenzhen Mindray Bio-Medical Electronics Co, Ltd (China) CL-2000i Ortho-Clinical Diagnostics (UK) Vitros Eci bioM rieux SA (France) Vidas Beckman Coulter Inc (USA) Access 2.
3 DiaSorin SpA (Italy) Liaison Analyser Sichuan Maccura Biotechnology Co, Ltd (China) IS1200. Roche Diagnostics GmbH Germany) Elecsys (Cobas e 601). Tosoh Corporation (Japan) AIA-2000. Snibe Co., Ltd. (China) Maglumi 2000. Fujirebio Inc. (Japan) Lumipulse G1200. LSI Medience Corporation (Japan) STACIA. Sysmex Corporation (Japan) HISCL-5000. Sanyo/Wako Chemical Industries Ltd (Japan) Accuraseed 19. 20. 21. FT4. 22. TSH. 23. Median deviations (%) of the assays to the APTM-4. before and after recalibration in 3 concentration intervals 24. 25. FT4 . ~ pmol/L ~ 26. TSH . ~ mIU/L 27.. or or .. ng/dL pmol/L. => .. (ED-ID-LC/MS) ifcc .. 28. or.
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