検査血液学領域の国際標準化に関して - Eiken

1 8 1 62 12 2016 379 CRM : Certified reference ma-terials 1, 2 1 1967 ICSH : international Council for Standardization in Haema-tology CLSI : Clinical Yohko KAWAI 107-0052 8-10-16 international University of Health & Welfare, Sanno affiliate hospital(8-10-16, Akasaka, Minato-ku, Tokyo)and Laboratory Standards Institute NCCLS : Na-tional Committee for Clinical Laboratory Standards 2005 ICSH WHO : World Health Organization 3 2000 JSLH : Japanese Society for Laboratory Hematology ISLH.

2 international Society for Laboratory Hematology ICSH 1 JCCLSISOJABJCTLMWHO IFCC CRM ICSH,CLS I,ISLH CRM BI PMTC212 WHOJAC RIAIS T/NMIJTC212 ISLHCLSI IF CC ICSHJSLH international trends in progress of laboratory hematology standardization 2 380 4 2 ICSH 2 2016 1 5 1970 NCCLS 1995 ISO/TC212 CLSI 1 6 ICSH WHO CLSI ICSH JSLH 2

3 JSLH ICSH JSLH 7 8 JSLH 9 10 Critical Value 11 12 MPV JSLH 13 14 2 2 3 ICSH lines/ 14 JSLH 1 ICSH CLSI ActivityICSHCLSIArea Committee on HematologyScopeInternationalInternationa lMembersIndustr y ProfessionalIndustr y Government CDC, FDA ProfessionalGuideline BasisScientific Data Generated, if needed,Based upon literature and standard of care Decision BasisExport opinion and LiteratureConsensus review and literatureSpellingHaematologyHematologyP ublicationsPeer Reviewed LiteratureSelf-publish Guidelines SoldBruce H.

4 Davis, MD, ISLH, Standardization in Hematology : Role of ICSH and CLSI 2 JSLH JSLH ICSH CLSI WHO JSLH: Japanese Society for Laborat ory Hemat olo gy ICSH: In ter nat ional Council for Standardiz at ion in Haemat ology CLSI: Clinical and Laborat ory Standards In st it ute WHO: World Health Organiz at io n ref er ence met hod inter national conventional ref er ence measurement procedure ref er ence measurement procedure 2 JSLH ICSH / JSLH Critical Values/ MPV JSLH 3 381 I.

5 8 4 3 1. CAP UK-NEAQS JSLH RCPA-CAP ICSH 3 ICSH JSLH 2009200820102011201220132015201420172016 IC SHISL H/JSL HJoi nt Symposium SSC* JSLH- FCM-Diff JSLH- FCM-Diff ( )MPV SSC* SSC* 2014 2014 SSC* 2009 *SSC standa rdi zation subcommittee : 3 ICSH Table 1.

6 Morphology Grading Table Cell Name Grading System Few/1+Mod/2+, Many/3+, RBCA nisocytosisMacrocytesOval macrocytesMicrocytesHypochromic cellsPolychromasiaAcanthocytesBite cellsBlister cellsEchinocytesElliptocytesIrregularlyc ontracted cellsOvalocytesSchistocytesSickle cellsSpherocytesStomatocytesTarget cellsTeardrop cellsBasophilic stipplingHowell-Jolly bodiesPappenheimer bodiesWBCD hle bodiesVacuolation neutrophil Hypogranulation neutrophil Hypergranulation neutrophil PlateletsGiant PlateletsN/AN/AN/AN/AN/AN/AN/AN/AN/AN/AN /AN/AN/A1 N/AN/AN/AN/AN/AN/AN/AN/AN/AN/AN/AN/AN/A1 1 - 2011 - 202-511 - 2011 - 20 5-20 5-201-21-2 5-20 5-201-2 5-201-21-2 5-20

7 5-20 5-20 5-20 5-202-32-32-44-84-84-811 - 20>20>20>5>20>20>20>20>2>2>20>20>2>20>2> 2>20>20>20>20>20>3>3>4>8>8>8>20 4 382 2. MCV RDW MCH MCHC Ret schistocyte 7 fragment 3. WHO2008 reac-tive abnormal 4. ICSH JSLH II.

8 10 SI SI ICSH JSLH 1. ICSH ICSH 1974 1976 SI g/L mmol/L 1982 15 4 ICSH g/L monomer Fe tetramer 4Fe mmol/L /l 1 /L 16 2012 ICSH 9 2013 4 13 2 5 18 2016 international Journal of Laboratory Hematology IJLH ICSH 10 ICSH ICSH

9 SI ICSH SI SI 5 5 383 x109/L per100 WBC x1012/L MCHC g/L L/L MCV RDW MPV PDW fL MCH pg 4 ICSH1982 SI SI SI RBC 106/ l1012/l106 Ht, PCV Hb g/dlg/dlg/l a mmol/l Fe b WBC 103/ l109/l106 WBC Diff Fraction 109/l gpgpgfmol Fe b a mmol/l Fe b 3fl1 Plt 103/ l109/l106 Ret 103/ lFraction109 ICSH 1976 b ICSH g/l mmol/l monomer tetramer Fe 4Fe.

10 5 ICSH2016 WBC Platelet counts x 109/LGiga/Lx 103/ LNumber/ LNumber/mm3 x 109/LSI ICSH .. WBC Differential count x 109/LPercentage x 103/ LNumber/ LNumber/mm3 x 109/L SI ICSH .. Nucleated RBC count x 109/Lper 100 WBCx 103/ L x 109/L per 100 WBC SI . 100 . RBC count x 1012/Lx 106/ LTera/LNumber/mm3 x 1012/LSI ICSH .. Hb, Haemoglobin g/Lg/dLmmol/Lg/100mLg/Lg/dL or g/100mL SI unit. ICSH mmol/L.