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 JSLH ICSH JSLH 7 8

3 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 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

7 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 SI ICSH SI SI 5 5 383

9 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 . 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.

10 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 . PCV/Ht, Haematocrit L/LPercentage L/LSI ICSH .MCV Mean Cell Volume fL m3fL SI ICSH ..MCH Mean cell Haemoglobin pgfmolpgSI ICSH ..MCHC Mean cell haemoglobin concentration Hb Hb Hb RDW Red Cell distribution width ,PDW Platelet distribution width and MPV Mean platelet volume . fL CVfL SI .. Reticulocytes x 109/LPercentage Giga/LNumber/mm3x 106/ L x 109/L SI ICSH.