PDFファイル - 医薬品医療機器総合機構
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1. 2 8 8 1 3 2 8C 3 1 000ppm 2 1 121 C 20 AA2. Tel 0120 03 6527 141 0032 1 11 2 4 4
3. A 0 01 1 4 AEB 0 005 2
4. 1 1000 ng mL 0 008 aau TF z C 1000ng mL 0 002 AN NINCE US UMUND M T 1000 ng mL ND 1 1000 ng mL ND Wr 804L 1000 ng mL ND 35 uL 1000ng mL ND 35 1L CK MB 1000 ng mL ND 1 i 1000ng mL ND 37 10 1 SUOMI AB 100zD 2 ARETE APUS hT EARE GT TEED 50 29
5. 80 gL 2 9 2 8 7 20 4 2 mg dL I ng mL ng mL 100 0 006 0 003 200 0 030 300 0 031 400 0 033 500 0 034 3 3 X100
6. 2015 6 2 cTn I Reag 2014 3 1 058615 01 1506 226A A AMX00041000 1 1 ECC CK MB CK HBs HIV1 HTV2 HCV
7. ea 0 034 ng mL 99 3 0 120 ng mL AMI 1 3 hor d a 3k 290901 7 BF c o NNN 0 ea aco T TEN NABC The National Academy of Clinical Biochemistry Standards 80ng mL ou uu 2m x Cii E a ZUSBU LIB D d euer d dci WR IFCC International Federation of Clinical Chemistry 24 3 a o DO n Hr 10 F v o Ja 2729 Wi RSS 1 AMI dha i PETE j i R ESC European Society of Cardiology ACC RE
8. rr I I EIA CLEIA CLEIA I IT HRP IT 1
9. 1I TI I HRP 1 OE HENE I HRP UMP e edit HRP I scs T psi DARET C 1 EDTA
10. 3 t 1 DR E 1 0 095ng mL 0 105ng mL 1 0 105ng mL 1 0 114 0 999 28 1 23ng mL 29ng mL 1 29ng mL 1 0 131 0 999
11. A 0 01 1 4 B 0 005 1 1 3 1 2 A B
12. 0 20 2SD 0 009ng mL 1 NCCLS EP17 1 150 I 450 1 600 0 012ng mL 2 4 2 I y CLIA ik x 260 0 976 y 0 979x 40 219 ng mL k 1 HBs HIV1 HIV2 HCV
13. 2 0 05 10ng mL 10 35ng mL 35 75ng mL 18 15 15 3 2 0 5 5ng mL 35 80 L 75ng mL 4 35 L 37 10 CV 10 4 3 A B 0 012 80 0ng mL TF 100zL 2 39 420nm D 1 3
14. 0 01 X 1 4 B 0 005 1 2 8 2 6 26 1 2 8C 1 52 2 2 8 C 1 52980 3 2 8 C 1 5238 4 A 2 8 C 6 26 5 B 2 8 C 6 26 a 058615 I 100 a 068010 A B 2 28mL 1 Tobacman LS Thin Filament Mediated Regulation of Cardiac Contraction Annu Rev Physiol 58 447 481 1996 2 Wil
15. 1 A 3 2 B I I 1 T C T 2 I N 31 9 I ACS I AMI 4 6 59
16. T and or CK MB 2 ECG elec 2 trocardiogram 3 1 AMI VS B 9 I IT 1 3
17. 1 CK MB LDH 9 I CK MB 1 MAR 9 I 1 1 4 ST ACS m9 1
18. American College of Cardiology 1 NACB National Academy of Clinical Biochemistry Standards of C 2 8C Laboratory Practices AMI ACS 8 24 I 9 9 2 8C fi URL AB 7 1 210 WHO World Health Organization Cl AMI AAB 7 1
19. Keffer JH The Cardiac Profile and Proposed Practice Guideline for Acute Ischemic Heart Disease Am J Clin Pathol 107 398 409 1997 13 Missov E Calzolari C Davy JM Leclercq F et al Cardiac tro ponin I in patients with hematologic malignancies Coron Artery Dis 8 537 541 1997 14 Markers in Cardiology Current and Future Clinical Applications Edited by Adams JE Apple FS Jaffe AS Wu AHB ISBNO0 87993 472 7 Futura Publishing Armonk NY 10504 2001 15 Lindahl B Diderholm E Langerquist B et al for the FRISC II Investigators Mechanisms behind the prognostic value of tro ponin T in unstable coronary artery disease FRISC Il substudy J Am Coll Cardiol 2001 38 1497 1498 16 Venge P Langerquist B Diderholm E et al on behalf of the FRISCII Study Group Clinical Performance of three cardiac tro ponin assays in patients with unstable coronary artery disease FRISC Il substudy Am J Cardiol 2002 89 1035 1041 17 Ottani F Galvani M Nicolini A et al Elevated cardiac troponin levels predict the risk of adverse outcome in patients with acute coronary syndrome Am Heart J 2000 40 917 927 18 Heidenreich PA Alloggiamento T Melsop K et al The prognos tic value of troponin in patients with non ST elevation acute coro nary syndromes a meta analysis J Am Coll Cardiol 2001 38 478 485 19 Summers M et al Luminogenic Reagent Using 3 chloro 4 hydroxy acetanilide to Enhance Peroxidase Lumino
20. ines Characteristics amp Utilization of Biochemical Markers in ACS and Heart Failure CLINICAL ACUTE CORONARY SYNDROMES Chapter 1 Version Date April 8 2004 30 World Health Organization Report of the Joint International Society and Federation of Cardiology WHO Task Force on Standardization of Clinical Nomenclature Nomenclature and Criteria for Diagnosis of Ischemic Heart Disese Circulation 59 607 609 1979 31 NCCLS Protocols for Determination of Limits of Detection and Limits of Quantitation Approved Guideline NCCLS document EP17 A ISBN 1 56238 551 8 NCCLS 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 2004 32 NCCLS Evaluation of Precision performance of Quantitative Measurement Methods Approved Guideline Second Edition NCCLS document EP5 A2 ISBN 1 56238 542 9 NCCLS 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 2004 33 NCCLS Method Comparison and Bias Estimation Using Patient Samples Approved Guideline Second Edition NCCLS document EP9 A2 ISBN 1 56238 472 4 NCCLS 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 2002 34 Deming WE Statistical Adjustment of Data New York NY John Wiley and Sons 1943 Tel 0120 03 6527 141 0032 1 11 2
21. kinson JM Grand JA Comparison of Amino Acid Sequence of TnI from Different Striated Muscles Nature 271 31 35 1978 3 4 3 Bodor GS Cardiac TnI A Highly Specific Biochemical Marker for Myocardial Infarction J Clin Immunoassay 17 1 40 44 1994 4 Vallins WJ et al Molecular Cloning of Human cTnI Using Polymerase Chain Reaction FEBS Letts 270 1 2 57 61 1990 5 Mair J et al Equivalent Early Sensitivities of Myoglobin CK MB Mass CK Isoform Ratios and Cardiac Troponins I and T for AMI Clin Chem 41 9 1266 1272 1995 6 Lerue C et al Cardiac Specific Immunoenzymometric Assay of Tnl in the Early Phase of AMI Clin Chem 39 6 972 979 1993 Adams JE et al Cardiac Troponin I A Marker with High Specificity for Cardiac Injury Circulation 88 1 101 106 1993 8 Apple FS et al Cardiac Troponin CK MB and Myoglobin for the Early Detection of AMI and Monitoring of Reperfusion Following Thrombolytic Therapy Clin Chim Acta 237 59 66 1995 9 Jaffe AS Elevations in cardiac troponin measurements false false positives Cardio Tox 2001 1 87 92 1 10 Galvani M Ottani F Ferrini D et al Prognostic Influence of Elevated Values of Cardiac Troponin I in Patients with Unstable Angina Circulation 95 2053 2059 1997 11 Antman EM Tanasijevic MJ Thompson B et al Cardiac Specific Troponin I Levels to Predict the Risk of Mortality in Patients with Acute Coronary Syndromes N Eng J Med 335 1342 1349 1996 12
22. l Chemiluminescence Clin Chem 41 873 1995 20 NCCLS Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture Approved Standard Fifth Edition NCCLS document H3 A5 ISBN 1 56238 515 1 NCCLS 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 2003 21 NCCLS Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens Approved Standard Fifth Edition NCCLS document H4 A5 ISBN 1 56238 538 0 NCCLS 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2004 22 CLSI How to Define and Determine Reference Intervals in the Clinical Laboratory Approved Guidelines Second Edition CLSI Document C28 A2 ISBN 1 56238 406 6 CLSI 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 2000 23 CLSI Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operator Characteristics ROC Plots Approved Edition CLSI Document GP10 A ISBN 1 56238 285 3 CLSI 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 2001 24 Joint European Society of Cardiology American College of Cardiology Committee Myocardial Infarction Redefined3 4A Consensus Document of the Joint European Society of Cardiology American College of Cardiology Committe for the Redefinition of Myocardial Infarction J Am Coll Cardiol 36 959 969 2000 25 Braunwald E Antman EM Beasley JW Califf RM Cheitlin MD Hochaman JS Jones RH Kereiakes D Kupersmith J Levi
23. n TN Pepine CJ Schaeffer JW Smith EE Steward DE Teroux P ACC AHA guidelines for the management of patients with unsta ble angina and non ST segment elevation myocardial infarction Executive summary and recommendations A report of the American College of Cardiology American Heart Association Task Force on Practice Guidelines Committee on the Management of Patients with Unstable Angina Circulation 2000 102 10 1193 1209 26 Braunwald E Antman EM Beasley JW Califf RM Cheitlin MD Hochaman JS Jones RH Kereiakes D Kupersmith J Levin TN Pepine CJ Schaeffer JW Smith EE Steward DE Teroux P ACC AHA guidelines for the management of patients with unsta ble angina and non ST segment elevation myocardial infarction a report of the American College of Cardiology American Heart Association Task Force on Practice Guidelines Committee on the Management of Patients with Unstable Angina 2002 27 Wu AH Apple FS Gibler WB Jesse RL Warshaw MM Valdes R Jr National Academy of Clinical Biochemistry Standards of Laboratory Practice Recommendations for the Use of Cardiac Markers in Coronary Artery Diseases Clinical Chemistry A5 1104 1121 1999 28 Panteghini M Apple FS Christenson RH Dati F Mair J Wu AH Use of Biochemical Markers in Acute Coronary Syndromes IFCC Scientific Division Committee on Standardisation of Markers of Cardiac Damage Clin Chem Lab Med 37 687 693 1999 29 NACB Laboratory Medicine Practice Guidel
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