PDFファイル - 医薬品医療機器総合機構
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1.2. 014 5 1 224AAAMX00178000 Sl E M E NN S 46pg mL 64ug mL 100ug mL 5800mg dL Di ione EXL Aug mL 9400mg dL i 10mg dL 0ug mL DIR interated chemistry system 6 OL 40ug mL 3Pug mL odule ES 0 16ug mL 400ug mL 12ug mL 4 0mg dL 100ug mL 3000mg dL BNP V G 85U mL 64ug mL a 8 0mg dL 500mg dL 10 0mg dL 0mg dL
3. la H pg mL n 0 99 0 03 0 997 7 0 2g f EP6 A 53 0 4371pg mL 6 LoD LOB a LoD 2 3pg mL LoD CLSI 4 60 596 59 854 LOB 1 5p mL LoD BNP LoB
4. 30ug mL 1 2mg dL ANP 30mg dL mg dL BNP BNP A 4000ng mL 16ug mL 0 40 SOE MOE proBNP 26 2 preproBNP DrOBN 32 C BNP77 108 NT proBNP1 76 p NT proBNP 1 76 2426
5. 1ug mL 0 51mg dL 30 60mg dL 60ug mL EE 4 0mg dL 60 L OP8g m o a0ue mL 6 1ngmt i 8 0mg dL 120ug mL EN 4 0ug mL 30ug mL 2 OO BA UE 8 Omg dL 1 0mg dL 6 0mg dL 3 ug mL 400mg dL
6. 500mg dL mg 420 lt 10 3 75 000pg ImL 49 10 3 60mg dL 3 9 000pg mL 0mg dL 420 10 NR 000pg mL 5 CC HC 4 uit 2 BNP49pg mL 2 cd NI o 6 4 1 420pg mL 10 SU _
7. gs BNP 0 LSE 96 99 BC 18 91 3 2 1 b 2 EDTA 20 5C 8 2 8C 12 EDTA DF 20 BC 8 BNP 94 99 91 9 7 8C 12 90 996 70 7 96 0 4
8. P NYHA 0 3 0 3546 ENTIRETIMIBG f 6 STEMI BNP 80pg mL 30 A to MI 4869 1 ACS ST BNP H 3 BNP 80pg mL 2 0 2 34 BNP 29204950 wl NC
9. RS ne Fiano ws IT OO Si 3 IS 8 A 9 S BE 4 WS i 8 ON NW 1 BNP ME Low 5250pg mL High PP Low LOw 1 000 29 80 12006 9 CV rd 3 T096 4 5 000pg m 51s EXL LM _
10. 612nm BNP MC2Ee0 LO BN Sa LOCI Luminescent Oxygen Channeling Immunoassay 9 0 x WE 5 SR 1 LOCI B EDTA x EDTA Vl PLB RUI 0 5 3 Pe BNP RG
11. 5 0mg dL 50mg dL 1 4 0mg dL 96ug mL OE ZR OE 2 E f 1 i 1 8 xh 60p mL 45pg mL BNP 1 596 m 0 75 SE BNP 45pg mL 1 6 5667 19 0 75 a _
12. 9 I a EA A ut KD82 3 BNP 80 EG 0 OD om 2 6 6 612nm nm N w 2 3 LOCI BNP
13. S 5pg mL CV2096 0 LOQ 5pg mL LoQ CLSI EP17 A CV20 9 1 EURO HBV HCV 5 2H 33 2 2H 3 3 1 LM1 1 NH
14. 4 6 M 8 eg J L 3 0mg dL 1 0mg dL 5 0mg dL 3 0U mL 5 0mg dL 0ug mL SO 1 Omg dL 20Lg mL 0 20mg dL 50mag dL NP BNP 503mg dL G 5000mg dL 7 0 N CNE ie Smg dL 36ug mL 2 gt 2 3 0mg dL 4ug mL
15. CV pg mL F 1 3 1 0 1 4 1 9 2 5 QC 903 11 1 1 2 16 9 1 9 MAS Cardiolmmune XL Liquid Control 1 34 1 3 3 8 1 4 4 1 163 g 0 1 8 3 3 2 0 3 476 4 9 1 0 7 6 1 6 C CLSI NCCLS EP5 A2 2S a Ne 20 3 pg mD ne BNP CLIA 0 91 6 11 0 88 1 00 EIA 0 86 g 88 0 984 00 0 CLSI NCCLS EP9 A Passing Bablok e 1 1 1994pg mL CLIA 7 1542pg mL 4 BNP 26 5880pg mL Multi 88 10796 9996 5 P 7
16. EDTA 182 73pg mL 4 5pg mL 20C 1 903pg mL lt 46 5pg mL 8 BC I o 0 DS 1 A 2 HH ES 18 4DE mL AF 2 VGCLSVRICE EP7 A RS 7 SO A 1 29 OR 2 SNR BN Oi 26820585gNe BNP pg mL 6 4 9 lt SS 49 10
17. RF624 012 5 2
18. pha 1 28 pg m DreDrO 56 92 Dg mL NT proBNPi si 1000pg mL Adrenomedullin 1ng mL s NT proBNPi s 1000pg mL Aldosterone 1000pg mL a NT proBNPi s 1000pg mL Angiotensin I 600pg mL 1 1 NT proBNPss4e 1000pg mL Angiotensin I 600pg mL 3 4 BNP NT proBNP4ze 1000pg mL Angiotensin 1000pg mL 3 CNPzss 1000pg mL Arg Vasopressin 1000pg mL a DreDroANFio4ias 1000pg mL Renin 50ng mL DreDrOANFsess 1000pg mL Urodilatin 1000pg mL a Aa 1 3 b f PO 1 BNP
19. 585 91 24 Mair J Hammerer Lercher Puschendorf B The impact of cardiac natriuretic peptide determination on the diagnosis and management of heart failure Clin Chem Lab Med 2001 39 571 88 25 Clerico A Del Ry S Giannessi D Measurement of cardiac natriuretic hormones atrial natriuretic peptide brain natriuretic 9 ang 6860 peptides in clinical practice the need for a new generation of immunoassay methods Clin Chem 26 Yan W Wu F Morser J Wu Q Corin A transmembrane cardiac serine protease acts as a pro atrial natriuretic peptide converting enzyme Proc Natl Acad Sci USA 2000 97 8525 9 27 Kelly R Struthers A Are natriuretic peptides clinically useful as markers of heart failure Ann Clin Biochem 2001 38 94 102 28 Daly C Fox K Henein M Natriuretic peptides in the diagnosis of heart disease first amongst equals Intl J Cardiol 2002 84 107 113 29 Tabbibizar R Maisel A The impact of B ne natriuretic peptide levels on the diagnoses and management of congestive heart failure Curr Op Cardiol 2002 17 340 4 30 Lee SC Stevens TL Sandberg SM Reuben BM Nelson SM Jougasaki M Redfield MM Burnett JC Jr The potential of brain natriuretic peptide as a biomarker for New York Heart Association class during the outpatient treatment of heart failure J Cardiac Failure 2002 8 149 54 31 Lubien E DeMaria A Krishnaswamy P Clopton P Koon J Kazanegra R Gardetto N Wanner E Maisel AS Utility of B natriuretic peptide in detecting dia
20. 38 519 4 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2003 xr oa 8 Pereira M Azevedo A Severo M Barros H Long term stability of endogenous B type natriuretic peptide after storage at 20 C or 80 C Clin Chem Lab Med 2008 46 8 1171 1174 9 Clinical and Laboratory Standards Institute NCCLS Interference Testing in Clinical Chemistry Approved Guideline Second Edition S00 document EP7 A2 ISBN 1 56238 584 4 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2 10 BNP 1993 41 4 397 403 11 Kricka LJ Human Anti Animal Antibody Interferences in Immunological Assays Clin Chem 1999 45 7 942 956 12 Vaidya HC Beatty BG Fliminating interference from heterophilic antibodies in a two site immunoassay for creatine kinase MB by using F ab conjugate and polyclonal mouse lgG Clin Chem 1992 38 1737 1742 13 Ryall RG Story CJ and Turner DR Reappraisal of the causes of the hook effect in two site immunoradiometric assays Anal Biochem 1982 127 308 315 14 Remme WJ Swedberg K Task Force Report guidelines for the diagnosis and treatment of chronic heart failure Eur Heart J 2001 22 1527 60 15 Hunt SA Baker DW Chin MH Cinquegrani MP Feldman AM Francis GS Ganiats TG Goldstein S Gredoratos G JessUD ML Noble RJ Packer M Silver MA Stevenson LW Gi
21. 43 Cheng V Kazanagra R Garcia A Lenert L Krishnaswamy P Gardetto N Clopton P Maisel A A rapid bedside test for B type natriuretic peptide predicts treatment outcomes in patients admitted for decompensated heart failure a pilot study J Am Coll Cardiol 2001 37 386 91 44 Stanek B Frey B Hulsmann M Berger R Sturm B Strametz Juranek J Bergler Klein J Moser P Bjic A Hartter E Pacher R Prognostic evaluation of neurohumoral plasma levels before and during beta blockertherapy in advanced left ventricular dystunction J Am Coll Cardiol 2001 38 436 42 45 DeLemos JA Morrow DA Bentley JH Omland T Sabatine MS McCabe CH Hall C Cannon CP Braunwald E The prognostic value of B type natriuretic peptide in patients with acute coronary syndromes N Engl J Med 2001 345 1014 21 46 0mland T Aakvaag A Bonarjee VVS Caidahl K Lie RT Nilsen DWT Sundsfjord JA Dickstein K Plasma brain natriuretic peptide as an indicator of left ventricular systolic function and long term survival atter acute myocardial infarction Circulation 1996 93 1963 69 47 Mega JL Morrow DA deLemos JA Sabatine MS Murphy SA Rifai N Gibson CM Antman EM Braunwald E BNP at Presentation and Prognosis in Patients with ST Elevation Myocardial Infarction An ENTIRE TIMI 23 Substudy J Am Coll Cardiol 2004 44 335 9 48 Morrow DA de Lemos JA Blazing MA Sabatine MS Murphy SA Jarolim P White HD Fox KA Califf RM Braunwald E Prognostic value of serial B type natriuretic pep
22. N 3 30 1 FIV HBV HOCV 4 i 2 8C 12 120 30 4 1 UlIman EF Kirakossian H Switchenko AC Ishkanian J et a
23. bbons RJ Antman EM Alpert JS Faxon DP Fuster V Jacobs AK Hiratzka LF Russell RO Smith SC Jr ACC AHA guidelines for the evaluation and management of chronic heart failure in the adult executive summary A report of the American College of Cardiology American Heart Association Task Force on Practice Guidelines J Am Coll Cardiol 2001 38 2101 13 16 Stein BC Levin RI Natriuretic peptides physiology therapeutic potential and risk stratification in ischemic heart disease Am Heart J 1998 135 914 23 17 Sagnella GA Measurement and significance of circulating natriuretic peptides in cardiovascular disease Clin Science 1998 95 519 29 18 Suzuki T Yamazaki T Yazaki Y The role of natriuretic peptides in the cardiovascular system Cardiovasc Res 2001 51 489 94 19 Levin ER Gardner DG Samson WK Natriuretic peptides N Engl J Med 1998 339 321 8 20 Wilkins M Redondo J Brown L The natriuretic peptide family The Lancet 1997 349 1307 10 21 Dickstein K Natriuretic peptides in detection of heart failure The Lancet 1998 35 3 4 22 Chen HH Burnett JC Jr The natriuretic peptides in heart failure diagnostic and therapeutic potentials Proc Assoc Am Physicians 1999 111 406 16 23 Hirata Y Matsumoto A Aoyagi T Ymaoki K Kumoro Suzuki T Ashida T Sugiyama T Hada Y Kuwajima 1 Nishinaga M Akioka H Nakajima 0 Nagai R Yazaki Y Measurement of plasma brain natriuretic peptide level as a guide for cardiac overload Cardiovascular Res 2001 51
24. l Luminescent oxygen channeling assay LOCI sensitive broadly applicable homogeneous immunoassay method Clin Chem 42 9 1996 1518 1526 2 UlIman EF Kirakossian H Sharat S Ping Wu Z Irvin BR et al Luminescent oxygen channeling immunoassay Measurement of particle binding kinetics by chemiluminescence Proc Natl Acad Sci USA Vol 91 pp 5426 5430 June 1994 Biochemistry 3 Clinical and Laboratory Standards Institute NCCLS Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture Approved Standard Fifth Edition CLSIINCCLS document H3 A5 ISBN 1 56238 515 1 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2003 4 Clinical and Laboratory Standards Institute NCCLS Procedures for the Handling and Processing of Blood Specimens pproved Guideline Third Edition CLSINCCLS document H18 A3 ISBN 1 56238 555 0 CLSI 940 West Valley Road uite 1400 Wayne PA 19087 1898 USA 2004 5 Shimizu H Aono K Masuta K et al Stability of brain natriuretic peptide BNP in human blood samples Clinica Chim Acta 1999 285 169 72 6 Shimizu H Aono K Masuta K Asada H Misaki A Teraoka H Degradation of human brain natriuretic peptide BNP by ontact activation of blood coagulation system Clin Chim Acta 2001 305 181 6 7 Clinical and Laboratory Standards Institute NCCLS Tubes and Additives for Venous Blood Specimen Collection Approved Standard fFifth Edition CLSINCCLS document H1 A5 ISBN 1 562
25. ntitation Approved Guideline CLSIINCCLS document EP17 A ISBN 1 56238 551 8 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2004 55 Clinical and Laboratory Standards Institute CLSI Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures Approved Guideline Second Edition CLSI document EP17 A2 ISBN 1 56238 795 2 CLSI 950 West Valley Road Suite 2500 Wayne PA 19087 USA 2012 03 3493 8400 3 1 A lt 1 1 1 1 DL 111 318B 2014 PN 10866023
26. operly BNP multinational study Circulation 2002 106 416 22 37 Wieczorek SJ Wu AHB Christenson R Krishnaswamy P Gottlieb S Rosano T Hager D Gradetto N Chiu A Bailly KR Maisel AS A rapid B type natriuretic peptide assay accurately diagnoses left ventricular dysfunction and heart failure a ulticenter evaluation Am Heart J 2002 144 834 9 38 Maisel AS Koon J Krishnaswamy P Kazanegra R Clopton P Gradetto N Morrisey NC Chiu A DeMaria A Utility of B natriuretic peptide as a rapid point of care test for screening patients undergoing echocardiography to determine left ventricular dysfunction Am Heart J 2001 141 367 74 39 Valli N Georges A Corcuff JB Barat JL Bordenave L Assessment of brain natriuretic peptide in patients with suspected heart failure comparison with radionuclide ventriculography data Clin Chim Acta 2001 306 19 26 40 McDonagh TA Robb SD Murdoch DR Morton JJ Ford Morrison CE Tunstall Pedoe H McMurray JJV Dargie HJ Biochemical detection of left ventricular systolic dysfunction The Lancet 1998 351 9 13 41 Berger R Huelsman M Strecker K Bojic A Moser P Stanek B Pacher R B type natriuretic peptide predicts sudden death in patients with chronic heart failure Circulation 2002 105 2392 97 42 Koglin J Pehlivanli S Schwaiblmair M Vogeser M Cremer P von Scheidt W Role of brain natriuretic peptide in risk stratification of patients with congestive heart failure J Am Coll Cardiol 2001 38 1934 41
27. stolic dysfunction comparison with doppler velocity recordings Circulation 2002 105 595 601 32 Fisher Y Filzmaier K Stieler H Graf J Fuhs S Franke A Janssens U Gressner AM Evaluation of a new rapid bedside test for quantitative determination of B type natriuretic peptide Clin Chem 2001 47 591 4 33 Maisel AS Krishnaswamy P Nowak RM McCord J Hollander JE Duc P Omland T Storrow AB Abraham WT Wu AHB Clopton P Steg PG Westheim A Wold Knudsen C Perez A Kazanegra R Herrmann H McCullough PA Rapid measurement of B type natriuretic peptide in the emergency diagnosis of heart failure New Engl J Med 2002 347 161 7 34 Dao Q Krishnaswamy P Kazanegra R Harrison A Amirnovin R Lenert L Clopton P Alberto J Hlavin P Maisel AS Wi of Bd B O06 natriuretic peptide in the diagnosis of congestive heart failure in an urgent care selting J Am Col Cardiol 35 Morrison IK mson A Krishnaswamy P Kazanegra R Clopton P Maisel AS Utility of a rapid B type natriuretic peptide assay in ditferentiating congestive heart failure from lung disease in patients presenting with dyspnea J Am Col Cardiol 002 39 202 9 36 McCullough PA Nowak RM McCord J Hollander JE Herrmann H Steg PG Duc P Westheim A Omland T Wold Knudsen C Storrow AB Abraham WT Lamba S Wu AHB Perez A Clopton P Krishnaswamy P Kazanegra R Maisel AS B type natriuretic peptide and clinical judgment in emergency diagnosis of heart failure analysis from the breathing not pr
28. tide testing during follow up of patients with unstable coronary artery disease JAMA 2005 294 22 2866 71 49 Richards AM Lainchbury JG Nicholls MG Troughton RW Yandel TG BNP in hormone guided treatment of heart failure Trends Endocrinol Metab 2002 13 151 5 50 Johnson W Omland T Hall C Lucas C Myking OL Collins C Pfeffer M Rouleau JL Stevenson LW Neurohormonal activation rapidly decreases after intravenous therapy with diuretics and vasodilators for class IV heart failure J Am Coll Cardiol 2002 39 1623 9 51 Clinical and Laboratory Standards Institute NCCLS Evaluation of Precision Performance of Quantitative Measurement Methods Approved Guideline Second Edition CLSI NCCLS document EP5 A2 ISBN 1 56238 542 9 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2004 52 Clinical and Laboratory Standards Institute NCCLS Method Comparison and Bias Estimation Using Patient Samples Approved Guideline Second Edition OD document EP9 A2 ISBN 1 56238 472 4 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2 53 Clinical and Laboratory Standards Institute NCCLS ggf00 of the Linearity of Quantitative Measurement Procedures A Statistical Approach Approved Guideline CLSINCCLS document EP6 A ISBN 1 56238 498 8 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2003 54 Clinical and Laboratory Standards Institute NCCLS Protocols for Determination of Limits of Detection and Limits of Qua
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