PDFファイル - 医薬品医療機器総合機構
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1. XE ri ACS 11 2 8C 28 1 000 ppm 1 2 12. 2 2 iPTH 2
3. iPTH EDTA iPTH 5 6 iPTH PTH 1 PTH PTH PTH
4. 223AIAMX00002000 20154 1He amp sT 3 2013 4 2 iPTH B m 1 iPTH 5 0 mL 1 34 PTH 1 34
5. 2 ADVIA Centaur CP 1 3 4 ACS 11 iPTH jiPTH 28H 14 2 SER 14
6. VAR A T OWE HRS TEE 1 a 200 dead volume 2 E TOUT 1900 pglmL
7. ADVIA Centaur ADVIA Centaur XP ADVIA Centaur XPT ADVIA Centaur CP 200 uL WY 50 pL 37 C 5 027 37 C 6 347 200pL 37C 2 5 37C 3 0 BF 1 WY 300pL 300p L NV B F Bbound F free PTH RLUs m T iPTH pg mL f pmolL SI 1 pgimL 0 106 pmol L CF CACS1809 8 0 10 3 mg dL OHA k 0 f 7 EDTA Druide 14
8. ACS 11 Dilution point 1900 pg mL Dilution factor 5 ACS 11 KB TUOS RIO EE 1 Dilution factor g Cu L 5 40
9. iPTH FTH iPTH 7 8 13 14 iPTH PTH OB ABA NED 2 PTH E
10. CD 2 2 es Enns SENT
11. pH lt 2 pH13 1 2 8C 2 8 C CIR
12. PTH 1 25 D 7 8 9 PTH PTH LES PTH PTH 8 iPTH 9425 84 iPTH N 1 34 iPTH PTH PTH iPTH 35 84 C
13. N PTH 1 7 16 1 2 5 1900 pglmL 0 265 201 pmol L 2 1 High Low RLU Olt High Low Lowl 0 14 28 7 2 28 3 CV 15 3 ADVIA Centaur XP XPT 1 CLEIA 20 y 0 96 x 4 72 r 0 97 n 130 2 EIA 20 y 0 91x 13 9 r 0 97 n 140 3 iPTH 15 0
14. EDTA DUIK ZEHE 8 4 4 C 72 48 70 C 8 lt 2 ADVIA Centaur 10 200 mgldL 3000 mgldL PH 40 mgldL 1000 ng lmL PTH pg mL 9
15. 20 0 mL 39 84 IR PTH 39 84 iPTH 2 1500 mL 0 5 0 1N 1500 mL 0 25N ADVIA Centaur CP 300 mL 1 2 PTH 1 PTH 01 34 2 PTH 39 84 A ADVIA Centaur ADVIA Centaur
16. 1 12 iPTH 2 PTH PTH iPTH PTH PTH iPTH 4 iPTH PTH N PTH C PTH C DES PTH C iPTH C 78 11 12 iPTH
17. T Am OPEC t EDTA HUIR xcu ifs Ze ER amp TEE CLSI Clinical and Laboratory Standards Institute 1000xg 15 20 1 1000xg 15 20H PTH GPTH iPTH ADVIA Centaur
18. 1210 0 T m 1 1 2 8 C 2 4 25 2 1 14 2 1 6 u iPTH 500 10492369 5 iPTH 100 10492368 1 gt 7 5000 1500 mL 03852677 ADVIA Centaur XP XPT JH 112219 1000 300 mL 0049704
19. 999 1 1610 4 pg mL 105 9 170 7 pmol L E 5 ACS 11 2 4 8 88 9 105 8 96 09 5 37 8 178 7 pglmL 4 0 19 0 pmol L iPTH 5 iPTH ADVIA Centaur 91 0 123 6 105 09 6 ADVIA Centaur XP XPT 3 12 4 3 nm 144 pgimL pmol L CV CV CV 40 4 4 3 5 2 5 8 7 8 223 8 23 7 3 4 1 5 7 0 859 3 91 1 3 5 2 8 4 6 ADVIA Centaur CP 4 1 2 2 20 10 2 n 160 pg mL pmol L CV CV CV 42 55 4 51 3 0 2 6 4 0 107 6 11 4 4 3
20. 4 3 6 1 455 5 48 3 1 4 1 9 2 4 733 3 77 7 2 6 7 3 7 7 1900 pg mL 201 pmol L 2 5 pglmL 0 265 pmol L iPTH 20 RLUs 2SD iPTH PTH 1 84 WHO 79 500 WHO ADVIA Centaur 73 ADVIA Centaur CP 62 a 1 2 3 HIV HBV HCV
21. 1908 4 pglmL 1 58 202 3 pmol L 185 ADVIA Centaur ADVIA Centaur iPTH ACS 180 ACS iPTH ACS 180 iPTH ADVIA Centaur iPTH 0 95 ACS 180 iPTH 6 48 pg mL r 0 99 ADVIA Centaur CP iPTH 3 84 1961 4 pglmL 0 41 207 9 pmol L 262 Mn HERR ADVIA Centaur CP ADVIA Centaur CP iPTH ADVIA Centaur iPTH ADVIA Centaur CP iPTH 0 99 ADVIA Centaur iPTH 8 39 pg mL Gr 0 997 iPTH 2 5 1682 pglmL 0 265 178 3 pmol L 197 ifi ff ADVIA Centaur CP iPTH ACS 180 iPTH ADVIA Centaur CP iPTH 0 97 ACS 180 iPTH 32 47 pgimL Gr 0 98 4 ADVIA Centaur XP XPT iPTH 1040 2 1824 1 pg mL 110 3 193 4 pmol L DE 5 ACS 11 2 4 8 91 3 116 3 99 8 ADVIA Centaur CP iPTH
22. 2 95 14 72 pglmL 1 48 7 63 pmolL 11 1 79 5 pgimL 1 18 8 43 pmol L Lies ADVIA Centaur ADVIA Centaur CP PERE 3 RLU 100 000 pgimL 10 600 pmol L iPTH PTH 2 iPTH IPTH No iPTHO E BALAN LEJE KOM 71V Z7 Lee EE
23. 3 ADVIA Centaur CP iPTH 10492394 2 iPTH 10492378 2x1 mL 1 2x1 mL 2 2x1 ml 3 1 2x2500 mL ADVIA Centaur XP XPTICP 03773025 2x1500 mL ADVIA Centaur XP XPTICP 01137199 112351 ACS Halm Ni 11 2x5mL 05699280 117228 1x10 mL 03479704 111088 1 Clinical and Laboratory Standards Institute formerly NCCLS Proce dures for the Handling and Processing of Blood Specimens Approved Guide line Third Edition Wayne PA Clinical and Laboratory Standards Institute 2004 NCCLS Document H18 A3 2 Boscato LM Stuart MC Heterophilic antibodies a problem for all immunoassays Clin Chem 1988 34 27 33 3 Clinical and Laboratory Standards Institute formerly NCCLS Inter ference Testing in Clinical Chemistry Approved Guideline Second Edition Wayne PA Clinical and Laboratory Standards Institute 2005 NCCLS document EP7 A2 4 Clinical and Laboratory Standards Institute formerly NCCLS How to Define and Determine Reference Intervals in the Clinical Laboratory Approved Guideline Second Edition Wayne PA Clinical and L
24. 6 PTH 1 34 300 0 74 PTH 39 68 100 000 0 005 PTH 39 84 100 000 0 024 PTH 44 68 100 000 0 007 PTH 53 84 100 000 0 003 100 000 0 0004 CLSI EP7 A23 ADVIA Centaur eH 1 1 2 ER 28 ADVIA Centaur IPTH 1 lt 0 1 ADVIA Centaur CP ACS 11 iPTH 1
25. aboratory Standards Institute 2000 NCCLS Document C28 A2 5 Glendenning P Laffer LLA Weber HK Musk AA Vasikaran SD Para thyroid Hormone is More Stable in EDTA Plasma Than in Serum Clin Chem 2002 48 766 767 6 Teal TK Wood JL Stevens PE Lamb EJ Stability of Bio Intact 1 84 Parathyroid Hormone ex Vivo in Serum and EDTA Plasma from Hemodialysis Patients Clin Chem 2004 50 1713 1714 7 Mundy GR Guise TA Hormonal control of calcium homeostasis Clin Chem 1999 45 1347 1352 8 Marx SJ Hyperparathyroid and hypoparathyroid disorders New England Journal of Medicine 2000 343 1863 1875 9 Friedman PA Mechanisms of renal calcium transport Exp Nephrol 2000 8 6 343 350 10 Akizawa T Fukagawa M Modulation of parathyroid cell function by calcium ion in health and uremia Am J Med Sci 1999 317 6 358 362 11 12 13 14 15 16 17 18 19 H Itani O Tsang RC Bone disease In Kaplan LA Pesce AJ Clinical chemistry theory analysis and correlation 3rd ed St Louis CV Mosby 1996 534 536 Endres DB Rude RK Mineral and bone metabolism In Burtis CA Ashwood ER Tietz textbook of clinical chemistry 2nd ed Philadel phia WB Saunders 1994 1914 1922 Casez J Pfammatter R et al Diagnostic approach to hypercalcemia relevance of parathyroid hormone and parathyroid hormone relat ed protein measurements Euro Jour of Int Med 2001 12 4 344 349 Johnson LR Doherty G et al Evaluatio
26. n of the performance and clinical impact of a rapid intraoperative parathyroid hormone assay in conjunction with preoperative imaging and concise parathyroid ectomy Clin Chem 2001 47 919 925 Lepage R Roy L Brossard JH et al A non 1 84 circulating parathy roid hormone PTH fragment interferes significantly with intact PTH commercial assay measurements in uremic samples Clin Chem 1998 44 805 809 Bilezikian JP Silverberg SJ Parathyroid hormone Does it have a role in the pathogenesis of osteoporosis Clin Lab Med 2000 20 3 559 567 Raisz LG Physiology and pathophysiology of bone remodeling Clin Chem 1999 45 1353 1358 Morley P Whitfield JF Willick GE Parathyroid hormone an anabolic treat ment for osteoporosis Current Pharmaceutical Design 2001 7 8 671 687 03 3493 8400 d 1 11 1 ADVIA Centaur ACS 180 Siemens 10492368M1 02 ADVIA Centaur 10492444 EN Rev D CP 10492464 Rev B
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