PDFファイル - 医薬品医療機器総合機構
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1. 2 8C 2 6 Ij 10 20mg mL 500mg dL 3000mg dL ize Sc pera A7 4 V y 2p2. PSA t 8E 1 1 1 PSA 2 2ng mL A PSA 1 8ng mL B C 0 123 C A B A PSA 33ng mL D PSA 27ng mL E F 0 113
3. 2
4. PSA 4 10ng mL ug L PSA PSA PSA PSA 4 10ng mL g L PSA PSA 2 0 0001 2 fPSA 95 2 fPSA 50 59 m 60 69 m z7 m lt 10
5. A 0 01 14 B 0 005 l 2 PSA 3 PSA 2 A B A
6. 28 ER 30zL 85L 37C 8 iti avyyaif HNE 12541 37C 5 20 A B 100 L 420nm Emy 24 37 2 PSA gt 50ng mL ug L
7. 2 8C 2 8 C 12 2 8 C 12 A B A B 7 3 1 000ppm 2 1 BE 121 20
8. 1 1 ng mL g L Hu g L ng mL PSA PSAII 6fPSA fPSA PSA PSA MIRE 100 50 A PSAI tPSAII PSA fPSA 534
9. PSA PSA 9 PSA PSA 2 fPSA PSA 4 10ng mL g L ey PSA fPSA fup s G3 CLEIA PSA PSA PSA
10. fPSA Reag 059889 02 1506 22600AMX01317000 2015 6 2 2014 10 1 EUZ PSA FI ETT Mc d Proclin300
11. 3 5 SM 1 1 2 3 4 PSA 1 2
12. 534 PSA II 283 tPSA 4 10ng mL ug L 283 91 2 7 82 1 12 66 fPSA tPSA fPSA 1 2 4 1 n e P fPSA 156 1 08 1 01 0 301 2 72 0 039 NA ng mL 127 0 825 0 729 0 198 4 49 0 044 NA ug L 283 0967 0 861 0198 449 0 030 NA tpsa 156 612 5 62 4 03 9 88 0 124 NAW ng mL 127 6 19 5 77 4 00 9 98 0 145 NA ug L 283 615 5 67 400 998 0094 NA 156 180 168 437 393 0 572 fPSA E 127 13 5 120 3 16 45 0 0 601 283 160 151 316 450 0436 NA NA P fPSA 2 t fPSA fPSA
13. 1 3 w 2 8 24 20 4 3 30 gL 24 20 15 30
14. A 00196 K 0496 B 0 005 1 000ppm 2 pue Fi 1 1 2 8C 2 2 8 C 52 2 8C 52 3 2 8 C 52 A B A 2 8 26 5 B 2 8 26 X
15. F D E D 2 PSA 1 2ng mL 5ng mL 16ng mL 18 3 5 PSA 1 2ng mL 5ng mL CV 10 2 0 015 50 ng mL g L D 187 ECLIA Passing Bablok r 0 99 y 1 02x 014 y x 50 h y 1 02x 0 14 i r 0 99 40 30 20 PSA ng mL 10 0 10 20 30 40 50 ECLIA ng mL 2 106 CLIA Passing Bablok 9 r 0 98 y 1 07x 0 11 y x 30 yy 107x 0 11 E v o0 HHTH 3 20 A 1 R K B 10 m 2 Ed
16. 1 4 HRP PSA A PSA PSA PSA M HRP i e PSA PSA PSA C gt
17. 0 0 10 20 30 CLIA ng mL 3 NIBSC National Institute for Biological Standards and Control WHO Reference Standard 96 668 1 HBV HCV HIV A 0 01 X 1496 B 0 005 ER E V E EOT E Proclin300
18. 3 2 B PSA PSA 6 PSA 34 000 PSA g1 ACT PSA PSA PSA BPH
19. 059889 PSA 100 a X 068010 A B 2 28mL 24 2 Wang MC Valenzuela LA Murphy GP and Chu TM Purification of a human prostate specific antigen Invest Urol 17 159 163 1979 3 Wang MC Papsidero LD Kuriyama M et al Prostate antigen a new potential marker for prostatic cancer The Prostate 2 89 96 1981 4 Papsidero LD Wang MC Valenzuela LA et al A Prostate Antigen in Sera of Prostatic Cancer Patients Cancer Res 40 2428 2432 1980 5 Oesterling JE Prostate specific antigen a critical assessment of the most useful tumor marker for adenocarcinoma of the prostate J Urol 145 907 923 1991 6 Stamey TA Kabalin JN McNeal JE et al Prostate specific antigen in the diagnosis and treatment of adenocarcinoma of the prostate II Radical prostatectomy treated patients J Urol 141 1076 1083 1989 7 Chybowski FM Larson Keller JJ Bergstralh EJ and Oestrling JE Predicting radionuclide bone scan findings in patients with newly diagnosed untreated prostate cancer prostate specific antigen is superior to all other clinical parameters J Urol 145 313 318 1991 8 Stamey TA Kabalin JN Ferrari M Prostate specific antigen in the diagnosis and treatment of adenocarcinoma of the prostate III
20. Indian Journal of Clinical Biochemistry 19 2 10 13 16 Sokoll L J Bruzek D J Dua R Dunn W Mohr P Wallerson G Eisenberger M Partin A W and Chan D W 2002 Short Term Stability of the Molecular Forms of Prostate Specific Antigen and Effect on Percent Complexed Prostate Specific Antigen and Percent Free Prostate Specific Antigen Urology 60 Supplement 4A 24 30 17 Calam RR Specimen Processing Separator Gels An Update J Clin Immunoassay 11 86 90 1988 18 Levinson SS The Nature of Heterophilic Antibodies and Their Role in Immunoassay Interference J Clin Immunoassay 15 108 115 1992 19 Thiel RP Oesterling JE Wojno KJ Partin AW Chan DW Carter HB et al A multicenter comparison of the diagnostic perform ance of free prostate specific antigen Urology 1996 48 6A 45 50 20 Young DS Effects of Drugs on Clinical Laboratory Tests ed 4 Washington D C AACC Press 1995 2D Friedman RB Young DS Effects of Disease on Clinical Laboratory Tests ed 3 Washington D C AACC Press 1997 22 Tryding N Tufvesson C Sonntag O eds Drug Effects in Clinical Chemistry ed 7 Stockholm The National Corporation of Swedish Pharmacies Pharmasoft AB Swedish Society for Clinical Chemistry 1996 23 Guess H A et al J Urol 155 1 3 1996 24 Andriole GL et al J Urol 175 5 1657 1662 2006 25 Marks LS et al J Urol 176 3 868 874 2006 26 Passing HW A New Biometrical Proce
21. 56 0 39 2 71 6 70 5 56 5 81 5 72 0 56 0 83 8 11 18 31 0 18 6 47 0 45 8 35 9 56 1 47 6 35 4 60 1 19 25 27 9 14 8 46 3 42 1 28 2 57 4 43 8 29 5 59 3 gt 25 11 2 4 36 26 0 19 2 9 05 36 2 20 3 9 63 37 9 2fPSA 3 fPSA 30 96 9 5 13 3 fPSA fPSA n 95 n 95 22 127 88 2 81 3 93 2 156 27 6 20 7 35 3 24 127 94 5 89 0 97 8 156 20 5 14 5 27 7 26 127 96 1 91 1 98 7 156 16 7 11 2 23 5 28 127 96 9 92 1 99 1 156 10 9 6 48 16 9 30 127 96 9 92 1 99 1 156 5 13 2 24 9 85
22. Radiation treated patients J Urol 141 1084 1087 1989 9 Stamey TA Kabalin JN Ferrari M Yang N Prostate specific anti gen in the diagnosis and treatment of adenocarcinoma of the prostate IV Anti androgen treated patients J Urol 141 1088 1090 1989 10 Catalona WJ Partin AW Slawin KM Brawer MK Flanigan RC Patel A et al Use of the percentage of free prostate specific anti gen to enhance differentiation of prostate cancer from benign prostatic disease A prospective multicenter clinical trial JAMA 2779 1542 1547 1998 11 Potter SR Reckwitx T and Partin AW The use of percent free PSA for early detection of prostate cancer J Andrology 20 4 449 453 1999 12 Catalona WJ Smith DS Wolfert RL Wang TJ Rittenhouse HG Ratliff TL et al Evaluation of percentage of free serum prostate specific antigen to improve specificity of prostate cancer screen ing JAMA 274 1214 1220 1995 13 Prestigiacoma AF Liua H Pettersson K Wolfert RL Stamey TA A Comparison of the Free Fraction of Serum Prostate Specific Antigen in men with Benign and Cancerous Prostates The Best Case Scenario The Journal of Urology 1996 156 350 354 14 Summers M et al Luminogenic Reagent Using 3 Chloro 4 Hydroxy Acetanilide to Enhance Peroxidase Luminol Chemiluminescence Clin Chem 41 873 1995 15 Kumari G R and Malati T 2004 Stability of Total and Free Prostate Specific Antigen in Serum Samples at Different Storage Conditions
23. dure of Testing the Equality of Measurements from Two Different Analytical Methods J Clin Chem Biochem 21 709 720 1983 Tel 0120 03 6527 141 0032 1 11 2 Tel 0120 03 6527 141 0032 1 11 2 4 4
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