PDFファイル - 医薬品医療機器総合機構
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1. 3 N 4 w 1 2 8C 2 20 5 UMUAR a pese 40m 5 dob 1 200 5 L2KUN6 200 x3 1 6 30mLx1 1 LL 2 0mLx2 2 H 2 0mLx2 2 2 75mLX2 12. 2 1 2 3 4 5 6 PPD
3. 1 High Low High Low 0 IUAImL 10 IUymL 10 IUAmL 0 IU mL 5 2 1 3 2 1 4 L2KUN6 0 625X 0 10 100 IUN ML L2KUNJ6 0 6732 0 10 500 IUN ML zur iz CLSI EP17 A LoB 0 03 IUA ML LoD 0 10 IU ML 3 CLSI EP5 A21 CV20 0 20 IU4mL L2KUN6 22 20 1 2 2
4. 0 10IU mL 1 1gE lt 0 10IUmL IgE 4 5 2 1 2 IgE 3 3 IgE
5. 90 1 2 1 1 2 8 Cia 90 2 2 8 90 3 L H IgE
6. 4 5 6 5 1 L H 2 3 L H 2 6 1 1 2 IgE
7. 16x100mm 2 8 30 20 6 2 2000 L2PWSM 2 IgE IgE D1 DC1LCM D2 DC2LCM M6 MC6LCM IgE L2SNCCM 3 2000 2000XPi L2KUNG SPE L2KUNJO SPJ 1 50 pL 50 pL 37 30 43 u L 37 30
8. 21700AMY00200000 222AIAMX00001000 L2KUN6 L2KUNJ6 2000 TL 2000XPi 1 2 3 4 5 6 7 1
9. 210 1 2 1 2 E ALP IgE 3 L IgE 4 H IgE 5 6 1 IgE 7 2 IgE 8 3 PPD 4 4 3 1 2 3 2 PPD HEAR E 1gE MAVE RE 2 CLEIA
10. 4 IgE 4 5 5 IgE 6 2 9 7 IgE 2 2
11. 4 5 6 7 2 8 C 7 20 6 8 15 25 9 2015 7 10
12. PPD 200 u LIE 37 5 5 L H IgE 1 2 65 4 1 open position 2 3
13. 48 1 101 107 2002 17 IgE DPC IgE 23 1 62 66 2003 18 7 DPC TIgE 23 4 298 303 2003 19 IgE 2000 56 6 420 425 2005 03 3493 8400 1 11 1 1 ZANE 1 HI
14. 40 80 CV 3 5 10 CV 4 5 12 L2KUNJ6 26 20 1 2 2 40 80 CV 3 0 10 CV 3 5 12 1 21 96 6 IU mL 94 112 6 1 7 2nd WHO IRP 75 502 1 1 HIV 1 2 HBs HCV HIV HBV HCV 2 3 0 1
15. IgE 8 IgE IV 9 0 IgE 10 11
16. IgE gE IgE 1 ALP IgE ALP 1 ALP IgE ALP 2 2 PPD PPD 2 ALP IgE 1 1 2 1 50 pL 3
17. 2 8 30 20 6 4 IgE 2 8 5 1 2 IgE 2 8 30 20 6 6 IgE 2 8 3 PPD 15 28 C 20 15 28 30 09 4 1 L2UNZ IgE 2000 L2UNZ
18. F31 0 997 2 F33 F33 0 996 2 F 35 F35 0 993 2 F 36 F36 0 995 2 F37 F37 0 999 2 F 40 xju F40 0 999 2 F 41 F41 0 999 2 F 44 F44 0 995 2 F 45 F45 0 998 2 F 47 F47 0 999 2 F48 F48 0 998 2 F 49 F49 0 997 2 F50 F50 98 3 2 F 51 F51 2 94 2 F 54 F54 90 3 2 F58 F58 92 3 2 F 59 F59 94 3 2 F 60 _F 60 2 92 3 2 F 61 F61 94 3 2 F75 F75 0 998 2 F76 gw F76 0 996 2 F77 8 F77 0 998 2 F78 F78 0 998 2 F 79 F79 0 999 2 F80 F80 0 997 2 F 81 F81 0 999 2 F 83 F83 0 997 2 F 84 F84 0 999 2 F 85 F85 0 999 2 F 86 F86 0 997 2 F 87 F87 0 998 2 F 88 F88 2 93 3 2 F 89 F89 0 999 2 F 90 F90 0 998 2 F91 FOL 0 997 2 F 92 F92 0 997 2 F93 HAA F93 95 2 F 94 F94 2 97 3 2 F 95 EE F95 0 999 2 F96 F96 0 997 2 F 97 F97 2 95 2 F 201 F201 0 998 2 F 20
19. DC1LCM DC2LCM MC6LCM IgE L2SNCCM 2 1 2 3 IgE 1UymL 1 IgE TUJmI IgE UmL 0 lt 0 10 0 10 0 34 1 0 35 0 69 2 0 70 3 49 3 3 50 17 4 4 17 5 52 4 5 52 5 99 9 6 100
20. 1 2 0mLx2 2 2 2 0mLx2 2 2 75mLx2 1 L2KUNJ6 200 x3 1 6 30mLx1 1 L 2 0mLx2 2 H 2 0mLx2 2 2 75mLX2 1 1 2 0mLx2 2 2 2 0mLx2 2 2 75mLX2 1 L2SUBM PPD 205mLX2 1 1 Tietz NW editor Clinical guide to laboratory tests 3rd ed Philadelphia WB Saunders 1995 358 2 Barbee RA et al Longitudinal changes in allergen skin test reactivity in a community population sample J Allergy Clin Immunol 1987 79 16 24 3 Bloch K Salvaggio J Use and interpretation of diagnostic immunologic laboratory tests JAMA 1982 246 2734 58 4 Aas K The diagnosis of hypersensitivity to ingested foods Clin Allergy 1978 8 39 50 5 Bleumink E Food allergy the chemical nature of the substance elicting symptoms World Rev Nutr Diet 1970 12 505 70 6 Lichtenstein LM et al IgE antibody measurements in ragweed hay fever relationship to clinical severity and the results of immunotherapy J Clin Invest 1973 52 472 82 7 Lowenstein H Cross reaction among pollen antigens Allergy 1980 35 198 200 8 Weber RW Nelso
21. 2 H2 6 H6 DI D2 D70 D71 D72 D73 T1 T1 0 996 24 T2 T2 0 996 2 T3 T3 0 997 2 T4 TA 0 995 2 T5 T5 0 994 2 T6 T6 0 995 2 T7 T7 0 996 2 T8 T8 0 997 2 T9 T9 0 998 2 T10 T10 0 994 2 T11 TII 0 999 2 T12 T12 0 998 2 T14 T14 0 994 2 T15 T15 0 997 2 T16 T16 0 998 2 T17 T17 0 998 2 T18 TIS 0 994 2 T19 T19 0 997 2 T20 T20 0 997 2 T21 T21 0 996 2 T 22 T22 0 994 2 T23 T23 0 997 2 T70 T70 0
22. HUJE Pe OLERARA I g EI 2 1 200mg L 2 500mg dI 3 3 000mg dL 3 IgE 4 2000 2000XPi 1 1 2 8
23. M205 M205 90 3 1 072 A 0 998 2 072 073 B 0 998 2 073 MP1 0 998 2 F1 F1 0 999 2 F2 F2 0 997 2 F3 F3 0 997 2 F4 F4 0 999 2 F5 513 F5 0 997 2 F6 K F6 0 996 2 F7 i kh F7 0 999 2 F8 F8 0 997 2 F9 F9 0 999 2 F10 F10 0 999 2 F 11 F11 0 999 2 F12 F12 0 996 2 F13 F13 0 999 2 F 14 F14 0 997 2 F15 F15 0 999 2 F 17 F17 0 996 2 F18 F18 0 998 2 F 20 F20 0 998 2 F23 F23 0 997 2 F 24 F24 0 998 2 F25 F25 0 999 2 F26 F26 0 995 2 F 27 F27 0 999 2 F 31
24. WS 0 999 2 W9 WI 0 996 2 W10 W10 0 998 2 W11 W11 0 999 2 W12 W12 0 998 2 W13 W13 0 997 2 W14 W14 0 996 2 W15 W15 0 995 2 W16 W16 0 999 2 W17 W17 0 997 2 W18 W18 0 993 2 W19 W19 0 995 2 W20 W20 0 995 2 W90 W90 2 90 3 2 WP1 0 998 2 5 WP5 2 92 3 2 HE MIK M1 MI 0 998 2 M2 M2 0 997 2 M3 M3 0 994 2 M4 M4 0 998 2 M5 M5 0 998 2 M6 M6 0 990 2 M8 M8 0 998 2 M9 M9 0 998 2 M10 M10 0 998 2 M11 M11 0 999 2 M12 M12 0 999 2 M13 M13 0 997 2 M14 M14 0 999 2 M16 M16 0 994 2 M70 M70 0 995 2
25. 1 2 MAA KIRKKAITA 3 4 7 8 9 10 11 3 1 HIV HBV HCV 1 000ppm 1 2 1 121 20 2 0 1
26. 2 F202 97 3 6 F 207 F207 97 3 2 F 209 F209 0 998 2 F 214 KULJE F214 2 90 3 2 F215 F215 0 998 2 F 225 F225 90 3 2 F 233 F233 0 995 2 F 254 F254 92 3 2 F 256 F256 95 3 2 F 290 F 290 90 3 2 F 329 KAH F329 2 90 3 2 F 338 F338 2 92 3 2 F 349 F349 2 91 3 2 F 350 F350 94 3 2 4 FP4 2 90 3 24 x 7 FP7 0 997 2 SE IE E1 a b XA El 0 995 2 E2 E2 0 997 2 E3 UREJA E3 0 999 2 E4 ji E4 0 997 2 E5 daw E5 0 997 2 E6 E6 0 997 2 E71 E71 0 998 2 E73 E73 0 999 2 E74 E74 0 996 2 E75 39 IWEK E75 0 998 2 E76 KUXMRERH E76 0 994 2 E78 E78 0 997 2 E80 E80 0 994 2 E81 bi E81 0 996 2 E 82 E82 0 996 2 E83 REK E83 0 996 2 E 84 E84 2 90 3 2 E86 E86 0 998 2 E87 E87 0 998 2 E88 ESS 0 997 2 EP1 0 997 2 KAI E
27. 998 2 T73 T73 0 997 2 T80 T80 0 999 2 G1 G1 0 997 2 G2 G2 0 995 2 G3 G3 0 998 2 G4 G4 0 998 2 G5 G5 0 998 2 G6 G6 0 998 24 G7 G7 0 998 2 G8 G8 0 998 2 G9 G9 0 997 2 G10 G10 0 996 2 G11 G11 0 997 2 G12 IZE G12 0 998 2 G13 G13 0 996 2 G14 G14 0 996 2 G15 G15 0 997 2 G16 G16 0 997 2 G17 G17 0 996 2 GP1 0 996 2 5 GP5 97 3 2 W1 W1 0 994 2 W2 W2 0 995 2 W3 W3 0 994 2 W4 W4 0 999 2 W5 W5 0 993 2 W6 W6 0 996 2 W7 W7 0 993 2 W8
28. X KE VA GA V VEJ TIRE 2 EP2 2 94 3 2 KA EX ZE TIRE EJVE vw h bi 1 1 11 0 999 2 12 I2 0 998 2 13 13 0 999 2 1 4 14 0 999 2 15 15 0 999 2 16 16 0 998 2 18 H 18 90 3 2 173 173 0 997 2 P4 P4 0 998 2 K82 K82 0 998 2 O1 Ki 01 2 93 3 2 C74 C74 2 91 3 1 2 3 10380875M1 12 PIEL2KUN 7 25 2014 01 21 PIL2KUNJ 3 2013 08 02
29. n HS Pollen allergens and their interrelationships Clin Rev Allergy 1985 3 291 318 9 Pecquet C IgE medited allergy to latex in 80 patients Presented at the XVth European Congress of Allergology and Clinical Immunology Paris 12 May 1992 10 Boscato LM Stuart MC Heterophilic antibodies a problem for all immunoassays Clin Chem 1988 34 27 33 11 CLSI Protocols for the Determination of Limits of Detection and Ouantitation Approved Guideline CLSI document EP17 A Vol 24 N0 34 CLSI 940 West Valley Road Suite 1400 Wayne Pennysylvania 19087 1898 USA 2004 12 Evalution of Precision Performance of Ouantitative Measurement Mrthods Approved Guideline Second Edition CLSI Document EP5 A2 CLSI 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 2004 13 Li TM Chuang T Tse S Hovanec Burns D EI Shami AS Development and validation of a third generation allergen specific IgE assay on the continuous random access IMMULITE 2000 analyzer Ann Clin Lab Sci 2004 34 1 67 74 14 Guilloux L Hamberger C Evaluation du dosage des IgE sp cifiques sur IIMMULITE 2000 DPC Immuno analyse amp Biologie Specialisee 2004 19 1 71 80 Available via www sciencedirect com 15 2000 23 3 199 201 1998 16 2000 IgE
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