PDFファイル - 医薬品医療機器総合機構
Contents
1. 2 95 1002. PoSt 2 1 400 pL 500 gL
3. PCR
4. DNA PCR PCR Abbott m2000sp
5. 10 10 0 NE 2 8C 6 10 2 8 C 10 C 10 2 30 C 2 8C 7 15 30 8
6. Abbott 2000sp Abbott m2000sp Abbott m2000sp Abbott m2000sp 96 Abbott Optical Adhesive Cover 96
7. 2 26 LOD 320 400 gL LOD CT NG 6 5 LOD 1 Zovirax 5
8. Abbott m2000sp 3 1 48 49 96 1 2 4 4 a Abbott m2000sp 1 Abbott m2000sp
9. 0 1 2 10
10. Abbott zz2000sp 2 3 2 2 30 2 30 14 0 1
11. 1 2 mL 1 2 mL 3 mL 1 2 mL 2 LOD DNA 320 400 gL cryptic plasmid 1 10 Opacity 1 11 2006 10 cryptic plasmid 377 9 140
12. 20 30 mL NAT
13. 1 FAM VIC Negative 2 n 31 FCNB FAM 34 28 34 74 FCNB VIC 34 35 34 61 3 Low mm 11 DC FAM 3 27 3 62 DC VIC 3 44 3 74 FAM VIC FCNB DC Abbott m2000sp Abbott m2000rt
14. 4J71 95 2 10 14 10C 90 1 2 Abbott m2000rt 96 Abbott m2000rt
15. X Y DNase Abbott m2000sp Abbott m2000sp s 96
16. DNase DNase
17. 2 4 3 ProClin EU Xi R S 1 SIA oS So SB BE DNA 1 EU Xn R S R20 21 22 R36 38
18. 1 2 30 14 10C 90 2 30 4
19. 96 1 96 Abbott 2000rt 3N20 01 3 2 8 2
20. 1L70 07 39 2000 CT NG 1L70 40 2000 CT NG 2
21. DC 2 2
22. 1 2 96
23. 623 A 17 95 95 n 9 b CT 621C 116 127 91 3 85 03 95 60 488 494 98 8 97 38 99 55 NG 617d 91 93 97 8 92 45 99 74 518 524 98 9 97 52 99 58 a A b A c 2 d 6 18 n 9 b CT 135 23 26 88 5 109 109 100 0 NG 133 12 12 100 0 119 121 98 3 CT 135 22 26 84 6 106 109 97 2 NG 134 12 13 92 3 117 121 96 7 CT 109 25 26 96 2 82 83 98 8 NG 109 28 29 96 6 80 80 100 0 CT 134 22 24 91 7 108 110 98 2 CT
24. 4 2000rt Abbott m2000rt 2000rt Abbott m2000rt FAM VIC NED ABI ROX X m2000rt Abbott m2000rt Abbott 2000rt
25. IC 2 gt gt 3 CT CN CO Positive CT
26. 1 CT PCR 1 CT PCR 2 CT PCR 1 CT PCR 2 NG PCR NG PCR CT PCR 1 CT PCR 2 NG PCR dNTP Mix dNTP dNTP Mix 4 Na 2 5 dATP 2 5 dCTP 2 5 dTTP 2 5 dGTP ProClin 950 AmpliTaq Cold DNA AmpliTaq Gold recombinant Thermus aquaticus ProClin 950 2
27. 200 gL 1000 gL Abbott 2000sp DNA DNA Abbott 2000sp 15 30 10C
28. 1 1 Abbott 2000sp 1
29. Abbott m2000sp 1 2 3 10 Abbott m2000sp Abbott 12 13 m2000rt 15 1 Abbott m2000sp
30. 1 2 2 8 2 8 25 25
31. 1 000 ppm 1 2 1 121C 20 96 3 96 96 DNA
32. 1L70 40 m2000rt 4J71 93 DNase Eo 3 7 Abbott 2000sp 1 1 0 4 mL 1 4 gL 2 96 1 25 pL 25 pL 3 Abbott m2000rt 96
33. 2 025 0 025 3 Delfen KY 0 25 0 025 0 25 0 025 1 x 106 cell mL 2 x 109 cell mL 8 Xx 104 cell mL Lubrin 0 25 6 0 025 Metrogel Vaginal 0 25 0 025 Miconazole 3 0 25 0 025 Monostat 1 Dose Treatment 0 25 0 025 Norforms Terazol 3 20gm I Vagi gard 0 25 0 025 Vagi gard Vagisil Vagisil Yeast gard 1 x 106 cell mL 2 x 102 cel mL 8 Xx 104 cell mL 2 Kingella dentrificans Veillonella parvula Kingella kingae Vibrio parahaemolyticus 96 1 Klebsiella oxytoca Weissella paramesenteroides URISTAT
34. 16 2 73 10 25 9 Cryptic Plasmid CN CN n SD SD SD SD SD 280 29 73 0 17 0 20 0 00 0 00 0 26 280 35 47 0 23 0 10 0 04 0 06 0 26 299 37 39 0 33 0 20 0 00 0 00 0 39 10 Cryptic Plasmid DC DC n SD SD SD SD SD SD 560 8 82 0 17 0 10 0 17 0 00 0 02 0 26 560 3 09 0 23
35. 500 uL 1 2 mL 400 uL n 2 DNA DNA Product Information 2 95 100 70 mL 2 DNA Abbott m2000sp 2000sp 200 mL Abbott m2000sp
36. cryptic plasmid 12 CT 1 LOD 320 400 kL 3 3 CT NG 3 95 n n CT 403 403 100 0 99 3 NG 403 403 100 0 99 3 4
37. CT NG DNA NNC No Negative Control CT NG QC QC CT NG DNA 1C 0
38. 2 30C 2 30C 14 2 30C 15 30C 8 2 8 7 2 1 1 2 a 30 15 30 8 2 8 7 48 1 1 1 DNA 1 1 6 10 1 12 13
39. DNA DNA ProClin 950 6 DNA DNA PCR Chlamydia trachomatis CT DNA Nesserzg gozo777oege NG DNA 5 1 DNA DNA
40. 2 Abbott m2000sp DNA DNA 1 192 CT NG m CT NG a 1 48 b 96 1 2 48 1 1 AccuGene m CT NG a 1 b 2
41. DNase DNase DNase 10 2 CT NG DNA CT NG DNA 0 1 v v
42. 1L70 07 1L70 39 m2000 CT NG 2 8 C 2 1 PCR Abbott m2000rt 25 Abbott m2000rt
43. 2 2 CLSI NCCLS EP10 A2 5 CN Abbott 2000sp n SD SD SD SD SD 2773 30 13 0 25 0 03 0 02 0 04 0 25 280 36 21 0 29 0 00 0 02 0 17 0 33 300 38 53 0 54 0 00 0 00 0 38 0 67 a 3 6 DC Abbott 2000sp DC n SD SD SD SD SD SD 5549 9 02 0 25 0 16 0 00 0 10 0 05 0 31 560 2 93 0 29 0 16 0 00 0 08 0 04 0 34 a 6
44. 2 8C 1 10 2 8 C 10 2 10 DNA 15 30C 3 HIV HBV HCV
45. Abbott m2000sp Abbott 2000sp 2 1 2
46. Abbott 2000sp Abbott 2000sp 96 DNA 96 96 Abbott m2000rt
47. Retest CT Negative Retest Positive Retest Negative NG CN CO Positive NG Negative NG Retest i eh Ne iosepe mewwe oszpe mewwell ss e DE EE EE LT 48 c ke 4sgpe mse RE p ssswaaem mees 5 ke Negewe wewwl A B C D
48. S35 eid S36 37 39 6 DNA EU Xn R S Re R36 38 4a SL 6 IID ui SIL IT en 16 2
49. HIV HBV HCV
50. 15 30 8 2 8 7 1 15 30 8 2 8 7 1 96 1 48 49 96 1 1 1 1 1 1 2 2 1 2 1 2 1 1 1 2 2 2 1 1 4 1 2 3 3
51. A CT NG B CT NG C NG CT D NG CT Result Details 1 00 Abbott m2000rt 1
52. 2 2 30 15 30 8 2 8 C 7 2 2 8 2 1 2 30 1 2 30
53. Abbott 2000rt 96 2 96
54. 70 70 9 1 6 10 CT NG DNA 8 9 1 1 2 control calibrator CT NG CN CO
55. 96 96 96 25 pL 96 6 25 pL 96 Abbott m2000rt 96
56. Abbott Optical Adhesive Cover 8 1 96 Abbott m2000rt DNA Abbott m2000rrt Abbott m2000rt l 2 Abbott m2000rt 96 Abbott m2000rt 2 15 Abbott m2000rt 96 1 3
57. 2 7 0 1 6
58. 7 CN Abbott m2000sp CN n SD SD SD SD SD 2779 30 71 0 22 0 02 0 02 0 10 0 24 280 36 52 0 31 0 02 0 04 0 37 0 48 295D 38 79 0 7 1 0 12 0 00 0 73 1 03 a 3 b 5 8 DC Abbott 2000sp DC n SD SD SD SD SD SD 5549 9 07 0 22 0 24 0 00 0 11 0 21 0 40 560 3 26 0 31 0 23 0 00 0 13 0 00 0 4 1 a 6 3
59. CT NG DNA CN 1 2 Abbott m2000sp 2 CN CT
60. PCR 2 505 535 nm 546 569 nm 4 CO 2 CT 4 4 NG 4 6 2 PCR 66090 1 92C 10 58 30 65C 60 45 Abbott m2000sp DNA Abbott 2000rt 25 pL lt 3 0 4 mL 3 0 25 mL 70 mL 0 4 mL DNA DNA 1 0 8 mL X 1 2 0 8 mL X 2 DNA 100pL 95 pL
61. 1 8 EC Cs Abbott m2000rt 1 2 3 596 pL 678 pL 6
62. Abbott m2000sp Abbott 2000rt 1 DNase 0 8 mL
63. Klebsiella pneumoniae Yersinia enterocolitica LOD Lactobacillus acidophilus 0 150 3 3 mg mL Abbott m2000rt 0 063 0 031 1 111 2 1 2 2R YS a YY
64. 1 2 3 3 250 pL 20 30 Abbott 2000rt 15 DNA 500 pL 1 2 mL 400 gL n 2
65. 250 pL 20 30 2 8 Abbott m2000sp 13 mm 13 mm 1 1 1 2
66. 5 851 767 Applera Spirit design CELERA Applera Corporation 270 2214 278 TEL 0120 031441 270 2214 278 TEL 047 385 2211 ABBOTT JAPAN CO LTD 2013 CELERA CE Abbott
67. 18 mc CT NG 2G28 98 192 48 X 4 2 0 696 mL Xx 4 3 0 078 mL X 4 1 0 778mLx4 0 53 mL Xx 4 1 Clinical and Laboratory Standards Institute formerly NCCLS Clinical Laboratory Ws7e Management Approved Guideline Third Edition CLSI Document GP05 A3 Wayne PA CLSI 2006 2 US Environmental Protection Agency EPA Guide for Infectious Waste Management Publication No EPA 530 SW 86 014 Washington DC US Environmental Protection Agency 1986 1 1 5 5 Rl R3 Al A24 3 Palmer L Falkow S A common plasmid of Chlamydia trachomatis Plasmid 1986 16 1 52 62 4 Meyer TE Gibbs CP Hass R Variation and control of protein expression in Neisseria Annu Rev Microbiol 1990 44 451 77 5 Brooks GE Olinger L Lammel CJ et al Prevalence of gene sequences coding for hypervariable regions of Opa protein II in Neisseria gonorrhoeae Mol Microbiol 1991 5 12 3063 72 6 Ripa T Nilsson PA A Chlamydia trachomatis strain with a 377 bp deletion in the cryPtic plasmid causing false negative nucleic acid amplification tests Sex Transm Dis 2007 34 255 56
68. 15 1 2 8 Abbott m2000sp Abbott m2000sp Abbott 2000sp DNA 2
69. Abbott m2000sp Abbott m2000sp
70. NG NG Abbott 2000rt CT NG DNA CT NG DNA 96
71. 1 14 DC DC n SD SD SD SD 30 8 63 0 08 0 17 0 00 0 19 60 2 42 0 31 0 17 0 00 0 35 15 CN CN n SD SD SD SD 30 31 24 0 09 0 07 0 00 0 12 60 37 27 0 39 0 10 0 00 0 41 553 39 53 0 84 0 18 0 00 0 86 5 16 DC DC n SD SD SD SD 30 8 70 0 09 0 14 0 00 0 17 60 2 67 0 39 0 12 0 00 0 4 1 5 320 400 ju 320 400 pL 6 1 STD
72. 2 3 9
73. 1 1 10 n 1 n 2 n 3 n 6 2 Abbott 2000sp CLSI IH NCCLS EP10 A2 13 CN CN n SD SD SD SD 30 30 52 0 08 0 07 0 12 0 16 60 36 73 0 31 0 00 0 11 0 33 594 39 18 0 65 0 29 0 21 0 74 a
74. 108 24 25 96 0 83 83 100 0 NG 133 11 11 100 0 122 122 100 0 NG 108 28 28 100 0 80 80 100 0 a A b A 54 1 B 19 95 95 n CT 541 72 75 96 0 88 8 99 2 456 466 97 9 96 1 99 0 NG 541 69 69 100 0 94 8 100 0 469 472 99 4 98 2 99 9 n CT NG CT NG CT NG CT NG 278 20 C CT NG CT NG CT NG CT NG n 278 278
75. 21 a 66 68 33 33 a C b C 22 n 89 89 89 89 100 100 97 1 100 0 15 16 93 8 3 3 100 0 14 14 100 0 3 3 100 0 37 38 97 4 27 27 100 0 a C b C 2 7 2 014 1 818 3 832 7 711 95 95 168 15 16 93 8 69 8 99 8 150 152 98 7 95 3 99 8 168 20 20 100 0 83 2 100 0 148 148 100 0 97 5 100 0 119 20 20 100 0 83 2 100 0 94 99 94 9 88 6 98 3 119 18 18 100 0 81 5 100 0 99 101 98 0 93 0 99 8 162 16 18 88 9 65 3 98 6 141 144 97 9 94 0 99 6 162 16 16 100 0 79 4 100 0 145 146 99 3 96 2
76. 96 7 94 1 95 8 98 4 97 1 97 9 98 3 97 1 97 8 91 0 97 7 93 4 93 5 87 3 91 4 95 5 96 6 95 9 99 6 99 1 99 4 99 6 99 1 99 4 98 1 98 6 98 3 99 4 99 7 99 5 98 3 100 0 99 1 99 1 99 3 99 2 24 n 619 22 1 594 2 91 7 99 8 607 18 1 567 1 94 7 99 8 1226 40 2 1181 3 93 0 99 8 617 25 1 590 1 96 200 99 6 593 16 1 576 0 100 0 99 8 1210 41 2 1166 1 97 6 99 8 569 24 3 561 1 96 0 99 5 587 16 1 570 0 100 0 99 8 1176 40 4 1131 1 97 6 99 6 137 29 4 702 2 93 5 99 4 688 18 4 662 4 81 8 99 4 1425 47 8 1364 6 88 7 99 4 676 188 9 482 1 99 5 99 0 535 7 0 0 1 87 5 100 0 1211 195 9 1009 2 99 0 99 5 823 228 587 3 98 7 99 2 643 11 0 632 0 100 0 100 0 1466 239 1219 3 98 8 99 6 1
77. DNA 2 PCR DNA DNA CT PCR 1 CT PCR 1 CT PCR 2 CT PCR 2 dNTP AmpliTaq Cold DNA PCR CT DNA Opa NG PCR NG PCR dNTP AmpliTaq Cold DNA PCR NG DNA 3 DNA DNA CT PCR 1
78. 0 4 mL CT 1 x 107 NG 320 2 3 3 405 12 Cryptic Plasmid 95 n n CT T1 405 405 100 0 99 3 NG T2 405 405 100 0 99 3 4 CT NGC 3 2 2 DNA 2 Abbott m2000rt DNA 5
79. Abbott m2000sp 1 NAT DNA
80. Cryptic Plasmid 95 n n CT 403 403 100 0 99 3 2 Abbott m2000sp CT NG 3 16 4 20 n 14 n 15 2 2 5 20
81. DNA RNA 3 1 x 10 7 0 4 mL Abbott m2000sp 3 HBV DNA HCV RNA PCR 4 8 5 6 ca AccuGene m CT NG 2G28 88 0 5 mL x 8 2 hy cf1 2 DNA ProClin 950 0 5 mL X 16 Achromobacter xerosis io a es CT NG DNA Acinetobacter calcoaceticus Lactobacillus delbrueckii subsp lactis DNA ProClin 950 Acinetobacter Iwoffii Lactobacillus jensenii
82. 0 09 0 08 0 00 0 04 0 26 3 CT NG T1 0 4 mL CT 320 NG 1 x 107 T2 0 4 mL CT 1 x 107 NG 320 2 3 3 405 11 95 n n CT T1 4009 397 99 3 98 1 NG T2 404 398 98 5 97 1 a 5 b 1 CT NG T1 0 4 mL CT 320 NG 1 x 107 T2
83. Abbott m2000rt 2 8 6 1 2 m2000 CT NG
84. AccuGene m CT NG Actinomyces israelii Legionella pneumophila 9K12 Aerococcus viridans 4 monocytogenes Abbott m2000sp OM DP OO Abbott m2000sp Alcaligenes faecalis Mobiluncus mulieris 60 Arcanobacterium pyogenes Morazxella Branhamella catarrhalis m2000 CT NG 1L70 Bacillus subtilis Morazxella lacunata Bacteroides fragilis Moraxella osloensis Bacteroides ureolyticus Morganella morganii 1L70 07 1L70 39 Bifidobacterium adolescentis Mycobacterium gordonae Bifidobacterium breve Mycobacterium smegmatis Brevibacterium linens Mycoplasma genitalium
85. CT PCR 2 DNA NG PCR 4 DNA 505 535 nm DNA 546 569 nm 576 596 nm 5 CO 2 1
86. Deinococcus radiodurans Pseudomonas putida PoSt IN92 02 Derxia gummosa Rahnella aquatilis 13 mm Eikenella corrodens Rhizobium radiobacter 5 mL Enterobactor aerogenes Rhodospirillum rubrum 20 1000 gL Enterobacter cloacae Ruminococcus productus 20 1000 gL Enterococcus avium Salmonella choleraesuis 1000 L Enterococcus faecalis Salmonella typhimurium 200 pL 4J71 95 95 100 Abbott Optical Adhesive Cover Gardnerella vaginalis Staphylococcus saprophyticus Enterococcus faecium Serratia marcescens Escherichia coli Staphylococcus aureus Fusobacterium nucleatum Staphylococcus epidermidis Gemella haemolysans Streptococcus agalactiae TR Haemophilis ducr
87. 100 0 92 21 21 100 0 83 9 100 0 71 71 100 0 94 9 100 0 92 15 15 100 0 78 2 100 0 77 77 100 0 95 3 100 0 5 208 210 99 0 244 245 99 6 71 73 97 3 86 86 100 0 75 75 100 0 85 86 98 8 62 62 100 0 73 73 100 0 7 714 23 n 619 607 1226 617 95 1212 969 87 1176 740 688 1428 670 534 1204 822 643 1465 99 32 91 61 34 95 8 33 91 71 43 114 129 62 191 171 84 255 F RI OO I OI DDIM 1 1 1 1 OTD NI F 2 556 68 1124 993 9 1108 520 545 1065 658 642 1300 02 463 986 637 952 1189 2 ITO TO TO TO TO NN IT NI
88. 1L70 OD MO Ri DNA Abbott mSample Preparation System DNA Candida albicans Neisseria flava a NE SPIN a 3 GLysispAA 20640 SN TRIS Candida parapsilosis Neisseria meningitidis B 1 GmWash 1pw A DR NES NING I TRIS Chlamydia pneumoniae Neisseria meningitidis D 2 mWash 2pAA Chlamydia psittaci Neisseria perflava Chromobacterium violaceum Pantoea agglomerans mElution Bufferpy4 Chryseobacterium meningosepticum Peptostreptococcus anaerobius Citrobacter freundii Plesiomonas shigelloides mMicroparticlespya Clostridium sporogenes Propionibacterium acnes 0 Corynebacterium genitalium Proteus mirabilis TE TH TI TE TT TE OR sO Corynebacterium xerosis Proteus vulgaris 5 i NT Cryptococcus neoformans Providencia stuartii 1N77 01 Cytomegalovirus Pseudomonas aeruginosa 5N92 01
89. 469849 R2 2013 6 2 2011 12 1 22300AMX01263000 m CT NG 1 2 3 4 5
90. 96 lt 25 pL 4 25 pL 0 596 mL 4 EC 0 678 mL 0 083 mL CCITT I NM ER i 1 92C 10 58U0 30 650 60 Mo 45 505 535 nm 546 569 nm 1 0C 1 2 8 10 2 8 10
91. eyi Streptococcus bovis Haemophilus influenzae Streptococcus mitis m2000sp 200 mL Helicobacter pylori Streptococcus mutans 906 B HBV Streptococcus pneumoniae 96 C HCV Streptococcus pyogenes 3N20 01 1 Streptococcus salivarius 2 Streptococcus sanguis DNA HIV 1 Streptomyces griseus 16 Trichomonas vaginalis 18 Ureaplasma urealyticum m2000 CT NG 1L70 1L70 07 1L70 39
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