Beckman Coulter Resource Library | Thermo Fisher Scientific - US
QMS® Vancomycin (VANCO)
In Vitro Rx Only
0373589 10017224
Quantitative Microsphere System (QMS) . . .
QMS® Vancomycin
.
, .
Amycolatopsis orientalis.1 aureus .2 , , . 20 40 µg/mL, 5 10 µg/mL.3 () () . .1
. 24 , , 90% . 6 . 55% . .4,5 , . .
QMS Vancomycin . . , - . . , , . .
QMS Vancomycin,
0373589, 10017224
:
0373589 1 1 x 22 mL 2 1 x 22 mL
10017224 1 1 x 19 mL 2 1 x 19 mL
- ()
<1,0% 0,05% <0,3% 0,05%
· . · ,
. ·
. , , . , . · , . , . · , () , , , . · , ( ).
: , .
, 2 8 °C. 32 °C.
· in vitro . · .
: QMS Vancomycin (VANCO) 5,0 % 2,0% (HSA). H317 - . H334 - .
A //. . / /. , . : . : , . : / . : . . / /// .
: / . HBsAg, -HIV 1/2 -HCV. . , .
QMS Vancomycin:
·
· ·
· EDTA (K3)
·
· EDTA (K2)
· ( )
QMS Vancomycin. .
· , .
· . · , . · ,
. . .6 · , 2 8 °C. , (-10 °C) 14 . · QMS Vancomycin ( ), , . .
· QMS Vancomycin,
0373589, 10017224
,
·
· QMS Vancomycin,
0373597
CAL A-F: 1 x 1,0 mL
, .
QMS Vancomycin CAL A (0,0 g/mL) .
100,0 µg/mL QMS Vancomycin CAL A (0,0 µg/mL) . , 0,55 µg/mL. , .
= x
= ( + CAL A)
QMS Vancomycin (6 ). , QMS Vancomycin A, B, C, D, E F.
. . , . : Vancomycin CAL A .
, / , . , / .
QMS Vancomycin: · 24 . · , . · , .
QMS Vancomycin µg/mL µmol/L. µg/mL µmol/L , µg/mL 0,69 1,44925.
, .
. , .
, , QMS Vancomycin. . , , .
, . , . , . . , . , .
« » « » .
20 40 µg/mL 5 10 µg/mL .7 , . . , , 80 100 µg/mL, 30 µg/mL.8,9 , .4
Hitachi 717 . .
(LOQ)/ (LOQ) QMS Vancomycin ( ±20% CV ±15%). LOQ 2,0 µg/mL.
2,5 µg/mL 100 µg/mL.
. . .
= x 100
(µg/mL) 100,0 75,0 50,0 37,5 25,0 17,5 10,0 7,5 5,0
: 99,61
(µg/mL)
95,02 73,24 52,25 39,70 27,65 17,45 9,27 6,83 4,97
%
95,02 97,65 104,50 105,88 110,61 99,70 92,70 91,11 99,33
EP6-A (NCCLS).10 QMS Vancomycin F (100,0 µg/mL) QMS Vancomycin A (0,0 µg/mL) 75,0, 37,5, 17,5, 7,5 2,5 µg/mL. QMS Vancomycin. . .
(µg/mL) 75,0 37,5 17,5 7,5 2,5
: 100,17
(µg/mL)
75,77 37,20 16,75 7,33 2,68
%
101,02 99,21 95,71 97,69 107,20
NCCLS EP9-.11 QMS Vancomycin FPIA . . 0,04 µg/mL 100 µg/mL. Passing-Bablok .
1,031
1,115
(R2)
0,970
146
NCCLS EP5-A.12
. , 20 . 2 . , , SD CV. .
2
N
SD CV (%)
(g/mL)
1
80
7,57
0,27 3,59
2
80
20,79
0,51
2,44
3
80
33,65
0,80
2,37
: <10% CV
SD CV (%) 0,43 5,72 0,97 4,66 0,95 2,83
SD CV (%) 0,70 8,84 1,29 6,21 1,72 5,12
, QMS Vancomycin , 10% . NCCLS EP7-.13 .
N
%
(g/mL)
10 g/dL
3
24,92
93,64
70 mg/dL
3
27,00
100,07
500 mg/dL
3
25,97
97,58
G (IgG)
6 g/dL
3
25,90
97,34
1.150 mg/dL
3
21,18
91,64
HAMA 1*
3
28,27
105,31
HAMA 2*
3
28,55
103,91
500 USP/mL
3
26,46
99,44
1.000 mg/dL
3
9,41
92,62
1.100 IU/mL
3
6,70
93,23
*HAMA = -
, . 25 µg/mL QMS Vancomycin. .
(g/mL) 100 50 25 10
% 0,99 0,29 0,16 0,04
CDP-I ( -I).14 . CDP-I 100 µg/mL 25 µg/mL . <5% .
G
5- V
1. Vancomycin: in Compendium of Pharmaceuticals and Specialties. Toronto, Canadian Pharmacist Associations, 2000:1668-70. 2. Jarvis WR. Epidemiology, appropriateness, and cost of vancomycin use. Clin Infect Dis 1998;26:1200-3. 3. Hospital Infection Control Practices Advisory Committee. Recommendations for preventing spread of vancomycin resistance. Infect Control Hosp Epidemiol 1995;16(2):105-13. 4. Wilhelm MP. Vancomycin. Mayo Clin Proc 1991;66:1165-70. 5. Moellering RC, Krogstad DJ, Greenblatt DJ. Pharmacokinetics of vancomycin in normal subjects and in patients with reduced renal function. Rev Infect Dis 1981;3[supp]:s230-5. 6. Dasgupta A, Dean R, Saldana S, et al. Absorption of therapeutic drugs by barrier gels in serum separator blood collection tubes. Am J Clin Pathol 1994;101(4): 456-61. 7. Tobin CM, Darville JM, Thomson AH, et al. Vancomycin therapeutic drug monitoring: is there a consensus view? The results of a UK National External Quality Assessment Scheme (UK NEQAS) for Antibiotic Assays Questionnaire. J Antimicrob Chemother 2002;50:713-8. 8. Cook FV, Farrar WE Jr. Vancomycin revisited. Ann Intern Med 1978;88(6):813-8. 9. Fong KL, Ho DW, Bogerd L, et al. Sensitive radioimmunoassay for vancomycin. Antimicrob Agents Chemother 1981;19(1):139-43. 10. Tholen DW, Kroll M, Astles JR, et al. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (EP6-A). Villanova, PA: The National Committee for Clinical Laboratory Standards, 2003. 11. Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (EP9-A). Wayne, PA: The National Committee for Clinical Laboratory Standards, 1995. 12. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline (EP5-A). Villanova, PA: The National Committee for Clinical Laboratory Standards, 1999. 13. Powers DM, Boyd JC, Glick MR, Miller WG. Interference Testing in Clinical Chemistry; Approved Guideline (EP7-A). Villanova, PA: The National Committee for Clinical Laboratory Standards, 2002. 14. Harris CM, Kopecka H, Harris TM. Vancomycin: structure and transformation to CDP-I. J Am Chem Soc 1983;105(23):6915-22.
: http://www.thermofisher.com/symbols-glossary
. QMS Vancomycin. 500 µg/mL 25 g/mL. . <0,3% .
B
Microgenics Corporation 46500 Kato Road Fremont, CA 94538 USA ...: 1-800-232-3342
B·R·A·H·M·S GmbH Neuendorfstrasse 25 16761 Hennigsdorf, Germany
, : www.thermofisher.com/diagnostics
: Thermo Fisher Scientific. © 2020 Thermo Fisher Scientific Inc. . Thermo Fisher Scientific .
0155171-M-EL 2020 11
3
Adobe PDF Library 15.0 Adobe InDesign 15.1 (Windows)