Levetiracetam Assay - Tema Ricerca
Levetiracetam Assay - Tema Ricerca
Levetiracetam Assay - Tema Ricerca
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<strong>Levetiracetam</strong> <strong>Assay</strong><br />
The ARK <strong>Levetiracetam</strong> <strong>Assay</strong> is intended for the quantitative determination<br />
of levetiracetam in human serum or plasma on automated clinical chemistry<br />
analyzers. <strong>Levetiracetam</strong> concentrations can be used as an aid in management<br />
of patients treated with levetiracetam.<br />
Key Points<br />
Homogeneous enzyme immunoassay<br />
Applicable onboard automated clinical chemistry analyzers<br />
Convenient, liquid-stable, ready-to-use<br />
Excellent calibration range<br />
Tested drugs and endogenous substances do not interfere<br />
Nonhazardous preservatives contain no sodium azide<br />
<strong>Assay</strong>s for the next generation
<strong>Levetiracetam</strong> <strong>Assay</strong><br />
CALiBRAtion RAnGe<br />
MetHoD CoMPARison<br />
500<br />
100<br />
90<br />
Gabapentin <strong>Assay</strong><br />
0<br />
tion RAnGe<br />
Calibrator Rate (mAbs/min)<br />
450<br />
400<br />
350<br />
35<br />
50<br />
0<br />
30<br />
40<br />
300<br />
0<br />
25<br />
30<br />
Slope<br />
1.01<br />
250<br />
20<br />
y-Intercept<br />
0.25<br />
20<br />
Correlation Coefficient (r 2 ) 0.97<br />
0<br />
200<br />
10<br />
No. of Samples<br />
305<br />
0 20 40 60 80<br />
15<br />
100<br />
0<br />
0 10 20 30 40 50 60 70 80 90 100<br />
<strong>Levetiracetam</strong> Concentration (μg/mL) 10<br />
Slope<br />
0.96<br />
0<br />
LC/MS/MS (μg/mL)<br />
y-Intercept<br />
-0.06<br />
ARK TM Calibration Range: 0.0 to 100.0 µg/mL<br />
Correlation ARK TM <strong>Assay</strong> Coefficient Range: (r 2.0 to 100.0 µg/mL<br />
5<br />
) 0.96<br />
LOQ: 2.0 µg/mL<br />
No. of Samples Linearity: 2.0 to 100.0 183µg/mL<br />
0<br />
0<br />
0 5 10 15 20 25 30 35 40<br />
ACCURACy<br />
0 5 inteRFeRenCe<br />
10 15 20 25 30 35 40<br />
Gabapentin Concentration (μg/mL)<br />
Tested LC-MS/MS endogenous (μg/mL) substances and co-administered drugs do not<br />
Theoretical Mean Recovered Percent<br />
RK TM Calibration Concentration Range: 0.0 to 40.0 Concentration<br />
μg/mL<br />
Recovery ARK TM <strong>Assay</strong> interfere* Range: with 0.75 ARK to <strong>Levetiracetam</strong> 40.0 μg/mL <strong>Assay</strong>. The major metabolite ucb<br />
LOQ: (μg/mL) 0.75 μg/mL (μg/mL)<br />
N = 6<br />
L057 does not cross-react.<br />
*≤10% error<br />
Cy<br />
100.0<br />
105.3<br />
105.3<br />
80.0<br />
79.3 inteRfeRenCe<br />
99.1 sAFety AnD stABiLity<br />
45.0<br />
44.1<br />
98.0<br />
Tested endogenous substances Reagent on-board and co-administered stability drugs do not<br />
retical Mean 20.0 Recovered Percent 19.2<br />
95.9<br />
Up to at least 60 days<br />
ntration Concentration 10.0<br />
Recovery interfere* with ARK Gabapentin <strong>Assay</strong>.<br />
10.0<br />
100.0<br />
*≤10% error<br />
/mL)<br />
(μg/mL)<br />
4.0<br />
N<br />
3.8<br />
= 6<br />
94.6<br />
Calibration Curve Stability<br />
.0<br />
41.2 2.0<br />
103.0 1.9 sAfety 95.8 And stABiLity Up to 40 days<br />
.0<br />
35.6<br />
101.7<br />
Reagent on-board stability Shelf Life of Reagents, Calibrators, and Controls<br />
Analytical recovery was determined by spiking levetiracetam into human<br />
.0<br />
27.9<br />
99.5<br />
18 months from date of manufacturing<br />
serum to produce concentrations across the assay range.<br />
Up to at least 60 days<br />
.0<br />
22.0<br />
100.0<br />
Calibration Curve Stability Safety<br />
.0<br />
16.0<br />
100.2<br />
Nonhazardous preservatives (no sodium azide)<br />
.0 PReCision 9.0<br />
99.7<br />
Up to 84 days<br />
.5<br />
3.6<br />
101.3<br />
Shelf Life of Reagents, Results Calibrators, shown are and typical Controls and may vary among laboratory analyzers.<br />
.0 WITHIN-RUN 2.1<br />
103.3<br />
18 months from date Available of manufacturing upon request: UKNEQAS profi ciency data.<br />
.0<br />
n = 1601.0<br />
Mean (μg/mL) 98.5 SD Safety CV (%)<br />
Control low<br />
7.5<br />
0.25 Nonhazardous 3.4 preservatives<br />
overy was determined by spiking gabapentin into human<br />
oRDeRinG inFoRMAtion<br />
Control mid<br />
29.4<br />
0.85 Contains 2.9 sodium azide ≤ 0.09%<br />
duce concentrations across the assay range.<br />
Ark<br />
Control high 73.4<br />
2.14 2.9<br />
<strong>Levetiracetam</strong> <strong>Assay</strong><br />
5024-0001-00<br />
Results shown are typical Arkand <strong>Levetiracetam</strong> may vary among Calibrator laboratory analyzers. 5024-0002-00<br />
on TOTAL<br />
Available upon request: Ark UKNEQAS <strong>Levetiracetam</strong> proficiency Control data.<br />
5024-0003-00<br />
n = 160 Mean (μg/mL) SD CV (%)<br />
UN<br />
Control low<br />
7.5<br />
0.34<br />
oRdeRinG<br />
4.5<br />
infoRMAtion<br />
0 Mean (μg/mL) SD CV (%)<br />
Control mid<br />
29.4<br />
1.08 3.7<br />
ow<br />
Control 2.5 high 0.0873.4<br />
3.3 Ark<br />
3.08<br />
Gabapentin <strong>Assay</strong><br />
5025-0001-00<br />
4.2<br />
id<br />
7.9<br />
0.21 2.6 Ark Gabapentin Calibrator<br />
5025-0002-00<br />
ARK Diagnostics, Inc.<br />
For Customer Support:<br />
igh Tri-level 24.6controls containing 0.48 levetiracetam 1.9 were assayed Arkin Gabapentin quadruplicate<br />
twice a day for 20 days. CLSI Guideline EP5-A2.<br />
Via Savena Antico 9/A Fax: 051.6240706<br />
Control Distribuito da:<br />
5025-0003-00<br />
1190 Bordeaux Drive<br />
Call toll free: 877-869-2320<br />
Sunnyvale, CA 94089-1209<br />
customersupport@ark-tdm.com<br />
40139 Bologna - ITALIA E-mail: diagnostica@temaricerca.com<br />
Tel: 408-747-0700 Fax: 408-747-0783 www.ark-tdm.com<br />
0 Mean (μg/mL) SD CV (%)<br />
Telefono: 051.6240700 Sito Web: www.temaricerca.com<br />
ow<br />
2.5<br />
0.14 5.6<br />
id<br />
7.9<br />
0.35 4.4<br />
igh 24.6<br />
0.88 3.6<br />
rols containing gabapentin were assayed in quadruplicate<br />
or 20 days. CLSI Guideline EP5-A2.<br />
ARK TM (μg/mL)<br />
80<br />
Method CoMPARison<br />
ARK TM (μg/mL)<br />
40<br />
70<br />
60<br />
ARK Diagnostics, Inc.<br />
1190 Bordeaux Drive<br />
Sunnyvale, CA 94089-1209<br />
Tel: 408-747-0700 Fax: 408-747-0783<br />
For Customer Support:<br />
© 2011 ARK Diagnostics, Inc. All rights reserved<br />
Call toll free: 877-869-2320<br />
All trademarks are property of Ark Diagnostics, Inc.<br />
customersupport@ark-tdm.com<br />
www.ark-tdm.com MKT09-003 Rev 05 January 2011
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