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KIT COMPOSITION
Reagent 1 (R-1) Buffer Reagent 4 x 20 ml
Reagent 2 (R-2) Antiserum Reagent 2 x 10 ml
PERFORMANCE
Precision
Precision Assay: Within Run
| Serum I |
Serum II |
Serum III |
N = 20
Mean = 69
SD = 0.64
CV = 0.9%
|
N = 20
Mean = 138
SD = 1.11
CV = 0.8%
|
N = 20
Mean = 207
SD = 1.35
CV = 0.7%
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Precision Assay: Between Runs
| Serum I |
Serum II |
Serum III |
N = 7
Mean = 94
SD = 1.4
CV = 1.5%
|
N = 7
Mean = 183
SD = 0.9
CV = 0.5%
|
N = 7
Mean = 345
SD = 3.5
CV = 1.0%
|
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Assay Range
10 - 350 mg/dl (multi-point calibration)
Correlation
A comparison of the K-ASSAY IgM kit and an INCSTAR IgM Test Kit was performed on a Hitachi 704 automated analyzer and a COBAS Mira.
The test results provided the following data.
Y
r
n
|
= 1.0927x - 0.71
= 0.98835
= 45
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INTERFERENCE
Bilirubin
Hemoglobin
Lipemia
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No interference up to 20 mg/dl
No interference up to 500 mg/dl
No interference up to 5%
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Tel: (206) 575-8068