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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 = 150
SD = 1.12
CV = 0.7%
|
N = 20
Mean = 296
SD = 2.06
CV = 0.7%
|
N = 20
Mean = 443
SD = 4.52
CV = 1.02%
|
Precision Assay: Between Runs
| Serum I |
Serum II |
Serum III |
N = 7
Mean = 92
SD = 1.98
CV = 2.2%
|
N = 7
Mean = 269
SD = 6.91
CV = 2.6%
|
N = 7
Mean = 356
SD = 8.47
CV = 2.4%
|
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Assay Range
20 - 800 mg/dl (multi-point calibration)
Correlation
A comparison of this K-ASSAY IgA and an Incstar IgA Test Kit was performed on a Hitachi
704 automated analyzer and a COBAS Mira. The test results provided the following data:
Y
r
n
X
Y
|
= 1.0188x - 6.73
= 0.9899
= 45
= ITA(Incstar)
= K-ASSAY ITA IgA
|
INTERFERENCE
Bilirubin
Hemoglobin
Lipemia
|
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