|
KIT COMPOSITION
Reagent 1 (R-1) Buffer Reagent 3 x 18 ml
Reagent 2 (R-2) Antiserum Reagent 2 x 7 ml
PERFORMANCE
Precision
The precision for the K-ASSAY HP assay was determined using packaged reagents, pooled human serum, and
a Hitachi 717 analyzer.
Precision Assay: Within Run
| Sample I |
Sample II |
N = 20
Mean = 68.15
SD = 0.88
CV = 1.3%
|
N = 20
Mean = 366
SD = 5.5
CV = 1.5%
|
Precision Assay: Between Runs
| Sample I |
Sample II |
N = 8
Mean = 85.9
SD = 0.8
CV = 0.972%
|
N = 8
Mean = 225.6
SD = 1.4
CV = 0.624%
|
|
Correlation
A comparison the the K-ASSAY HP assay and an Incstar Haptoglobin Test Kit was performed
using a Hitachi 717. The test results provided the following data:
Y
r
n
X
Y
|
= 0.937X + -9.25
= 0.993
= 60
= Incstar Haptoglobin Test Kit
= K-ASSAY HP assay
|
| X min |
= 34 |
Y min
|
= 4
|
| max |
= 26 |
max
|
= 267
|
| mean |
= 109 |
mean
|
= 93
|
INTERFERENCE
Bilirubin F and C
Hemoglobin
Lipemia
|
No interference up to 20 mg/dl
No interference up to 500 mg/dl
No interference up to 5%
|
|
Tel: (206) 575-8068