|
KIT COMPOSITION
Reagent 1 (R-1) Buffer Reagent 4 x 20 ml
Reagent 2 (R-2) Antiserum Reagent 2 x 8 ml
PERFORMANCE
Precision
The precision for the K-ASSAY Prealbumin assay was determined using packaged reagents, pooled
human serum, and a Hitachi 717 analyzer.
Precision Assay: Within Run
| Sample I |
Sample II |
Sample III |
N = 20
Mean = 11.2
SD = 0.145
CV = 1.29%
|
N = 20
Mean = 24.9
SD = 0.289
CV = 1.16%
|
N = 20
Mean = 57.0
SD = 0.767
CV = 1.35%
|
|
Correlation
A comparison of the K-ASSAY Prealbumin assay and a similar Prealbumin assay was
performed on a Hitachi 717. The test results provided the following data.
Y
r
n
X
Y
|
= 0.9164x + -0.332
= 0.9924
= 50
= Similar Prealbumin assay
= K-ASSAY Prealbumin assay
|
| X min |
= 5.7 |
Y min
|
= 4.2
|
| max |
= 43.2 |
max
|
= 38.4
|
| mean |
= 22.89 |
mean
|
= 20.64
|
INTERFERENCE
Bilirubin F and C
Hemoglobin
Lipemia
|
No interference up to 22 mg/dl
No interference up to 470 mg/dl
No interference up to 5%
|
|
Tel: (206) 575-8068