KIT COMPOSITION
|
Reagent 1 (R-1)
|
|
Reagent 2 (R-2)
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PERFORMANCE
Sensitivity
The minimum detection limit for HDL-Cholesterol concentration utilizing this
reagent on a Hitachi 717 is 1 mg/dl.
Precision
Precision studies were performed in 48 runs over a period of 24 days
following the NCCLS EP5-T2 Tentative Guideline using a Hitachi 717
analyzer. Samples of human pooled serum were used.
Precision Assay:
|
Mean (mg/dl) |
SD |
Total CD % |
SD |
Within Run CV% |
34.1
47.78
62.2
37.2
49.2
57.9
|
0.42
0.66
0.41
|
1.2
1.2
0.6
|
0.4
0.8
0.9
|
1.2
1.6
1.5
|
|
Correlation
Comparison of K-ASSAY
Direct HDL-Cholesterol Reagent (Y) with the CDC HDL-Cholesterol
designated comparison method (X) following the NCCLS EP9-A . The test results provided the following data:
Y
r
n
|
=
0.9488 X + 2.0
= 0.987
= 47
|
Comparison of K-ASSAY Direct
HDL-Cholesterol Reagent (Y) with another company's homogeneous HDL-Cholesterol
Reagent (X) following the NCCLS EPA9-A Approved Guideline.
Y
r
n
|
=
0.989 X + 1.522
= 0.993
= 49
|
Linearity
1 to 150 mg/dl on a Hitachi 717 analyzer based on serial dilution of
a sample of high-content HDL-Cholesterol pooled human serum.
INTERFERENCE
Bilirubin
Hemolysis
Lipemia
|
No interference up to
30 mg/dl
No interference up to 500 mg/dl
No interference up to 5 mg/d
|
|
Tel: (206) 575-8068