Cholestech Accuracy Venous Samples
Cholestech LDX
Performance Evaluation
Accuracy - Venous Samples
Total cholesterol results from the Cholestech LDX were compared with a
validated method traceable to the CDC-modified Abell-Kendall reference
method to National Institute of Standards and Technology (NIST)
standards.
HDL cholesterol results were compared with a validated method, utilizing dextran sulfate/magnesium chloride precipitation and enzymatic cholesterol determination. The HDL cholesterol comparison method is based on the selected method for HDL cholesterol and has documented agreement with the CDC Reference Method.
Triglyceride test results were compared with a validated method, utilizing hydrolysis with lipase. The comparison method has documented agreement with a CDC Reference Method.
Glucose results were compared with a hexokinase reference method.
The range of values tested (mg/dL) were as follows:
| TC | 120-300 |
| HDL | 26-85 |
| TRG | 40-500 |
| GLU | 25-575 |
Results:
X= Reference Method (Serum)
Y= Cholestech LDX Analyzer (venous whole blood)
|
TC
|
HDL
|
TRG
|
GLU
|
|
| n (number of pairs) = |
40
|
40
|
40
|
40
|
| slope = |
0.98
|
0.97
|
1.0
|
0.99
|
| y-intercept = |
2.41
|
0.23
|
0.13
|
1.01
|
| correlation coefficient = |
0.97
|
35
|
250
|
150
|
| bias at |
200
|
35
|
250
|
150
|
|
-1%
|
-2%
|
0%
|
0%
|
X= Reference Method (Serum)
Y= Cholestech LDX Analyzer (plasma)
|
TC
|
HDL
|
TRG
|
GLU
|
|
| n (number of pairs) = |
40
|
40
|
40
|
40
|
| slope = |
1.01
|
0.96
|
1.0
|
1.01
|
| y-intercept = |
3.21
|
2.41
|
12.44
|
4.92
|
| correlation coefficient = |
0.96
|
0.94
|
0.97
|
0.98
|
| bias at |
200
|
35
|
250
|
150
|
|
-3%
|
3%
|
5%
|
4%
|
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