Cholestech Accuracy Venous SamplesCholestech 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%