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LDX Performance EvaluationLDX Performance Evaluation

Cholestech LDX
Performance Evaluation

Introduction
The performance of the Cholestech LDX System has been evaluated for all analytes. The data shown here are from testing done in the Cholestech quality assurance laboratories as well as field studies, demonstrating excellent precision and accuracy on all analytes.

Precision
Within-run precision testing was done on samples of venous whole blood, plasma, and control sera. The statistical result of that testing are summarized below.

Day-to-day precision
Testing was done by running control sera and plasma twice a day, for several days. The statistical results of the testing are summarized below.

Total Cholesterol

Human Plasma
Whole Blood (heparin)

Level 1
Level 2
Level 1
Level 2
Within-run Precision



n =
20
20
10
10
X (mg/dL)
180
304
184
299
SD (mg/dL)
5.7
10.6
4.6
7.3
CV (%) =
3.2
3.5
2.5
2.4




Control Material

Human Serum
Level 1
Level 2
Day-to-Day Precision



n =
20
20
20
X (mg/dL)
172
161
244
SD (mg/dL)
3.7
4.3
8.6
CV (%) =
2.2
2.7
3.5