Multi-Lipid Panel Test Accuracy Study

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Accuracy Study

Accuracy/Method Correlation
 Reference Methods:

• Cholesterol: Abell-Kendall traceable method and PTS PANELS Cholesterol Test Strips
•  HDL Cholesterol: Abell-Kendall traceable method and PTS PANELS HDL Cholesterol Test Strips
• Triglycerides: CRMLN reference method and PTS PANELS Triglycerides Test Strips

Samples for Cholesterol and HDL cholesterol were run by the Abell-Kendall method by a certified Cholesterol Reference Method Laboratory Network (CRMLN) lab. Triglycerides were also run at the same CRMLN lab using an enzymatic assay. Method standardization studies were also performed for PTS test methods in comparison to CDC reference methods at a CRMLN laboratory. These studies are done to validate appropriate calibration of a manufacturers' lipid testing method.2

Additionally, Lipid Panel Test Strips were run by laboratory professionals and the results were compared to results from PTS PANELS Test Strips run on a CardioChek ST or CardioChek PA instrument. Results from both methods were then compared using least squares linear regression.

RESULTS

A B
Graphics (p.2-3) Graphics (p.2-5)

C
Graphics (p.2-7) Fig. 1 Linear regression plots for PTS Methods and Reference Methods. (A) Total Cholesterol, Equation for line: PTS Cholesterol = -1.83 + 1.01 (Abell-Kendall cholesterol); r = 0.91, N = 125. (B) Triglycerides, Equation for line: PTS Triglycerides = 2.8 + 0.97(CRMLN Laboratory Trig. Method); r = 0.97, N = 111 (C) HDL Cholesterol, Equation for line: PTS HDL Cholesterol = -4.1 + 1.1 (Abell-Kendall HDL Chol.); r = 0.89, N = 87.

Table 1.  Lipid Panel Method Comparison

  Lipid Panel - Cholesterol Lipid Panel - HDL Cholesterol Lipid Panel - Triglycerides
No. of Samples  95 95 95
Correlation Coefficient (r)  0.90 0.90 0.96
Bias at 200 mg/dL, +0.05% at 40 mg/dL, -3.25% at 150 mg/dL, +1.32%
Bias at 240 mg/dL, -3.13% At 60 mg/dL, +4.17% at 200 mg/dL, +3.24%

PTS PANELS Cholesterol (r=0.91, Fig. 1A), Triglycerides (r=0.97, Fig. 1B), and HDL Cholesterol (r=0.89, Fig. 1C), correlated well to the Abell-Kendall traceable methods for total cholesterol and HDL cholesterol, as well as to the CRMLN triglycerides laboratory method. In comparison of the Lipid Panel Test Strips against the single test method, Cholesterol (r=0.91, Table 1), Triglycerides (r=0.96, Table 1), and HDL Cholesterol (r=0.90, Table 1) all correlated well. Overall, a small bias was observed, between 3 to 4% (Table 1) at clinical decision points for cholesterol, HDL cholesterol, and triglycerides testing.

Method standardization studies demonstrated that the Lipid Panel Test Strips are standardized to methods traceable to CRMLN laboratory methods. Figure 2 demonstrates the very high level of agreement of the PTS reference method to the CRMLN values for cholesterol (r=0.989), HDL cholesterol (r=0.989), and triglycerides (r=0.994).

A B
Graphics (p.3-4) Graphics (p.3-6)

C
Graphics (p.3-8) Fig. 2 Method standardization comparison.
 (A). Total Cholesterol, Equation for line: PTS Reference Cholesterol 3.1 + 0.924(CRMLN Cholesterol); r = 0.989, N = 43. (B) HDL Cholesterol, Equation for line: PTS Reference HDL Cholesterol = 3.1 + 0.924(CRMLN HDL Cholesterol); r = 0.989, N =43. (C) Triglycerides, Equation for line: PTS Reference Triglycerides 0.098 + 0.955(CRMLN Triglyceride); r = 0.994, N = 44.