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Comparative Performance of Two Point-of-Care Analysers for Lipid Testing by Mark DS Shephard, Beryl C Mazzachi, Anne K Shephard

The aim of this study was to compare the analytical performance of the Cholestech LDX and CardioChek PA lipid point-of-care devices to a CDC-certified laboratory. Inter-assay imprecision (n=10) for blood samples from 2 patients with different lipid profiles was 3.0% for total cholesterol, 2.6% for triglyceride, 5.2% for HDL cholester- ol and 6.2% for calculated LDL cholesterol on the Cholestech, and 4.4% for total cholesterol, 4.8% for trigly- ceride, 7.0% for HDL cholesterol and 7.4% for calculated LDL cholesterol on the Cardiochek. In a patient comparison study (n=100), correlation coefficients (r) between the POCT and laboratory methods were greater than 0,90 for all tests for the Cholestech and greater than 0.84 for all tests for the Cardiochek. The mean difference (bias) between the results obtained on the Cholestech LDX and the laboratory method was not statistically significant; however the mean difference between the CardioChek and the laboratory method was statistically significant for total, HDL and LDL cholesterol (one way analysis of variance with Scheffe post-hoc test). The Cholestech LDX met the NCEP goal for total error for all analytes except LDL cholesterol. The CardioChek PA system met the NCEP total error goal for triglyceride but not the other lipid analytes. We conclude that the Cholestech LDX device is a suitable POCT device for cardiovascular risk assessment in the primary care setting, while the Cardiochek device requires more study and refinement.

DOI: Clin. Lab. 2007;53:561-566