AN EVALUATION OF 2 COMPACT ANALYZERS USED FOR LIPID ANALYSIS

Background. A number of relatively inexpensive compact analyzers are a vailable for use in physician offices and outpatient clinics to measur e total cholesterol and, more recently, high-density lipoprotein (HDL) cholesterol and triglycerides. This study was designed to document th e analytical performance of two of them, the Abbott Vision and the Kod ak Ektachem DT60, for assays of total cholesterol, HDL cholesterol, tr iglycerides, and calculated low-density lipoprotein (LDL) cholesterol. Methods. Lipid profiles were measured from venous blood samples of 70 subjects with each test device, and results were compared with those from a laboratory standardized to the Centers for Disease Control. Coe fficient of variation (CV) of multiple measurements from three pools o f human serum (ie, precision), mean percent difference between device and standard laboratory results (ie, accuracy or bias), and 95% tolera nce intervals (total error) were determined. The correct classificatio n of patients into risk categories with device results was compared wi th the standardized laboratory results. Results. The average CVs for t otal cholesterol, triglycerides, and HDL cholesterol with the Vision a nalyzer were 3.6%, 4.4%, and 10.5%, respectively, and with the DT60, 5 .0%, 4.1%, and 6.8%, respectively. The average percent biases for the same analytes with the Vision analyzer were 0.2%, 4.0%, and -2.3%, res pectively, and with the DT60, -2.1%, 12.1%, and 0.1%, respectively. To tal error assessments indicated that total and HDL cholesterol measure ments in individual patients met the guidelines of the National Choles terol Education Program with both devices, but that triglycerides and LDL cholesterol measurements did not. Classification of subjects into risk groups based on total or LDL cholesterol gave clinically satisfac tory results with either device. Conclusions. More precise measurement technology for LDL cholesterol is needed. Physicians and others who r ely on compact analyzer results for diagnosis and treatment decisions should consider the degree of inaccuracy and imprecision in these valu es.