A-374 Analytical Performance Assessment and Comparison of Point of Care Testing (POCT) Devices for Blood Lipids Measurements

Abstract Background Cardiovascular diseases (CVDs) are the leading cause of death in the U.S. and worldwide. According to the World Health Organization (WHO), worldwide, 85% of CVD deaths are due to heart disease and strokes, and over 75% occur in low- and middle-income countries (LMICs). Early detection and treatment are key to preventing the consequences of CVD. Point-of-care testing (POCT) devices offer alternatives to screening large populations for CVD risk. Although POCT are increasingly used for screening, only few information is available about their accuracy and reliability. Methods Eight POCT devices for blood lipids that previously successfully participated in the CDC CVD Biomarker Standardization Programs were used in this preliminary study. The analytical performance for all eight devices was assessed using split sample comparisons to the CDC reference measurement procedures for measurements performed in whole blood (WB) and serum. Specifically, the accuracy of total cholesterol (TC) was determined in WB and serum. The accuracy of high-density lipoprotein-cholesterol (HDL-c), and low-density lipoprotein-cholesterol (LDL-c) was determined in serum. The precision of TC, HDL-c, LDL-c, and triglycerides (TG) was determined in WB and serum. Results The reference values of the specimens from 20 donors ranged between 154–279 mg/dL, 36.9–109 mg/dL, and 71.1–182 mg/dL for TC, HDL-c, and LDL-c in serum, and between 145–210 mg/dL for TC in WB. Preliminary assessments found that the mean bias for each instrument ranged from -7.86%–13.82% and from -11.90%–3.24% for TC in WB and serum, respectively. For serum HDL-c samples, the mean bias ranged from −6.81%–15.43%. The mean bias for serum LDL-c samples ranged from −22.40% to 3.08%. For three devices, approximately 30% of the WB measurements and approximately 50% of the serum measurements were reported as outside of the measurement range. The mean imprecision for each instrument ranged from 2.2%–13.75% and from 1.88%–11.76% for TC in WB and serum, respectively. For HDL-c, the mean imprecision ranged from 5.36%–23.21% and from 2.30% to 26.69% in WB and serum, respectively. The mean imprecision ranged from 4.82%–20.34% and from 3.06%–20.54% for LDL-c in WB and serum, respectively. For TG, the mean imprecision ranged from 5.78%–23.91% and from 1.71%–11.02% in WB and serum, respectively. Conclusion These preliminary findings about the analytical performance of POCT devices indicate notable differences in accuracy and precision for lipids measured in WB and serum, with serum measurements being more likely within performance requirements than WB measurements. Some devices appear to be more likely to report values outside the measurement range even though reference values are within the measurement range of the device. Further studies to verify these preliminary findings with more individual donor samples are underway.