Comparing the Accuracy of 2 Point-of-Care Lipid Testing Devices

Abstract

Background: Device manufacturers have improved technology since studies were last published, thus warranting an updated analysis. Objective: Two point-of-care (POC) cholesterol testing devices were directly compared to a venous sample to determine device accuracy. Methods: Institutional review board (IRB)–approved study collected finger-stick blood samples analyzed by Cholestech LDX (Cholestech Corporation, Hayward, California) and CardioChek Plus (Polymer Technology Systems Inc, Indianapolis, Indiana) devices and compared to venous blood for 30 study participants. Statistical analyses were completed using StatisPro. Intraclass correlation coefficients were generated, and the average difference expected to be within the industry standards of total cholesterol (TC; ±10%), high-density lipoprotein (HDL) cholesterol (±12%), and triglycerides (TG; ±15%). Results: The POC devices produced clinically equivalent values when compared to the same patients’ samples analyzed in a reference laboratory. The average difference calculated from the actual individual paired percentage bias with the Integra analyzer: venous—TC −3.8%, HDL −6.9%, TG −1.8%; CardioChek—TC −7.8%, HDL −6.2%, TG 5.1%; and Cholestech—TC 0.5%, HDL −4.5%, TG −3.3%. The average of the actual paired percentage bias with the Roche Cobas analyzer: CardioChek—TC −4.2%, HDL 0.8%, TG 7.0% and Cholestech—TC 4.6%, HDL 2.6%, TG −1.6%. Conclusion: Both screening devices operated within industry accuracy standards.