Abstract:

Objective：To evaluate the clinical correlation between the CardioChek PA analyzer (CCPA) and a clinical laboratory reference method to use for screening program purposes. Methods: Fasting blood samples were collected on 325 patients (age: 23-86 years). One venous sample was collected using a serum tube for the evaluation on a Beckman reference analyzer. A second venous sample was collected in a lithium heparin tube and was evaluated on the CCPA analyzer. Linear regression analyses and Bland-Altman method were performed for each measured analyte: total cholesterol (TC), high density lipoproteincholesterol (HDL-C), triglycerides (TG) and low density lipoprotein-cholesterol (LDL-C). Results: Our results demonstrated a good clinical agreement for TC, HDL-C, TG and LDL-C（97.0%, 92.9%, 92.4% and 83.7%）in comparison with the CCPA to the reference analyzer. The correlation coefficients were 0.875, 0.813, 0.910, 0.864, respectively. P values all < 0.001. There was no significant difference in the detection rate of hyperlipidemia in TC, HDL-C and LDL-C. Conclusion: We have identified the pre-analytic phase as an important step to guarantee the quality of results and indicated that the CCPA is a reliable lipid point-of-care testing system that can be used for the application of clinical screening anywhere.

Key words:  Dyslipidemias, Point-of-care testing, Cardiovascular diseases