血脂快速分析仪检测血脂的可靠性研究

目的：评价血脂快速分析仪CardioChek PA（CCPA）快速检测血脂的可靠性。方法： 连续收集325例（23~86岁）阜外医院血脂中心入院患者的空腹血样，血清管采集第1份静脉血样并用Beckman分析仪检测血脂各成分，肝素锂管采集第2份静脉血样并使用CCPA分析仪检测，对二者的检测结果进行比较。采用线性回归分析和Bland-Altman法评价两种检测方法获得的总胆固醇（total cholesterol，TC）、高密度脂蛋白胆固醇（high density lipoprotein-cholesterol，HDL-C）、甘油三酯（triglycerides，TG）和低密度脂蛋白胆固醇（low density lipoprotein-cholesterol，LDL-C）的相关性。结果： CCPA检测结果与实验室检查结果具有良好的一致性，其TC、HDL-C、TG和LDL-C的相关系数分别为0.875、0.813、0.910、0.864，对回归方程中的变量有无回归关系进行方差分析，P均＜0.001。两种检测方法检测TC、HDL-C、TG和LDL-C的临床一致百分比分别为97.0%、92.9%、92.4%和83.7%，两种检测方法血脂异常的检出率在TC、HDL-C和TG中没有统计学差异。结论： 在严格控制血样采集质量的基础上，CCPA快速血脂检测系统与实验室常规检测法具有良好相关性，是一种可靠的床旁临床血脂筛查工具。

Study on the reliability of CardioChek PA for measuring lipid profile

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 col-lected 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 analy-ses 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 0.875,0.81 3,0.91 0,0.864,respectively.P values all <0.001 .There was no significant difference in the detection rate of hyperlipidemia in TC,HDL-C and LDL-C.Conclu-sion: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 appli-cation of clinical screening anywhere.