Department of Laboratory Medicine, Korea University Guro Hospital, Seoul, Korea.
J Clin Lab Anal. 2021 Dec;35(12):e24055. doi: 10.1002/jcla.24055. Epub 2021 Oct 25.
Point-of-care (POC) testing provides quick results and includes tests for blood glucose and lipid profiles. We evaluated the newly developed POC device, the GCare Lipid Analyzer, which is used to measure glucose, total cholesterol (TC), triglyceride (TG), and high-density lipoprotein cholesterol (HDL-C) levels.
Venous and capillary blood samples were collected from patients who visited Korea University Guro Hospital. The results obtained using the GCare Lipid Analyzer were compared with those obtained using the TBA 2000FR chemistry analyzer and YSI 2300 STAT Plus analyzer. The glucose system evaluation process was based on the International Organization for Standardization 15197:2013 guidelines.
The correlation coefficients (R) for TC, TG, and HDL-C were 0.965, 0.969, and 0.943 in capillary blood and 0.969, 0.990, and 0.956 in venous blood, respectively. The total errors for TC, TG, and HDL-C of the lipid profile using venous blood were all acceptable at 6.6%, 9.3%, and 11.6%, respectively. For glucose concentrations <100 mg/dl, 96.1% of the measured glucose levels were within ±15 mg/dl in venous samples and 100% were within ±15 mg/dl in capillary samples. For glucose concentrations ≥100 mg/dl, 100% and 99.5% of the measured glucose levels were within 15% for venous and capillary blood, respectively.
The performance of the GCare Lipid Analyzer is acceptable for both blood glucose and lipid profile testing, indicating that it is reliable for use in patients with diabetic dyslipidemia.
即时检测(POC)提供快速结果,包括血糖和血脂谱检测。我们评估了新开发的即时检测设备,GCare 血脂分析仪,用于测量血糖、总胆固醇(TC)、甘油三酯(TG)和高密度脂蛋白胆固醇(HDL-C)水平。
从访问韩国大学古罗医院的患者中采集静脉和毛细血管血样。使用 GCare 血脂分析仪获得的结果与 TBA 2000FR 化学分析仪和 YSI 2300 STAT Plus 分析仪获得的结果进行比较。血糖系统评估过程基于国际标准化组织 15197:2013 指南。
毛细血管血中 TC、TG 和 HDL-C 的相关系数(R)分别为 0.965、0.969 和 0.943,静脉血中分别为 0.969、0.990 和 0.956。静脉血脂质谱 TC、TG 和 HDL-C 的总误差均在 6.6%、9.3%和 11.6%以内,可接受。对于血糖浓度<100mg/dl,静脉血中 96.1%的测量血糖水平在±15mg/dl 以内,100%的测量血糖水平在±15mg/dl 以内。对于血糖浓度≥100mg/dl,静脉血和毛细血管血中 100%和 99.5%的测量血糖水平分别在 15%以内。
GCare 血脂分析仪在血糖和血脂谱检测方面的性能均可接受,表明其在糖尿病血脂异常患者中可靠。