Simultaneous point-of-care testing of blood lipid profile and glucose: Performance evaluation of the GCare Lipid Analyzer

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: POC; diabetes mellitus; dyslipidemia; glucose; lipid; point-of-care testing.

FIGURE 1

Picture of the GCare Lipid Analyzer showing its two inlets, (A) one for lipid panel testing using a GCare Lipid Profile Test Strip; and (B) another for glucose testing using a GCare Glucose Test Strip. Courtesy: Green Cross Medical Science

FIGURE 2

Bland–Altman plot of the data obtained using the GCare Lipid Analyzer for: (A) total cholesterol (TC), (B) triglycerides (TG), and (C) high‐density lipoprotein cholesterol (HDL‐C) in capillary and venous blood samples, compared to the mean TC, TG, and HDL‐C using the reference values obtained using the Toshiba TBA TBA2000FR chemistry analyzer

FIGURE 3

Passing–Bablok regression analysis of the GCare Lipid Analyzer findings for capillary and venous blood samples compared to the reference levels estimated by the Toshiba TBA2000FR chemistry analyzer for (A) total cholesterol (TC), (B) triglyceride (TG), and (C) high‐density lipoprotein cholesterol (HDL‐C)

FIGURE 4

System accuracy plot of the measured blood glucose levels using the GCare Lipid Analyzer with a GCare Glucose Test Strip compared with those obtained using the YSI 2300 STAT Plus Analyzer (reference value), obtained from three different lots using (A) venous and (B) capillary blood samples. (C) Plot of user capillary blood glucose results obtained from one lot