Performance evaluation of Barozen Lipid Plus for point-of-care testing of lipid profiles: a method comparison study
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Background: The quick and easy nature of point-of-care (POC) testing devices allows regular monitoring of serum lipid levels to increase efficiency. The purpose of this study was to assess a POC lipid analyzer, Barozen Lipid Plus (MICO Biomed Co., Ltd.), which uses capillary blood to measure total cholesterol (TC), triglycerides (TGs), and high-density lipoprotein cholesterol (HDL-C). Methods: Capillary and venous blood samples were collected from 110 participants at a single center in Korea between June 10 and June 26, 2021. TC, TG, and HDL-C measurements using Barozen Lipid Plus were compared with measurements using our reference device, the Roche-Hitachi Cobas 8000 c702 (Hitachi High-Technologies Corporation). This study followed the guidelines of the Clinical and Laboratory Standards Institute and the Clinical Laboratory Improvement Amendments. We surveyed participants regarding the convenience of the POC device using a questionnaire following the completion of blood collection. Results: When compared to the reference equipment, the measurements obtained using Barozen Lipid Plus were more than 95% satisfactory within TC±10%, TG±25%, and HDL-C±30%. The coefficient of variation in the repeatability testing was within 5% for TC, 5% for TGs, and 7% for HDL-C. The survey results indicated high levels of satisfaction. No adverse events were reported. Conclusion: These findings suggest that Barozen Lipid Plus is reliable for measuring lipid profiles and can therefore be used to monitor lipid levels at the time and place of patient care.
Abstract
Background: The quick and easy nature of point-of-care (POC) testing devices allows regular monitoring of serum lipid levels to increase efficiency. The purpose of this study was to assess a POC lipid analyzer, Barozen Lipid Plus (MICO Biomed Co., Ltd.), which uses capillary blood to measure total cholesterol (TC), triglycerides (TGs), and high-density lipoprotein cholesterol (HDL-C). Methods: Capillary and venous blood samples were collected from 110 participants at a single center in Korea between June 10 and June 26, 2021. TC, TG, and HDL-C measurements using Barozen Lipid Plus were compared with measurements using our reference device, the Roche-Hitachi Cobas 8000 c702 (Hitachi High-Technologies Corporation). This study followed the guidelines of the Clinical and Laboratory Standards Institute and the Clinical Laboratory Improvement Amendments. We surveyed participants regarding the convenience of the POC device using a questionnaire following the completion of blood collection. Results: When compared to the reference equipment, the measurements obtained using Barozen Lipid Plus were more than 95% satisfactory within TC±10%, TG±25%, and HDL-C±30%. The coefficient of variation in the repeatability testing was within 5% for TC, 5% for TGs, and 7% for HDL-C. The survey results indicated high levels of satisfaction. No adverse events were reported. Conclusion: These findings suggest that Barozen Lipid Plus is reliable for measuring lipid profiles and can therefore be used to monitor lipid levels at the time and place of patient care.
참고문헌 (37)
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