Park Hae-Il, Lee Seong-Su, Son Jang-Won, Kwon Hee-Sun, Kim Sung Rae, Chae Hyojin, Kim Myungshin, Kim Yonggoo, Yoo Soonjib
Department of Laboratory Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon-si Gyeonggi-do, Republic of Korea.
Catholic Laboratory Development and Evaluation Center, Clinical Research Coordinating Center, Catholic Medical Center, Seoul, Republic of Korea.
J Clin Lab Anal. 2016 Nov;30(6):849-858. doi: 10.1002/jcla.21947. Epub 2016 Apr 13.
Element™ Auto-coding Blood Glucose Monitoring System (BGMS; Infopia Co., Ltd., Anyang-si, Korea) was developed for self-monitoring of blood glucose (SMBG).
Precision, linearity, and interference were tested. Eighty-four capillary blood samples measured by Element™ BGMS were compared with central laboratory method (CLM) results in venous serum. Accuracy was evaluated using ISO 15197:2013 criteria.
Coefficients of variation (CVs; mean) were 2.4% (44.2 mg/dl), 3.7% (100.6 mg/dl), and 2.1% (259.8 mg/dl). Linearity was shown at concentrations 39.25-456.25 mg/l (y = 0.989 + 0.984x, SE = 17.63). Up to 15 mg/dl of galactose, ascorbic acid, and acetaminophen, interference > 10.4% was not observed. Element™ BGMS glucose was higher than CLM levels by 3.2 mg/dl (at 200 mg/dl) to 8.2 mg/dl (at 100 mg/dl). The minimum specification for bias (3.3%) was met at 140 and 200 mg/l glucose. In the Clarke and consensus error grids, 100% of specimens were within zone A and B. For Element™ BGMS values, 92.9% (78/84) to 94.0% (79/84) were within a 15 mg/dl (< 100 mg/dl) or 15% (> 100 mg/dl) of the average CLM value.
Element™ BGMS was considered an appropriate SMBG for home use; however, the positive bias at low-to-mid glucose levels requires further improvement.
Element™自动编码血糖监测系统（BGMS；韩国安阳市Infopia有限公司）是为自我血糖监测（SMBG）而开发的。
对其精密度、线性和干扰进行了测试。将Element™ BGMS测量的84份毛细血管血样与中心实验室方法（CLM）检测的静脉血清结果进行比较。使用ISO 15197:2013标准评估准确性。
变异系数（CVs；平均值）分别为2.4%（44.2mg/dl）、3.7%（100.6mg/dl）和2.1%（259.8mg/dl）。在39.25 - 456.25mg/l浓度范围内呈线性（y = 0.989 + 0.984x，SE = 17.63）。高达15mg/dl的半乳糖、抗坏血酸和对乙酰氨基酚未观察到干扰>10.4%。Element™ BGMS测得的血糖比CLM水平高3.2mg/dl（200mg/dl时）至8.2mg/dl（100mg/dl时）。在血糖浓度为140和200mg/l时达到偏差的最低规格要求（3.3%）。在克拉克误差网格和共识误差网格中，100%的样本位于A区和B区。对于Element™ BGMS的值，92.9%（78/84）至94.0%（79/84）在平均CLM值的15mg/dl（<100mg/dl）或15%（>100mg/dl）范围内。
Element™ BGMS被认为是适合家庭使用的自我血糖监测设备；然而，中低葡萄糖水平的正偏差需要进一步改进。
