床旁监测血糖仪葡萄糖氧化酶法及脱氢酶法准确度评估  

Accuracy of blood-glucose monitoring system by using glucose oxidase or glucose dehydrogenase

作　　者：邸玉玮[1] 郑卫东[1] 梁雪冰[1] 戴耀宗[1] 

机构地区：[1]广东省医学科学院,广东省人民医院检验科,广州510018

出　　处：《中华内分泌代谢杂志》2011年第8期634-635,共2页Chinese Journal of Endocrinology and Metabolism

摘　　要：以生化分析仪检测为参照，比较葡萄糖氧化酶法及脱氢酶法血糖仪的准确度。检测新鲜肝素锂化静脉血临床样本。根据ISO15197，血糖仪的两种方法检测结果偏倚100％在±0．56mmol/L内（〈4．2mmol/L），≥99．7％在±20％内（≥4．2mmol/L）；根据EF9-A2，两种方法的预期误差〈10％，略〉5％；低、高血糖症界值处（〈3．89mmol/L或〉6．1lmmol/L），两种方法的κ〉0．6。两种方法间的κ〈0．6。血糖仪葡萄糖氧化酶法、脱氢酶法准确度符合ISO15197要求，与生化分析仪检测方法的差异不影响临床应用，其结果用于低、高血糖症判读一致性好。Blood samples were detected by 24 blood-glucose meters using glucose oxidase and another 18 glucose meters using glucose dehydrogenase. The plasma glucose was detected by the auto-chemistry analyzer as control. According to ISO15197 and EF9-A2, the bias of results from both glucose meters 100% fall in the range of ± 0. 56 mmol/L（ 〈4. 2 mmol/L）and ≥ 99. 7% in the range of ±20% （ ≥4. 2 mmol/L） , predicted bias were all less than the true bias（Bc）. As κ〉0. 6, the results from both glucose meters were in accordance with the results from auto- chemistry analyzer in judging hyperglycemia（ 〉6. 11 mmoL/L） and hypoglycemia（ 〈3.89 mmol/L）. Between the results from the two blood-glucose meters, κ〈0. 6. The accuracy of both glucose-meters are accepted for the purpose of clinical diagnosis and treatment.

关 键 词：血糖 测定 准确性 

分 类 号：R446.1[医药卫生—诊断学]