床旁监测血糖仪葡萄糖氧化酶法及脱氢酶法准确度评估

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±0.56 mmol/L内(＜4.2mmol/L),≥99.7%在±20%内(≥4.2 mmol/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(＜3.89 mmol/L或＞6.11mmol/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.

Abstract：

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 ISO1 5197 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 autochemistry 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.

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

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 ISO1 5197 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 autochemistry 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.