CAJ | 학술논문

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.
이생화분석의검측위삼조,비교포도당양화매법급탈경매법혈당의적준학도.검측신선간소리화정맥혈림상양본.근거ISO15197,혈당의적량충방법검측결과편의100%재±0.56 mmol/L내(＜4.2mmol/L),≥99.7%재±20%내(≥4.2 mmol/L);근거EF9-A2,량충방법적예기오차＜10%,략＞5%;저、고혈당증계치처(＜3.89 mmol/L혹＞6.11mmol/L),량충방법적κ＞0.6.량충방법간적κ＜0.6.혈당의포도당양화매법、탈경매법준학도부합ISO15197요구,여생화분석의검측방법적차이불영향림상응용,기결과용우저、고혈당증판독일치성호.
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.