便携式血糖仪与全自动生化分析仪临床标本血糖比对检验评价

摘要

Objective To compare the consistency of the blood glucose results detected by the portable glucometer and automatic biochemical analyzer in the clinical patients for evaluating the accuracy of the portable glucometer .Methods The blood glucose val‐ues in 433 patients were detected by 42 glucosemeters (four different models) and the automatic biochemical analyzer ,and the re‐sults were compared .The glucose values of capillary blood (finger) detected by the glucosemeters were operated by 90 registered nurses .Simultaneously ,venous blood samples were collected for emergently detecting serum glucose with the hexokinase method by the Roche Cobas 8000 automatic biochemical analyzer .The differences in the detections between the glucometer and biochemical an‐alyzer were analyzed with the processing plot by the Bland‐Altman method and Parkes error grid analysis (EGA ) .Results The differences of results between glucometer and biochemical analyzer had statistical significance (t= -4 .128 ,P<0 .05) .The blood glucose level was (6 .88 ± 3 .16 mmol/L) for glucosemeters and (6 .72 ± 3 .27)mmol/L for the biochemical analyzer ,bias was 0 .16 mmol/L ,with a precision (standard deviation) of 0 .79 mmol/L and mean absolute difference of 0 .57mmol/L .The differences be‐tween four models of glucometer and biochemical analyzer were not statistically significant (F=1 .276 ,P=0 .282) .The influence of hematocrit level on the difference between these two kinds of method had no statistically significance .58 cases (13 .4% ) had the discrepance of more than 1 .11 mmol/L between the two kinds of method .100 % detection results were distributed in the zone A and B of Parkes EGA .Conclusion The glucose values detected by glucometer and biochemical analyzer have significant difference . When the abnormal result detected by glucometer may affect the patient′s safety ,which should be submitted to the clinical labora‐tory for verification .%目的：比较便携式血糖仪和全自动生化仪测定临床患者血液葡萄糖结果的一致性，评价血糖仪测定血糖的准确度。方法四种型号42台血糖仪与全自动生化仪比对检测433例患者血液葡萄糖。由90位护士用血糖仪检测患者毛细血管血（手指）血糖，同时抽取静脉血用罗氏Cobas8000全自动生化仪己糖激酶法以急症方式检测血清葡萄糖。血糖仪与生化仪测定血糖的差异按照Bland‐Altman方法进行绘图分析。并进行Parkes误差网格分析。结果血糖仪与生化仪血糖比对结果差异有显著性意义（t＝－4．128，P＜0．05），血糖仪葡萄糖浓度为（6．88±3．16）mmol／L ，生化分析仪为（6．72±3．27）mmol／L ，偏倚0．16 mmol／L ，精密度（标准差）0．79 mmol／L ，平均绝对偏差0．57 mmol／L。四种型号血糖仪与生化仪差值相互之间的差异无显著性意义（F＝1．276，P＝0．282）。红细胞比容水平对两种方法间差异的影响无显著性意义。两种方法血糖相差不低于1．11 mmol／L的有58例（占13．4％）。100％的结果落在Parkes误差网格分析的A区和B区。结论血糖仪与生化仪检测患者血糖的差异有显著性意义。当血糖仪检测结果异常有可能影响患者安全时，应当送检验科确认。