4种便携式血糖仪与生化分析仪的一致性和抗干扰能力的研究

Comparison of the consistency among four portable blood glucose meters and biochemical analyzer and study of their anti-interference ability

目的通过对不同便携式血糖仪与贝克曼库尔特AU5800全自动生化分析仪(AU5800)检测血糖结果的一致性比对和抗干扰能力的研究,为临床选择适合的血糖仪提供参考。方法共选取4种不同检测原理的2台进口(A和B)和2台国产(C和D)血糖仪,与AU5800同时检测不同浓度的血糖并进行比较,分析其一致性。分别检测低、中和高值血糖的3个红细胞比容(HCT)水平样本。选取常见干扰物,包括维生素C(VC)、半乳糖、麦芽糖和胆红素,观察各血糖仪对这些干扰物的抗干扰能力是否符合要求。结果与AU5800比较,两种进口血糖仪与AU5800的检测一致性较好,符合ISO 15197:2013标准要求,但是两种国产血糖仪的一致性尚不能满足标准要求,国产C、D符合率分别为88.00%和92.00%。与HCT为45.00%时比较,在中、高值血糖样本中,HCT为25.00%、65.00%时国产C的偏倚分别为20.22%、-31.93%、31.03%和-24.39%,国产D的偏倚分别为47.50%、-28.79%、46.52%和-30.05%,差异均有统计学意义(P<0.05)。抗干扰研究中,VC为0.5、1.0 g/L时,国产C检测低浓度血糖的偏倚分别为0.60、1.31 mmol/L,差异有统计学意义(P<0.05),其他血糖仪检测结果差异无统计意义(P>0.05)。在半乳糖、麦芽糖和胆红素干扰实验中,4种血糖仪检测结果差异均无统计学意义(P>0.05)。结论进口A和B血糖仪的检测一致性较好,国产C和D的检测结果受HCT影响,且中、低HCT时呈正偏差,高HCT呈负偏差,VC对国产C的检测有干扰。因此,应根据需求选择适合的血糖仪,避免内外源性干扰物影响。

Objective To study on the consistency between different portable blood glucose meter and beckman-coulter AU5800 automatic biochemical analyzer and their anti-interference ability and to provide reference for clinical selection of suitable blood glucose meter.Methods Two imported(A and B)and two home-made(C and D)blood glucose meters with four different detection principles were selected to detect different concentrations of blood glucose simultaneously with AU5800.Three samples of hematocrit(HCT)levels of low,medium,and high blood glucose were measured with blood glucose meters.Vitamin C(VC),galactose,maltose and bilirubin with different concentrations were selected to observe whether the anti-interference ability of each glucose meter met the requirements.Results The two imported blood glucose meters had a good consistency with AU5800 and met the requirements of ISO 15197:2013,but the consistency of the two home-made blood glucose meters could not meet the requirements of the standards.The coincidence rates of home-made C and D were 88.00%and 92.00%,respectively.Compared with HCT 45.00%of sample,the bias of home-made C in HCT 25.00%and 65.00%were 20.22%,-31.93%,31.03%and-24.39%in the middle and high blood glucose samples,the differences were statistically significant(P<0.05);the bias of home-made D in HCT 25.00%and 65.00%were 47.50%,-28.79%,46.52%and-30.05%,the difference were statistically significant(P<0.05).In the anti-interference study,when VC were 0.5 g/L and 1.0 g/L,the bias of home-made C were 0.60 mmol/L and 1.31 mmol/L in low glucose,the differences were statistically significant(P<0.05),while the results of other glucose meters showed no statistical difference.Conclusion The results of imported A and B glucose meters were in good agreement.The results of home-made C and D were influenced by HCT,and positive deviation was found in medium HCT,negative deviation was found in high HCT.VC interferes with the measurement of home-made C.Therefore,the glucose meter should be selected according to the needs to avoid the influence of endogenous and exogenous distractors.