The Establishment Of The Evaluating System For Glucose Meter And Its Application In Quality Assessment Of POCT

ObjectiveTo establish the evaluating system for glucose meter detection through summarizing the contrast research results at home and abroad between glucose meter and biochemical analyzers in blood glucose detection,analyzing their differences and correlation so as to gain reliable comprehensive conclusion and to provide scientific evidence-based medicine so as to solve the problems in quality assessment of POCT and to provide better clinical application of POCT.Methods1.Systematical review of glucose meter detection was made by adopting Meta-analysis, including making out the retrieval strategy, collecting the related literature, fixing the standard for retrieval absorbing and depleting,making quality assessment and information collection were made of the retrieval from Cochrane's registered data bank, MEDLINE, EMBASE, CMB,CNKI and VIP.The Meta-analysis was applied with RevMan 4.2.10 provided by the Cochrane Collaboration for data analyzing,the target type of this study was continuity variables and weighted mean difference(WMD) was applied in summery statistic;Peto was applied for summery statistic of homogeneity test while random effect model (D-L) was applied for summery statistic of heterogeneity test;Forest plots were applied in detection the summery statistic and the symmetric degree of funnel plots was used to analyze the bias.2.Evalusting system for glucose meter was applied in guiding the quality assessment of POCT.Results1. In total there were 1090 retrievals,654 in English and 436 in Chinese ,according to the fixed standard for absorbing and depleting,finally,10 in English and 18 in Chinese were absorbed.Based on the fixed standard of quality grading,the assessment of the absorbed retrievals pointed out 0 of Grade A,17 of Grade B and 11 of Grade C.A statistic heterogeneity was detected out in each study of glucose meter detection except the study with of Abbot and Roche glucose meter in heterogeneity test. The result of sensitivity analysis tells us :After removing low-quality studies,the analysis result of capillary blood subgroup was changed which indicate instability of the analysis result. The remaining results are basically the same in each group,which proves the analysis results were relative steady,and the conclusion was reliable basically. The funnel plots of Roche glucose meter subset was symmetrical.The funnel plots of the rest of subgroup displayed asymmetric in various degrees,which explained that there were still certain publication biases. The results of meta-analysis: The blood glucose value of the third and forth group of different blood glucose levels, Johnson & Johnson glucose meter group were lower than laboratary method and the blood glucose value of Abbot glucose meter group was higher than laboratary method.The blood glucose value of the rest subgroups are nearly compared with laboratary method.2. On the basis of this study we discuss about POCT such as how to design study, analyze heterogeneity, analyze sensitivity and contrlo confounding factors and so on.We Summed up for POCT data handling and analysis and search for the application to guide quality assessment and control of POCT.Conclusion1. The establishment of the evaluating system for glucose meter is very important for clinical application of glucose meter.The blood glucose value measured by different brands of glucose meter is different compared with the value measured by biochemical analyzer: The blood glucose value of Roche glucose meter is nearly compared with laboratary method. The blood glucose value of Johnson & Johnson glucose meter is lower than laboratary method and the blood glucose value of Abbot glucose meter is higher than laboratary method. Technicians should adjust the reference range of blood glucose when they using deferent brand glucose meter.In the middle value of blood glucose ,the blood glucose value of glucose meter is nearly compared with laboratary method.However, when the value of blood glucose is very high or low,the results showed significant differences, then technicians should suggest these Patients to determinate their blood glucose by laboratary method.2. It is difficult to estimate the quality of POCT through traditional methods. By evalusting system for glucose meter was applied in guiding the quality assessment of POCT,we can solve some questions in POCT quality assessment such as Heterogeneity reagents, samples of diversity source, complexity of apparatus using environments.