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目的评价三诺生物传感股份有限公司生产和销售的金准血糖测试系统(Go1d AQ)的准确度。方法 6家临床机构共纳入600例受试者,采集受试者静脉血及末梢毛细血管血,并分别用金准血糖测试系统、罗氏卓越型血糖测试系统(ACCU-CHEKperforma)和YSI葡萄糖乳酸分析仪测试静脉血糖及末梢血糖,其中,金准血糖测试系统共测试3批次试条。以YSI测得的血浆葡萄糖值为参考值评价金准血糖测试系统的准确度,用Consensus误差栅格分析图分析两种测定方法血糖结果的一致性,用线性回归方法分析两者的相关性,采用等效性检验分析金准血糖测试系统与YSI分析仪测试结果的等效性。结果共获得600例患者的血糖值,金准血糖测试各批次试条与YSI的静脉及末梢血糖差值(100%)均落在±0.83 mmol/L(当血糖浓度<5.55 mmol/L)或±15%以内(当血糖浓度≥5.55 mmol/L)。罗氏卓越型血糖测试系统的准确度符合率为99.6%。误差栅格分析图显示,金准血糖测试系统静脉血糖值100%都落在A区,罗氏卓越型99.8%落在A区;金准和罗氏卓越血糖测试系统末稍血糖均100%落在A、B区。金准血糖测试系统各批次试条与YSI测得静脉及末稍血糖值在整体水平上存在直线关系(r≥o.996,R2≥0.993)。罗氏卓越与YSI的线性相关性r≥0.995,R~2≥0.990。等效性检验显示,金准型血糖测试系统对静脉及末梢血糖的测试结果等效于YSI测试系统。结论金准血糖测试系统具有良好的准确度,能反映血糖的真实水平。
Objective To evaluate the accuracy of Go1d AQ produced and marketed by Sannuo Bio-Sensor Co., Ltd. Methods A total of 600 subjects were enrolled in 6 clinical institutions. Venous blood and peripheral capillary blood were collected from the 6 clinical institutions. The blood samples were collected from the patients using the gold standard blood test system, the ACCU-CHEKperforma and the YSI glucose lactate test Instrument test venous blood glucose and peripheral blood glucose, which, the quasi-blood glucose test system test a total of 3 batches of test strips. YSI measured plasma glucose value as a reference value to evaluate the accuracy of the quasi-blood glucose test system, Consensus error grid analysis of the two methods to determine the consistency of the results of blood glucose, linear regression analysis of the correlation between the two, Equivalence test was used to analyze the equivalency of the test results between the gold quasi-blood glucose test system and the YSI analyzer. Results A total of 600 patients were obtained. The difference of blood glucose between the test and YSI was ± 0.83 mmol / L (when the blood glucose concentration was less than 5.55 mmol / L) Or ± 15% (when blood glucose concentration ≥ 5.55 mmol / L). Roche Excellence Blood Glucose Test System accuracy of 99.6%. Error raster analysis showed that 100% of the venous blood glucose of the quasi-blood glucose test system fell in the A area, and 99.8% of the Roche’s excellent fell in the A area. The quasi-Roche blood glucose test system 100% Area B Gold quasi blood glucose test system batches of test strips and YSI measured intravenous and terminal blood glucose levels in the overall level there is a linear relationship (r ≥ 0.992, R2 ≥ 0.993). Roche excellence and YSI linear correlation r ≥ 0.95, R ~ 2 ≥ 0.909. Equivalence tests showed that the quasi-blood glucose test system is equivalent to the YSI test system for venous and peripheral glucose measurements. Conclusion Jin quasi blood glucose test system has good accuracy, can reflect the true level of blood sugar.