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目的按照JCI认证标准对床旁检验(Point of Care Testing,POCT)血糖仪进行定期评价和有效管理。方法将35台POCT血糖仪进行编号,分别用低浓度和高浓度质控品连续检测20次,计算变异系数,评价血糖仪检测重复性。不同血糖浓度的临床标本同时用POCT血糖仪和全自动生化分析仪测定,对检测结果进行比对分析。结果在重复性检测中,血糖浓度<4.2 mmol/L时35台血糖仪的变异系数在2.99%~7.14%,血糖浓度≥4.2 mmol/L时的变异系数在4.47%~7.20%。连续3次比对试验中,POCT血糖仪的合格率分别为77.1%,82.9%和94.3%。结论采用JCI认证标准对POCT血糖仪进行质量控制和持续改进,有效保证了医疗和患者的安全。
Objective To evaluate and manage the Point of Care Testing (POCT) blood glucose meter regularly according to the JCI certification standard. Methods 35 POCT blood glucose meters were numbered and continuously tested with low and high quality controls for 20 times respectively to calculate the coefficient of variation and to evaluate the repeatability of the blood glucose meter. Clinical samples with different blood glucose concentrations were simultaneously measured by POCT blood glucose meter and automatic biochemical analyzer, and the test results were compared and analyzed. Results The coefficient of variation of 35 blood glucose meters was 2.99% -7.14% at glucose concentrations <4.2 mmol / L and 4.47% -7.20% at glucose concentrations ≥ 4.2 mmol / L. The success rate of POCT blood glucose meter was 77.1%, 82.9% and 94.3% respectively in three successive comparison tests. Conclusion The quality control and continual improvement of POCT blood glucose meter using JCI certification standard have effectively ensured the medical and patient safety.