YY/T0654-2008标准对全自动生化分析仪的性能评价

Performance evaluation full automatic chemistry analyzer according to the standards of YY/T0654-2008

目的 应用我国医药行业标准YY/T0654-2008对国产全自动生化分析仪的工作性能进行全面性能评价.方法 采用中华人民共和国医药行业标准YY/T0654-2008〈全自动生化分析仪Automatic chemistry analyzer〉对国产全自动生化分析仪进行了杂散光、吸光度线性范围、吸光度准确度、吸光度稳定性、吸光度重复性、样品携带污染率、加样准确度与重复性、临床项目批内精密度等性能指标进行了检测.结果 该仪器杂散光符合要求,吸光度线性范围0.000-3.827A,吸光度准确度、稳定性符合要求,吸光度重复性CV%为0.28%,样品携带污染率0.13%,ALT、UREA、TP三个项目的批内精密度变异系数（CV%）分别为2.50%、1.84%和1.08%.结论 通过一系列实验的测试,国产全自动生化分析仪各项指标参数均符合行业标准YY/T0654-2008的要求.

Objective To evaluation the measurement characteristic of domestic - made CS- 800B automatic chemistry analyzer according to the trade standards of YY/T0654 - 2008. Methods According to the trade standards （YY/T 0654 - 2008 ）, the China - made automatic chemistry analyzer＇ s stray light, absorbance linearity, absorbance accuracy, absorbance stability, absorbanc repeatability, sample - to - sample carryover rate,sample pipetting precision and aectrracy, reagent pipetting precision and accuracy, the withinrun precision of ALT, TP and UREA were be evaluated. Results The stray light, absorbance accuracy and absorbance stability of the China - made automatic chemistry analyzer was conform to the trade standards - YY/T0654 - 2008. The absorbance linearity range was 0.00 - 3. 827Abs. The coeff/cient variation of absorbanc repeatability was 0.28%. The sample- to- sample carryover rate was 0.13%. The within - run eoeffleient variation of .ALT, UREA and TIP was 2.50 %, 1.84 %, 1.08 %. Conclusion The measurement characteristic of evalualed China - made automatic chemistry anaiyzer fit in with the trade standards request.