OLYMPUS全自动生化分析仪性能鉴定

目的探讨全自动生化分析仪的性能鉴定方法和技术要素。方法对OLYMPUS AU2700生化仪进行温度准确度与波动、杂散光、吸光度线性范围、吸光度稳定性、吸光度重复性、吸光度准确度、加样误差、加试剂误差、样品携带污染率、项目准确性、项目的批内精密度和批间精密度等指标进行检查,并与行业标准和厂家说明书标准进行比对。结果孵育温度为(36.84±0.07)℃,波动度0.11℃,5只比色杯杂散光均大于4.10。吸光度线性范围不小于2.5时,各测定值相对偏倚在±5%以内。340、380、480、600 nm 4个波长的吸光度变化均远小于0.01。吸光度重复性CV值为0.450%。2 mL样品分配的精确度整体CV≤1.5%;5 mL样品分配精确度整体CV≤0.8%。内、外圈试剂分配精确度CV分别为0.40%和0.32%。5组测定的平均携带污染率为0.241 1%。ALP、Mg、P、AMY、Ca、AST、TP、ALB 8个项目定值质控的测定结果均在质控靶值±2sd范围之内。批内精密度与批间精密度介于0.953%～4.713%之间。ISE单元电极选择性[Na]=150 mmol/L,[K]=4 mmol/L。结论 OLYMPUSAU2700生化仪的性能符合最新的行业推荐标准,生化仪的性能鉴定应进一步完善与规范。

Study on the OLYMPUS automatic biochemical analyzer

Objective To discuss the method and indicators of the technical performance of the automatic biochemical analy-zer. Methods Check the accuracy and fluctuation of temperature , stray light, the range of the absorbance, repeatability and accu-racy of the absorbanee, sampling error, reagent error, sample carrying contamination rate, accuracy of the assays, and the intra and inter circle precision. Then,the results were compared with the industry standards and the manufacturer's instructions. Results The incubation temperature is 36.84±0.07 ℃ and the fluctuation of temperature is 0. 11 ℃. The stray light of the five colori-metric cups is over 4. 10. The relative bias is within±5% when the linear range of the absorbance is over 2.5. The changes of the absorbanec are all far below 0.01 for the wavelength of 40nm,380nm,480nm and 600nm. The CV of absorbance repeatability is 0. 450%. The average CV is below 1.5% for the distribution of 2 mL sample and below 0. 8% for that of 5 mL sample. The CV of the reagent distribution is 0.40% and 0.32% for the inner and outer colorimetric cups respectively. The average sample carrying con-tamination rate of all the 5 groups is 0.2411%. The detection results of the control are all within the range of ±2SD for the assays of ALP、Mg、P、AMY、Ca、AST、 TP and ALB. The intra and inner CV is within 0. 953%～4.713%. The selective of the ISE unit is 150 mmol/L for Na and 4 mmol/L for K. Conclusion the technical performance of OLYMPUS AU2700 agrees with the newest in-dustry standards, and the evaluation of the technical performance for the automated biochemical analyzer should be further perfec-ted and standardized.