对罗氏E601化学发光仪光子数降低检测结果准确度的验证

The verification of the test results accuracy in the Roche E601 chemiluminescence instrument photo number decreasing

目的：通过对罗氏E601电化学发光分析仪准确度的验证，探讨仪器光子数的改变是否对结果有影响。方法：分析检测项目光子数与罗氏厂家提供的光子数的差别，包括项目：FT3（游离三碘甲状腺原氨酸）、FT4（游离甲状腺素）、FSH（促卵泡生成素）、LH（促黄体生成素）、E2（雌二醇）、PRL（泌乳素）、INS（胰岛素）。批内精密度用罗氏提供的中高两个质控水平连续20次重复性实验，批间精密度每天两个水平检测，连续检测20d；携带污染率用病人高值混合血清；准确度分别用罗氏提供定值不同批号定标液和2013卫生部第二次室间内分泌质控品验证。结果：在定标光子数部分低于罗氏厂家提供的范围的情况下，批内、批间CV〈10%，均小于试剂盒声明的不精密度，携带污染率对检测结果无影响，准确度用不同批号定标液和2013卫生部第二次内分泌质控作比对，检测值与靶值相对偏差（Bias）可以接受。结论：罗氏E601电化学发光分析仪在光子数降低的情况下，准确度是可靠的，可以延缓更换检测池。

Objective：To investigate the lipid levels of four different occupational populations including teachers, police, Bank clerks and civil servants in FOSHAN, and provide the basis for different occupational population to prevent cardiovascular disease.Methods： To analysis the photon number detection project photon number the differences with Roche manufacturers to provide, including the project： FT3（Free three iodothyronine）,FT4（free thyroxine）, FSH （follicle stimulating hormone）, LH （luteinizing hormone）, E2 （Estradiol）, PRL （lactation element）, INS （insulin）. batch precision with 20 consecutive experimental repeatability by Roche to provide medium and high quality control standards, detection of inter batch precision every two levels, continuous detection of 20d; contamination rate by high value mixed serum of patients; accuracy respectively by Roche to provide fixed value different batches of calibration solution and the Ministry of health 2013 second room endocrine QC verification. Results：In the range of calibration of photon number part below the Roche manufacturers provide the case, within group, between group CV〈10%, were less than kit statement imprecision, carryover effects on no result detection, precision with different batches of calibration solution and 2013 Ministry of health second times endocrine quality control to compare, detection value and target value relative deviation （Bias） can accept.Conclusions： The Roche E601 chemiluminescence instrument in photon number reduced circumstances, the accuracy is reliable, can delay the replacement of the detecting pool.