国产全自动化学发光测定仪检测糖类抗原242和糖类抗原50的分析性能验证

The Verification of Analytical Performance of Sugar Antigen 242 and Sugar Antigen 50 Detected by Domestic Automatic Chemiluminescence Assay

目的在ISO15189实验室认可中对深圳新产业全自动化学发光测定仪Maglumi4000Plus检测糖类抗原242和糖类抗原50的分析性能进行验证。方法参考美国临床和实验室标准化协会(CLSI)系列文件和相关文献,结合实际工作,对深圳新产业全自动化学发光测定仪Maglumi4000Plus检测糖类抗原242和糖类抗原50的精密度、正确度、线性范围、临床可报告范围和生物参考区间进行验证。结果CA242批内精密度和批间精密度CV均小于厂家声明,CA50批内精密度和批间精密度CV均小于厂家声明,验证通过;CA242的5个不同批号的室间质控品测量值与靶值的偏倚为5.25%~11.74%,CA50的5个不同批号的室间质控品测量值与靶值的偏倚为6.53%~12.47%,均在可接受范围内;CA242浓度在1.78~195.00IU/mL范围内其测定的线性相关系数R2为0.9995,CA50浓度在7.09~498.27IU/mL范围内其测定的线性相关系数R2为0.9999;CA242的临床可报告范围上限可扩展至3120.00IU/mL,CA50的临床可报告范围上限可扩展至为7972.32IU/mL;20名健康体检者检测CA242的浓度范围为0.97~10.38IU/mL,20名健康体检者检测CA50的浓度范围为0.50~18.62IU/mL。结论深圳新产业全自动化学发光测定仪Maglumi4000Plus检测CA242和CA50的精密度、正确度、线性范围、临床可报告范围、生物参考区间均和厂家声明基本一致,能够保证检测结果的准确,满足临床检验的需要;而且国产试剂较进口试剂价格低廉,能够降低医疗成本,可以在临床实验室推广使用。

Objective To verify the analytical performance of carbohydrate antigen242 and carbohydrate antigen50 detected by automatic chemiluminescence analyzer Maglumi 4000 Plus and evaluate through ISO 15189 laboratory accreditation.Methods Based on series of documents from American association for clinical and laboratory standardization(CLSI)and related literature,as well as our practical work,The Shenzhen manufactured new industrial automatic chemiluminescence detector Maglumi 4000 Plus was used to test carbohydrate antigen242 and carbohydrate antigen50.The precision,accuracy,linear range,clinical reportable range and biological reference range were measured for validation.Results Internal precision and inter-batch precision CV of CA242 batches were less than manufacturer′s statement,and internal precision and inter-batch precision CV of CA50 batches were less than manufacturer′s statement.The deviation between the measured values and the target values of the five different batches of CA242 was from 5.25%to 11.74%,while the deviation between the measured values and the target values of 5 different batches of CA50 was from 6.53%to 12.47%,which were all within the acceptable range.The linear correlation coefficient( R 2 )of CA242 in the range of 1.78-195.00IU/mL was 0.9995,The linear correlation coefficient( R 2)of CA50 in the range of 7.09-498.27IU/mL was 0.9999.The upper limit of clinical reportable range of CA242 could be extended to 3120.00IU/mL,while the upper limit of clinical reportable range of CA50 could be extended to 7972.32IU/mL.The concentration of CA242 detected by 20 healthy subjects ranged from 0.97IU/mL to 10.38IU/mL.The concentration range of CA50 detected was 0.50-18.62IU/mL.Conclusion The precision,accuracy,linear range,clinical reportable range and biological reference range of CA242 and CA50 detected by Maglumi 4000 Plus are consistent with the manufacturer′s statement,which can ensure the accuracy of test results and meet the needs of clinical testing.Moreover,since the domestic reagents are cheaper than imported reagents,this system can reduce medical costs and be widely used in clinical laboratories.