亚辉龙iflash3000A化学发光仪检测乙肝病毒血清标志物性能评价

Performance evaluation of detection system of Yahuilong iflash3000A chemiluminescence instrument

目的:对亚辉龙iflash3000A化学发光仪开展的项目进行性能评价。方法:参照厂家声明的标准及美国临床实验室标准化协会(CLSI)系列文件对乙型肝炎病毒血清标志物检测项目的精密度、分析测量范围、正确度、携带污染率进行性能评价。结果:iflash3000A对血清标志物检测项目的批内精密度和批间精密度均符合性能评价的要求;分析测量范围验证的回归方程均符合斜率在0.97~1.03内以及相关系数r≥0.975(或r^(2)≥0.95)的要求;正确度验证结果各项目的符合率均在判定标准要求内;携带污染率验证结果≤10^(-6)。结论:iflash3000A所有检测项目均符合主要性能指标评价要求,可以保证实验室以上检测项目结果的准确可靠,为临床对乙型肝炎病毒的感染情况进行诊断、治疗、预后提供准确的检测结果。

Objective:To evaluate the performance of the project carried out by the Yahuilong iflash3000A chemiluminescence instrument.Methods:The performance,accuracy,analytical measurement range,accuracy,and carry-over contamination rate of hepatitis B virus serum marker test items were evaluated with reference to the manufacturer′s declared standards and the American Society of Clinical Laboratory Standards(CLSI)series documents.Results:Iflash3000A′s intra-batch precision and inter-batch precision of serum marker test items met the requirements of performance evaluation;the regression equations verified by the analysis and measurement range were consistent with the slope within the range of(0.97~1.03)and the correlation coefficient r≥0.975(or r^(2)≥0.95),the conformity rate of each item of the correctness verification result is within the requirements of the judgment standard;the verification result of the carryover pollution rate≤10^(-6).Conclusion:All the test items of iflash3000A meet the requirements of the main performance index evaluation,which can ensure the accuracy and reliability of the test items above the laboratory and provide accurate test results for clinical diagnosis,treatment,and prognosis of hepatitis B virus infection.