摘要
目的评价日本积水公司血清人唾液化糖链抗原6(KL-6)检测试剂盒在罗氏MODULAR P800全自动生化分析仪上的分析性能。方法参照国内行业标准及国际指南的要求,对血清KL-6检测试剂盒在罗氏MODULAR P800生化分析仪上的不精密度、正确度、分析检测范围、临床可报告范围、检测限、生物参考区间验证及抗干扰能力进行全面评价。结果低值和高值2个水平的KL-6质控品日内不精密度分别为3.15%和0.98%,日间不精密度分别为4.99%和1.66%,均低于厂商声明的标准。校准验证结果显示,不同水平校准品测量结果与偏差均<2%。线性范围和临床可报告范围分别为50~5000U/mL和50~15000U/mL;验证定量检测限(LoQ)为50.0U/mL。以表观健康体检成人各74例的血清标本验证试剂说明书声明生物参考区间,结果只有3例超出,符合率为95.9%,验证通过。采用商业化干扰标准物质检测结果显示,在游离胆红素20mg/dL以下,结合胆红素20mg/dL以下,血红蛋白500mg/dL以下,乳糜微粒2000FTU以下对检测结果影响轻微。结论日本积水公司血清KL-6检测试剂盒在罗氏MODULAR P800全自动生化分析仪上的分析性能与厂商声明一致,符合临床要求,本检测系统可应用于实验室临床标本检测。
Objective To evaluate the analytical performance of serum salivary liquefied sugar chain antigen6(KL-6)detection kit of Japan Jishui Company on Roche MODULAR P800 automatic biochemical analyzer.Methods Referring to the requirements of domestic industry standards and international guidelines,inaccuracy,accuracy,analytical detection range,clinically reportable range,detection limit,biological reference range validation and anti-interference ability of serum KL-6 test kit on Roche MODULAR P800 biochemical analyzer were comprehensively evaluated.Results Two levels of KL-6 quality control products were 3.15%and 0.98%in-day precision,4.99%and 1.66%in-day precision,respectively,which were lower than the standard declared by the manufacturer.The calibration verification results showed that the measurement results and deviations of calibrators with different concentrations were less than 2%.The linear range and the clinically reportable range were 50-5000 U/mL and 50-15000 U/mL respectively.The validation quantitative detection limit(LoQ)was 50.0 U/mL.The bio-reference interval was declared in the specifications of validation reagents for 74 adult serum samples of apparent health examination.Only 3 cases exceeded the bio-reference interval,and the coincidence rate was 95.9%.The validation was successful.The results of commercial interference standard substance test showed that the results of free bilirubin 20 mg/dL,conjugated bilirubin 20 mg/dL,hemoglobin 500 mg/dL and chyle particles 2000 FTU had slight influence on the test results.Conclusion The analysis performance of serum KL-6 test kit of Japan Jishui Company on Roche MODULAR P800 automatic biochemical analyzer is consistent with the manufacturer′s statement and meets the clinical requirements.The detection system can be applied to laboratory clinical specimens detection.
作者
岳道远
邓玲艳
王旭
潘莹莹
胡卫红
YUE Daoyuan;DENG Lingyan;WANG Xu;PAN Yingying;HU Weihong(Department of Clinical Laboratory,Tongji Hospital Affiliated to Tongji Medical College,Huazhong University of Science and Technology,Wuhan,Hubei 430030,China)
出处
《国际检验医学杂志》
CAS
2019年第22期2786-2790,共5页
International Journal of Laboratory Medicine
关键词
唾液化糖链抗原
不精密度
正确度
可报告范围
生物参考区间验证
salivary liquefied sugar chain antigen
inaccuracy
accuracy
reportable range
biological reference interval validation
