血清基质金属蛋白酶-3检测试剂盒用于MODULAR P800型全自动生化分析仪中的性能评价

A performance evaluation about detection kit of MMP-3 in MODULAR P800 fully automatic biochemical analyzer

目的:评价MODULAR P800型全自动生化分析仪应用定量检测基质金属蛋白酶-3(MMP-3)方法的分析性能。方法:依据国家系列行业标准及国际指南要求,对MMP-3试剂盒在MODULAR P800型生化分析仪应用中的不精密度、准确度、灵敏度、线性范围、临床可报告范围、生物参考区间及抗干扰能力进行全面评价;采集表观健康体检者男性、女性各65名的血清标本,验证试剂盒说明书中的生物参考区间。结果:低浓度(30 ng/ml)及高浓度(160 ng/ml)两个水平MMP-3质控品日内不精密度分别为4.6%和1.2%,日间不精密度分别为5.8%和2.3%,均低于厂商的日内不精密度10%及日间不精密度10%;不同浓度校准品测量结果与靶值相比偏差均<3%;验证定量检出限为10 ng/ml;线性范围和临床可报告范围分别为10~1600 ng/ml和10~8000 ng/ml,表观健康体检者的血清标本验证结果中,只有2名的标本超出试剂盒说明书中生物参考区间,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<20 mg/dl、结合胆红素<20 mg/dl,血红蛋白<500 mg/dl,乳糜<2000 FTU(福尔马肼浊度)对检测结果影响轻微。结论:Modular P800型全自动生化分析仪测定血清MMP-3的分析性能与厂商数据一致,符合临床要求,可以应用于临床。

Objective:To evaluate the analysis performance of the method of MODULAR P800 fully automatic biochemical analyzer in quantitative detecting matrix metalloproteinase-3(MMP-3).Methods:According to the requirements of series of national industrial standards and international guidelines,to implement comprehensive evaluation for series of performance characteristics,such as imprecision,accuracy,sensitivity,linearity or analytical measurement range(AMR),clinical reportable range(CRR),biological reference intervals and anti-interference ability,of MMP-3 kit that was used in the Roche/Hitachi Modular P800 automatic biochemical analyzer.The serum samples of male(65 cases)and female(65 cases)with apparent healthy who received physical examination were collected,and the biological reference interval of kit specification was verified.Results:The within-day imprecision of the two levels(low concentration:30ng/ml and high concentration:160ng/ml)of MMP3 quality control were 4.6%and 1.2%respectively.And the inter-day imprecision of them were 5.8%and 2.3%respectively,and all of them were lower than those of the manufacturer's imprecision statement,which was 10%for within-run imprecision and 10%for inter-day impression.And calibration results showed the biases between different concentrations of calibrators and target value were less than 3%.And the limit of quantitative(LoQ)of verification was 10 ng/ml.And AMR and CRR were 10-1600 ng/ml and 10-8000 ng/ml respectively.In the verification results of serum samples of persons with apparent healthy,only two results exceeded biological reference interval of kit specification,and the verification results were passed.The detection results that adopted commercialization interference standard materials showed that the influences were slight when free bilirubin was less than 20mg/dl,and conjugated bilirubin was less than 20mg/dl,and hemoglobin was less than 500 mg/dl and chyle was less than 2000FTU(Formazin turbidity).Conclusion:The performance characteristics of Roche/Hitachi modular P800 analyzer in detecting MMP-3 are consistent with the manufacturer's statements and they also meet the clinical requirements.And it can be used in clinical measurement.