体外诊断试剂质量评价方案建立初探.docxVIP

体外诊断试剂质量评价方案建立初探

摘要】目的：探讨体外诊断试剂质量评价方案的建立，为本院选择性价比高的体外诊断试剂提供参考依据。方法：以四川新健康成生物股份有限公司生产的肌酐测定试剂盒（肌氨酸氧化酶法）为例,通过对该试剂的试剂空白、批内精密度、测定范围、分析灵敏度和准确度的检测，对结果进行综合分析，建立体外诊断试剂质量评价方案。结果：本次检测结果可见，试剂空白≤0.0075；批内精密度≤2.78%；测定范围相关系数r=0.9998，在[0.0，70.0]μmol/L区间内，︱绝对偏差︱≤4.5μmol/L，在[70.0，10608.0]μmol/L区间内，︱相对偏差︱≤4.84%；分析灵敏度≥0.0275；准确度︱相对偏差︱≤3.18%。结论：通过建立合理的体外诊断试剂质量评价方案，有利于更加准确的掌握产品质量，选择性价比高的产品，减轻患者负担并为临床疾病的诊断提供更可靠的辅助支撑。

【关键词】体外诊断试剂；试剂空白；批内精密度；测定范围；分析灵敏度；准确度

【中图分类号】R608??????????【文献标识码】A??????????【文章编号】1007-8231（2015）05-0099-03

TopreliminaryexploreestablishmentofqualityevaluationschemeoftheIVD???NongLan-zhi.

(ThelaboratorymedicineofthematernalandchildhealthhospitalofTiandeng,Guangxi.China,532800)

【Abstract】Objective?TopreliminaryexploreestablishmentofqualityevaluationschemeoftheIVD,inordertoprovidereferencefortheselectionofthehighcostinvitrodiagnosticreagents.Method?Forexampleofthecreatinineassaykitbysarcosineoxidasemethod,bytestingthereagentblank,batchprecision,determinationrange,analysissensitivityandaccuracy,andtheresultswereanalyzedcomprehensively,andtoestablishqualityevaluationmethodoftheIVD.Results?Thedetectionresultscouldbeseenthat,thereagentblankwasnomorethan0.0075;thebatchprecisionwasnomorethan2.78%;therwas0.9998,inthe[0.0，70.0]μmol/L,theabsolutedeviationabsolutevaluewasnomorethan4.5μmol/L,inthe[70.0，10608.0]μmol/L,theabsolutevalueofrelativedeviationwasnomorethan4.84%;theanalysissensitivity?wasnolessthan0.0275;theaccuracywasnomorethan3.18%.Conclusion?Throughtheestablishmentofareasonableevaluationmethodforthequalityofinvitrodiagnosticreagents,itisadvantageoustomastertheproductqualitymoreaccurately,selecttheproductwithhighperformancepriceratio,reducetheburdenofpatientsandprovidemorereliablesupportforthediagnosisofclinicaldiseases.

【keywords】IVD;Reagent