诊断试剂加速稳定性试验方案Attachment-VII-Test-Protocol-for-Accelerated-Stability-Test20160202[1].docx

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1、TestProtocolforAcceleratedStabilityTest1. TestObjectiveTheacceleratedstabilitytestisperformedtodeterminethevalidperiodoftheAdvancedQualityiwOneStepEbolaTest.2. PrincipleThetestwasbasedonthemodelArrheniusModelofhightemperatureacceleratedtest.Theaccelerationfactorisexpressedas:AF=exp(Eak)*(lTh)-(lTs)l

2、+(RHu11-RHsii),where,Ea:thestartenergy(eV),K:theboltzmann,sconstantandk=8.6*10E-5eVK,T:theabsolutetemperature,RH:therelativehumidity(in%),Thesubscriptu:thenormalstate,Thesubscripts:wastheaccelerationstate(e.g.Rhunreferredtothenpowerofrelativehumidityundernormalstate),n:generallynwas2.Sincetheproduct

3、ispackedinaluminumfoilbags,thehumidityfactorwasnotconsidered;theproductisstoredunder2-30oC,andthetemperatureofacceleratedstabilitytestis50C.thentheaccelerationfactorAF=exp(0.8*1058.6)*(1/(273+30)-1/(27350)=6.69242,anditcanbecalculatedthat,for24monthsofvalidperiod,thelimeforacceleratedtestat50is:24mo

4、nths6.69242=3.586months.3. MaterialsandMethods3.1 MaterialsAdvancedQualityOneStepEbolaTest,lotnumber:1.ot#1:Lot#2:Lot#3:1.ODqualitycontrol1,preparedbyNPantigen1fromWuhanInstituteofVirology,CAS;1.ODqualitycontro!2,preparedbyNPantigen2(fromFitzgeraldIndustries):3.2 Steps3.2.1 Storethethreebatchesofrea

5、gentsat50forupto4months;3.2.2 Whenstoredat50for0months,1months,2months,3months,4months,thethreebatchesofreagentsweretestedbythequalitycontrols,toinvestigateproducts5performancecharacteristicsofqualitycontrols.3.2.3 Testingwithqualitycontrols:ThetestresultofLODqualitycontrol1waspositive;ThetestresultofLODqualitycontrol2waspositive;4.TestResults4.1Testresultofstorageat50LotNo.TestresultOmonthstorage1monthsstorage2monthsstorage3monthsstorage4monthsstorage5.Conclusions