Quidel Triage MeterPro - Quality Assurance Functions; Internal Device Quality Assurance

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additionalreagents.Eachdevicecontainsafullcompleme ntof reagentsthatarerequiredtoperformthe
immunoassay.
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TheQuidelTriagetestshavebeendesignedtoincludeassaycontrolsineachtestdevicethatmonitorthe
assayprocedureandthereagentintegrity.Theassaycontrolspresentauniqueandvaluableextensionto
thetraditionalapproachtoqualitycontrolusingliquidreagents.Iftheproductisstoredunderspecifie d
conditions,
properfunctioningoftheassaycontrolsindicatesthatthetestdeviceisvalidandproper
adherencetoassayprotocolhasbeenfollowed.TheassaycontrolsintheQuidelTriagetestsrequirethe
needtoreͲthinkthefrequencywithwhichexternalqualitycontrolspecimensshouldbetested.
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TheQuidelTriage
testshavebeendesignedtoyieldlong Ͳtermreagentstability.Inaddition, thesystem
providesqualitycontrolparametersinthreeseparateanddistinctcategories:
 Internaldevicecontrols
 Meterelectroniccontrols
 Softwarecontrols.
Thecombinationofthesequalitycontrolfeaturesprovides moreinformationaboutthevalidityofeach
assaythancanbeprovidedbythemoretraditionalmethodsofreagentandassayprocedurevalidation.
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QualityAssuranceFunctions
1. InternalDeviceQualityAssurance
 InternalPositiveControlZone
 BaselineControlZone
 TimingControlZone
 ZoneQualityRequirements(TraceQC)
2. MeterQualityAssurance
 SelfͲTestMode
 InternalCalibrationChip
 ElectronicQCDevice
 BarCode
3. SoftwareQualityAssurance
 SupervisorCODECHIP
module
 UserID#
 PatientID# 
 Resultmemorystorage
 QCFrequency
 QCLockouts 
4. QualityControlSamples
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InternalDeviceQualityAssurance
TheInternalControlZonesarebuiltͲin functionalimmunoassays.Thiscontrolverifiesthatthedevice
functionedproperlyandthattheassaywascorrectlyperformed.TheInternalPositiveControlZoneensures
thattheantibodies,thereagentreconstitution,thetimegateandthedeviceflowarefunctioning properly.
Themanufacturersetsacceptablerangesfor
thecontrolzonesforeachlotofreagents.
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TheBaselineControlZonemonitorsthepresenceofinterferingsubstancesinthepatientsamplethat may
altertheimmunoassayprocess.Ifaspecimencontainsasubstancethathasamajoreffectonthehighand