Quidel Triage MeterPro - Meter Quality Assurance; Software Quality Assurance

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lowcontrolsandthebaselinecontrolandtherebyontheimmunoassay,theresultsarenotdisplayedand
erroneousresultsarenotreported.
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TheTimingControlZonemonitorsassaycompletion.Ifaninadequateamountofspecimenisaddedtothe
testdeviceorifaspecimenclotsinthedevice,this
controlwillpreventthedisplayoftheresults.
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ATraceQCalgorithmhasbeenprogrammedwhichevaluates the size,locationandsignaltonoiseratioof
eachzoneonthedevice.Aberrationsinzonequalityexceedingpresetlimitswillcauserejectionofoneor
moreoftheassayresults.
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MeterQualityAssurance
TheSelfͲTestModeisinitiatedeachtimethemeteristurnedON.IntheselfͲtestmodethemeterscansan
InternalCalibrationChip.Eachcalibration chipscanisusedtovalidateandadjust,ifnecessary,themeter
calibration.IntheselfͲtestmode,theavailablememoryforpatientresults
ischecked.Whenthecapacityis
belowapreͲsetlimit,theremainingcapacityisrelatedviaascreenmessage.Thesoftwareprogramis
evaluatedandisterminatedifcorrupted.SoftwaretestresultsandCODECHIPmoduledataareverifiedfor
integritybeforeeachuse.
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AQCDeviceisprovided
witheachmetertoallowtheusertofurtherchecktheintegrityofthemeter.The
simulatorcontainssixfluorescentzonesofvaryingintensitythataremeasuredbythemeter.TherearepreͲ
programmedacceptablerangesforthesixzones.Inaddition,thezonesallowthemetertocheckfor
horizontalandverticalalignmentofthezonemeasurementtoverifylaseralignmentanddevicetransport.
TheQCDevicealsoconfirmslaserstability.
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ABarCodeisprintedonthebottomofeverytestdevicetoidentifythereagentlotnumberandtoprevent
theuseofexpiredreagents.
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SoftwareQualityAssurance
ThesoftwareQAiscontrolledthroughavarietyofsoftwarefeatures,someofwhichcanbeoptional
dependingontheenvironmentinwhichtheassayisperformed.InaPointͲofͲCarelocation,adesignated
supervisorcanselectprogramparameterstoensureadherencetoqualitystandards.Inacentrallaboratory
location,
selectedparameterscanbebypassedifdesired.
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ASupervisorCODECHIPmoduleisprovidedwitheachmeter.ThisCODECHIPmoduleallowsaccessto
meterfunctionsnotavailabletotheroutineuser.Theadditionalfunctionsareselectionofparameter
settingsanddownloadingandde letionofresultsfromthemetermemory.
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AUserIDcanbeassignedinthesoftwaretolimitaccesstothepatienttestingmodetoonlythose
individualswhohavebeenproperlytrainedandhavedemonstratedtestingproficiency.AUserIDand
expirationdateareprogrammedintothemetermemoryandaresubsequentlyassociatedwithallpatient
resultsgeneratedbytheuser.Thisallowsthesupervisortoreviewusers’testingfrequency,andintheevent
offrequenttestfailures,toidentifypotentialproblemsintraining.
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AnadditionalsecurityfeatureoftheUserIDisthepartialmaskingoftheIDondisplaysandprintouts.This
preventsunauthorized
individualsfromdetectingandusinganexistingUserID.Thisfeatureisoverridden
whentheSupervisorCODECHIPmoduleisinstalled.
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