Biosite Triage MeterPro - Quality Assurance Functions

M-2Rev F
care & maIntenance
M-2
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
 • SelfTest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
Internal Device Quality Assurance
The Internal Positive Control Zone is a functional immunoassay. 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 zone for each lot of reagents.
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 low controls and the baseline control and thereby on
the immunoassay, the results are not displayed and erroneous results are not reported.
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.
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.