Rev AM-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 contr
ol 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 T
race QC algorithm has been pr
ogrammed which evaluates the size, location and signal
to noise ratio of each zone on the device. Aber
rations in zone quality exceeding pr
eset
limits will cause r
ejection of one or mor
e of the assay r
esults.
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