The analyzer's software incorporates statistical methods to ensure accurate results. The lamp
flashes up to 13 time points for rate chemistries, and typically three time points for endpoint
chemistries. To ensure that the analyzer is functioning properly, the distribution of flashes at
each time point is analyzed, and the standard deviation is compared to a pre-determined
limit.
2.
Quality Control During Analysis
During analysis, the analyzer checks its internal components and the reagent rotor to ensure
the accuracy of the results.
a. Analyzer
Before analysis begins, the analyzer's photometer takes readings with the light path
obstructed and unobstructed to determine the appropriate light intensity range, and then
checks that the range is within specification. It also continually checks the performance
of the motor, flash, and optics during analysis.
b. Reagent Rotor
During analysis, the analyzer tests the reagent rotor to confirm the following:
Each rotor contains reagents to detect exposure to extreme conditions such as tempera-
ture and humidity. The message
reagents are within the expected ranges. Otherwise, no results are printed and a "run can-
celed" message appears in the display.
The analyzer monitors the performance of the reactions. For rate chemistries, the ana-
lyzer confirms that the reactions are linear with time, that the slope is within range, and
whether the substrate has been depleted. In endpoint chemistries, the analyzer verifies
the flatness (completeness) of the endpoints.
7-2
calibration factors
expiration date
all reagent beads are present
timing of fluid movement through the rotor
diluent and sample mixing
sufficient sample in the rotor
reagent beads dissolve when mixed with diluted sample
Calibration and Quality Control
is printed in the results when results from these
QC OK