PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Assays/Reagents
Not for Customer Distribution
86
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
)
Frequently Asked Questions (FAQ)
Question
Response
Why are linearity claims only up to the
highest calibrator?
•
Non-linear assays (C3, C4, Hapt, IgA, IgG,
IgM, and TRF):
accuracy by recovery
cannot be guaranteed beyond the highest
calibrator. The AEROSET System uses %EXT
to prevent extrapolation.
•
Linear assays (ApoA, ApoB, and PAlb):
accuracy above the highest calibrator is
dependant on calibrator concentrations,
which vary from lot to lot. The AEROSET
System uses %EXT to prevent
extrapolation. Although R&D testing
supports linearity beyond the highest
calibrator, linearity was defined up to the
high calibrator. Data from a large cohort of
samples indicate very few samples will
exceed the highest calibrator
concentration.
Why are calibration modes for ApoA, ApoB,
and PAlb linear if the calibration curves are
not straight?
Although the graphs appear non-linear for
these assays, the calibrations approximate a
linear response close enough to ensure
accurate results across the calibration range.
Therefore, the calibration modes were defined
as linear for each of these assays.
When the Specific Proteins assays were
originally launched for the AEROSET System,
only two levels of controls were run for
precision. Why are three levels of controls
now included for precision?
• Commercial trilevel controls were used for
the ARCHITECT
®
c
8000
®
precision testing.
The Level 3 control is approximately the
same concentration as the Level 2 control
used in original AEROSET testing.
• The revised package inserts now include a
combination of AEROSET and/or
c
8000
data. The data were selected based on the
highest total %CV for each control level,
independent of the instrument on which
they were tested.
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