PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Assays/Reagents
Not for Customer Distribution
166
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
Why does the RF assay have a Reaction Check
programmed but the CRP assay does not?
The shape of the RF progress curve allows for
use of the Reaction Check feature. At
concentrations > 30 mg/dL, the CRP progress
curve does not demonstrate enough
difference in Read Times A & B for the
Reaction Check flag to detect each
occurrence. However, it was verified that the
EXT and High flags work appropriately with
CRP.
Why do AEROSET RF control means listed in
the Precision section of the package insert not
match those for
c
8000
®
?
Precision studies for the AEROSET and
c
8000
Systems were performed at different times
with different lots of control material. The
lots are referenced as Lots A and B in the
package insert to note this difference.
Does the milky composition of the RF R2
reagent have any impact on instrument
dispense components?
No impact was observed over several years of
internal product evaluation.
Did the RF assay cause any build-up in the
high-concentration waste pump manifold
tubing?
No impact was observed over several years of
internal product evaluation.
If a reagent kit was not mixed properly before
use then discovered after the fact, would it be
acceptable to mix and run controls to
determine whether to continue use? The
amount of volume used for testing prior to
mixing would have some impact on the
suitability for use, but is it correct that we
have only control performance to use in
evaluating that?
It would be acceptable to continue if only a
small quantity of reagent was used. You would
not want the ratio of liquid reagent and
concentration of the microparticles to change
in the R2 cartridge. The cartridge should be
mixed by gentle inversion, then evaluate
controls.
As the lamp ages and performance
diminishes, should we assume that results will
increase for this assay? Logically, less lamp
intensity would translate as additional
turbidity, and therefore higher concentration.
Were any study data generated with a
diminished lamp?
A specific study has not been performed to
evaluate diminished lamp intensity.
Frequently Asked Questions (FAQ) (Continued)
Question
Response