PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
Assays/Reagents
AEROSET
®
System Troubleshooting Guide
123
94816-107—November 2004
Is the assay number for the new CRP assay the
same as the original CRP assay?
Yes. However, this it not an issue because the
“original” CRP assay was never released to
customers.
A new Import Disk—Serum Proteins
Version 2.0 was released with the new CRP
assay.
Conv Units SI Units
Old Import Disk LN 4E43-03
4E43-06
New Import Disk LN 2K89-02
2K90-02
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 CRP 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 done 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 CRP R2
reagent have any impact on instrument
dispense components?
No impact was observed over several years of
internal product evaluation.
Did the CRP 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.
Frequently Asked Questions (FAQ) (Continued)
Question
Answer
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