PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Assays/Reagents
Not for Customer Distribution
122
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
The CRP R2 reagent contains latex
microparticles. Is inversion of R2 reagent
required before every run to ensure the
particles do not settle?
Inversion is not required before running the
test. The latex microparticles are very small
and remain suspended after the R2 cartridge is
initially inverted and placed on the Reagent
Carousel.
Although a specific study was not performed,
we suspect the carousel movement keeps the
microparticles suspended.
How much control variability should be
observed between reagent lots of the CRP
assay?
The CRP assay was tested with a minimum of
three lots. These lots included freshly
prepared reagent, and one nearing the
expiration date. Minimal variability in
controls was observed. Control ranges (also
called Action Limits) were not reset with a
change in reagent lot.
How would results be affected if reagent kits
are inadvertently frozen during delivery? The
package insert does not address this issue.
The customer should check QC performance.
Freeze/thaw studies by the OEM supplier
support acceptable performance with frozen
material.
Will customers have an issue if there are not
enough Abbott assay users when results from
a proficiency survey are compared to other
manufacturers’ CRP assays?
OPEN QUESTION – Under evaluation.
We do not have data for this. However, CAP
Proficiency Survey specimens were recently
run at Abbott, as they are for all on-market
products. We will review the results and
communicate them internally when
published by CAP.
Were gel barrier tubes tested for use with the
CRP assay?
A study has not yet been performed with gel
barrier tubes. However, this will be considered
for a future study.
If CRP is not inverted before use, what errors
are observed?
A specific study has not been performed.
However, if latex particles have settled to the
bottom of the reagent cartridge and are not
pipetted, it is possible that low absorbance
values could be observed.
Is the Hitachi method for CRP a turbidimetric
method?
Boehringer Mannheim reagents for use on
Hitachi instruments are described in the BM
package inserts as “immunological
agglutination” which is a turbidimetric
method.
Frequently Asked Questions (FAQ) (Continued)
Question
Answer
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