PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Assays/Reagents
Not for Customer Distribution
164
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
Were plasma specimens evaluated for use with
the RF assay?
Yes. Initially, it was the project development
team’s goal to develop a plasma claim for the
RF assay application. Acceptable performance
was observed with the majority of plasma
specimens.
However, there is a small population of
plasma specimens that will generate a falsely
elevated result. Therefore, it was not possible
to generate a reliable plasma claim and
customers should not use plasma specimens
with the RF assay.
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’ RF assays?
CAP surveys do not work with RF and should
not be used. The cause for this is under
investigation. The RF assay cannot be used
with plasma specimens, and CAP survey
sample is based on plasma as well as other
processing which makes it a very artificial
matrix.
Were gel barrier tubes tested for use with the
RF assay?
A study has not yet been performed with gel
barrier tubes. However, this will be considered
for a future study.
Frequently Asked Questions (FAQ) (Continued)
Question
Response
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