PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Assays/Reagents
Not for Customer Distribution
90
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
Frequently Asked Questions (FAQ)
Question
Response
Why are Phenytoin precision data from only
two instruments included in the package
insert?
Because of instrument issues, data from only
two instruments will be included in the
package insert but additional studies are being
performed for inclusion at a later date.
Why are AEROSET precision data different
than the
c
8000
®
precision data presented?
Precision was performed for all four TDM
assays at the same time on both the
c
8000
and AEROSET Systems. Testing was repeated
on the AEROSET for all four assays because of
additional requirements for a daily blank
calibration and calibration with each new
wedge.
Why is it now necessary to calibrate with each
new reagent cartridge?
It is necessary to recalibrate with each new
cartridge to optimize performance, and to
achieve 28 days reagent onboard stability and
14 days calibration stability. Also, this
eliminates the need to recap reagent
cartridges and place them back in the
refrigerator, which is necessary with other
vendor products, such as Olympus.
How is Abbott’s precision claim determined?
Abbott’s package insert claim for total
precision is CV < 7% for Carbamazepine and
Phenobarbital, and CV < 8% for Phenytoin
and Theophylline. These are based on initial
product requirements used in product
development. The validation and verification
testing demonstrated total precision of less
than 7%. Representative data are included in
the package insert.
What is the benefit of running a blank
calibration (using CAL 1) once each day of
assay use?
It provides an additional level of robustness to
assay performance.
Why was the method comparison data
changed from the previous package insert?
Slope, correlation coefficient, and Y-intercept
were recalculated using least squares
regression; this aligns with the method used
to calculate
c
8000 data.
Was there a change to the TDM onboard
stability?
Yes, changes were made to provide an
additional level of robustness to onboard
stability.
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