PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
Assays/Reagents
AEROSET
®
System Troubleshooting Guide
163
94816-107—November 2004
Frequently Asked Questions (FAQ)
Question
Response
How much shift is observed for the RF
Bio-Rad Liquichek control toward the end of
shelf life?
The Bio-Rad Liquichek Immunology control
package insert states, “Variation over time and
between laboratories may be caused by
differences in laboratory technique,
instrumentation and reagents or by
manufacturer test method modifications.”
For the Abbott Clinical Chemistry RF assay
application, we used control ranges of
approximately 15%. In one case, the control
ranges needed to be reset for controls near
expiration. In one other case, controls
possibly stored inappropriately required
reevaluation after control ranges were
established.
Based on our experience, however, the need
to reevaluate control ranges should be
infrequent.
The RF 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 RF assay?
The RF 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.
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