PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
Assays/Reagents
AEROSET
®
System Troubleshooting Guide
65
94816-107—November 2004
Cross Reactivity
Refer to
Assay-specific Information
in this section for
additional assay-specific cross reactivity information. Each
DOA assay includes a table which lists cross reactivity testing
performed on the AEROSET System by SYVA; this information
is not included in the Abbott Clinical Chemistry Drugs of
Abuse package inserts.
Method Comparison
For the qualitative drug of abuse assays
Amphetamine/Methamphetamine, Barbiturates,
Benzodiazepines, Cannabinoids, Cocaine, Methadone,
Opiates, Phencyclidine, and Propoxyphene, urine samples
known to be free from interfering substances or other drugs
should be used. Run 40 positive and 40 negative specimens.
The concentration of drug should cover the entire assay range,
with particular emphasis at the cutoff concentration. All
discrepant data points between the AEROSET DOA assay and
comparative method should be investigated further by GC/MS
to confirm the results.
Because the Ethanol assay is a quantitative assay, routine
method comparison studies should be performed. Serum and
urine samples known to be free from interfering substances or
other drugs should be used. Run 40 positive and 40 negative
specimens. The concentration of drug should cover the entire
assay range.
For the
c
8000
®
System, the package insert describes rate results
between the cutoff rate and ± 25% rate, also the ± 50% rate.
For the AEROSET System, only results between the cutoff rate
and ± 25% rate are discussed, not the ± 50% rate. This is
because of the new Guidance for Industry and FDA staff
document,
Premarket Submission and Labeling Recommendations
for Drugs of Abuse Screening Tests
, released December 2, 2003.
AEROSET method comparison rate results were completed
before the guidance document was updated.