PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution Assays/Reagents
AEROSET
®
System Troubleshooting Guide 169
94816-107—November 2004
Valproic Acid (MULTIGENT
®
)
Accuracy by Recovery
Five midpoint samples were prepared by mixing
1:1 proportions of each calibrator with the next highest
calibrator.
For example: 100 µL CAL 1 (0 µg/mL) + 100 µL CAL 2
(12.5 µg/mL) yields a 6.25 µg/mL standard.
Each midpoint sample was tested in triplicate and results are
listed in the following table.
Interference Information
Any assay using mouse antibodies has potential for
interference from human anti-mouse antibodies (HAMA) in
the patient sample. To test this, we obtained a normal human
serum pool (control) and two types of human anti-mouse
antibodies, HAMA type 1 and HAMA type 2. We then spiked
them with identical amounts of valproic acid. Each sample
was assayed in duplicate on the AEROSET System using the
MULTIGENT Valproic Acid assay. The means of both duplicate
HAMA samples were compared to the mean of the control
normal human serum. Test results show a recovery of
100 +
10%.
Expected Average Diff
Midpoint # (µg/mL) (µg/mL) %Recovery (µg/mL)
1 6.25 5.61 89.8 -0.64
2 18.75 19.10 101.9 0.35
3 37.50 37.60 100.3 0.10
4 75.00 78.41 104.5 3.41
5 125.00 122.52 98.0 -2.48
N
Mean
(µg/mL)
%Recovery
Control 2 98.24 —
HAMA 1 2 90.96 92.6
HAMA 2 2 94.2 95.9
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