The flow immunosensor works on a principle somewhat distinct from othe
r immunoassay systems in that it performs a displacement immunoassay.
Antibody-coated matrices are saturated with fluorescently labeled benz
oylecgonine (BE), which is released and measured in the presence of BE
-containing urine and measured downstream from the matrix. The same an
tibody matrix can be used for many samples. A flow immunosensor instru
ment, built by US Drug Testing, Inc., has recently received 'Premarket
Notification' (510(K)) from the Food and Drug Administration (FDA) to
screen urine for the presence of the cocaine metabolite BE. The perfo
rmance of the flow immunosensor for screening BE in urine was validate
d by comparison with results of a blind study using the Syva EMIT, the
Abbott TDx and gas chromatography-mass spectroscopy (CC-MS). Potentia
lly interfering drugs were also spiked into urine and evaluated using
the flow immunosensor. While the FDA approval is for determining wheth
er the BE concentration is above or below the 300 mu g/l cutoff recomm
ended by the National Institute of Drug Abuse, we have also shown that
the flow immunosensor can be adapted to produce quantitative determin
ations of the amount of BE in the urine samples. The reliability of th
e quantitation was confirmed by testing 100 urine samples containing u
nknown amounts of BE using the flow immunosensor, CC-MS and the Abbott
TDx system. Comparison of quantitative data obtained using the immuno
sensor and CC-MS showed a 97% correlation, compared with a much lower
value for data from the TDx and CC-MS.