Appeal No. 2001-1587
Application No. 08/506,268
a test strip, and contact between the two is maintained while one end of the test
strip is contacted with an eluant liquid. The eluant moves up the test strip and
elutes the analyte (e.g., drug molecules) from the wiping surface. After the
eluant (and any eluted analyte) reaches a “detection zone” at the other end of the
test strip, the presence of analyte is determined immunologically. The claims on
appeal are directed to this assay method and a test kit for performing the
method.
The specification makes clear that a critical feature of the disclosed assay
is that contact is maintained during the test procedure between the wiping
surface and the test strip. See pages 7-8:
After wiping a contaminated surface with a wiping surface, an area
of the test strip surface contacts said wiping surface between the
eluant application zone and the target zone, with a slight pressure
being preferably applied. . . .
The pressure exerted on the wiping surface should be sufficient
enough to allow a planar fluid contact between the two surfaces.
. . . .
Possible eluting liquids are water or buffer solutions that are
conventionally used in immunoassays. The liquid travels along the
strip in direction toward the target zone . . . while passing the zone
with a pressed-on wiping surface. Surprisingly, it has been found
that the analyte molecules adhering to the wiping surface are taken
up in the liquid flow and transported to the following zones.
See also the paragraph bridging pages 8 and 9:
Surprisingly, it has been found that the sensitivity of the method of
the invention is significantly higher than that of the prior art. The
efficiency of the wiping and transfer of analyte from the wiping
surface onto the test strip is against all expectations so high that
this method allows the detection of absolute amounts of down to 10
ng of analyte, especially drugs on surfaces. The method involves
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