Appeal No. 2001-1392 Page 2
Application No. 08/900,586
Claim 1 is illustrative of the subject matter on appeal and is reproduced
below:
1. A method for determining the concentration of an analyte in a sample
of body fluid which comprises the steps of:
a) providing a test matrix in the form of a strip through which the fluid
sample can flow by capillarity, said strip having a first region which
contains mobile specific binding partner for the analyte which
binding partner bears a visually detectable label and can react
with the analyte to form an analyte/labeled binding partner
complex, at least one second region which contains immobilized
analyte or an immobilized binding partner which is specific for an
epitope of the analyte different than that to which the labeled
binding partner is specific, at least one third region which contains
means for capturing the analyte/labeled specific binding partner
complex which is not bound in the second region and a fourth
region which contains means for colorimetrically producing a
visually detectable signal the intensity of which corresponds to the
level of a second analyte in the sample of body fluid whose
concentration is clinically related to that of the first analyte whose
concentration is being determined;
b) developing the matrix by applying a sample of body fluid
suspected of containing the first and second analytes thereto
thereby allowing it to contact the labeled specific binding partner
so that analyte present in the fluid sample binds to the labeled
specific binding partner to form a complex while leaving excess,
unreacted labeled binding partner free to further react whereby the
fluid sample carries the analyte/labeled binding partner complex
and unreacted labeled binding partner along the matrix by
capillarity to the second region containing the immobilized analyte
in which region unreacted labeled binding partner is bound to the
immobilized analyte in inverse relationship to the concentration of
the first analyte in the fluid test sample or the analyte /labeled
specific binding partner complex is bound to the immobilized
specific binding partner in a direct relationship to the
concentration of first analyte in the fluid test sample; and the
labeled specific binding partner which did not bind to the second
region is carried by capillarity to the third region where it is
immobilized by the immobilization means;
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