Chemistry: analytical and immunological testing – Involving an insoluble carrier for immobilizing immunochemicals
Reexamination Certificate
2005-08-09
2005-08-09
Nguyen, Bao-Thuy L. (Department: 1641)
Chemistry: analytical and immunological testing
Involving an insoluble carrier for immobilizing immunochemicals
C436S517000, C436S514000, C436S528000, C436S530000, C436S541000, C436S810000, C422S051000, C422S051000, C422S051000, C422S051000, C422S067000, C435S007100, C435S007930, C435S007940, C435S970000, C435S252310
Reexamination Certificate
active
06927068
ABSTRACT:
An assay method and kit for detecting the presence of a predesignated, target IgG antibody in a sample selected from one or more patient bodily fluids. The method comprises the following steps: (a) contacting the sample of one or more patient bodily fluids with a membrane-bound recombinant protective antigen to bind to the target IgG antibody in the sample; (b) previously, simultaneously or subsequently to step (a), binding the protective antigen (PA) with a conjugated label producing a detectable signal; and (c) detecting the signal whereby the presence of the target IgG antibody is determined in the sample by the intensity of the signal. The method can further comprise the step of evaluating immunization status of the patient from whom the sample came by comparing the signal or lack thereof with immunizations previously received by the patient. In a preferred embodiment, the recombinant protective antigen (PA) specifically binds to anthrax protective antigen-specific IgG antibodies. Preferably, the immunoassay of the present invention comprises a lateral-flow assay comprising a membrane, a conjugated label pad, and a recombinant protective antigen (PA) bound to the membrane.
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Kelly John R.
Simonson Lloyd G.
Hemby, Jr. Joseph K.
Nguyen Bao-Thuy L.
The United States of America as represented by the Secretary of
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