Diagnostic test kits with improved detection accuracy

Chemistry: analytical and immunological testing – Involving an insoluble carrier for immobilizing immunochemicals

Reexamination Certificate

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C436S514000, C436S512000, C436S513000, C436S531000, C436S526000, C436S533000, C436S538000, C436S806000, C436S824000, C435S002000, C435S005000, C435S287200, C435S287900, C435S803000, C435S805000, C435S970000, C422S051000, C422S051000, C422S067000

Reexamination Certificate

active

07829347

ABSTRACT:
A diagnostic test kit that provides an integrated system for accurately detecting a test analyte over a broad range of possible concentrations is provided. One feature of the integrated system is that it is capable of indicating whether an analyte is within the “hook effect” region. Based on this indication, a technique may be selected for correlating a measured signal intensity to an analyte concentration or range of concentrations. For example, when it is determined that the test sample falls outside the “hook effect” region, the analyte concentration may be determined using one portion of a dose response curve. On the other hand, when it is determined that the test sample falls within the “hook effect” concentration, the analyte concentration may be determined using another portion of the dose response curve. Alternatively, the sample may simply be diluted for re-performing the assay. Regardless of whether the test sample is within or outside of the “hook effect” concentration, another feature of the integrated detection system of the present invention is that it is internally calibrated to provide a more accurate quantitative or semi-quantitative result to a user.

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