Patent ID: 7374950

Claim:
In an immunochemical assay device of the type wherein, a base member; at least one array disposed on said base member, said array comprising: (i) at least one reservoir pad having sufficient porosity and volume to receive and contain a liquid; (ii) a wicking membrane disposed distally to said at least one reservoir pad, said wicking membrane having sufficient porosity and volume to absorb a substantial proportion of the sample received in said at least one reservoir pad; and (iii) at least one first filter zone which is separate and distinct from said at least one reservoir pad and wicking membrane, and interposed between and contiguous with said wicking membrane and said at least one reservoir pad; (iv) at least one second filter zone which is separate and distinct from said at least one reservoir pad, said wicking membrane and said first filter zone, and contiguous with said wicking membrane, and said first filter zone, said second filter zone having sufficient porosity and volume to receive and containing a liquid sample on which the assay is to be performed; at least one additional immobilized immunochemical component disposed in at least one assay indicia zone of said wicking membrane downstream of said at least one reservoir pad and defining assay indicia, wherein the improvement comprises: incorporation of an immunoassay for determining the presence of NT-proBNP; said NT-pro-BNP assay in qualitative or in quantitative determination used for diagnosing congestive heart failure and predicting mortality in congestive heart failure patients, thereby aiding in the stratification of congestive heart failure in accordance with New York Heart Association (NYHA) classification guidelines and including a goat polyclonal antibody specific for amino acids 26-51 of NT-pro-BNP and a monoclonal antibody specific to amino acids 1-25 of NT-pro-BNP, wherein at least one of the goat polyclonal antibody and/or the monoclonal antibody is disposed within the at least one filter zone; with a proviso that if only one of the goat polyclonal antibody or the monoclonal antibody is disposed within the at least one filter zone, said at least one additional immobilized immunochemical component comprises the other of the goat polyclonal antibody specific to amino acids 26-51 of NT-pro-BNP or the monoclonal antibody specific for amino acids 1-25 of NT-pro-BNP.