초록 ▼

An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the te

An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing. The improved test strip comprises (a) an upper support strip having a fluid receiving port and (b) a lower support strip having a color change viewing port and securely sandwiched therebetween (c) a spreading mesh screen for uniformly distributing the fluid, (d) a chemically treated separating layer for removing an undesirable element, e.g. red blood cells, from the fluid received from the mesh screen, (e) an isotropic membrane chemically treated with a reagent indicator solution for removing any remaining portions of the undesirable element, producing a color change proportionate to the amount of the suspected analyte in the fluid and facilitating an end-point ramp test, and (f) volume control dam partitions for retaining fluid on and in the strip.

대표청구항 ▼

[ What I claim is:] [1.] A diagnostic sanitary test strip device for measuring an analyte of interest in a heterogenous fluid sample, said test strip comprising:(a) an upper support layer defining a sample receiving port for receiving the fluid sample therein;(b) means for retaining the fluid sample

[ What I claim is:] [1.] A diagnostic sanitary test strip device for measuring an analyte of interest in a heterogenous fluid sample, said test strip comprising:(a) an upper support layer defining a sample receiving port for receiving the fluid sample therein;(b) means for retaining the fluid sample to prevent spillage of the sample from said strip to make said test strip sanitary, wherein said retaining means comprises a plurality of dam partitions penetrating said test strip, said dam partitions being defined by indentations formed in said upper layer;(c) means, in vertical alignment and contiguous contact with said sample receiving port, for uniformly spreading the fluid sample in said receiving port before allowing said fluid sample to vertically pass through said spreading means;(d) means, in contiguous contact with said spreading means, for filtering the fluid sample received from said spreading means to remove at least one undesirable element in the fluid sample prior to passing the fluid sample through said filtering means;(e) a reaction membrane, in contiguous contact with said filtering means, having a predetermined porosity, said membrane retaining a reagent solution capable of reacting with the analyte of interest to produce a color change in said membrane corresponding to the amount of analyte present in the fluid sample; and(f) a lower support layer in contiguous contact with said membrane and having a reaction viewing port in vertical alignment with said membrane for displaying said color change, wherein said retaining means, said spreading means, said filtering means, and said reaction membrane interpose said lower support and said upper support to secure said test strip.