Diagnostic sanitary test strip
6 Assignments
0 Petitions
Accused Products
Abstract
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 no more than two operative layers and: (a) a reaction membrane containing a reagent capable of reacting with the analyte of interest to produce a measurable change in said membrane; (b) an upper support layer defining a sample receiving port for receiving the fluid sample thereat; (c) one or more structures for directing the sample containing the analyte of interest through at least a portion of said reaction membrane; and (d) a lower support layer having a reaction viewing port in vertical alignment with said membrane for displaying said measurable change, said lower support being associated with said upper support to secure said reaction membrane in said test strip.
37 Citations
62 Claims
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1-28. -28. (canceled)
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29. A diagnostic test strip for providing an indication of at least one of the presence, the absence or the amount of an analyte of interest in a heterogeneous fluid sample, the test strip comprising:
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a first support layer comprising a sample receiving port for receiving the fluid sample;
a second support layer comprising a reaction viewing port for displaying the indication;
a plurality of operative layers between the first and second support layers, the first and second support layers securing the plurality of operative layers therebetween;
the plurality of operative layers comprising no more than two operative layers, the no more than two operative layers comprising;
a first operative layer in contact with the first support layer and in vertical alignment with the sample receiving port, the first operative layer comprising a material for receiving a fluid sample containing the analyte of interest; and
a second operative layer having a first side at least partially in contact with the first operative layer, and an opposite side in contact with the second support layer and in vertical alignment with the reaction viewing port, the second operative layer comprising a reaction membrane for receiving the analyte of interest through the first operative layer, the second operative layer containing a reagent for reacting with the analyte of interest to produce a measurable change in color for display in the reaction viewing port. - View Dependent Claims (30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49)
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50. A diagnostic test strip for providing an indication of at least one of the presence, the absence or the amount of glucose analytes in a blood sample, the test strip comprising:
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a first support layer comprising a sample receiving port for receiving the blood sample;
a second support layer comprising a reaction viewing port for displaying the indication;
a plurality of operative layers between the first and second support layers, the first and second support layers being secured together so as to secure the plurality of operative layers therebetween;
the plurality of operative layers comprising no more than two operative layers, the no more than two operative layers comprising;
a first operative layer secured to the first support layer and in vertical alignment with the sample receiving port, the first operative layer comprising a material for receiving a blood sample and for spreading the sample so as to distribute glucose analytes therein to a second operative layer; and
the second operative layer having a first side at least partially in contact with the first operative layer, and an opposite side secured to the second support layer and in vertical alignment with the reaction viewing port, the second operative layer comprising a reaction membrane for receiving glucose analytes from the blood sample through the first operative layer, the second operative layer containing a reagent for reacting with the glucose analytes to produce a measurable change in color for display in the reaction viewing port. - View Dependent Claims (51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62)
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Specification