US6284550B1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Diagnostic sanitary test strip
Assignee: Bank of America NA
•
Filing: 1999-06-25
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Granted: 2001-09-04
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Expires: 2019-06-25
Abstract
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 (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.
Inventors
- 👤 Patrick Carroll
- 👤 Jon Schneider
- 👤 Douglas E. Bell
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-05 11:42
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/525; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/81; Y10S435/97; Y10S436/00; Y10S436/805; Y10S436/807; Y10S436/81; Y10S436/815; Y10S436/827
Claims Analysis
Total Claims: 30
Claim 1
Independent Claim
127 words
A diagnostic sanitary test strip device having a unitary construction for measuring an analyte of interest in a heterogeneous fluid sample, said test strip comprising: (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.
Claim 2
Dependent Claim
127 words
A diagnostic sanitary test strip device having a unitary construction for measuring an analyte of interest in a heterogeneous fluid sample, said test strip comprising: (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.
Claim 3
Dependent Claim
23 words
The test strip of claim 1 , further comprising a plurality of dam partitions defined by indentations formed in said upper support layer.
Claim 4
Dependent Claim
17 words
The test strip of claim 2 , wherein said dam partitions are oriented around said receiving port.
Claim 5
Dependent Claim
22 words
The test strip of claim 1 , wherein said reagent comprises reactants that facilitate an end-point test in a corresponding reflectance meter.
Claim 6
Dependent Claim
14 words
The test strip of claim 4 , wherein said reagent includes an enzyme solution.
Claim 7
Dependent Claim
30 words
The test strip of claim 1 , wherein said reagent in said reaction membrane comprises a red blood cell binding agent for capturing red blood cells from the fluid sample.
Claim 8
Dependent Claim
16 words
The test strip of claim 6 , wherein said red blood cell binding agent comprises lectins.
Claim 9
Dependent Claim
24 words
The test strip of claim 1 , wherein said reagent in said reaction membrane is capable of detecting glucose analytes in the fluid sample.
Claim 10
Dependent Claim
31 words
The test strip of claim 7 , wherein said reagent in said reaction membrane includes an indicator chemical capable of visually indicating the amount of glucose analytes in the fluid sample.
Claim 11
Dependent Claim
25 words
The test strip of claim 1 , wherein the mesh openings in said separating layer are smaller than said mesh openings in said spreading screen.
Claim 12
Dependent Claim
24 words
The test strip of claim 1 , wherein said reaction membrane comprises an isotropic membrane such that said membrane has a substantially uniform porosity.
Claim 13
Dependent Claim
15 words
The test strip of claim 11 , wherein said membrane comprises a material containing polysulfone.
Claim 14
Dependent Claim
26 words
The test strip of claim 2 wherein said upper support layer comprises at least one detent for mating with securing posts in a corresponding reflectance meter.
Claim 15
Dependent Claim
24 words
The test strip of claim 2 , wherein said reagent in said reaction membrane is capable of detecting cholesterol analytes in the fluid sample.
Claim 16
Dependent Claim
24 words
The test strip of claim 2 , wherein said reagent in said reaction membrane is capable of detecting osteoporosis analytes in the fluid sample.
Claim 17
Dependent Claim
24 words
The test strip of claim 2 , wherein said reagent in said reaction membrane is capable of detecting ketones analytes in the fluid sample.
Claim 18
Dependent Claim
24 words
The test strip of claim 2 , wherein said reagent in said reaction membrane is capable of detecting theophylline analytes in the fluid sample.
Claim 19
Dependent Claim
24 words
The test strip of claim 2 , wherein said reagent in said reaction membrane is capable of detecting H1AC analytes in the fluid sample.
Claim 20
Dependent Claim
23 words
The test strip of claim 2 , further comprising indicia of proper orientation and insertion of said test strip in a corresponding meter.
Claim 21
Dependent Claim
24 words
The test strip of claim 19 , wherein said indicia comprises a light absorption medium on an exposed surface of said upper support layer.
Claim 22
Dependent Claim
23 words
The test strip of claim 1 , wherein said measurable change in said reagent corresponds to the amount of analyte of interest present.
Claim 23
Dependent Claim
72 words
The test strip of claim 1 , further comprising: (d) a spreading screen, in vertical alignment and contiguous contact with said sample receiving port, for receiving said sample containing an analyte of interest, said spreading screen having mesh openings of a predetermined size sufficient to facilitate uniform distribution of said sample over said screen in the area of said receiving port before allowing said sample to vertically pass through said mesh openings.
Claim 24
Dependent Claim
67 words
The test strip of claim 22 , further comprising: (e) a separating layer, in contiguous contact with said spreading screen, for receiving the sample containing the analyte of interest from said spreading screen, said separating layer having mesh openings and being treated with a chemical solution for separating at least one undesirable element from the fluid sample prior to passing the fluid sample through said mesh openings.
Claim 25
Dependent Claim
24 words
The test strip of claim 2 , wherein said reagent in said reaction membrane is capable of detecting fructosamine analytes in the fluid sample.
Claim 26
Dependent Claim
24 words
The test strip of claim 19 , wherein said indicia comprises an arrow on said upper support layer to indicate proper direction of insertion.
Claim 27
Dependent Claim
32 words
The test strip of claim 22 , wherein said spreading screen is pre-treated with a reagent capable of reacting with the analyte of interest to produce a measurable change in said membrane.
Claim 28
Dependent Claim
32 words
The test strip of claim 22 , wherein said separating layer is pre-treated with a reagent capable of reacting with the analyte of interest to produce a measurable change in said membrane.
Claim 29
Dependent Claim
23 words
The test strip of claim 2 wherein said dam partitions comprise four dam partitions positioned approximately 90° apart around a sample receiving port.
Claim 30
Dependent Claim
14 words
The test strip of claim 28 wherein said sample receiving port is substantially circular.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2004-09-03 | 2005-03-05 | 2005-09-04 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-09-03 | 2009-03-05 | 2009-09-04 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-09-03 | 2013-03-05 | 2013-09-04 | $7700.00 | Window Closed / Lapsed |