CA2554776A1 - Test strip composition and method to measure cholesterol from low density lipoproteins - Google Patents

Test strip composition and method to measure cholesterol from low density lipoproteins Download PDF

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Publication number
CA2554776A1
CA2554776A1 CA002554776A CA2554776A CA2554776A1 CA 2554776 A1 CA2554776 A1 CA 2554776A1 CA 002554776 A CA002554776 A CA 002554776A CA 2554776 A CA2554776 A CA 2554776A CA 2554776 A1 CA2554776 A1 CA 2554776A1
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CA
Canada
Prior art keywords
surfactant
test strip
reagents
combination
copolymeric
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Granted
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CA002554776A
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French (fr)
Other versions
CA2554776C (en
Inventor
Gregory M. Lawrence
John Pasqua
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Polymer Technology Systems Inc
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Individual
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Publication of CA2554776A1 publication Critical patent/CA2554776A1/en
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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/525—Multi-layer analytical elements
    • G01N33/526—Multi-layer analytical elements the element being adapted for a specific analyte
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/92—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving lipids, e.g. cholesterol, lipoproteins, or their receptors
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/04—Endocrine or metabolic disorders
    • G01N2800/044—Hyperlipemia or hypolipemia, e.g. dyslipidaemia, obesity

Abstract

Cholesterol from Low Density Lipoproteins (LDL-C) is measured directly with a test strip at room temperature using a reagent that takes advantage of the varying surface charge density on LDLs and non-LDLs to selectively make LDL~C
available for testing.

Claims (32)

1. A room-temperature method for directly determining the concentration of LDL cholesterol in whole blood, plasma or serum comprising contacting the sample with reagents that selectively make LDL-C available for detection.
2. The method of claim 1, wherein the reagents react differently with LDLs and non-LDLs as a function of the relative surface charge density on LDLs and non-LDLs in the sample.
3. The method of claim 1, wherein the reagents comprise cations, polyanions, cyclodextrin derivatives, a copolymeric surfactant and a surfactant for the copolymeric surfactant.
4. The method of claim 3, wherein the cations include a divalent metal.
5. The method of claim 4, wherein the divalent metal is magnesium.
6. The method of claim 3, wherein the canons include a positively charged amine effective to bind lipoproteins.
7. The method of claim 6, wherein the amine is triethanolamine hydrochloride.
8. The method of claim 3, wherein the polyanion is dextran sulfate.
9. The method of claim 3, wherein the cyclodextrin derivative is alpha cyclodextrin sulfate.
10. The method of claim 3, wherein the copolymeric surfactant is a polyoxyethylene-polyoxypropylene-polyoxyethylene hybrid, having a molecular weight range from about 2,100 to about 6,000 with a preponderance of polyoxyproylene.
11. A combination of reagents suitable for use on a test strip that can selectively cause LDL-C to become available for measurement.
12. The reagent combination of claim 11, comprising cations, polyanions, cyclodextrin derivatives, a copolymeric surfactant and a surfactant for the copolymeric surfactant.
13. The reagent combination of claim 12, wherein the cations include a divalent metal.
14. The reagent combination of claim 12, wherein the divalent metal is magnesium.
15. The reagent combination of claim 12, wherein the canons include a positively charged amine effective to bind lipoproteins.
16. The reagent combination of claim 15, wherein the amine is triethanolamine hydrochloride.
17. The reagent combination of claim 11, wherein the polyanion is dextran sulfate.
18. The reagent combination of claim 11, wherein the cyclodextrin derivative is alpha cyclodextrin sulfate.
19. The reagent combination of claim 11, wherein the copolymeric surfactant is a polyoxyethylene-polyoxypropylene-polyoxyethylene hybrid, having a molecular weight range from about 2,100 to about 6,000 with a preponderance of polyoxyproylene.
20. The reagent combination of claim 11, wherein the reagents include a high molecular weight blocking copolymer surfactant effective to bind non-LDLs and a low molecular weight surfactant effective to increase the solubility of the blocking copolymer surfactant.
21. A vertical flow test strip for use in the direct detection of cholesterol produced from low density lipoproteins in a whole blood, plasma or serum sample, the test strip comprising:
a) a membrane for blocking or slowing the progress of red blood cells through the test strip;
b) a supply of a combination of reagents that can selectively cause LDL-C to become available for measurement; and c) a cholesterol detection membrane.
22. The test strip of claim 21, comprising cations, polyanions, cyclodextrin derivatives, a copolymeric surfactant and a surfactant for the copolymeric surfactant.
23. The test strip of claim 22, wherein the cations include a divalent metal.
24. The test strip of claim 22, wherein the divalent metal is magnesium.
25. The method of claim 22, wherein the cations include a positively charged amine effective to bind lipoproteins.
26. The method of claim 25, wherein the amine is triethanolamine hydrochloride.
27. The test strip of claim 21, wherein the polyanion is dextran sulfate.
28. The test strip of claim 21, wherein the cyclodextrin derivative is alpha cyclodextrin sulfate.
29. The test strip of claim 21, wherein the copolymeric surfactant is a polyoxyethylene-polyoxypropylene-polyoxyethylene hybrid, having a molecular weight range from about 2,100 to about 6,000 with a preponderance of polyoxyproylene.
30. The test strip of claim 21, wherein the reagents include a high molecular weight blocking copolymer surfactant effective to bind non-LDLs and a low molecular weight surfactant effective to increase the solubility of the blocking copolymer surfactant.
31. The test strip of claim 21, wherein the blocking membrane is impregnated with at least some of the supply of a combination of reagents.
32. The test strip of claim 21, further comprising at least one intermediate membrane impregnated with at least some of the supply of a combination of reagents.
CA2554776A 2004-02-03 2005-02-03 Test strip composition and method to measure cholesterol from low density lipoproteins Active CA2554776C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US54168104P 2004-02-03 2004-02-03
US60/541,681 2004-02-03
US10/962,272 2004-10-11
US10/962,272 US7435577B2 (en) 2004-02-03 2004-10-11 Direct measurement of chlolesterol from low density lipoprotein with test strip
PCT/US2005/003234 WO2005074609A2 (en) 2004-02-03 2005-02-03 Test strip composition and method to measure cholesterol from low density lipoproteins

Publications (2)

Publication Number Publication Date
CA2554776A1 true CA2554776A1 (en) 2005-08-18
CA2554776C CA2554776C (en) 2012-12-04

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CA2554776A Active CA2554776C (en) 2004-02-03 2005-02-03 Test strip composition and method to measure cholesterol from low density lipoproteins

Country Status (12)

Country Link
US (1) US7435577B2 (en)
EP (1) EP1725650B1 (en)
JP (1) JP4785753B2 (en)
CN (1) CN104931712A (en)
AU (1) AU2005209856B2 (en)
BR (1) BRPI0507386B1 (en)
CA (1) CA2554776C (en)
EA (1) EA010414B1 (en)
IL (1) IL177226A (en)
PL (1) PL1725650T3 (en)
WO (1) WO2005074609A2 (en)
ZA (1) ZA200606561B (en)

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Also Published As

Publication number Publication date
CN104931712A (en) 2015-09-23
EA200601415A1 (en) 2006-12-29
WO2005074609A3 (en) 2006-01-19
US20050170447A1 (en) 2005-08-04
AU2005209856A1 (en) 2005-08-18
ZA200606561B (en) 2008-01-08
JP2007523325A (en) 2007-08-16
EA010414B1 (en) 2008-08-29
PL1725650T3 (en) 2015-07-31
JP4785753B2 (en) 2011-10-05
CA2554776C (en) 2012-12-04
EP1725650B1 (en) 2014-11-26
IL177226A0 (en) 2006-12-10
BRPI0507386A (en) 2007-07-10
AU2005209856B2 (en) 2010-06-10
BRPI0507386B1 (en) 2017-01-24
EP1725650A2 (en) 2006-11-29
EP1725650A4 (en) 2012-03-21
IL177226A (en) 2011-09-27
WO2005074609A2 (en) 2005-08-18
US7435577B2 (en) 2008-10-14

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