Multizone analytical element and method for analyte determination
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
C12Q-001/32
C12Q-001/48
G01N-033/52
출원번호
US-0600641
(1984-04-16)
발명자
/ 주소
Eikenberry, Jon N.
출원인 / 주소
Eastman Kodak Company
대리인 / 주소
Tucker, J. Lanny
인용정보
피인용 횟수 :
16인용 특허 :
7
초록▼
A multizone analytical element for the determination of an analyte in an aqueous liquid comprises a registration zone and a porous spreading zone to receive and transport the aqueous liquid. The spreading zone contains a nonpolymeric quaternary ammonium compound represented by either of the structur
A multizone analytical element for the determination of an analyte in an aqueous liquid comprises a registration zone and a porous spreading zone to receive and transport the aqueous liquid. The spreading zone contains a nonpolymeric quaternary ammonium compound represented by either of the structures: ##STR## wherein represents a single or double bond; R 1, R 2, R 3 and R 4 are independently alkyl; aryl; cycloalkyl; or alkaryl; provided that R 1, R 2, R 3 and R 4 together comprise at least 12 carbon atoms; or R 1 and R 2 taken together with the nitrogen atom, form a quaternary 5- to 16-membered heterocyclic ring; or R 1, R 2 and R 3 taken together with the nitrogen atom, form a quaternary 5- to 16-membered heterocyclic ring; and X - is a monovalent anion. This element is particularly useful for rate determinations of enzymes, such as alanine aminotransferase and aspartate aminotransferase, in liquids containing bilirubin or protein which may interfere with the accuracy of the assay.
대표청구항▼
1. A multizone analytical element for the determination of an analyte which determination is substantially unaffected by the presence of bilirubin, said element comprising, in fluid contact, a registration zone, and a porous spreading zone containing a nonpolymeric quaternary ammonium compound r
1. A multizone analytical element for the determination of an analyte which determination is substantially unaffected by the presence of bilirubin, said element comprising, in fluid contact, a registration zone, and a porous spreading zone containing a nonpolymeric quaternary ammonium compound represented by the structures: ##STR## wherein represents a single or double bond; R 1, R 2, R 3 and R 4 are independently alkyl of 1 to 30 carbon atoms; aryl of 6 to 14 carbon atoms; cycloalkyl of 5 to 20 carbon atoms; or alkaryl of 7 to 30 carbon atoms; provided that R 1, R 2, R 3 and R 4 together comprise at least 12 carbon atoms; or R 1 and R 2 taken together with the nitrogen atom, form a quaternary 5- to 16-membered heterocyclic ring and R 3 and R 4 are as defined above and comprise together at least 12 carbon atoms; or R 1, R 2 and R 3 taken together with the nitrogen atom, form a quaternary 5- to 16-membered heterocyclic ring and R 4 is as defined above and comprises at least 12 carbon atoms; and X - is a monovalent anion; said quaternary ammonium compound being present in said spreading zone in an amount effective to substantially eliminate interference caused by bilirubin on said analyte determination. 2. The element of claim 1 wherein said quaternary ammonium compound is present in an amount of at least about 0.1 mg/m 2 . 3. The element of claim 1 wherein R 1 and R 2 are independently alkyl of 1 to 6 carbon atoms; R 3 and R 4 are independently alkyl of 1 to 30 carbon atoms, aryl of 6 to 14 carbon atoms, or alkaryl of 7 to 30 carbon atoms; provided that R 1, R 2, R 3 and R 4 together comprise at least 12 carbon atoms; or R 1, R 2 and R 3, taken together with the nitrogen atom, form a quaternary 5- to 16-membered heterocyclic ring and R 4 is alkyl comprising at least 12 carbon atoms; and X - is halide or nitrate. 4. The element of claim 3 wherein R 1 and R 2 are independently alkyl of 1 to 6 carbon atoms; R 3 and R 4 are independently alkyl of 1 to 30 carbon atoms, provided that R 1, R 2, R 3 and R 4 together comprise at least 12 carbon atoms; or R 1, R 2 and R 3, taken together with the nitrogen atom, form a quaternary 6- to 10-membered heterocyclic ring and R 4 is alkyl comprising at least 12 carbon atoms, said quaternary ammonium compound being present in an amount effective to substantially eliminate interfering effects of both bilirubin and protein on said analyte determination. 5. The element of claim 4 wherein said quaternary ammonium compound is a heterocyclic amine represented by the structure (Ib) wherein R 1, R 2 and R 3, taken together with the nitrogen atom, complete a 6- to 10-membered quaternary heterocyclic ring. 6. The element of claim 1 wherein said quaternary ammonium compound is selected from the group consisting of: ##STR## wherein R' is alkyl of 12, 14 or 16 carbon atoms; ##STR## 7. The element of claim 1 containing an interactive composition for said analyte. 8. A multizone analytical element for the determination of an analyte which determination is substantially unaffected by the presence of bilirubin, said element comprising a support having thereon, in order and fluid contact, a registration zone, and a porous spreading zone containing a nonpolymeric quaternary ammonium compound represented by the structures: ##STR## wherein represents a signal or double bond; R 1, R 2, R 3 and R 4 are independently alkyl of 1 to 30 carbon atoms; aryl of 6 to 14 carbon atoms; cycloalkyl of 5 to 20 carbon atoms; or alkaryl of 7 to 30 carbon atoms; provided that R 1, R 2, R 3 and R 4 together comprise at least 12 carbon atoms; or R 1 and R 2 taken together with the nitrogen atom, form a quaternary 5- to 16-membered heterocyclic ring and R 3 and R 4 are as defined above and comprise together at least 12 carbon atoms; or R 1, R 2 and R 3 taken together with the nitrogen atom, form a quaternary 5- to 16-membered heterocyclic ring and R 4 is as defined above and comprises at least 12 carbon atoms; and X - is a monovalent anion; said quaternary ammonium compound being present in said spreading zone in an amount effective to substantially eliminate interference caused by of bilirubin on said analyte determination; and said element containing an interactive composition for an analyte to be determined. 9. The element of claim 8 wherein said interactive composition is a NADH-based reagent composition. 10. A multilayer analytical element for the rate determination of an enzyme in an aqueous liquid, said element comprising a support having thereon, in order and fluid contact, a registration layer containing at least one component of said interactive composition, and an isotropically porous spreading layer to receive and transport said aqueous liquid, said spreading layer containing a nonpolymeric quaternary ammonium compound represented by the structures: ##STR## wherein represents a single or double bond; R 1, R 2, R 3 and R 4 are independently alkyl of 1 to 30 carbon atoms; aryl of 6 to 14 carbon atoms; cycloalkyl of 5 to 20 carbon atoms; or alkaryl of 7 to 30 carbon atoms; provided that R 1, R 2, R 3 and R 4 together comprise at least 12 carbon atoms; or R 1 and R 2 taken together with the nitrogen atom, form a quaternary 5- to 16-membered heterocyclic ring and R 3 and R 4 are as defined above and comprise together at least 12 carbon atoms; or R 1, R 2 and R 3 taken together with the nitrogen atom, form a quaternary 5- to 16-membered heterocyclic ring and R 4 is as defined above and comprises at least 12 carbon atoms; and X - is a monovalent anion; said quaternary ammonium compound being present in said spreading zone in an amount of at least about 0.1 mg/m 2 ; and said element containing a NADH-based reagent composition which can interact with an enzyme to be determined. 11. The element of claim 10 wherein said analyte is aspartate aminotransferase and said interactive composition comprises NADH, L-aspartate, α-ketoglutarate, lactate dehydrogenase, malate dehydrogenase and pyridoxal phosphate, or said analyte is alanine aminotransferase and said interactive composition comprises NADH, L-alanine, α-ketoglutarate, lactate dehydrogenase and pyridoxal phosphate. 12. The element of claim 10 wherein said spreading layer comprises a blush polymer. 13. The element of claim 10 wherein R 1 and R 2 are independently alkyl of 1 to 6 carbon atoms; R 3 and R 4 are independently alkyl of 1 to 30 carbon atoms, aryl of 6 to 14 carbon atoms, or alkaryl of 7 to 30 carbon atoms; provided that R 1, R 2, R 3 and R 4 together comprise at least 12 carbon atoms; or R 1, R 2 and R 3, taken together with the nitrogen atom, form a quaternary 5- to 16-membered heterocyclic ring and R 4 is alkyl comprising at least 12 carbon atoms; and X - is halide or nitrate. 14. The element of claim 13 wherein R 1 and R 2 are independently alkyl of 1 to 6 carbon atoms; R 3 and R 4 are independently alkyl of 1 to 30 carbon atoms, provided that R 1, R 2, R 3 and R 4 together comprise at least 12 carbon atoms; or R 1, R 2 and R 3, taken together with the nitrogen atom, form a quaternary 6- to 10-membered heterocyclic ring and R 4 is alkyl comprising at least 12 carbon atoms. 15. The element of claim 14 wherein said quaternary ammonium compound is ##STR## 16. A method for the determination of an analyte in an aqueous liquid, which determination is substantially unaffected by the presence of bilirubin, said method comprising the steps of: A. physically contacting a sample of said liquid containing the analyte together with an interactive composition for said analyte and a multizone analytical element to provide a detectable change in said element, said element comprising, in fluid contact, a registration zone, and a porous spreading zone to receive and transport an applied sample of said aqueous liquid, said spreading zone containing a nonpolymeric quaternary ammonium compound represented by the structures: ##STR## wherein represents a single or double bond; R 1, R 2, R 3 and R 4 are independently alkyl of 1 to 30 carbon atoms; aryl of 6 to 14 carbon atoms; cycloalkyl of 5 to 20 carbon atoms; or alkaryl of 7 to 30 carbon atoms; provided that R 1, R 2, R 3 and R 4 together comprise at least 12 carbon atoms; or R 1 and R 2 taken together with the nitrogen atom, form a quaternary 5- to 16-membered heterocyclic ring and R 3 and R 4 are as defined above and comprise together at least 12 carbon atoms; or R 1, R 2 and R 3 taken together with the nitrogen atom, form a quaternary 5- to 16-membered heterocyclic ring and R 4 is as defined aove and comprises at least 12 carbon atoms; and X - is a monovalent anion; said quaternary ammonium compound being present in said spreading zone in an amount effective to substantially eliminate interference caused by of bilirubin on said analyte determination; and B. measuring said detectable change. 17. The method of claim 16 wherein said detectable change is in the rate of formation of a detectable species. 18. The method of claim 16 wherein said detectable change is in the rate of disappearance of a detectable species. 19. The method of claim 16 wherein said interactive composition is incorporated within said analytical element. 20. The method of claim 16 wherein said analyte is aspartate aminotransferase and said interactive composition comprises NADH, L-aspartate, α-ketoglutarate, lactate dehydrogenase, malate dehydrogenase and pyridoxal phosphate; or said analyte is alanine aminotransferase and said interactive composition comprises NADH, L-alanine, α-ketoglutarate, lactate dehydrogenase and pyridoxal phosphate. 21. The method of claim 16 wherein R 1 and R 2 are independently alkyl of 1 to 6 carbon atoms; R 3 and R 4 are independently alkyl of 1 to 30 carbon atoms, provided that R 1, R 2, R 3 and R 4 together comprise at least 12 carbon atoms; or R 1, R 2 and R 3, taken together with the nitrogen atom, form a quaternary 6- to 10-membered heterocyclic ring and R 4 is alkyl comprising at least 12 carbon atoms, said quaternary ammonium compound being present in an amount effective to substantially eliminate interfering effects of both bilirubin and protein on said analyte determination.
Goffe ; deceased Charles A. (late of Brockport NY BY Patricia A. Goffe ; executrix) Rand Royden N. (Rochester NY) Wu Tai W. (Rochester NY), Integral analytical element.
Phillips, Roger; McGarraugh, Geoffery; Jurik, Franklin A.; Underwood, Raymond D., Method for the determination of glucose employing an apparatus emplaced matrix.
Phillips, Roger; McGarraugh, Geoffery; Jurik, Franklin A.; Underwood, Raymond D., Reagents test strip adapted for receiving an unmeasured sample while in use in an apparatus.
Phillips Roger ; McGarraugh Geoffery ; Jurik Franklin A. ; Underwood Raymond D., Reflectance measurement of analyte concentration with automatic initiation of timing.
Phillips Roger (Palo Alto CA) McGarraugh Geoffery (Scotts Valley CA) Jurik Franklin A. (San Mateo CA) Underwood Raymond D. (Red Bluff CA), Whole blood glucose test strip.
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