Determination of total creatine kinase or an isoenzyme with a multilayer analytical element
First Claim
1. A multilayer analytical element for the determination of total creatine kinase or a creatine kinase isoenyzme, said element comprising three or more layers and containing in one or more of said layers, a substrate for creatine kinase, said element also comprising a support having thereon,a registration layer containing a binder material at a coverage of at least about 8 g/m2 and an indicator composition which provides a detectable change in response to the reaction of said substrate with said creatine kinase or said isoenzyme,a reagent layer, andan isotropically porous spreading layer containing an activator for creatine kinase, said layers being in order from said support and in fluid contact.
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Abstract
A multilayer analytical element for the determination of creatine kinase comprises a support having thereon, in order and in fluid contact, a registration layer and an isotropically porous spreading layer. The registration layer contains a binder material at a coverage of at least about 8 g/m2, which coverage improves the stability and keeping properties of the element in high humidity environments. This element is useful in an analytical method for determining total creatine kinase or any one of its isoenzymes, e.g. creatine kinase-MB.
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Citations
19 Claims
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1. A multilayer analytical element for the determination of total creatine kinase or a creatine kinase isoenyzme, said element comprising three or more layers and containing in one or more of said layers, a substrate for creatine kinase, said element also comprising a support having thereon,
a registration layer containing a binder material at a coverage of at least about 8 g/m2 and an indicator composition which provides a detectable change in response to the reaction of said substrate with said creatine kinase or said isoenzyme, a reagent layer, and an isotropically porous spreading layer containing an activator for creatine kinase, said layers being in order from said support and in fluid contact.
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8. A multilayer analytical element for the determination of creatine kinase-MB, said element comprising a nonporous support having thereon, in order from said support and in fluid contact,
a registration layer containing a binder material at a coverage of at least about 10 g/m2, and an indicator composition which provides an optical density change in response to adenosine-5'"'"'-triphosphate or its reaction product, a reagent layer containing creatine phosphate, adenosine-5'"'"'-diphosphate, adenosine-5'"'"'-monophosphate and P1,P5 -di(adenosine-5'"'"')pentaphosphate, and an isotropically porous spreading layer containing an activator for creatine kinase and one or more antibodies for creatine kinase-MM.
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12. A method for the determination of total creatine kinase or a creatine kinase isoenzyme in an aqueous liquid, said method comprising the steps of:
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(A) contacting a sample of said liquid with an analytical element comprising three of more layers and containing in one or more of said layers, a substrate for creatine kinase, said element also comprising a support having thereon, a registration layer containing a binder material at a coverage of at least about 8 g/m2 and an indicator composition which provides a detectable change in response to the reaction of said substrate with said creatine kinase or said isoenzyme, a reagent layer, and an isotropically porous spreading layer containing an activator for creatine kinase, said layers being in order from said support and in fluid contact, and (B) determining the resulting detectable change. - View Dependent Claims (13, 14, 15)
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Specification