US 5,318,894 AGranted

Composition, device and method of assaying for peroxidatively active substances

AssigneeMiles Inc.

InventorMichael J. Pugia

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Abstract

A new and improved test device and method of determining the presence or concentration of a peroxidatively active substance, such as hemoglobin, in a test sample are disclosed. The test device includes a test pad comprising a suitable carrier matrix incorporating an indicator reagent composition capable of interacting with a peroxidatively active substance to produce a detectable or measurable response. In addition, a new and improved indicator reagent composition, comprising an indicator dye, such as a redox indicator, like a benzidine indicator; a hydroperoxide; a metal ion complex; and a phosphorous compound having the general structural formula ##STR1## wherein R.sub.1 or R.sub.2 is selected from the group consisting of hydrogen, an unsubstituted or a substituted alkyl moiety including from one to about twelve carbon atoms, an unsubstituted or a substituted aromatic moiety and a residue of an aliphatic or an aromatic polyhydric compound; and wherein X is 0, S or NH; such as glyceryl-2-phosphate or phenyl dihydrogen phosphate, is incorporated into a carrier matrix, or used in a wet phase assay, to provide a more accurate and trustworthy assay of a test sample for a peroxidatively active substance. The improved method and composition are especially useful in the assay of urine for occult blood.

Claims3

Dependent claims

A solid state test device composition capable of exhibiting a sufficient color transition upon contacting a test sample to demonstrate the presence or concentration of a peroxidatively active substance in the test sample consisting essentially of:

(a) a redox indicator selected for the group consisting of benzidine;
3,3',5,5'-tetraalkylbenzidine, wherein the alkyl group includes from one to six carbon atoms;
2,7-diaminofluorene;
bis-(N-ethyl-quinol-2-one)-azine;
(N-methylbenzthiazol-2-one)-(1-ethyl-3-p henyl-5-methyltriazol-2-one)-azine;
and combinations thereof;
(b) an organic hydroperoxide selected for the group consisting of cumene hydroperoxide, t-butyl hydroperoxide, diisopropylbenzene dihydroperoxide, 1-hydroxycyclohexane-1-hydroperoxide, 2,5-dimethylhexane-2,5-dihydroperoxide, paramethane hydroperoxide, 1,4-diisopropylbenzene monohydroperoxide, p-t-butylisopropylbenzene hydroperoxide, 2-(hydroperoxyisopropyl)-6-isopropylnaphthalene, tetralin hydroperoxide and combinations thereof;
(c) a ferric ion complex;
(d) a phosphorous compound having the formula ##STR9## wherein R.sub.1 or R.sub.2 is a substituted or an unsubstituted aromatic moiety selected for the group consisting of benzene, naphthalene, pyrrole, furan, pyrimidine, thiophene, pyridine, pyrazine, indole, quinoline, carbazole, purine, and isoquinoline, or a polyhydric substituent selected from the group consisting of ethylene glycol, propylene glycol, butylene glycol, hexanediol, glycerol, neopentyl glycol, diethylene glycol, dipropylene glycol, triethylene glycol, cyclopentanediol, and cyclohexanediol;
and wherein X is O, S or NH;
and
(e) a suitable carrier vehicle.

9 more elements

Dependencies are inferred from the claim text.