Reagent test strip for determination of blood glucose

Claim 2

A reagent test strip for use in an apparatus for determining a concentration of glucose in a sample of whole blood, the apparatus comprising optical means for detecting intensity of light at wavelengths of about 635 nm and about 700 nm reflected from at least a portion of a matrix disposed near one end of the strip, which matrix comprises a) a sample receiving surface for receiving the whole blood sample and passing a portion of it toward a testing surface opposite thereto, b) a structure that selectively retards the passage of red blood cells through the matrix, whereby any portion of the sample that is visible from the testing surface does not absorb light to any appreciable extent at about 700 nm, and c) a reagent for indicating the glucose concentration by creating at the testing surface, about 15 seconds after the sample becomes visible there, a reduction in K/S at about 700 nm of at least about 0.2, thereby simulating the absorbance of hemoglobin in blood, and a reduction in reflectance at about 635 nm that is indicative of the glucose concentration, the reagent comprising a dye precursor selected from dyes and dye couples in the group consisting of bis[4-(N-alkyl-4-sulfopropyl)amino-2,6-dimethylphenyl]methane (BISMAP); 10-carboxymethylaminocarbonyl)-3,7-bis(dimethylamino) phenothiazine, sodium salt (leuco methylene blue); 4-aminoantipyrene (AAP) and N-ethyl-N-(3-sulfopropyl)-3,5-dimethylaniline, sodium salt (MAPS); 3-methyl-6-sulfonyl-2-benzothiazolinone hydrazone, sodium salt (SMBTH) and MAPS; AAP and N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline, sodium salt (MAOS); and SMBTH and MAOS.

Claim 3

The strip of claim 1 in which the matrix comprises a membrane that has pores that trap the red blood cells of the whole blood sample.

Claim 4

The strip of claim 1 in which the matrix comprises a polysulfone membrane.

Claim 5

The strip of claim 1 in which the matrix comprises an anisotropic membrane.

Claim 6

The strip of claim 4 in which the membrane has pores that are larger near the sample receiving surface and smaller near the testing surface.

Claim 9

A reagent test strip for use in an apparatus for determining a concentration of glucose in a sample of whole blood, the apparatus comprising optical means for detecting intensity of light at wavelengths of about 635 nm and about 700 nm reflected from at least a portion of a matrix disposed near one end of the strip, which matrix comprises a) a sample receiving surface for receiving the whole blood sample and passing a portion of it toward a testing surface opposite thereto, b) a structure that selectively retards the passage of red blood cells through the matrix, whereby any portion of the sample that is visible from the testing surface does not absorb light to any appreciable extent at about 700 nm, and c) a reagent for indicating the glucose concentration by creating at the testing surface, about 15 seconds after the sample becomes visible there, a reduction in K/S at about 700 nm of at least about 0.2, thereby simulating the absorbance of hemoglobin in blood, and a reduction in reflectance at about 635 nm that is indicative of the glucose concentration, the reagent comprising (i) a first dye precursor selected from a dye and dye couples in the group consisting of BISMAP; 3-methyl-2-benzothiazolinone hydrazone hydrochloride (MBTH) and N-ethyl-N-(3-sulfopropyl)aniline, sodium salt (ALPS); SMBTH and ALPS; AAP and N-ethyl-N-(3sulfopropyl)-3,5-dimethoxyaniline, sodium salt (DAOS); and (ii) a second dye precursor selected from dyes and dye couples in the group consisting of leuco methylene blue; N-carboxylmethylaminocarbonyl)-4,4'-bis(dimethylamino)diphenylamine, sodium salt (leuco Bindschedler's green); N-methyl-N-phenyl-1,4-benzenediamine (NCP-04) and ALPS; N-methyl-N-(3-methylphenyl)-1,4-benzenediamine (NCP-05) and DAPS; and N-methyl-N-(3-methoxylphenyl)-1,4-benzenediamine (NCP-06) and N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3-methoxyaniline, sodium salt (ADOS).

Claim 10

A reagent test strip for use in an apparatus for determining a concentration of glucose in a sample of whole blood, the apparatus comprising optical means for detecting intensity of light at wavelengths of about 635 nm and about 700 nm reflected from at least a portion of a matrix disposed near one end of the strip, which matrix comprises a) a sample receiving surface for receiving the whole blood sample and passing a portion of it toward a testing surface opposite thereto, b) a structure that selectively retards the passage of red blood cells through the matrix, whereby any portion of the sample that is visible from the testing surface does not absorb light to any appreciable extent at about 700 nm, and c) a reagent for indicating the glucose concentration by creating at the testing surface, about 15 seconds after the sample becomes visible there, a reduction in K/S at about 700 nm of at least about 0.2, thereby simulating the absorbance of hemoglobin in blood, and a reduction in reflectance at about 635 nm that is indicative of the glucose concentration, the reagent comprising (i) a first dye precursor selected from a dye and dye couples in the group consisting of BISMAP; 3-methyl-2-benzothiazolinone hydrazone hydrochloride (MBTH) and N-ethyl-N-(3-sulfopropyl)aniline, sodium salt (ALPS); SMBTH and ALPS; AAP and N-ethyl-N-(3sulfopropyl)-3,5-dimethoxyaniline, sodium salt (DAOS); and (ii) a second dye precursor selected from dyes and dye couples in the group consisting of leuco methylene blue; N-carboxylmethylaminocarbonyl)-4,4'-bis(dimethylamino)diphenylamine, sodium salt (leuco Bindschedler's green); N-methyl-N-phenyl-1,4-benzenediamine (NCP-04) and ALPS; N-methyl-N-(3-methylphenyl)-1,4-benzenediamine (NCP-05) and DAPS; and N-methyl-N-(3-methoxylphenyl)-1,4-benzenediamine (NCP-06) and N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3-methoxyaniline, sodium salt (ADOS).

Claim 11

The strip of claim 7, in which the first and second dye precursor each include a composition selected from the group consisting of ALPS, DAPS, and DAOS.