Body fluid analyte meter & cartridge system for performing combined general chemical and specific binding assays
First Claim
1. A combination body fluid analyte meter and cartridge system, comprising:
- (a) a body fluid analyte meter, comprising;
a housing;
a logic circuit disposed within the housing;
a visual display disposed on the housing; and
a measurement system disposed within the housing; and
(b) a cartridge, comprising;
at least one lateral flow assay test strip, the lateral flow assay test strip comprising;
(i) a lateral flow transport matrix;
(ii) a specific binding assay zone on the transport matrix for receiving a fluid sample and performing a specific binding assay to produce a detectable response, and (iii) a general chemical assay zone on the transport matrix for receiving the fluid sample and performing a general chemical assay to produce a detectable response;
wherein the cartridge is dimensioned to be receivable into the body fluid analyte meter such that the measurement system is positioned to detect the responses in the specific binding assay zone and the general chemical assay zone in the lateral flow assay test strip.
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Accused Products
Abstract
A combination body fluid analyte meter and cartridge system, having: (a) a body fluid analyte meter, with: a housing; a logic circuit disposed within the housing; a visual display disposed on the housing; and a measurement system disposed within the housing; and (b) a cartridge, having: at least one lateral flow assay test strip, the lateral flow assay test strip having: (i) a lateral flow transport matrix; (ii) a specific binding assay zone on the transport matrix for receiving a fluid sample and performing a specific binding assay to produce a detectable response, and (iii) a general chemical assay zone on the transport matrix for receiving the fluid sample and performing a general chemical assay to produce a detectable response; wherein the cartridge is dimensioned to be receivable into the body fluid analyte meter such that the measurement system is positioned to detect the responses in the specific binding assay zone and the general chemical assay zone in the lateral flow assay test strip.
224 Citations
158 Claims
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1. A combination body fluid analyte meter and cartridge system, comprising:
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(a) a body fluid analyte meter, comprising;
a housing;
a logic circuit disposed within the housing;
a visual display disposed on the housing; and
a measurement system disposed within the housing; and
(b) a cartridge, comprising;
at least one lateral flow assay test strip, the lateral flow assay test strip comprising;
(i) a lateral flow transport matrix;
(ii) a specific binding assay zone on the transport matrix for receiving a fluid sample and performing a specific binding assay to produce a detectable response, and (iii) a general chemical assay zone on the transport matrix for receiving the fluid sample and performing a general chemical assay to produce a detectable response;
wherein the cartridge is dimensioned to be receivable into the body fluid analyte meter such that the measurement system is positioned to detect the responses in the specific binding assay zone and the general chemical assay zone in the lateral flow assay test strip. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64)
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65. A cartridge for use with a body fluid analyte meter, the cartridge comprising:
(a) at least one lateral flow assay test strip, the lateral flow assay test strip comprising;
(i) a lateral flow transport matrix;
(ii) a specific binding assay zone on the transport matrix for receiving a fluid sample and performing a specific binding assay to produce a detectable response, and (iii) a general chemical assay zone on the transport matrix for receiving the fluid sample and performing a general chemical assay to produce a detectable response;
wherein the cartridge is dimensioned to be receivable into a body fluid analyte meter such that a measurement system in the body fluid analyte meter is positioned to detect the responses in the specific binding assay zone and the general chemical assay zone in the lateral flow assay test strip. - View Dependent Claims (66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 109, 110, 111, 112, 113, 114, 115)
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108. The system of claim 105107, wherein the conjugate removal zone is formed by the junction between the first and second membranes.
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116. A lateral flow assay test strip, comprising:
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(i) a transport matrix;
(ii) a specific binding assay zone on the transport matrix for receiving a fluid sample and performing a specific binding assay to produce a detectable response, and (iii) a general chemical assay zone on the transport matrix for receiving the fluid sample and performing a general chemical assay to produce a detectable response, wherein the lateral flow assay test strip is formed from a single continuous membrane of material. - View Dependent Claims (117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152)
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138. The system of claim 135425, wherein the labeled indicator reagent is a colored microparticle conjugated to an anti-HbA1c antibody.
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153. A transverse flow assay test strip, comprising:
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a transport matrix comprising a stack of membranes;
a specific binding assay zone on the transport matrix for receiving a fluid sample and performing a specific binding assay to produce a detectable response, and a general chemical assay zone on the transport matrix for receiving the fluid sample and performing a general chemical assay to produce a detectable response. - View Dependent Claims (154, 155, 156, 157)
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158. A lateral flow assay test strip, comprising:
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a lateral flow transport matrix;
a specific binding assay zone on the transport matrix for receiving a fluid sample and performing a specific binding assay to detect the level of human albumin present in the fluid sample, and a general chemical assay zone on the transport matrix for receiving the fluid sample and performing a general chemical assay to detect the level of creatinine present in the fluid sample.
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Specification