MULTIPLE ANALYTE ASSAY DEVICE WITH SAMPLE INTEGRITY MONITORING SYSTEM
First Claim
1. A device for use in determining whether the integrity of a fluid analyte sample has been compromised and for contemporaneously assaying the sample for the presence or absence of multiple analytes, the device comprising:
- (A) a base having adjacent slots therein of sufficient length for insertion of an analyte test strip therein, wherein each slot is defined by (a) a floor, (b) raised walls depending upwardly from the floor to separate each adjacent slot from the next, and (c) at least one open end;
(B) a multiplicity of analyte test strips having an upstream and a downstream end, wherein each analyte test strip occupies a separate slot of the base so the upstream end of each analyte test strip protrudes out of the open end of each slot;
(C) a sample integrity monitoring system, the system comprising;
(a) a carrier membrane lying parallel to each analyte test strip;
(b) a sample integrity determinant pad in fluid communication with the carrier membrane; and
, (c) determinants incorporated into the integrity determinant pad, which determinants provide a detectable signal for a parameter indicative of the condition of the fluid;
wherein neither the carrier membrane nor the integrity determinant pad are in appreciable fluid communication with any of the analyte test strips.
1 Assignment
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Accused Products
Abstract
An assay device, a fluid analyte sample separator device and methods for use of thereof for determining whether the integrity of a fluid analyte sample has been compromised and for contemporaneously assaying the sample for the presence or absence of multiple analytes, such as drugs of abuse. The device is composed of a housing having separate slots therein for insertion of one or more analyte test strips, one end of which protrudes from the housing, and one or more units of a sample integrity monitoring system. The device may be used in dipstick or cassette form. An analyte sample separator for division of sample and retention of uncontaminated sample for further testing is also provided. The analyte test strips and sample integrity monitoring system are replaceable, so that the panel of analytes and of sample condition parameters tested can be customized.
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Citations
42 Claims
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1. A device for use in determining whether the integrity of a fluid analyte sample has been compromised and for contemporaneously assaying the sample for the presence or absence of multiple analytes, the device comprising:
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(A) a base having adjacent slots therein of sufficient length for insertion of an analyte test strip therein, wherein each slot is defined by (a) a floor, (b) raised walls depending upwardly from the floor to separate each adjacent slot from the next, and (c) at least one open end;
(B) a multiplicity of analyte test strips having an upstream and a downstream end, wherein each analyte test strip occupies a separate slot of the base so the upstream end of each analyte test strip protrudes out of the open end of each slot;
(C) a sample integrity monitoring system, the system comprising;
(a) a carrier membrane lying parallel to each analyte test strip;
(b) a sample integrity determinant pad in fluid communication with the carrier membrane; and
,(c) determinants incorporated into the integrity determinant pad, which determinants provide a detectable signal for a parameter indicative of the condition of the fluid;
wherein neither the carrier membrane nor the integrity determinant pad are in appreciable fluid communication with any of the analyte test strips. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 27, 28, 29, 30, 31, 32, 39, 41, 42)
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14. A device for use in determining whether the integrity of a fluid analyte sample has been compromised and for contemporaneously assaying the sample for the presence or absence of multiple analytes, the device comprising:
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(A) a base having adjacent slots therein of sufficient length for insertion of a analyte test strip therein, wherein each slot is defined by (a) a floor, (b) raised walls depending upwardly from the floor to separate each adjacent slot from the next, and (c) at least one open end;
(B) a multiplicity of analyte test strips having an upstream and a downstream end, wherein each analyte test strip occupies a separate slot of the base so the upstream end of the analyte test strip protrudes out of the open end of the slot;
(C) a sample integrity monitoring system, the system comprising;
(a) a carrier membrane inserted into a slot of the base;
(b) a sample integrity determinant pad in fluid communication with the carrier membrane;
(c) determinants incorporated into the sample integrity determinant pad, which determinants provide a detectable signal for a parameter indicative of the condition of the fluid;
wherein neither the carrier membrane nor the sample integrity determinant pad are in appreciable fluid communication with any of the analyte test strips; and
,(D) a cap enclosing the protruding ends of the analyte test strips, the cap comprising;
(a) a sample port formed through which fluid analyte sample may be applied to the protruding ends of the analyte test strips; and
,(b) a floor opposing the sample port, the floor comprising a wall having a raised bar therein which defines a fluid reservoir beneath the sample port. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 40)
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33. An assay system for determining whether the integrity of a fluid analyte sample has been compromised and for contemporaneously assaying the sample for the presence or absence of an analyte, the assay system comprising:
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(A) an analyte test strip having an upstream and a downstream end, (B) a sample integrity monitoring system at the downstream end of the analyte test strip, the sample integrity monitoring system comprising;
(a) a carrier membrane;
(b) a sample integrity determinant pad in fluid communication with the carrier membrane; and
,(c) determinants incorporated into the sample integrity determinant pad, which determinants provide a detectable signal for a parameter indicative of the condition of the fluid;
wherein the sample integrity monitoring system is not in appreciable fluid communication with the analyte test strip. - View Dependent Claims (34, 35, 36, 37, 38)
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Specification