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US 10,648,974 B2Granted
Ethyl glucuronide lateral flow test strips, immunoassays, devices and methods for detecting or measuring thereof
AssigneeCarehealth America Corporation
InventorsPaul Kenneth Johnson, Jacqueline Ann Gale
Life of this patent
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Abstract
Ethyl glucuronide (EtG) lateral flow immunoassay test strips, devices, and methods, useful for testing for alcohol ingestion for alcohol abuse or related diseases and treatment monitoring.
Claims12
An Ethyl glucuronide (EtG) lateral flow test strip immunoassay system for detecting ethyl glucuronide in a fluid sample, the system comprising:
- (a) a lateral flow test strip, the test strip comprising:
- (i) at least one type of capillary flow material capable of reproducibly providing lateral flow of the fluid sample through the test strip to reproducibly interact and detect EtG using a detectably labeled EtG-specific antibody;
- and a first detectable label and a second detectable label comprised in the test strip, the test strip providing:
- (1) a positive result, with a first colored band only developing;
- (2) a negative result, with both a second colored band and the first colored band developing;
- or
- (3) an invalid result, with only the second colored band developing or no bands;
- (ii) a sample application area, comprising a sample application component;
- (iii) a labeled EtG labeled antibody area, comprising a detectably labeled EtG specific antibody provided in or to the test strip material, the detectably labeled EtG specific antibody comprising an EtG specific antibody conjugated to a detectable label component and soluble in or conducted along the test strip by capillary action of the fluid sample after application to the test strip;
- (iv) a first detection area comprising the first detectable label as a first labeled moiety that binds the detectably labeled EtG specific antibody, when the concentration of EtG in the fluid sample is below a pre-selected threshold value between 100 and 2000 ng/mL;
- wherein the binding of the detectably labeled EtG specific antibody below the pre-selected threshold results in the negative result with both the first colored band and the second colored band;
- and
- wherein the detectably labeled EtG specific antibody does not detectably or significantly bind the first detectable label and also does not provide the negative result, when the EtG in the fluid sample is above the pre-selected threshold value;
- (v) a second detection area comprising the second detectable label as a second labeled moiety that binds the detectably labeled EtG specific antibody, when the concentration of the EtG in the fluid sample is above the pre-selected threshold value between 100 and 2000 ng/mL;
- and
- wherein the binding of the detectably labeled EtG specific antibody above the pre-selected threshold results in the positive result with only the first colored band;
- and
- wherein the detectably labeled EtG specific antibody does not detectably or significantly bind the first detectable label, when the EtG in the fluid sample is above the pre-selected threshold value;
- and
- wherein, when the assay is invalid, the binding of the detectably labeled EtG specific antibody results in the invalid result with only the second colored band, or no bands;
- and wherein the detectably labeled EtG specific antibody does not detectably or significantly bind the second detectable label.
18 more elements
A method for an ethyl glucuronide (EtG) lateral flow test strip immunoassay for detecting ethyl glucuronide in a fluid sample above or below a threshold value, the method comprising:
- (a) providing a lateral flow test strip, the test strip comprising:
- (i) at least one type of capillary flow material capable of reproducibly providing lateral flow of a urine, bodily fluid or tissue sample through the test strip to reproducibly interact and detect EtG using a detectably labeled EtG-specific antibody;
- and a first detectable label and a second detectable label comprised in the test strip, the test strip providing:
- (1) a positive result, with a first colored band only developing;
- (2) a negative result, with both a second colored band and the first colored band developing;
- or
- (3) an invalid result, with only the second colored band developing or no bands;
- (ii) a sample application area, comprising a sample application component;
- (iii) a labeled EtG labeled antibody area , comprising a detectably labeled EtG specific antibody provided in or to the test strip material, the detectably labeled EtG specific antibody comprising an EtG specific antibody conjugated to a detectable label component and soluble in or conducted along the test strip by capillary action of the urine or control sample after application to the test strip;
- (iv) a first detection area comprising the first detectable label as a first labeled moiety that binds the detectably labeled EtG specific antibody, when the concentration of EtG in the urine or control sample is below a pre-selected threshold value between 100 and 2000 ng/mL;
- wherein the binding of the detectably labeled EtG specific antibody below the pre-selected threshold results in the negative result with both the first colored band and the second colored band;
- and
- wherein the detectably labeled EtG specific antibody does not detectably or significantly bind the first detectable label and also does not provide the negative result, when the EtG in the urine or control sample is above the pre-selected threshold value;
- (v) a second detection area comprising the second detectable label as a second labeled moiety that binds the detectably labeled EtG specific antibody, when the concentration of the EtG in the urine or control sample is above the pre-selected threshold value between 100 and 2000 ng/mL;
- and
- wherein the binding of the detectably labeled EtG specific antibody above the pre-selected threshold results in the positive result with only the first colored band;
- and
- wherein the detectably labeled EtG specific antibody does not detectably or significantly bind the first detectable label, when the EtG in the urine or control sample is above the pre-selected threshold value;
- and
- wherein, when assay is invalid, the binding of the detectably labeled EtG specific antibody results in the invalid result with only the second colored band, or no bands;
- and wherein the detectably labeled EtG specific antibody does not detectably or significantly bind the second detectable label;
- (b) applying the fluid sample to the test strip;
- and
- (c) determining whether the fluid sample comprises EtG above or below the threshold.
21 more elements
Dependencies are inferred from the claim text.