Reagents, methods, and systems for detecting therapeutic agents to monitor adherence to nucleoside reverse transcriptase inhibitor metabolites
AssigneeOrasure Technologies, Inc.
InventorsGiffin DAUGHTRIDGE, Keith KARDOS, Sharanappa Basappa RAJUR, Kim HWA-OK, Asharani Dhondiram KADAM
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Abstract
The invention provides novel compounds, reagents, systems, and methods for detecting a metabolite related to a NRTI in a biological sample, and uses thereof in monitoring adherence to pre-exposure prophylaxis. Such reagents comprise NRTI derivatives, analogs, NRTI derivatives conjugates, along with antibodies directed to same, which are useful for antibody-based methods, such as a lateral flow immunoassay and other point of care devices.
Claims20
An antibody that specifically binds to tenofovir diphosphate comprising:
- an immunoglobulin heavy chain and an immunoglobulin light chain,
- wherein a variable region of said heavy chain comprises:
- (i) a CDR1 region comprising an amino acid sequence selected from the group consisting of SEQ ID NOs:
- 2, 10, 18, and 26;
- (ii) a CDR2 region comprising an amino acid sequence selected from the group consisting of SEQ ID NOs:
- 3, 11, 19, and 27;
- and/or
- (iii) a CDR3 region comprising an amino acid sequence selected from the group consisting of SEQ ID NOs:
- 4, 12, 20, and 28;
- and
- wherein a variable region of said light chain comprises:
- (i) a CDR1 region comprising an amino acid sequence selected from the group consisting of SEQ ID NOs:
- 6, 14, 22, and 30;
- (ii) a CDR2 region comprising an amino acid sequence selected from the group consisting of SEQ ID NOs:
- 7, 15, 23, and 31;
- and/or
- (iii) a CDR3 region comprising an amino acid sequence selected from the group consisting of SEQ ID NOs:
- 8, 16, 24, and 32.
A method for performing a lateral flow assay to detect tenofovir diphosphate in a fluid sample of a patient, wherein the patient is prescribed or administered an NRTI regimen comprising tenofovir, comprising:
- (a) applying a fluid sample to a sample pad;
- (b) allowing said sample to flow laterally along the sample pad to a conjugated label pad;
- wherein said conjugated label pad comprises a first reagent conjugated to a detectable label, and wherein a portion of the conjugated label pad and a portion of the sample pad forms a first interface;
- (c) allowing said sample to flow laterally along the conjugated label pad to a membrane;
- wherein a portion of the membrane and a portion of the conjugated label pad forms a second interface;
- and wherein said membrane comprises at least one second reagent bound to the membrane to form a test line;
- (d) binding the first reagent to the second reagent to form a second reagent-first reagent complex at the test line, and causing the detectable label to form a detectable signal at the test line;
- and
- (e) diagnosing the patient as non-adherent to a treatment or prophylactic regimen in the presence of a detectable signal;
- or adherent to a treatment or prophylactic regimen in the absence of a detectable signal.
10-14. (canceled)
A device for performing a lateral flow assay to detect tenofovir diphosphate in a fluid sample of a patient, wherein the patient is prescribed or administered an NRTI regimen comprising tenofovir, comprising:
- (a) a sample pad for contacting the fluid sample;
- (b) a conjugated label pad, the conjugated label pad having a first reagent conjugated to a detectable label, a portion of the conjugated label pad and a portion of the sample pad forming a first interface;
- (c) an assay comprising a membrane, a portion of the membrane and a portion of the conjugated label pad forming a second interface;
- and
- (d) at least one second reagent bound to the membrane to form a test line, the first interface allowing fluid to flow from the sample pad to the conjugated label pad and contact the detectable label, the second interface allowing fluid to flow from the conjugated label pad to the membrane and to contact the at least one membrane-bound second reagent to form to a second reagent-first reagent complex, and cause the detectable label to form a detectable signal at the test line;
- wherein the presence of a detectable signal indicates non-adherence to a treatment or prophylactic regimen in the patient, and wherein the absence of a detectable signal indicates adherence to a treatment or prophylactic regimen in the patient.
18-22. (canceled)
24-26. (canceled)
Dependencies are inferred from the claim text.