Solid phase multi-analyte assay

• US 10,539,580 B2
• Filed: 04/29/2009
• Issued: 01/21/2020
• Est. Priority Date: 04/29/2008
• Status: Active Grant

• Current Assignee: Psychemedics Corporation
• Original Assignee: Psychemedics Corporation
• Inventors: Hill, Virginia, Atefi, Mohammad, Schaffer, Michael I.
• Primary Examiner(s): Brown, Melanie
• Assistant Examiner(s): Moerschell, Richard
• Application Number:
  US12/990,451
• Publication Number:
  US 20110118138A1
• Time in Patent Office: 3,919 Days
• Field of Search: None
• CPC Class Codes: G01N 2474/20 Immunohistochemistry assay
• CPC Class Codes: G01N 33/94 involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
• CPC Class Codes: G01N 33/9486 Analgesics, e.g. opiates, aspirine

Abstract

Compositions and methods for detecting the presence and/or amount of one or more analytes, including analytes such as drugs of abuse, are provided. The compositions include two or more analytes associated with a solid phase, e.g., a particle or a multiwell plate. The compositions and methods also allow the simultaneous, tandem, or serial determination of the presence and/or amount of two or more analytes of interest in a sample.

Claims

1. A method for determining the amount of an analyte of interest in a sample, the method comprising contacting a solid phase composition with i) an antibody specific for the analyte of interest and ii) the sample under competitive binding conditions, and determining the amount of the analyte of interest in the sample;

wherein;

the solid phase composition comprises a polystyrene solid phase support and at least two different conjugates, wherein each conjugate comprises an albumin covalently conjugated to a drug of abuse or metabolite thereof selected from the group consisting of benzoylecgonine, an amphetamine, tramadol, PCP, morphine, oxycodone, methadone, cotinine, a benzodiazepine, buprenorphine, fentanyl, and a cannabinoid;

wherein the antibody specific for the analyte of interest binds to one of the at least two different conjugates;

the analyte is a drug of abuse or a metabolite thereof;

the at least two different conjugates are bound noncovalently or via adsorption to the polystyrene solid phase support;

the at least two different conjugates are randomly affixed as a mixture to a single solid phase component of the polystyrene solid phase support, wherein the polystyrene solid phase support comprises a plurality of single solid phase components, and each single solid phase component of the polystyrene solid phase support comprises the at least two different conjugates; and

the antibody specific for the analyte of interest is labeled or a labeled secondary antibody is introduced which is specific for the antibody specific for the analyte of interest.

2. The method of claim 1, wherein the antibody is detectably labeled.

3. The method of claim 2, wherein the antibody is detectably labeled with a fluorescent, luminescent, radioactive, or enzymatic label.

4. The method of claim 1, wherein the antibody is not labeled.

5. The method of claim 1, further comprising removing antibody that is not bound to the solid phase composition.

6. The method of claim 1, wherein the amount of the analyte is determined in the sample by comparing a signal generated by the antibody bound to the single solid phase component of the solid phase composition in the sample with a signal generated by the antibody bound to the single solid phase component of the solid phase composition in a control sample that does not comprise the analyte of interest.

7. The method of claim 6, wherein the antibody specific for the analyte of interest is labeled.

8. The method of claim 6, wherein the signal generated by the antibody bound to the single solid phase component of the solid phase composition is derived from a labeled secondary antibody which is specific for the antibody specific for the analyte of interest.

9. The method of claim 7 or 8, wherein the label is a fluorescent, luminescent, radioactive, or enzymatic label.

10. The method of claim 1, further comprising contacting the single solid phase component of the solid phase composition with a second antibody, where the second antibody is specific for the at least second different analyte bound to the single solid phase component, and determining the amount of the second analyte in the sample.

11. The method of claim 1, wherein the albumin is selected from HSA and BSA.

12. The method of claim 1, wherein the analyte of interest is selected from cocaine, benzoylecgonine, cocaethylene, norcocaine, PCP, amphetamine, methamphetamine, cannabinoids, THC, carboxy-THC, heroin, codeine, morphine, 6-monoacetylmorphine (MAM), oxycodone, 3,4-methylenedioxyamphetamine (MDA);

and 3,4-methylenedioxymethamphetamine (MDMA).

13. The method of claim 1, wherein the sample is a bodily sample or a sample derived from a bodily sample.

14. The method of claim 13, wherein the bodily sample is from a human, and is selected from a tissue sample of the brain, heart, lung, kidney, liver, muscle, bone, stomach, intestines, and skin;

a biological fluid selected from urine, blood, plasma, serum, saliva, semen, sputum, cerebral spinal fluid, mucus, sweat, vitreous liquid, and milk; and

a keratinized structure.

15. The method of claim 14, wherein the bodily sample is a keratinized structure.

16. The method of claim 1, wherein the single solid phase component is a microwell of a microplate.

17. The method of claim 1, wherein the sample is derived from hair.

18. The method of claim 1, wherein the analyte of interest is selected from cocaine, PCP, an amphetamine, tramadol, a cannabinoid, morphine, oxycodone, methadone, fentanyl, cotinine, buprenorphine, and a benzodiazepine.