DEVICES, METHODS, AND KITS FOR MULTIPLEXING A FLUID SAMPLE VIA FLUID SAMPLE REUSE

• US 20190331675A1
• Filed: 06/06/2017
• Published: 10/31/2019
• Est. Priority Date: 06/17/2016
• Status: Abandoned Application

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Inventors: Ledden, David
• Application Number:
  US16/310,088
• Publication Number:
  US 20190331675A1
• Time in Patent Office: Days
• CPC Class Codes: G01N 33/48714 for determining substances foreign to the organism, e.g. drugs or heavy metals drugs by chemical analysis G01N33/94
• CPC Class Codes: G01N 33/5308 for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites
• CPC Class Codes: G01N 33/541 Double or second antibody , i.e. precipitating antibody
• CPC Class Codes: G01N 33/54306 Solid-phase reaction mechanisms
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/573 for enzymes or isoenzymes
• CPC Class Codes: G01N 33/577 involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens; G01N33/53 - G01N33/576 take precedence
• CPC Class Codes: G01N 33/68 involving proteins, peptides or amino acids involving lipoproteins G01N33/92
• CPC Class Codes: G01N 33/74 involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors

Abstract

Devices, methods, and kits for detecting at least two analytes present within a small volume single fluid sample obtained from patient for the creation of a multiplexed panel of the various analytes present within the single fluid sample are disclosed.

Claims

1. A device for detecting the presence of at least two analytes in a patient'"'"'s single fluid sample, the device comprising:

a pipetting station, wherein the pipetting station is configured to receive at least two pipettes, wherein the at least two pipettes comprises a first pipette having a first immobilized binding partner specific to a first analyte present on an inner surface of the first pipette and a second pipette having a second immobilized binding partner specific to a second analyte present on an inner surface of the second pipette, wherein the analyte specificity of the first immobilized binding partner is different than the analyte specificity of the second immobilized binding partner;

wherein the first pipette is disposable within a fluid sample receptacle configured to hold a patient'"'"'s single fluid sample, the first pipette configured to withdraw at least a portion of the single fluid sample into the first pipette such that the first immobilized binding partner is brought into contact with the withdrawn single fluid sample to thereby form a first analyte-binding partner complex if a first analyte is present in the single fluid sample; and

further wherein a non-reacted portion of the single fluid sample is re-dispensable from the first pipette into the fluid sample receptacle, and thereafter the second pipette is disposable within the fluid sample receptacle whereby the second pipette is configured to withdraw at least a portion of the re-dispensed fluid sample such that the second immobilized binding partner is brought into contact with the re-dispensed fluid sample to thereby form a second analyte-binding partner complex if a second analyte is present in the re-dispensed fluid sample.

2. The device of claim 1, wherein the single fluid sample is selected from the group consisting of whole blood, blood plasma, blood serum, saliva, sputum, cerebrospinal fluid (CSF), intestinal fluid, intraperotineal fluid, cystic fluid, sweat, interstitial fluid, tears, mucus, urine, bladder wash, and semen.

3. The device of claim 1, wherein the patient'"'"'s single fluid sample comprises a volume from about 1 microliter to about 100 microliters.

4. The device of claim 3, wherein the volume of the patient'"'"'s single fluid sample is about 50 microliters.

5. The device of claim 1, wherein the sample receptacle is selected from the group consisting of a well, cuvette, tube, vial, and capillary.

6. The device of claim 1, wherein the first analyte and second analyte are selected from the group consisting of cardiac markers, infectious disease serological analytes, therapeutic drugs, drugs of abuse, hormones, cancer markers, infectious disease nucleic acid analytes, autoimmune disease nucleic acid markers, proteins, vitamins, cofactors, metabolites, and combinations thereof.

7. The device of claim 1, wherein the first immobilized binding partner and the second immobilized binding partner are selected from the group consisting of intact monoclonal antibodies, polyclonal antibodies, multi-specific antibodies, bispecific antibodies, antibody fragments, receptors, ligands, aptamers, antigens, antibody substitute proteins or peptides, molecular imprinted polymers, and combinations thereof.

8. The device of claim 7, wherein the first immobilized capture antibody and the second immobilized capture antibody are selected from the group consisting of IgG, IgE, IgM, IgD, IgA, IgG1, IgG2, IgG3, IgG4, IgA1, IgA2, and combinations thereof.

9. A method for detecting the presence of at least two analytes in a patient'"'"'s single fluid sample, the method comprising the steps of:

upon receipt of a patient'"'"'s single fluid sample which may comprise at least two analytes, placing the patient'"'"'s single fluid sample in a sample receptacle;

drawing the single fluid sample into a first pipette that is disposed within the sample receptacle, wherein a first immobilized binding partner is present on an inner surface of the first pipette and the first immobilized binding partner is brought into contact with the withdrawn single fluid sample such that a first analyte-binding partner complex is formed if a first analyte is present in the single fluid sample;

re-dispensing a non-reacted portion of the withdrawn single fluid sample from the first pipette and into the fluid sample receptacle;

drawing at least a portion of the re-dispensed fluid sample into a second pipette that is disposed within the sample receptacle, wherein a second immobilized binding partner is present on an inner surface of the second pipette, the second immobilized binding partner comprising an analyte specificity different from that of the first immobilized binding partner, further wherein the second immobilized binding partner is brought into contact with the re-dispensed fluid sample such that a second analyte-binding partner complex is formed if a second analyte is present in the re-dispensed fluid sample; and

detecting the presence of the first analyte-binding partner complex and the presence of the second analyte-binding partner complex.

10. The method of claim 9, wherein the patient'"'"'s single fluid sample is selected from the group consisting of whole blood, blood plasma, blood serum, saliva, sputum, cerebrospinal fluid (CSF), intestinal fluid, intraperotineal fluid, cystic fluid, sweat, interstitial fluid, tears, mucus, urine, bladder wash, and semen.

11. The method of claim 9, wherein the patient'"'"'s single fluid sample comprises a volume from about 1 microliter to about 100 microliters.

12. The method of claim 11, wherein the volume of the patient'"'"'s single fluid sample is about 50 microliters.

13. The method of claim 9, wherein the sample receptacle is selected from the group consisting of a well, cuvette, tube, vial, and capillary.

14. The method of claim 9, wherein the first analyte and second analyte are selected from the group consisting of cardiac markers, infectious disease serological analytes, therapeutic drugs, drugs of abuse, hormones, cancer markers, infectious disease nucleic acid analytes, autoimmune disease nucleic acid markers, proteins, vitamins, cofactors, metabolites, and combinations thereof.

15. The method of claim 9, wherein the first immobilized binding partner and the second immobilized binding partner are selected from the group consisting of intact monoclonal antibodies, polyclonal antibodies, multi-specific antibodies, bispecific antibodies, antibody fragments, receptors, ligands, aptamers, antigens, antibody substitute proteins and peptides, molecular imprinted polymers, and combinations thereof.

16. The method of claim 15, wherein the first immobilized binding partner and the second immobilized binding partner are selected from the group consisting of IgG, IgE, IgM, IgD, IgA, IgG1, IgG2, IgG3, IgG4, IgA1, IgA2, and combinations thereof.

17. The method of claim 9, wherein the detection of the first analyte and the second analyte is conducted via chemiluminescent detection, fluorescent detection, and combinations thereof.

18. A kit for detecting the presence of at least two analytes in a patient'"'"'s single fluid sample, the kit comprising:

at least two pipettes, wherein the at least two pipettes comprises a first pipette having a first immobilized capture antibody specific to a first analyte present on an inner surface of the first pipette and a second pipette having a second immobilized capture antibody specific to a second analyte present on an inner surface of the second pipette, wherein the analyte specificity of the first immobilized capture antibody is different than the analyte specificity of the second immobilized capture antibody;

a fluid sample receptacle, wherein the fluid sample receptacle is configured to hold a patient'"'"'s single fluid sample; and

providing instructions to a user to allow the user to use the kit to identify the presence of at least two analytes in the single fluid sample.