Devices, methods, and kits for multiplexing a fluid sample via fluid sample reuse

Patent metadata

Field	Value
Publication number	US-11585808-B2
Application number	US-202117174431-A
Country	US
Kind code	B2
Filing date	Feb 12, 2021
Priority date	Jun 17, 2016
Publication date	Feb 21, 2023
Grant date	Feb 21, 2023

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.

First claim

What is claimed is:

1. A method for detecting the presence of at least two analytes in a patient's single volume of fluid sample, the method comprising the steps of:
placing the patient's single volume of fluid sample in a sample receptacle;
drawing the single volume of fluid sample into a first pipette that is disposed within the sample receptacle, wherein a first immobilized binding partner specific to a first analyte is present on an inner surface of the first pipette and the first immobilized binding partner is brought into contact with the withdrawn single volume of fluid sample such that a first analyte-binding partner complex is formed if a first analyte is present in the single fluid sample;
re-dispensing a non-reacted portion of the withdrawn single volume of fluid sample from the first pipette and into the fluid sample receptacle;
drawing at least a portion of the re-dispensed single volume of fluid sample into a second pipette that is disposed within the sample receptacle, wherein a second immobilized binding partner specific to a second analyte 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 single volume of 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; and
wherein the first and second pipettes are attached to a pipetting station that attaches the first and second pipettes to one another, whereby the pipetting station sequentially disposes the at least two pipettes within the fluid sample receptacle for performing the drawing and re-dispensing steps.

2. The method of claim 1 , 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, intraperitoneal fluid, cystic fluid, sweat, interstitial fluid, tears, mucus, urine, bladder wash, and semen.

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

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

5. The method 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.

6. The method 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 and peptides, molecular imprinted polymers, and combinations thereof.

7. The method of claim 6 , 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.

8. The method of claim 1 , wherein the detection of the first analyte and the second analyte is conducted via chemiluminescent detection, fluorescent detection, and combinations thereof.

9. The method of claim 1 , wherein the pipetting station sequentially disposes the at least two pipettes within the fluid sample receptacle via automated processes.

10. A method for detecting the presence of at least two analytes in a patient's single volume of fluid sample, the method comprising the steps of:
placing the patient's single volume of fluid sample in a sample receptacle, wherein the patient's single fluid sample comprises a volume from about 1 microliter to about 100 microliters;
drawing the single volume of fluid sample into a first pipette that is disposed within the sample receptacle, wherein a first immobilized binding partner specific to a first analyte is present on an inner surface of the first pipette and the first immobilized binding partner is brought into contact with the withdrawn single volume of 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 volume of fluid sample from the first pipette and into the fluid sample receptacle;
drawing at least a portion of the re-dispensed single volume of fluid sample into a second pipette that is disposed within the sample receptacle, wherein a second immobilized binding partner specific to a second analyte 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 single volume of 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; and
wherein the first and second pipettes are attached to a pipetting station that attaches the first and second pipettes to one another, whereby the pipetting station sequentially disposes the at least two pipettes within the fluid sample receptacle for performing the drawing and re-dispensing steps.

11. The method of claim 10 , 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, intraperitoneal fluid, cystic fluid, sweat, interstitial fluid, tears, mucus, urine, bladder wash, and semen.

12. The method of claim 10 , 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.

13. The method of claim 10 , 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.

14. The method of claim 10 , wherein the detection of the first analyte and the second analyte is conducted via chemiluminescent detection, fluorescent detection, and combinations thereof.

15. The method of claim 10 , wherein the pipetting station sequentially disposes the at least two pipettes within the fluid sample receptacle via automated processes.

16. A kit for detecting the presence of at least two analytes in a patient's single volume of fluid sample, the kit comprising:
at least two pipettes, wherein the at least two pip

Assignees

• Siemens Healthcare Diagnostics Inc

Inventors

• Ledden David

Classifications

• G01N33/74

  involving hormones {or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors} · CPC title

• G01N33/54366 Primary

  Apparatus specially adapted for solid-phase testing · CPC title

• G01N33/48714

  for determining substances foreign to the organism, e.g. drugs or heavy metals (drugs by chemical analysis G01N33/94) · CPC title

• G01N33/5308

  for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites · CPC title

• G01N33/68

  involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)} · CPC title