Systems and methods for detecting infectious diseases

Patent metadata

Field	Value
Publication number	US-10522245-B2
Application number	US-201615356972-A
Country	US
Kind code	B2
Filing date	Nov 21, 2016
Priority date	Sep 6, 2013
Publication date	Dec 31, 2019
Grant date	Dec 31, 2019

Abstract

Systems, methods, and devices for detecting infections in a clinical sample are provided. Small-volume clinical samples obtained at a point-of-service (POS) location and may be tested at the POS location for multiple markers for multiple diseases, including upper and lower respiratory diseases. Samples may be tested for cytokines, or for inflammation indicators. Dilution of samples, or levels of detection, may be determined by the condition or past history of a subject. Test results may be obtained within a short amount of time after sample placement in a testing device, or within a short amount of time after being obtained from the subject. A prescription for treatment of a detected disorder may be provided, and may be filled, at the POS location. A bill may be automatically generated for the testing, or for the prescription, may be automatically sent to an insurance provider, and payment may be automatically obtained.

First claim

What is claimed is:

1. A method of detecting a disease marker, comprising:
a) introducing a cartridge comprising at least two different types of samples into an automatic sample processing device, wherein one of said samples comprises a swab sample carried on a swab, wherein said automatic sample processing device comprises:
i) a sample handling system configured to transport at least a portion of one of said samples and being configured to transport an independently movable assay unit; and
ii) an optical detector;

b) contacting one of said samples, or a portion thereof, with a movable assay unit, or a reagent, or both, for the performance of an assay for the detection of a disease marker;
c) positioning one of said samples, or portion thereof, at a location suitable for detection of an optical signal from the sample or portion thereof by said optical detector;
d) detecting the presence of a disease marker; and
e) processing the other of said samples using said automatic sample processing device to perform a second assay to detect a second disease marker.

2. The method of claim 1 , wherein said swab is entirely contained in the cartridge.

3. The method of claim 2 , wherein said sample obtained using said swab was obtained by swabbing a mouth, a throat, a nasal passage, a vaginal area, or other body cavity of a subject.

4. The method of claim 1 , wherein one of said samples comprises a sample obtained using said swab, and another of said samples comprises a blood sample.

5. The method of claim 1 , wherein said sample has a volume of less than about 500 microliters.

6. The method of claim 4 , comprising performing two or more assays for the detection of disease markers, and detecting two or more disease markers in said samples, or in one or more portions thereof.

7. The method of claim 6 , comprising detecting the presence of a nucleic acid disease marker and a protein disease marker.

8. The method of claim 1 , wherein said disease marker is selected from a nucleic acid disease marker, a protein disease marker, a saccharide, a prostaglandin, a cytokine, histamine, a steroid, and a marker for inflammation.

9. The method of claim 6 , wherein said two or more disease markers are selected from a nucleic acid disease marker, a protein disease marker, a saccharide, a prostaglandin, a cytokine, histamine, a steroid, and a marker for inflammation.

10. The method of claim 1 , wherein said disease marker is a marker for inflammation selected from prostaglandins, tumor necrosis factor alpha (TNF-α), interleukin-1 (IL-1), interleukin-8 (IL-8), interleukin-12 (IL-12), interferon gamma (IF-γ), bradykinin, complement system molecules, blood-clotting factors, C-reactive protein, erythrocyte sedimentation rate (ESR), white blood cell count, and morphological changes in blood and other cells.

11. The method of claim 1 , wherein the method is a point-of service method performed at a point-of-service location.

12. The method of claim 5 , wherein the method is a point-of service method performed at a point-of-service location.

13. The method of claim 1 , wherein the method may be performed in less than about 40 minutes.

14. The method of claim 4 , wherein the method may be performed in less than about 40 minutes.

15. A method of detecting a disease marker, comprising:
a) introducing a cartridge comprising at least two different types of samples into an automatic sample processing device, wherein one of said samples comprises a swab sample carried on a swab, wherein said automatic sample processing device comprises:
i) a sample handling system configured to transport at least a portion of one of said samples and being configured to transport an independently movable assay unit; and
ii) an optical detector;

b) contacting one of said samples, or a portion thereof, with a movable assay unit, or a reagent, or both, for the performance of an assay for the detection of a disease marker;
c) positioning one of said samples, or portion thereof, at a location suitable for detection of an optical signal from the sample or portion thereof by said optical detector;
d) detecting the presence of a disease marker; and
e) processing the other of said samples using said automatic sample processing device to perform a second assay to detect a second disease marker;
wherein said one of said samples comprises a blood sample.

16. A method of detecting a disease marker, comprising:
a) introducing a cartridge comprising at least two different types of samples into an automatic sample processing device, wherein one of said samples comprises a swab sample carried on a swab, wherein said automatic sample processing device comprises:
i) a sample handling system configured to transport at least a portion of one of said samples and being configured to transport an independently movable assay unit; and
ii) an optical detector;

b) contacting one of said samples, or a portion thereof, with a movable assay unit, or a reagent, or both, for the performance of an assay for the detection of a disease marker;
c) positioning one of said samples, or portion thereof, at a location suitable for detection of an optical signal from the sample or portion thereof by said optical detector;
d) detecting the presence of a disease marker; and
e) processing the other of said samples using said automatic sample processing device to perform a second assay to detect a second disease marker;

wherein said disease marker comprises a nucleic acid disease marker and said second disease marker comprise a protein disease marker.

Assignees

• Theranos Ip Co Llc

Inventors

• Lui Clarissa
• Holmes Elizabeth A

Classifications

• G01N33/56994

  Herpetoviridae, e.g. cytomegalovirus, Epstein-Barr virus · CPC title

• G16H10/40 Primary

  for data related to laboratory analysis, e.g. patient specimen analysis · CPC title

• G01N33/56944

  Streptococcus · CPC title

• C12Q1/6893

  for protozoa · CPC title

• G01N2469/20

  Detection of antibodies in sample from host which are directed against antigens from microorganisms · CPC title