Method and device for combined detection of viral and bacterial infections

• US 10,408,835 B2
• Filed: 12/02/2015
• Issued: 09/10/2019
• Est. Priority Date: 05/20/2008
• Status: Active Grant

• Current Assignee: Rapid Pathogen Screening, Inc
• Original Assignee: Rapid Pathogen Screening, Inc
• Inventors: Sambursky, Robert P., VanDine, Robert W., Babu, Uma Mahesh, Condon, Peter
• Primary Examiner(s): Crawford, Erik B
• Application Number:
  US14/956,956
• Publication Number:
  US 20160084832A1
• Time in Patent Office: 1,378 Days
• Field of Search: None
• CPC Class Codes: B01J 2219/00576 fluorophore
• CPC Class Codes: B01J 2219/00648 by the use of solid beads
• CPC Class Codes: B01J 2219/00725 Peptides
• CPC Class Codes: B01J 2219/0074 Biological products
• CPC Class Codes: B01J 2219/00743 Cells
• CPC Class Codes: B82Y 30/00 Nanotechnology for materials or surface science, e.g. nanocomposites
• CPC Class Codes: G01N 2333/4703 Regulators; Modulating activity
• CPC Class Codes: G01N 2333/4737 C-reactive protein
• CPC Class Codes: G01N 2333/914 Hydrolases (3)
• CPC Class Codes: G01N 2469/00 Immunoassays for the detection of microorganisms
• CPC Class Codes: G01N 33/54346 Nanoparticles
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/569 for microorganisms, e.g. protozoa, bacteria, viruses
• CPC Class Codes: G01N 33/56911 Bacteria
• CPC Class Codes: G01N 33/56983 Viruses

Abstract

A lateral flow assay is capable of detecting and differentiating viral and bacterial infections. A combined point of care diagnostic device tests markers for viral infection and markers for bacterial infection, to effectively assist in the rapid differentiation of viral and bacterial infections. In some preferred embodiments, bimodal methods and devices determine if an infection is bacterial and/or viral. A dual use two strip sample analysis device includes a first lateral flow chromatographic test strip to detect MxA and a low level of C-reactive protein and a second lateral flow chromatographic test strip to detect high levels of C-reactive protein. In some preferred embodiments, the sample is a fingerstick blood sample.

Claims

1. A device for the detection of a bacterial and/or viral marker in a sample, comprising:

a) a first lateral flow chromatographic test strip comprising;

a first reagent zone for detecting a low level intensity of C-reactive protein comprising at least one first reagent specific to C-reactive protein such that, when the sample contacts the first reagent, a first labeled complex forms if the low level intensity of C-reactive protein is greater than a threshold concentration present in the sample;

a second reagent zone comprising at least one second reagent specific to detect an intensity of MxA such that, when the sample contacts the second reagent, a second labeled complex forms if MxA is present in the sample indicative of detecting the viral marker being in the sample; and

a first detection zone comprising a first binding partner which binds to the first labeled complex, indicative of detecting the bacterial marker being in the sample, wherein the threshold concentration to obtain a positive visual result for the low level intensity of C-reactive protein in the first detection zone of the first lateral flow chromatographic test strip is equal to or greater than a serum equivalent of approximately 6-15 mg/L of C-reactive protein; and

a second binding partner which binds to the second labeled complex; and

b) a second lateral flow chromatographic test strip parallel in a lateral flow direction to the first lateral flow chromatographic test strip, comprising;

at least one third reagent zone for detecting a high level intensity of C-reactive protein comprising at least one third reagent specific to C-reactive protein, wherein the third reagent only detects a level intensity of C-reactive protein that is higher in intensity than the low level intensity of C-reactive protein detected by the first reagent, such that, when the sample contacts the third reagent, a third labeled complex forms if the high level intensity of C-reactive protein is present in the sample; and

a second detection zone comprising a third binding partner which binds to the third labeled complex wherein the threshold concentration to obtain a positive result for the high level intensity of C-reactive protein in the second detection zone of the second lateral flow chromatographic test strip is equal to or greater than a serum equivalent of approximately 60-100 mg/L;

wherein the second lateral flow chromatographic test strip does not comprise reagent and detection zones for detecting MxA.

2. The device of claim 1, wherein the threshold concentration to obtain a positive result for the low level of C-reactive protein in the first detection zone of the first lateral flow chromatographic test strip is equal to or greater than a serum equivalent of approximately 10 mg/L of C-reactive protein.

3. The device of claim 1, wherein a threshold concentration to obtain a positive result for the high level of C-reactive protein in the second detection zone of the second lateral flow chromatographic test strip is equal to or greater than a serum equivalent of approximately 80 mg/L.

4. The device of claim 1, wherein a threshold concentration to obtain a positive result for MxA in the first detection zone of the first lateral flow chromatographic test strip is equal to or greater than approximately 40 ng/ml.

5. The device of claim 1, wherein a threshold concentration to obtain a positive result for MxA in the first detection zone of the first lateral flow chromatographic test strip is equal to or greater than approximately 15-250 ng/ml.

6. The device of claim 1, wherein the first lateral flow chromatographic test strip further comprises a lysis zone comprising at least one lysis agent, wherein the lysis agent contacts the sample on the first lateral flow chromatographic test strip.

7. The device of claim 1, wherein the second lateral flow chromatographic test strip further comprises a lysis zone comprising at least one lysis agent, wherein the lysis agent contacts the sample on the second lateral flow chromatographic test strip.

8. The device of claim 1, wherein the first lateral flow chromatographic test strip further comprises a first sample application zone downstream of the first reagent zone and the second reagent zone, and upstream the first detection zone.

9. The device of claim 1, wherein the second lateral flow chromatographic test strip further comprises a second sample application zone downstream of the third reagent zone and upstream of the second detection zone.

10. The device of claim 1, wherein the sample is a blood sample.

11. The device of claim 1, wherein the sample contains leukocytes.