RAPID TESTS FOR INSURANCE UNDERWRITING

• US 20140072959A1
• Filed: 03/14/2013
• Published: 03/13/2014
• Est. Priority Date: 09/12/2012
• Status: Abandoned Application

• Current Assignee: Force Diagnostics Inc.
• Original Assignee: Force Diagnostics Inc.
• Inventors: DETERMAN, Tedd C., CURRAN, Michael P., MULCONREY, Brian, OSTROW, David H.
• Application Number:
  US13/831,157
• Publication Number:
  US 20140072959A1
• Time in Patent Office: Days
• US Class Current: 435/5
• CPC Class Codes: G01N 2333/4737 C-reactive protein
• CPC Class Codes: G01N 2333/58 Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Brain natriuretic peptide [BNP, proBNP]; Cardionatrin; Cardiodilatin
• CPC Class Codes: G01N 2333/775 Apolipopeptides
• CPC Class Codes: G01N 2800/08 Hepato-biliairy disorders other than hepatitis
• CPC Class Codes: G01N 33/50 Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/56988 HIV or HTLV
• CPC Class Codes: G01N 33/57434 of prostate
• CPC Class Codes: G01N 33/576 for hepatitis
• CPC Class Codes: G01N 33/6854 Immunoglobulins
• CPC Class Codes: G01N 33/723 Glycosylated haemoglobin

Abstract

The present invention relates to rapid test devices, kits and systems comprising the rapid test devices for assessing at least two analytes in a sample derived from a life or health insurance applicant, said at least two analytes being selected from the group consisting of a human immunodeficiency virus (HIV) antigen (e.g., a HIV polypeptide), a HIV polynucleotide, an anti-HIV antibody, a hepatitis C virus (HCV) antigen (e.g., a HCV polypeptide), a HCV polynucleotide, an anti-HCV antibody, a liver enzyme alanine transaminase (ALT), a liver enzyme aspartate transaminase (AST), nt-probnp (or NT-proBNP), probnp (or proBNP), cotinine, nicotine, cocaine, a metabolite of cocaine (e.g., benzoylecgonine), prostate-specific antigen (PSA), apolipoprotein A-1 (ApoA1), apolipoprotein B (ApoB), Hemoglobin A1c and high-sensitivity C-reactive protein (hsCRP). The present invention also relates to methods for using the rapid test devices, kits and systems as part of the assessment of the life or health insurance applications.

Claims

1. A kit for assessing a life or health insurance applicant, which kit comprises at least two rapid test devices (e.g., singleplex or multiplex rapid test devices), said rapid test devices are configured to assess at least two analytes in a sample derived from a life or health insurance applicant, said at least two analytes being selected from the group consisting of a human immunodeficiency virus (HIV) antigen (e.g., a HIV polypeptide), a HIV polynucleotide, an anti-HIV antibody, a hepatitis C virus (HCV) antigen (e.g., a HCV polypeptide), a HCV polynucleotide, an anti-HCV antibody, a liver enzyme alanine transaminase (ALT), a liver enzyme aspartate transaminase (AST), nt-probnp (or NT-proBNP), probnp (or proBNP), cotinine, nicotine, cocaine, a metabolite of cocaine (e.g., benzoylecgonine), prostate-specific antigen (PSA), apolipoprotein A-1 (ApoA1), apolipoprotein B (ApoB), Hemoglobin A1c and high-sensitivity C-reactive protein (hsCRP), and preferably, said kit can be used for assessing a life or health insurance applicant at point of presence.

2. The kit of claim 1, which comprises at least 5 rapid test devices, and wherein the rapid test devices are configured to assess 5 analytes selected from the group consisting of an anti-HIV antibody, an anti-HCV antibody, cotinine or nicotine, cocaine or benzoylecgonine, and Hemoglobin A1c.

3. The kit of claim 1, wherein at least one of the rapid test devices is selected from the group consisting of a lateral flow test device, a flow through test device, a microfluidic test device, an immunochromatography test device, a single use cartridge or test device, a disposable test device, a self-contained test device, a point of care test device, a microsphere based test device, a nanoparticle based test device, a test strip device, a spot test device, a centrifugal device, and a pump based test device.

4. The kit of claim 1, wherein at least one of the rapid test devices can be used to conduct a test within about 12 hours.

5. The kit of claim 6, which comprises at least 5 lateral flow test devices, and wherein the lateral flow test devices are configured to assess 5 analytes selected from the group consisting of an anti-HIV antibody, an anti-HCV antibody, cotinine or nicotine, cocaine or benzoylecgonine, and Hemoglobin A1c.

6. A system for assessing a life or health insurance applicant, which system comprises the kit of claim 1.

7. The system of claim 6, which further comprises:

a) a means for assessing an additional health indicator of the life or health insurance applicant;

b) a means for obtaining at least two different types of samples from the life or health insurance applicant; and

/or

c) machine-readable information, e.g., a bar code.

8. The system of claim 6, which further comprises:

a) a reader to assess the detectable signal;

b) a means for recording, storing and/or sending test results in an electronic format;

c) a software program and/or algorithm that collates and/or optimizes all data inputs such as assay results, BMI, application, release form, attending physician statement (APS), medical information bureau (MIB) record, motor vehicle record (MVR), credit report and prescription or transaction history record into one electronically transferrable or printable file; and

/or

d) and/or an apparatus, software and/or algorism for forensic voice analysis that detects emotions in the human voice.

18. The method of claim 17, which is conducted using the kit of claim 1.

9. A lateral flow test device for assessing a life or health insurance applicant, which device is configured to assess at least two analytes in a sample derived from a life or health insurance applicant, said at least two analytes being selected from the group consisting of a HIV antigen (e.g., a HIV polypeptide), a HIV polynucleotide, an anti-HIV antibody, a HCV antigen (e.g., a HCV polypeptide), a HCV polynucleotide, an anti-HCV antibody, a liver enzyme alanine transaminase (ALT), a liver enzyme aspartate transaminase (AST), nt-probnp (or NT-proBNP), probnp (or proBNP), cotinine, nicotine, cocaine, a metabolite of cocaine (e.g., benzoylecgonine), PSA, ApoA1, ApoB, Hemoglobin A1c and hsCRP, and

said device comprises a porous matrix that comprises at least two distinct test locations on said porous matrix, each of said test locations comprising a test reagent that binds to an analyte or another binding reagent that binds to said analyte, or is an analyte or an analyte analog that competes with an analyte in said sample for binding to a binding reagent for said analyte, and said test reagents at said at least two test locations bind to at least two different analytes or different binding reagents that bind to said different analytes, or are different analytes or analyte analogs, wherein a liquid sample flows laterally along said test device and passes said test locations to form a detectable signal to assess said at least two analytes in a sample, and the formation of said detectable signal requires the use of a detectable label.

10. The device of claim 9, which is configured to assess 5 analytes selected from the group consisting of an anti-HIV antibody, an anti-HCV antibody, nicotine or cocaine, cocaine or benzoylecgonine, and Hemoglobin A1c.

11. The device of claim 9, wherein a substance is dried on a portion of the matrix upstream from the test locations, the dried substance being capable of being moved by a liquid sample and/or a further liquid to the test locations and/or a control location to generate a detectable signal, the dried substance being at least one of the second binding reagent that binds to the analyte, the second binding reagent that binds to another binding reagent that binds to the analyte, the analyte or the analyte analog, each of the second binding reagent, analyte or analyte analog comprises a detectable label.

12. The device of claim 9, which is configured to receive at least two different types of samples, e.g., two different types of samples from the applicant.

13. The device of claim 12, wherein the test locations are in the same or different liquid flow pathway.

14. A system for assessing a life or health insurance applicant, which system comprises the device of claim 9.

15. The system of claim 14, which further comprises:

a) an instruction for using the system for assessing mortality and/or morbidity risk of the life insurance or health applicant, and/or making a decision on the insurance application from the life insurance applicant;

b) a means for assessing an additional health indicator of the life or health insurance applicant;

c) a means for assessing an identifier of the life or health insurance applicant;

d) a means for obtaining at least two different types of samples from the life or health insurance applicant;

e) a means for collecting more than one finger stick of blood from the life or health insurance applicant to increase the volume of blood sample to be able to run multiple assays on the blood sample; and

/or

f) a finger stick device that simultaneously makes at least two punctures at once to increase the amount of blood sample volume needed to perform multiple assays on the blood sample; and

/or

g) machine-readable information, e.g., a bar code.

16. The system of claim 14, which further comprises:

a) a reader to assess the detectable signal;

b) a means for recording, storing and/or sending test results in an electronic format;

c) a software program and/or algorithm that collates and/or optimizes all data inputs such as assay results, BMI, application, release form, attending physician statement (APS), medical information bureau (MIB) record, motor vehicle record (MVR), credit report and prescription or transaction history record into one electronically transferrable or printable file; and

/or

d) and/or an apparatus, software and/or algorism for forensic voice analysis that detects emotions in the human voice.

21. The method of claim 17, which is conducted using the system of claim 14.

17. A method for assessing a life or health insurance applicant, which method comprises:

a) assessing the presence, absence and/or amount of at least two analytes in a sample derived from a life or health insurance applicant using a rapid test, said at least two analytes being selected from the group consisting of a HIV antigen (e.g., a HIV polypeptide), a HIV polynucleotide, an anti-HIV antibody, a HCV antigen (e.g., a HCV polypeptide), a HCV polynucleotide, an anti-HCV antibody, a liver enzyme alanine transaminase (ALT), a liver enzyme aspartate transaminase (AST), nt-probnp (or NT-proBNP), probnp (or proBNP), cotinine, nicotine, cocaine, a metabolite of cocaine (e.g., benzoylecgonine), PSA, ApoA1, ApoB, Hemoglobin A1c and hsCRP, and

b) assessing an insurance application from said life or health insurance applicant based on the test results obtained in step a).

19. The method of claim 17, which is conducted using the system of claim 6.

20. The method of claim 17, which is conducted using the device of claim 9.

22. The method of claim 17, wherein the liquid sample is a body fluid sample.

23. The method of claim 17, which comprises assessing 5 analytes selected from the group consisting of an anti-HIV antibody, an anti-HCV antibody, cotinine or nicotine, cocaine or benzoylecgonine and Hemoglobin A1c.

24. The method of claim 17, wherein the detectable signal is assessed by a reader.

25. The method of claim 17, wherein a sample derived from a life or health insurance applicant without fasting (e.g., food fasting) is used.

26. The method of claim 17, which further comprises:

a) assessing an additional health indicator of a life or health insurance applicant;

b) assessing an identifier of a life or health insurance applicant; and

/or

c) conducting forensic voice analysis of the voice of an applicant.

27. The method of claim 17, which is conducted at a point of presence.

28. The method of claim 17, wherein the test results and collated information are transmitted to an insurance decision maker within about 24 hours from the time when a sample is obtained from the applicant.