IP Library › Patent Application 10989973
Patent Application
App. No. 10/989,973

Methods and kits for predicting an infectious disease state

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Patent No.
US None
App. No.
10/989,973
Abstract

The present invention discloses methods for predicting an infectious disease state of a subject. The methods are rapid, simple, and do not require culturing of the causative infectious agent.

Claims (112)

1 . A method of rapidly determining the disease state of a subject, wherein said disease is caused by an infectious organism, comprising the steps of:

a) providing a nasopharyngeally derived sample from said subject;

b) contacting a binding agent directly to said sample, wherein said binding agent is capable of specifically binding to an epitope derived from said infectious organism;

c) allowing said binding agent to specifically bind to and form a complex with said epitope derived from said infectious organism present in said sample; and

d) detecting said complex, wherein said detection is positive if concentration of said infectious organism in said sample is greater than or equal to a reference concentration, and said detection is negative if concentration of said infectious organism in said sample is less than said reference concentration.

2 . The method of claim 1 , wherein positive detection indicates that the subject is diseased.

3 . The method of claim 1 , wherein negative detection indicates that the subject is not diseased.

4 . The method of claim 2 , wherein said positive detection is optionally quantitative.

5 . The method of claim 1 , wherein said infectious organism is selected from the group consisting of pathological bacteria, pathological viruses, and pathological eukaryotes.

6 . The method of claim 1 , wherein said disease is acute otitis media.

7 . The method of claim 6 , wherein said infectious organism is non-typable Haemophilus influenzae.

8 . The method of claim 6 , wherein said infectious organism is Streptococcus pneumoniae.

9 . The method of claim 6 , wherein said infectious organism is Moraxella catarrhalis.

10 . The method of claim 6 , wherein said infectious organism is a Group A Streptococcus.

11 . The method of claim 10 , wherein said Group A Streptococcus is Streptococcus pyogenes.

12 . The method of claim 1 , wherein said disease is a respiratory tract infection.

13 . The method of claim 12 , wherein said respiratory tract infection is an influenza-like illness.

14 . The method of claim 13 , wherein said infectious organism is a virus.

15 . The method of claim 14 , wherein said virus is an influenza virus.

16 . The method of claim 14 , wherein said virus is a rhinovirus.

17 . The method of claim 14 , wherein said virus is a respiratory syncytial virus.

18 . The method of claim 14 , wherein said virus is an adenovirus.

19 . The method of claim 14 , wherein said virus is a parainfluenza virus.

20 . The method of claim 14 , wherein said virus is a coronavirus.

21 . The method of claim 14 , wherein said virus is a metapneumovirus.

22 . The method of claim 13 , wherein said infectious organism is a bacterium.

23 . The method of claim 22 , wherein said bacterium is Streptococcus pneumoniae.

24 . The method of claim 22 , wherein said bacterium is Chlamydia pneumoniae.

25 . The method of claim 22 , wherein said bacterium is Mycoplasma pneumoniae.

26 . The method of claim 12 , wherein said respiratory tract infection is pneumonia.

27 . The method of claim 26 , wherein said pneumonia is a bacterial pneumonia.

28 . The method of claim 27 , wherein said infectious organism is a Group A Streptococcus pneumoniae.

29 . The method of claim 28 , wherein said Group A Streptococcus is Streptococcus pyogenes.

30 . The method of claim 27 , wherein said infectious organism is Streptococcus pneumoniae.

31 . The method of claim 27 , wherein said infectious organism is Klebsiella pneumoniae.

32 . The method of claim 27 , wherein said infectious organism is a Staphylococcus species.

33 . The method of claim 27 , wherein said infectious organism is Haemophilus influenzae.

34 . The method of claim 27 , wherein said infectious organism is Chlamydia pneumoniae.

35 . The method of claim 27 , wherein said infectious organism is Mycoplasma pneumoniae.

36 . The method of claim 27 , wherein said infectious organism is a Pseudomonas species.

37 . The method of claim 26 , wherein said pneumonia is a viral pneumonia.

38 . The method of claim 37 , wherein said infectious organism is a respiratory syncytial virus.

39 . The method of claim 37 , wherein said infectious organism is a rhinovirus.

40 . The method of claim 37 , wherein said infectious organism is an adenovirus.

41 . The method of claim 37 , wherein said infectious organism is an influenza virus.

42 . The method of claim 37 , wherein said infectious organism is a parainfluenza virus.

43 . The method of claim 37 , wherein said infectious organism is a coronavirus.

44 . The method of claim 37 , wherein said infectious organism is a hantavirus.

45 . The method of claim 37 , wherein said infectious organism is a cytomegalovirus.

46 . The method of claim 37 , wherein said infectious organism is a metapneumovirus.

47 . The method of claim 26 , wherein said pneumonia is a fungal pneumonia.

48 . The method of claim 47 , wherein said infectious organism is Histoplasma capsulatum.

49 . The method of claim 47 , wherein said infectious organism is Coccidioides immitis.

50 . The method of claim 47 , wherein said infectious organism is Blastomyces dermatitidis.

51 . The method of claim 47 , wherein said infectious organism is Paracoccidioides brasiliensis.

52 . The method of claim 47 , wherein said infectious organism is a Candida species.

53 . The method of claim 47 , wherein said infectious organism is an Aspergillus species.

54 . The method of claim 47 , wherein said infectious organism is a Mucor species.

55 . The method of claim 47 , wherein said infectious organism is Cryptococcus neoformans.

56 . The method of claim 47 , wherein said infectious organism is Pneumocystis carinii.

57 . The method of claim 12 , wherein said respiratory tract infection is bronchitis.

58 . The method of claim 57 , wherein said infectious organism is a bacterium.

59 . The method of claim 58 , wherein said bacterium is a Mycoplasma species.

60 . The method of claim 58 , wherein said bacterium is Mycoplasma pneumoniae.

61 . The method of claim 58 , wherein said bacterium is Chlamydia pneumoniae.

62 . The method of claim 58 , wherein said bacterium is Bordatella pertussis.

63 . The method of claim 58 , wherein said bacterium is a Group A Streptococcus.

64 . The method of claim 63 , wherein said Group A Streptococcus is Streptococcus pyogenes.

65 . The method of claim 58 , wherein said bacterium is Streptococcus pneumoniae.

66 . The method of claim 58 , wherein said bacterium is Moraxella catarrhalis.

67 . The method of claim 58 , wherein said bacterium is Haemophilus influenzae.

68 . The method of claim 58 , wherein said bacterium is Haemophilus parainfluenzae.

69 . The method of claim 58 , wherein said bacterium is Staphylococcus aureus.

70 . The method of claim 57 , wherein said infectious organism is a virus.

71 . The method of claim 70 , wherein said virus is an influenza virus.

72 . The method of claim 70 , wherein said virus is a parainfluenza virus.

73 . The method of claim 70 , wherein said virus is an adenovirus.

74 . The method of claim 70 , wherein said virus is a rhinovirus.

75 . The method of claim 70 , wherein said virus is a respiratory syncytial virus.

76 . The method of claim 70 , wherein said virus is a coronavirus.

77 . The method of claim 70 , wherein said virus is a hantavirus.

78 . The method of claim 70 , wherein said virus is a metapneumovirus.

79 . The method of claim 12 , wherein said respiratory tract infection is sinusitis.

80 . The method of claim 79 , wherein said infectious organism is a bacterium.

81 . The method of claim 80 , wherein said bacterium is a Streptococcus species.

82 . The method of claim 80 , wherein said bacterium is Streptococcus pneumoniae.

83 . The method of claim 80 , wherein said bacterium is Haemophilus influenzae.

84 . The method of claim 80 , wherein said bacterium is a Staphylococcus species.

85 . The method of claim 80 , wherein said bacterium is Staphylococcus aureus.

86 . The method of claim 80 , wherein said bacterium is a Neisseria species.

87 . The method of claim 79 , wherein said infectious organism is a fungus.

88 . The method of claim 1 , wherein said disease is conjunctivitis.

89 . The method of claim 88 , wherein said infectious organism is a bacterium.

90 . The method of claim 89 , wherein said bacterium is a Group A Streptococcus.

91 . The method of claim 90 , wherein said Group A Streptococcus is Streptococcus pyogenes.

92 . The method of claim 89 , wherein said bacterium is Streptococcus pneumoniae.

93 . The method of claim 89 , wherein said bacterium is Staphylococcus epidermidis.

94 . The method of claim 89 , wherein said bacterium is a Haemophilus species.

95 . The method of claim 89 , wherein said bacterium is Haemophilus influenzae.

96 . The method of claim 89 , wherein said bacterium is Neisseria meningitidis.

97 . The method of claim 89 , wherein said bacterium is Neisseria gonorrhoeae.

98 . The method of claim 89 , wherein said bacterium is Moraxella lacunata.

99 . The method of claim 89 , wherein said bacterium is a Chlamydia species.

100 . The method of claim 88 , wherein said infectious organism is a virus.

101 . The method of claim 1 , wherein said nasopharyngeally derived sample is selected from the group consisting of a nasopharyngeal swab, a nasopharyngeal wash, nasopharyngeal discharge, nasopharyngeal aspirate, nasal swab, nasal wash, nasal discharge, nasal aspirate, and a combination thereof.

102 . The method of claim 1 , wherein said method further comprises simultaneous or parallel detection of more than one infectious organism.

103 . The method of claim 1 , wherein said epitope is modified.

104 . The method of claim 1 , wherein said binding agent comprises an antibody or antibody fragment.

105 . The method of claim 1 , wherein said binding agent comprises a functional group or a detectable label.

106 . The method of claim 1 , wherein said binding agent is used in more than one form.

107 . The method of claim 1 , wherein said binding agent is further capable of binding to a mimotope that mimics said epitope derived from said infectious organism.

108 . A kit for performing the method of claim 1.

Assignments (9)
RELEASE OF SECURITY INTEREST IN INTELLECTUAL PROPERTY RECORDED AT REEL 036994, FRAME 0192 AND REEL 037115, FRAME 0498 Recorded Oct 5, 2017
From: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS COLLATERAL AGENT
To: ALERE CONNECT, LLC; ALERE SAN DIEGO, INC. (FKA BIOSITE INC. OR FKA CHOLESTECH CORP. OR FKA HEMOSENSE INC. OR FKA INVERNESS MEDICAL-BIOSTAR INC. OR FKA ISCHEMIA TECHNOLOGIES, INC. OR FKA TWISTDX, INC.); ALERE SCARBOROUGH, INC. (FKA MATRITECH, INC. FKA ADVANTAGE DIAGNOSTICS CORP. OR FKA BINAX, INC. OR FKA MILANO ACQUISITION CORP.); INNOVACON, INC. (FKA APPLIED BIOTECH, INC. OR FKA AMEDITECH INC.); IONIAN TECHNOLOGIES, LLC (FKA IONIAN TECHNOLOGIES, INC.); QUALITY ASSURED SERVICES INC. (FKA ZYCARE INC.); STANDING STONE, LLC; ESCREEN, INC.
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ASSIGNMENT OF IP SECURITY AGREEMENT, PREVIOUSLY RECORDED AT REEL 036994, FRAME 0192 Recorded Nov 16, 2015
From: GENERAL ELECTRIC CAPITAL CORPORATION, AS RETIRING ADMINISTRATIVE AGENT
To: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS SUCCESSOR ADMINISTRATIVE AGENT
Reel/Frame 037115/0498 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Oct 29, 2015
From: ALERE CONNECT, LLC; ALERE SAN DIEGO, INC. (FKA BIOSITE INC. OR FKA CHOLESTECH CORP. OR FKA HEMOSENSE INC. OR FKA INVERNESS MEDICAL-BIOSTAR INC. OR FKA ISCHEMIA TECHNOLOGIES, INC. OR FKA TWISTDX, INC.); ALERE SCARBOROUGH, INC. (FKA MATRITECH, INC. FKA ADVANTAGE DIAGNOSTICS CORP. OR FKA BINAX, INC. OR FKA MILANO ACQUISITION CORP.); INNOVACON, INC. (FKA APPLIED BIOTECH, INC. OR FKA AMEDITECH INC.); IONIAN TECHNOLOGIES, LLC (FKA IONIAN TECHNOLOGIES, INC.); QUALITY ASSURED SERVICES INC. (FKA ZYCARE INC.); STANDING STONE, LLC; ESCREEN, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 036994/0192 →
NOTICE OF RELEASE OF SECURITY INTEREST IN PATENTS RECORDED AT REEL 026557 FRAME 0287 Recorded Jun 23, 2015
From: GENERAL ELECTRIC CAPITAL CORPORATION, AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
To: ADVANTAGE DIAGNOSTICS CORPORATION; ALERE MEDICAL, INC.; ALERE SAN DIEGO, INC.; ALERE SCARBOROUGH, INC.; AMEDITECH INC.; APPLIED BIOTECH, INC.; BINAX, INC.; BIOSITE INCORPORATED; CHOLESTECH CORPORATION; GENECARE MEDICAL GENETICS CENTER, INC.; HEMOSENSE, INC.; INSTANT TECHNOLOGIES, INC.; INVERNESS MEDICAL - BIOSTAR INC.; ISCHEMIA TECHNOLOGIES, INC.; MATRITECH, INC.; MATRIA HEALTHCARE, INC.; ZYCARE, INC.
Reel/Frame 036011/0581 →
CHANGE OF NAME Recorded Aug 26, 2011
From: BINAX, INC.
To: ALERE SCARBOROUGH, INC.
Reel/Frame 026817/0588 →
SECURITY AGREEMENT Recorded Jul 7, 2011
From: ADVANTAGE DIAGNOSTICS CORPORATION; ALERE MEDICAL INCORPORATED; ALERE SAN DIEGO, INC.; ALERE SCARBOROUGH, INC.; AMEDITECH INC.; APPLIED BIOTECH, INC.; BINAX, INC.; BIOSITE INCORPORATED; CHOLESTECH CORPORATION; GENECARE MEDICAL GENETICS CENTER, INC.; HEMOSENSE, INC.; INSTANT TECHNOLOGIES, INC.; INVERNESS MEDICAL - BIOSTAR INC.; ISCHEMIA TECHNOLOGIES, INC.; MATRITECH, INC.; ZYCARE INC.; MARTIA HEALTHCARE, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION
Reel/Frame 026557/0287 →
SECOND LIEN INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jun 27, 2007
From: IM US HOLDINGS, LLC, A DELAWARE LIMITED LIABILITY COMPANY; INVERNESS MEDICAL INNOVATIONS, INC., A DELAWARE CORPORATION; ADVANTAGE DIAGNOSTICS CORPORATION, A DELAWARE CORPORATION; APPLIED BIOTECH, INC., A CALIFORNIA CORPORATION; BINAX, INC., A DELAWARE CORPORATION; FIRST CHECK DIAGNOSTICS CORP., A DELAWARE CORPORATION; FOREFRONT DIAGNOSTICS, INC., A CALIFORNIA CORPORATION; INCA ACQUISITION, INC., A DELAWARE CORPORATION; INNOVATIVE MOBILITY, LLC, A FLORIDA LIMITED LIABILITY COMPANY; INSTANT TECHNOLOGIES, INC., A VIRGINIA CORPORATION; INVERNESS MEDICAL - BIOSTAR, INC., A DELAWARE CORPORATION; INVERNESS MEDICAL INTERNATIONAL HOLDING CORP., A DELAWARE CORPORATION; INVERNESS MEDICAL INTERNATIONAL HOLDING CORP. II, A DELAWARE CORPORATION; INNOVATIONS RESEARCH, LLC, A DELAWARE LIMITED LIABILITY COMPANY; INVERNESS MEDICAL, LLC, A DELAWARE LIMITED LIABILITY COMPANY; ISCHEMIA TECHNOLOGIES, INC., A DELAWARE CORPORATION; IVC INDUSTRIES, INC., A DELAWARE CORPORATION; INNOVACON, INC., A DELAWARE CORPORATION; OSTEX INTERNATIONAL, INC., A WASHINGTON CORPORATION; QUALITY ASSURED SERVICES, INC., A FLORIDA CORPORATION; SELFCARE TECHNOLOGY, INC., A DELAWARE CORPORATION; SPDH, INC., A DELAWARE CORPORATION; UNIPATH ONLINE, INC., A MASSACHUSETTS CORPORATION; WAMPOLE LABORATORIES, LLC, A DELAWARE LIMITED LIABILITY COMPANY
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT
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FIRST LIEN INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jun 26, 2007
From: IM US HOLDINGS, LLC, A DELAWARE LIMITED LIABILITY COMPANY; INVERNESS MEDICAL INNOVATIONS, INC., A DELAWARE CORPORATION; ADVANTAGE DIAGNOSTICS CORPORATION, A DELAWARE CORPORATION; APPLIED BIOTECH, INC., A CALIFORNIA CORPORATION; BINAX, INC., A DELAWARE CORPORATION; FIRST CHECK DIAGNOSTICS CORP., A DELAWARE CORPORATION; FOREFRONT DIAGNOSTICS, INC., A CALIFORNIA CORPORATION; INCA ACQUISITION, INC., A DELAWARE CORPORATION; INNOVATIVE MOBILITY, LLC, A FLORIDA LIMITED LIABILITY COMPANY; INSTANT TECHNOLOGIES, INC., A VIRGINIA CORPORATION; INVERNESS MEDICAL - BIOSTAR, INC., A DELAWARE CORPORATION; INVERNESS MEDICAL INTERNATIONAL HOLDING CORP., A DELAWARE CORPORATION; INVERNESS MEDICAL INTERNATIONAL HOLDING CORP. II, A DELAWARE CORPORATION; INNOVATIONS RESEARCH, LLC, A DELAWARE LIMITED LIABILITY COMPANY; INVERNESS MEDICAL, LLC, A DELAWARE LIMITED LIABILITY COMPANY; ISCHEMIA TECHNOLOGIES, INC., A DELAWARE CORPORATION; IVC INDUSTRIES, INC., A DELAWARE CORPORATION; INNOVACON, INC., A DELAWARE CORPORATION; OSTEX INTERNATIONAL, INC., A WASHINGTON CORPORATION; SELFCARE TECHNOLOGY, INC., A DELAWARE CORPORATION; SPDH, INC., A DELAWARE CORPORATION; UNIPATH ONLINE, INC., A MASSACHUSETTS CORPORATION; QUALITY ASSURED SERVICES, INC., A FLORIDA CORPORATION
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT
Reel/Frame 019477/0268 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 9, 2006
From: PIASIO, ROGER N.; FADEN, HOWARD
To: BINAX, INC.
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