IP Library Granted Patent US 9,134,303
Granted Patent B1
US 9,134,303 · App. 09/139,720 · Granted Sep 15, 2015

ICT immunoassay for

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Quick Facts
Patent No.
US 9,134,303
App. No.
09/139,720
Granted
Sep 15, 2015
Kind
B1
Abstract

The present invention involves extracting from Legionella bacteria, particularly L. pneumophila bacteria, an essentially protein-free O-polysaccharide or carbohydrate antigen, coupling this antigen to an activated chromatographic column through a protein spacer molecule which is first conjugated to the antigen, utilizing the column thus prepared for the affinity purification of raw polyvalent antibodies to the same Legionella bacterium from which the O-polysaccharide or carbohydrate antigen was separated—thereby obtaining antigen-specific antibodies which are useful for the rapid detection of the corresponding Legionella bacterium or its antibody in human bodily fluids such as urine, sputum, blood and the like or in environmental samples suspected of harboring the Legionella bacterium.

Claims (14)

1. A device for determining the presence of Legionella pneumophila serogroup 1 in a liquid sample, the device comprising:

a porous test strip comprising a sample receiving zone;

multiple binding agents, each binding agent comprising:

antigen specific affinity-purified polyclonal antibodies conjugated to a detectable particle, wherein the antigen specific affinity-purified polyclonal antibodies specifically bind a Legionella pneumophila serogroup 1 O-polysaccharide antigen and

wherein the binding agents are essentially free of antibodies that bind proteins of Legionella pneumophila serogroup 1 O-polysaccharide;

multiple capture agents; and

a capture zone;

wherein the porous test strip defines a liquid flow path extending downstream from the sample receiving zone and along which liquid received by the sample receiving zone can pass at least to the capture zone, the binding agents are disposed in a dried state along the flow path of the test strip downstream from the sample receiving zone and upstream from the capture zone, the binding agents are mobilizable by liquid passing along the flow path, and the capture agents are disposed in the capture zone and are each capable, in the presence of Legionella pneumophila serogroup 1 in a liquid sample received by the sample receiving zone, of binding a complex comprising one of the binding agents bound to the antigen.

2. The device of claim 1 , wherein the capture agents are antibodies.

3. The device of claim 2 , wherein the capture agents are polyclonal antibodies.

4. The device of claim 1 , wherein the detectable particle is a color-producing particle.

5. The device of claim 3 , wherein the detectable particle is colloidal gold.

6. The device of claim 1 , wherein the detectable particle is a color-producing particle and the capture agents are antibodies.

7. The device of claim 1 , wherein the presence of Legionella pneumophila serogroup 1 in a liquid sample is determined within fifteen minutes of applying the liquid sample to the device.

Assignments (8)
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
Reel/Frame 019477/0808 →
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 →
SECURITY AGREEMENT Recorded May 11, 2005
From: BINAX, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT
Reel/Frame 016561/0835 →
INVALID RECORDING. SEE REEL 010038, FRAME 0147. (RE-RECORD TO ADD OMITTED PAGES SHOWING ADDITIONAL CONVEYING PARTIES). Recorded Apr 28, 1999
From: KOULCHIN, VLADIMIR ANDREI
To: BINAX, INC.
Reel/Frame 009962/0838 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 28, 1999
From: KOULCHIN, VLADIMIR ANDREI; MOORE, NORMAN JAMES; MOLOKOVA, ELENA VALENTIN
To: BINAX, INC.
Reel/Frame 010038/0147 →