Rapid lateral flow assay for determining exposure to Mycobacterium tuberculosis and other mycobacteria
First Claim
1. A method for detecting the presence of at least one antibody to Mycobacterium tuberculosis antigens, the antibody present in a sample selected from one or more patient bodily fluids, which comprises the following steps:
- (a) contacting the sample with a conjugated label having an indicator dye, thereby forming an antibody-conjugated label complex;
(b) allowing the antibody-conjugated label complex to migrate along a lateral-flow assay membrane and contact at least one membrane-bound Mycobacterium tuberculosis antigen, thereby forming an antigen-antibody complex and causing the indicator dye to precipitate and form a detectable signal; and
(c) detecting the signal, whereby the presence of the antibody is determined in the sample by the presence of the signal.
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Accused Products
Abstract
An assay method and kit is disclosed for detecting the presence of at least one predesignated, target antibody to a mycobacterium in a sample selected from one or more patient bodily fluids. The method comprises the following steps: (a) contacting the sample of one or more patient bodily fluids with at least one mycobacterium antigen on a lateral-flow assay membrane to bind to the target antibody in the sample; (b) previously, simultaneously or subsequently to step (a), binding the at least one mycobacterium antigen with a conjugated label producing a detectable signal; and (c) detecting the signal whereby the presence of the target antibody is determined in the sample by the intensity or presence of the signal. The method can further comprise the step of evaluating immunization status of the patient from whom the sample came by comparing the signal or lack thereof with immunizations previously received by the patient and in comparison to a known standard control. In a preferred embodiment, the mycobacterium antigen specifically binds to Mycobacterium tuberculosis specific antibodies. Preferably, the immunoassay of the present invention comprises a lateral-flow assay comprising a membrane, a conjugated label pad, and at least one mycobacterium antigen bound to the membrane. In a preferred embodiment, the at least one mycobacterium antigen is selected from the group consisting of 38 kDa and 16 kDa antigens.
48 Citations
29 Claims
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1. A method for detecting the presence of at least one antibody to Mycobacterium tuberculosis antigens, the antibody present in a sample selected from one or more patient bodily fluids, which comprises the following steps:
- (a) contacting the sample with a conjugated label having an indicator dye, thereby forming an antibody-conjugated label complex;
(b) allowing the antibody-conjugated label complex to migrate along a lateral-flow assay membrane and contact at least one membrane-bound Mycobacterium tuberculosis antigen, thereby forming an antigen-antibody complex and causing the indicator dye to precipitate and form a detectable signal; and
(c) detecting the signal, whereby the presence of the antibody is determined in the sample by the presence of the signal. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 21, 22, 23, 24, 25)
- (a) contacting the sample with a conjugated label having an indicator dye, thereby forming an antibody-conjugated label complex;
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11. An immunoassay kit for detecting at least one antibody to Mycobacterium tuberculosis antigens, the antibody present in a sample selected from one or more patient bodily fluids, which comprises:
- (a) a sample pad, (b) a conjugated label pad, the conjugated label pad having an indicator dye, a portion of the conjugated label pad and a portion of the sample pad forming a first interface, (c) a lateral-flow assay comprising a membrane, a portion of the membrane and a portion of the conjugated label pad forming a second interface, and (d) at least one Mycobacterium tuberculosis antigen bound to the membrane, the first interface allowing fluid to flow from the sample pad to the conjugated label pad and contact the indicator dye wherein the antibody present in the sample forms an antibody-conjugated label complex, the second interface allowing fluid to flow from the conjugated label pad to the membrane and to contact the at least one membrane-bound Mycobacterium tuberculosis antigen to form to an antigen-antibody complex and cause the indicator dye to precipitate and form a detectable signal.
- View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 26, 27, 28, 29)
Specification