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.