Rapid Lyme antigen test for detection of Lyme disease

摘要

A method for detecting B. burgdorferi antigens in body fluid samples, such as urine. Polyclonal antibodies are used that bind to 31, 34, and 39 kDa B. burgdorferi antigens, wherein the polyclonal antibodies function as immobilized capture antibodies. Detection antibodies are used, having an enzyme linked thereto, which also bind to the B. burgdorferi antigens. A body fluid sample is reacted with the detection antibodies to form complexes between the detection antibodies and the B. burgdorferi antigens in the body fluid sample. The complexes are reacted with the immobilized capture antibodies, wherein the complexes become linked to the capture antibodies. A substrate is added to the complexes linked to the capture antibodies, wherein the substrate is converted by the enzyme to a visual and/or detectable product if B. burgdorferi antigens are present in the body fluid sample.

主权项

1. A method for detecting Borrelia burgdorferi antigens in urine samples, comprising:
1) providing a capillary membrane lateral flow test assay strip having a first end a second opposite end; said assay strip comprising
a. a reaction zone near said first end, wherein said reaction zone includes detection antibodies having an enzyme linked thereto, and further wherein said detection antibodies are capable of forming antigen-detection antibody complexes;a test zone near said second opposite end, wherein said test zone includes (i) polyclonal capture antibodies immobilized within said test zone that have reactivity to 39 kDa B. burgdorferi antigen, and (ii) a substrate; 2) placing a urine sample on said first end of the assay strip; 3) migrating said urine sample into the reaction zone, wherein said detection antibodies bind to B. burgdorferi antigens to form antigen-detection antibody complexes linked to the enzyme; 4) migrating the urine sample into the test zone, wherein the antigen-detection antibody complexes linked to the enzyme engage the immobilized polyclonal capture antibodies, thereby causing the enzyme to convert the substrate to a visible or detectable product if 39 kDa B. burgdorferi antigens are present in the urine sample.