Manufacturing lateral flow tests for tuberculosis diagnosis: choosing a reactants completion and sensing regime

Abstract

To develop technologies for rapid out-of-laboratory diagnoses of tuberculosis based on the level of specific antibodies, the requirements for the antibody preparations and their combinations used in the analysis were studied, as well as procedures for the manufacture of a multimembrane composite. A comparative characterization of various recombinant antigens in terms of diagnostic sensitivity and specificity was carried out. The possibility of increasing the diagnostic sensitivity to 15%–20% when using multi-antigen mixtures (cocktails) of antigens was shown. The requirements for the manufacture of multi-membrane composites—test strips for diagnostics—were determined. The correspondence of the minimum detectable level of specific antibodies to the diagnostic threshold of 0.2 mg/ml was shown. Testing of test systems via the most effective cocktails of antigens on blood samples from healthy and sick subjects was carried out.