METHOD FOR DIAGNOSING TUBERCULOSIS Russian patent published in 2023 - IPC G01N33/541 G01N33/569 G01N33/577 

FIELD: medicine; phthisiology.

SUBSTANCE: invention can be used to diagnose tuberculosis. Detection of anti-tuberculosis antibodies in the serum of patients for a specific bacterial antigen of M. tuberculosis complex is carried out. Identification of anti-tuberculosis antibodies is carried out in a heterologous two-site enzyme-linked immunosorbent assay of the "heterosandwich" type, the main components of the test in which are monoclonal antibodies (MAT) against the antigens of M. tuberculosis CFP10, MPT63, representing these antigens on an affinity substrate and antibodies from the serum of a person with tuberculosis, directed against these antigens. Specific anti-tuberculosis antibodies in the studied human serum samples are detected, excluding non-specific "background" binding of natural serum antibodies. If the concentration in the serum of patients with IgG antibodies anti-2F9 MAT is above 5.703 µg/ml, or the concentration of IgG antibodies anti-2H2 MAT is above 3.047 µg/ml, or the concentration of IgG antibodies anti-1A5 MAT is above 44.611 µg/ml, or the concentration of IgA antibodies anti-1A5 MAT is above 9.516 µg/ml tuberculosis is diagnosed.

EFFECT: method provides the possibility of increasing the sensitivity and accuracy of diagnosis of tuberculosis due to the determination of anti-tuberculosis antibodies in the serum of patients by enzyme immunoassay.

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