Clinical evaluation of a serological assay using a monoclonal antibody (TB72) to the 38 kDa antigen of Mycobacterium tuberculosis. 1994

G H Bothamley, and R M Rudd
London Chest Hospital, UK.

We examined an enzyme-linked immunosorbent assay (ELISA) modification of a radioimmunoassay, using the TB72 monoclonal antibody, as a serological test for tuberculosis in a clinical setting. Sera were obtained from 238 patients with suspected pulmonary tuberculosis, 30 patients treated for tuberculosis, 28 contacts, and 480 random samples from inpatients. Antibody levels were measured as the dilution of serum causing 50% inhibition of binding of the TB72 monoclonal antibody, which binds to an epitope of the 38 kDa antigen specific to the Mycobacterium tuberculosis complex, a positive titre being > 3. Positive antibody titres were present in 21 out of 25 (84%) patients with smear-positive and 22 out of 27 (82%) patients with smear-negative, culture-positive tuberculosis, and 37 out of 41 (90%) patients successfully treated for tuberculosis but without bacteriological confirmation of disease. Three out of 82 (4%) patients with a firm alternative diagnosis to tuberculosis gave a positive result. Serological tests were negative within 2.5 yrs of successful treatment. Patients without a definite diagnosis one year after tuberculosis had been suspected, and those who had received inadequate treatment for tuberculosis, were frequently positive (21 out of 31 and 21 out of 32, respectively). Positive tests concurred with tuberculin reactivity in 8 out of 11 contacts given chemoprophylaxis. Screening of 480 random serum samples gave 22 positive titres, 16 of which were not associated with tuberculosis; none of these 16 had an antibody titre > 10. We conclude that the TB72 test provides additional information in the diagnosis and treatment of tuberculosis. Antibody titres > 10 suggests active tuberculosis; titres of 3-10 merit observation.

UI MeSH Term Description Entries
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009169 Mycobacterium tuberculosis A species of gram-positive, aerobic bacteria that produces TUBERCULOSIS in humans, other primates, CATTLE; DOGS; and some other animals which have contact with humans. Growth tends to be in serpentine, cordlike masses in which the bacilli show a parallel orientation. Mycobacterium tuberculosis H37Rv
D011863 Radioimmunoassay Classic quantitative assay for detection of antigen-antibody reactions using a radioactively labeled substance (radioligand) either directly or indirectly to measure the binding of the unlabeled substance to a specific antibody or other receptor system. Non-immunogenic substances (e.g., haptens) can be measured if coupled to larger carrier proteins (e.g., bovine gamma-globulin or human serum albumin) capable of inducing antibody formation. Radioimmunoassays
D004797 Enzyme-Linked Immunosorbent Assay An immunoassay utilizing an antibody labeled with an enzyme marker such as horseradish peroxidase. While either the enzyme or the antibody is bound to an immunosorbent substrate, they both retain their biologic activity; the change in enzyme activity as a result of the enzyme-antibody-antigen reaction is proportional to the concentration of the antigen and can be measured spectrophotometrically or with the naked eye. Many variations of the method have been developed. ELISA,Assay, Enzyme-Linked Immunosorbent,Assays, Enzyme-Linked Immunosorbent,Enzyme Linked Immunosorbent Assay,Enzyme-Linked Immunosorbent Assays,Immunosorbent Assay, Enzyme-Linked,Immunosorbent Assays, Enzyme-Linked
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D000939 Epitopes Sites on an antigen that interact with specific antibodies. Antigenic Determinant,Antigenic Determinants,Antigenic Specificity,Epitope,Determinant, Antigenic,Determinants, Antigenic,Specificity, Antigenic
D000942 Antigens, Bacterial Substances elaborated by bacteria that have antigenic activity. Bacterial Antigen,Bacterial Antigens,Antigen, Bacterial
D012680 Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed) Specificity,Sensitivity,Specificity and Sensitivity

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