Sensitivity and specificity of a multi-antigen ELISA test for the serological diagnosis of tuberculosis.
A new serological assay (DETECT-TB, BioChem ImmunoSystems), using three recombinant proteins and two synthetic peptides for the detection of the anti-Mycobacterium tuberculosis IgG, was evaluated using a panel of serum specimens collected from 100 tuberculosis (TB) patients and 270 controls, in comparison with a homemade ELISA test using purified protein derivative (PPD) as antigen. DETECT-TB presented a higher sensitivity (75%) compared to PPD-ELISA (56%; P < 0.01), while the specificity of each assay was similar (DETECT-TB 97%; PPD-ELISA 100%; P > 0.80). Receiver operating characteristics (ROC) analysis obtained with these data confirmed the higher level of performance of DETECT-TB in comparison with PPD-ELISA. Considering the rapidity, cost-effectiveness and simplicity of this assay, its use may provide useful clinical information aiding in the rapid diagnosis of difficult TB cases.
Amicosante
M
M
Department of Medical Sciences, University of Modena, Italy. massimo.amicosante@uniroma2.it
Houde
M
M
Guaraldi
G
G
Saltini
C
C
D000328:Adult; D016022:Case-Control Studies; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D012680:Sensitivity and Specificity; D014376:Tuberculosis / Q000175:diagnosis*