EVALUATION OF THE MYCODOT(TM) TEST FOR THE DIAGNOSIS OF TUBERCULOSIS IN HIV-SEROPOSITIVE AND SERONEGATIVE PATIENTS

SETTING: Patients were recruited from Siriraj, Bamrasnaradura, and Cen tral Chest Hospitals, the three major hospitals responsible for tuberc ulosis patients in Bangkok, Thailand, and vicinity. OBJECTIVE: To eval uate a new rapid serologic test, the MycoDot(TM) test, for diagnosis o f tuberculosis (TB). DESIGN: The study was conducted as a cross-sectio nal survey. A total of 594 patients were tested with the MycoDot(TM) t est. This included 142 human immunodeficiency virus (HIV) seropositive patients with active TB, 144 HIV seronegative patients with active TB , 153 HIV seropositive controls, and 155 HIV seronegative controls. RE SULTS: The sensitivity of the MycoDot(TM) test for detection of TB was 40.1% in HIV seropositive patients, compared with 63.2% in HIV serone gative patients (P < 0.001). If only patients with laboratory proven T B were evaluated, the sensitivity was 40.6% in seropositive and in 70. 8% seronegative patients. The sensitivity of the MycoDot(TM) test was similar in TB patients with pulmonary and extra-pulmonary disease. The sensitivity of the test in patients with CD4 counts greater than or e qual to 200 cells/mm(3) was significantly higher than in those with CD 4 counts <200 cells/mm(3). The specificity of the test was 97.4%, and was identical in HIV seropositive and seronegative individuals. CONCLU SION: The MycoDot(TM) test had a higher sensitivity for the diagnosis of TB among HIV seronegative than HIV seropositive patients. Although the MycoDot(TM) test has a less than optimal sensitivity, the test spe cificity approaches 100%. It may be useful in patients with suspected TB and negative smears and in extrapulmonary TB.