Abstract: Objective To evaluate the value of TB-SA(Tuberculosis-Specific Antigen) test in the diagnosis of tuberculosis.Methods 230 active tuberculosis patients(60 bacteriological-positive pulmonary patients,131 bacteriological-negative pulmonary patients,39 extra-pulmonary patients) and 96 non-tuberculosis respiratory system disease patients were recruited from May 2004 to November 2004 in Shandong Provincial Chest Hospital,and 41 healthy controls were from Shandong University,all specimens including sputum,pleural effussion,seroperitoneum, cerebrospinal fluid were submitted for Mycobacterium tuberculosis smear,culture,sera specimens from 367 cases were studied for TB-SA antibody by ELISA method.Results The total sensitivity of TB-SA test by ELISA serology method with sera from active tuberculosis patients was 67.8%,the sensitivities of subgroup of those with active pulmonary tuberculosis patients and extrapulmonary tuberculosis patients were 67.6% and 59.0%(P>0.05),respectively; the total specificity was 76.6%,the specificities of TB-SA test with sera from the no-tuberculosis respiratory system disease patients and healthy controls were 72.9% and 85.4%,respectively.Conclusions The TB-SA test was a kind of rapid,simple,relatively sensitive and specific method for diagnosis tuberculosis,especially in bacteriological-negative pulmonary tuberculosis,extra-pulmonary and childhood tuberculosis patients to aid in clinical decision making,which were hard to obtain specimens.

Key words: Mycobacterium tuberculosis, Tuberculosis antibody, Diagnosis