[A cooperative clinical study on the evaluation of an antibody detection test kit (MycoDot Test) for mycobacterial infections. Cooperative Study Group for MycoDot Test].

To determine the usefulness of a diagnostic kit for mycobacterial infection, we performed a five-hospital cooperative clinical study using serodiagnosis kits (MycoDot Test) to detect antibody for lipoarabinomannan (LAM) which is a membrane-derived component of mycobacterial species. We tested LAM antibody in the sera of patients with mycobacterial infection as well as healthy persons. Procedures for using the serodiagnosis kit are actually simple. Out of 130 cases of active pulmonary tuberculosis, 103 cases (79%) were positive for anti-LAM, and cases out of 24 cases of active atypical mycobacterial infection, 15 (63%) were positive. On the contrary, only 4% of healthy volunteers (1 out of 25 persons) were positive on this test. In conclusion, this diagnostic kit might be a useful test for early and supportive diagnosis of mycobacterial infections based on its sensitivity and specificity.