Tuberculosis Clinical Trial
Official title:
Evaluation of Urine Lipoarabinomannan ELISA In Diagnostics of Childhood Tuberculosis
In children, it remains quite difficult even in developed countries, to prove a diagnosis of
Tuberculosis (TB). New means for diagnosis of this disease are currently being researched.
One candidate test is Lipoarabinomannan ELISA from Urine, which has shown good sensitivity
of up to 80% in adults.
Our study aims to evaluate this test in the diagnosis of children with TB.
Among candidate new diagnostics for TB, a test for mycobacterial Lipoarabinomannan (LAM)
excretion in urine has shown promising results in one Tanzanian study: The sensitivity for
detecting TB culture-positive patients was 80.3%. Of 103 healthy volunteers, only one gave a
false positive result (Boehme, 2005).
Until now, there are only data concerning this test for diagnosis of adult disease. For
evaluation of routine use in children in countries like Malawi, we are starting a
prospective study. Children 0-14 years of age with suspected TB will be investigated using
TB culture as the gold standard. In sputum samples, microscopy will be done. Simultaneously,
LAM Elisa from the patient´s urine will be done.
;
Time Perspective: Prospective
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