Lipoarabinomannan (LAM) Enzyme-Linked Immunosorbent Assay (ELISA) in Diagnostics of Childhood Tuberculosis (TB)

University Hospital Bonn (UKB)

Status: Unknown

Conditions: Tuberculosis

Study type: Observational

Funder types: Other

Identifiers

NCT00512330

LAM ELISA in childhood TB

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 250 estimated patients

Sex: All

Ages: Under 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 0-14 years
• suspicion of active TB or TB contact

Exclusion criteria

• no informed consent