Evaluation of a LAM FLISA for the Diagnosis of Tuberculosis
Evaluation of a LAM FLISA for the Diagnosis of Tuberculosis
Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide.
 Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis
 require advanced and expensive diagnostic methods that restrict their availability in
 resource limited countries where the burden of tuberculosis is highest. The development of
 rapid point of care diagnostics is required.

 Lipoarabinomannan (LAM) is part of the bacterial cell wall in M. tuberculosis. It is released
 when bacteria are multiplying or dying. LAM can be detected in the urine since it is filtered
 from the blood in the kidneys. The detection of LAM in the urine by conventional enzyme
 linked immuno-sorbent assay (ELISA) techniques was hampered in the past by a low sensitivity
 and multiple processing steps. Recently, fluorescence linked immuno-sorbent assay (FLISA) has
 been shown to detect LAM in concentrations that are several magnitudes lower that with ELISA
 based methods. Furthermore the procedure requires less separate steps for processing the
 sample.

 This study aims to validate the new diagnostic test by comparing patients with (a) confirmed
 tuberculosis (n=25), (b) infection with non-tuberculous mycobacteria (n=25), (c) bronchial
 carcinoma (n=25), (d) suspected tuberculosis but confirmed alternative diagnosis (estimated
 n=20). Single blood and urine samples of these groups will be used to evaluate the
 sensitivity and specificity of the test.

 In patients with confirmed tuberculosis the LAM FLISA will also be assessed as a biomarker
 for the monitoring of tuberculosis treatment success. Initially, 2-5 samples blood and urine
 are required during the first week, followed by twice weekly and weekly sampling intervals
 over a period of 12 weeks maximum. The study participation ends when the patient is
 discharged from hospital.

 As a substudy, the blood samples will be used to evaluate an enzyme linked immuno-sorbent
 assay (ELISA) for the detection of lipid antigens that are specific for Mycobacterium
 tuberculosis.
Inclusion Criteria:

 1. Suspected or confirmed infection with M. tuberculosis (MTB) or confirmed infection
 with non-tuberculous mycobacteria (NTM) or confirmed bronchial carcinoma

 2. Oral and written consent to study participation (children: parent's consent)

 Exclusion Criteria:

 1. Inability to follow the study requirements

 2. Patient in custodianship or guardianship