Reasons for false-positive lipoarabinomannan ELISA results in a Tanzanian population.

Lipoarabinomannan (LAM), a cell wall component of mycobacteria, can be detected in the urine of tuberculosis (TB) patients. Advantages of this diagnostic include the ease of sample collection and test methods. However, as with most new TB diagnostics, LAM tests have been evaluated in well-controlled laboratory settings and subsequently need assessment under real working conditions. Our experience showed that the diagnosis of TB using the detection of LAM in urine under field conditions is prone to false-positive results due to contamination. Dust and soil, but also stool, seemed to lead to increased OD values and thus false-positive results of the enzyme-linked immunosorbent assay (ELISA) for LAM; however, contamination with blood, as well as bacterial or fungal organisms, had no influence. The collection of urine for the detection of LAM should therefore follow strict collection criteria in order to avoid contamination.

Electronic-nose technology using sputum samples in diagnosis of patients with tuberculosis.

We investigated the potential of two different electronic noses (EN; code named "Rob" and "Walter") to differentiate between sputum headspace samples from tuberculosis (TB) patients and non-TB patients. Only samples from Ziehl-Neelsen stain (ZN)- and Mycobacterium tuberculosis culture-positive (TBPOS) sputum samples and ZN- and culture-negative (TBNEG) samples were used for headspace analysis; with EN Rob, we used 284 samples from TB suspects (56 TBPOS and 228 TBNEG samples), and with EN Walter, we used 323 samples from TB suspects (80 TBPOS and 243 TBNEG samples). The best results were obtained using advanced data extraction and linear discriminant function analysis, resulting in a sensitivity of 68%, a specificity of 69%, and an accuracy of 69% for EN Rob; for EN Walter, the results were 75%, 67%, and 69%, respectively. Further research is still required to improve the sensitivity and specificity by choosing more selective sensors and type of sampling technique.

Low sensitivity of a urine LAM-ELISA in the diagnosis of pulmonary tuberculosis.

BACKGROUND: The development and evaluation of rapid and accurate new diagnostic tools is essential to improve tuberculosis (TB) control in developing countries. In a previous study, the first release of a urine LAM-ELISA by Chemogen (Portland, USA) has been evaluated with a promising sensitivity and specificity for the diagnosis of pulmonary TB. In the present study, the now commercially available assay has been clinically assessed regarding its diagnostic value alone and in combination with clinical co-factors. METHODS: The test was applied to two urine samples from 291 consecutively enrolled Tanzanian patients with suspected pulmonary tuberculosis. The participants were subsequently assigned to classification groups according to microbiological, clinical and radiological findings at recruitment and during a maximum follow up period of 56 days. RESULTS: Only 35 out of 69 pulmonary TB cases -confirmed by smear microscopy and/or solid culture and/or liquid culture- showed at least one positive LAM-ELISA result (sensitivity 50.7%). The sensitivity was noticeably higher in females (66.7%) and in HIV positive participants (62.0%). The specificity amounted to 87.8% and was determined in participants with negative results in all microbiological tests and with sustained recovery under antibiotic treatment at day 56. Correlation with urinalysis revealed that proteinuria was significantly and positively associated with LAM-positivity (P = 0.026). CONCLUSION: This commercially available generation of LAM-ELISA does not appear to be useful as an independent diagnostic test for pulmonary tuberculosis. The question whether the assay is suitable as a supplemental device in the diagnosis of HIV-associated TB, requires further investigations.