Evaluation of a new phage amplification technology for rapid diagnosis of tuberculosis.

ABSTRACT

PURPOSE: Rapid diagnosis of tuberculosis is essential to initiate timely and appropriate treatment to curb the spread of this potentially life threatening disease. The purpose of this study was to evaluate a phage amplification technology viz., FASTPlaque TB,TM for the diagnosis of tuberculosis. METHODS: We evaluated the clinical utility of this new assay by analyzing 50 respiratory and 40 non-respiratory specimens, using FASTPlaque TB TM kit (Biotec Laboratories, UK) and the performance was compared with TB Bactec 460 semi-automated liquid culture system and conventional LJ culture method. RESULTS: In case of respiratory specimens phage assay gave good specificity (100%) compared with TB Bactec whereas with respect to LJ method the sensitivity and specificity were 93.1% and 88.2% respectively. In case of non-respiratory specimens comparison of results obtained by phage assay showed sensitivity of 90.9% and specificity of 88.8% with respect to TB Bactec and 87.5% and 93.8% with respect to LJ method. CONCLUSIONS: We believe that this new low cost assay may have widespread applicability, especially in developing countries, due to its manual format and rapid reporting of results.