Performance of FASTPlaqueTB™ and a modified protocol in a high HIV prevalence community in South Africa
International Journal of Tuberculosis and Lung Disease
Biotec Laboratories South Africa Ltd., Cape Town, South Africa; Foundation for Innovative New Diagnostics, Cape Town, South Africa; Médecins Sans Frontières, Cape Town, South Africa; Infectious Disease Epidemiology Unit, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa; Biotec Laboratories South Africa (Pty) Ltd., PO Box 50615, Waterfront, Cape Town 8002, South Africa
Modifications in the FASTPlaqueTB™ test protocol have resulted in an increase in the analytical limits of detection. This study investigated whether the performance of a modified prototype was able to increase the detection of smear-negative, culture-positive sputum samples as compared to the first generation FASTPlaqueTB test. Modifications to the FASTPlaqueTB did result in increased detection of smear-negative samples, but this was associated with a decrease in the specificity of the test. Before the FASTPlaqueTB can be considered as a viable replacement for smear microscopy and culture for the identification of tuberculosis, further work is required to resolve the performance issues identified in this study. © 2009 The Union.
adolescent; article; community; controlled study; culture medium; diagnostic test; human; Human immunodeficiency virus prevalence; microscopy; performance; priority journal; sensitivity and specificity; South Africa; sputum analysis; sputum smear; tuberculosis; comorbidity; comparative study; Human immunodeficiency virus infection; lung tuberculosis; methodology; microbiological examination; microbiology; prediction and forecasting; South Africa; sputum; Comorbidity; HIV Infections; Humans; Microbial Sensitivity Tests; Predictive Value of Tests; South Africa; Sputum; Tuberculosis, Pulmonary