Performance assessment of SD Bioline TB MPT64 assay for the diagnosis of Mycobacterium tuberculosis complex in Lagos, Nigeria

Abstract

ABSTRACT This study assessed the performance of SD Bioline MPT64 immunochromatographic test for the identification of Mycobacterium tuberculosis complex (MTBC) in Nigeria. A total of 157 mycobacterial isolates, comprising 120 (76.4%) MTBC (M. tuberculosis, 112; M. africanum, 5; M. bovis, 3) and 37 (23.6%) non-tuberculous mycobacteria (NTM) isolates from patients attending six DOTS centers in Lagos between June 2012 and July 2014 were analyzed. All the isolates were grown on Bactec MGIT960 liquid media and identified in parallel by the conventional method and MPT64 immunochromatographic test. Discrepant results were resolved using the line probe assay. The comorbid disease rates for HIV and type 2 diabetes were 20.9% and 8.2%, respectively. Compared to the conventional method, SD Bioline MPT64 identified 117 MTBC isolates correctly, producing a sensitivity of 97.5% (95% CI, 92.9–99.2) at a shorter growing median time of 11 days compared to 26 days by the conventional method. The three undetected MTBC were confirmed by the line probe assay to be M. tuberculosis strains. The test also identified all the NTM correctly producing a specificity of 100% (95% CI, 90.7–100). This study supports the integration of SD Bioline TB MPT64 antigen test into diagnostic workflow for rapid MTBC case identification in Nigeria.