Impact of the Mycobaterium africanum West Africa 2 Lineage on TB Diagnostics in West Africa: Decreased Sensitivity of Rapid Identification Tests in The Gambia.

Diagnostics for rapid confirmation of positive liquid cultures presumptive of Mycobacterium tuberculosis bacteria, based on the detection of the MPT64 antigen, are being used in many TB diagnostic laboratories worldwide. Of note, diagnostic performance of these tests in West Africa, where TB is uniquely caused by the geographically restricted Mycobacterium africanum (Maf 1 and 2) and Mycobacterium tuberculosis lineages, has not been properly assessed. Although M. tuberculosis and M. africanum are genetically related, they differ in various aspects. Amongst several differences, Maf 2 grows significantly slower than Mtb bacteria. Because secretion of the MTP64 protein is dependent on the bacterial growth rate, we found that the MPT64 rapid test performance for detecting Maf 2 was lower in our setting in The Gambia. These findings might be relevant for other West African Maf 2 endemic countries where this rapid test is commonly used, as Maf 2 infected patients might have been missed in the past. Our finding emphasizes the need to thoroughly consider the presence of bacterial variants specific to certain regions during product development and implementation of novel diagnostic tests.