Biomarker discovery for diagnosis and treatment of tuberculosis: a role for biobanking?

Abstract

The identification and validation of tuberculosis (TB) biomarkers is urgently needed, especially since TB is the second most common infectious cause of death worldwide, despite the fact that it is curable. TB biomarkers, whether host or pathogen specific, would provide prognostic information about pathogenic processes, current health status, and future disease risk of the patient. Thus, a need exists for research development of cost-effective, accurate, and rapid diagnostic assays, in particular, a TB point-of-care test to differentiate between active disease and latent infection and to detect drug resistance in human immunodeficiency virus (HIV)-infected and -uninfected individuals as well as children. Obtaining access to high-quality biospecimens with the associated clinical data in statistically relevant numbers is of the utmost importance; however, it can be a major challenge. Biobanks play an important role as a tool/link that would aid in the collection, validation, and storage of human and/or bacterial specimens. As the ideal sample type for a reliable biomarker is currently unknown, and volumes are not clearly defined, it becomes important to ensure that various sample types are collected, handled correctly, and stored appropriately in order to be fit for this purpose, as new technologies develop over time. Generally, sample collection processes are not standardized, and clinical data capturing is poor; all of which would have an impact on biomarker validation studies. Biobanks can address these shortfalls by ensuring the tight application of standardized protocols, quality control, and address the effects of preanalytical and storage variation on a broad range of sample types. This review gives an overview of global TB challenges, with regard to diagnosis and treatment; needs in the identification and validation of TB biomarker; and the role of open-access and certified biobanks as an essential component in the development of novel TB drugs and diagnostic tests for both public health and personalized medicine.