Improving diagnosis and case management of patients with tuberculosis: A review of gaps, needs and potential solutions in accessing laboratory diagnostics

Tuberculosis (TB) recently surpassed HIV/AIDS as the deadliest infectious disease. Despite some advancements in technologies and programs, TB remains a global health epidemic that, without significant gains in better diagnostic and management, will not abate. This review describes the molecular diagnostic gaps, needs, and potential solutions for improving access to diagnosis and management of patients with drug susceptible and drug resistant TB. The ultimate goal is to improve laboratory diagnostics and better individualized managementof detected TB, and make an important contribution toward eliminating this global epidemic. Rationale: Tuberculosis persists as one of the world's most deadly infectious disease. To make substantive progress toward TB elimination and end the global tuberculosis epidemic by 2035, innovative approaches and technologies are essential. Among the various related and complementary scientific and clinical milestones toward elimination, including vaccine development and new therapeutic regimens, one of the greatest challenges is to address the gaps in existing diagnostics. Current diagnostic technologies fall short in meeting the complex nature of the disease and its epidemiologic profile. This review concentrates and outlines the priorities for development of laboratory diagnostic tools for screening and diagnosing TB. Approach: The approaches and priorities described in this manuscript are based on identified gaps of current laboratory diagnosis of different clinical forms of TB. Closing these gaps will enable national programs to more efficiently diagnose TB, monitor treatment efficacy, and control drug resistance. Prioritization is based on technologies that address facilitate a more patient-centered approach, and are appropriate for low-resource and high-burden TB settings. New diagnostics must complement current or anticipated developments elsewhere and accelerate increased coverage, quality, and impact at the lower levels of the healthcare system.