The NanoDisk-MS Assay: A New Frontier in Biomarker-Based Tuberculosis Diagnostics?

Abstract

Tuberculosis (TB)2 is a chronic, progressive infection caused by microorganisms within the Mycobacterium tuberculosis (MTB) complex. Despite global initiatives, TB remains a significant public health threat and a major cause of morbidity and mortality worldwide. According to the 2017 World Health Organization (WHO) Global Tuberculosis Report, TB was the ninth leading cause of death worldwide, causing an estimated 1.6 million deaths, including 374000 deaths among those with HIV infection. Additionally, an estimated 10.4 million people developed TB in 2016. The WHO's END TB Strategy aims to reduce the number of TB deaths by 90% and reduce the number of new cases by 80% by 2030. To achieve these goals, the WHO has outlined 3 key areas of need, including the need for major advancements in TB diagnostics (1). Rapid and accurate diagnosis of active TB and initiation of treatment are critical to control the spread of disease. TB diagnostics, however, continue to rely on traditional techniques, including microscopy and mycobacterial culture. The diagnosis of TB begins with an assessment of symptoms and exposure history. Patients determined to be at risk for TB should be evaluated with a tuberculin skin test or interferon-γ release assay, and, if TB is suspected, specimens should be collected for examination by microscopy and culture (2–4). Detection of acid fast bacilli (AFB) on microscopic examination of stained specimens is a rapid and inexpensive diagnostic tool, but it is limited in its analytical sensitivity, which has been reported to range from 20% to 80% for sputum (5). In addition, clinical sensitivity is reduced in individuals with a small organism burden, such as in children, individuals with HIV infection, and in individuals with extrapulmonary TB (EPTB) infection. In addition, microscopy has limited analytical specificity because AFB detected by microscopy may represent MTB or …