Nanodisk-MS Assay for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients
Nanodisk-MS Assay for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients
Diagnosis and treatment of tuberculosis are often delayed in hospitalized patients, leading
 to worse outcomes. Rapid diagnosis of tuberculosis currently relies on microscopy and
 molecular techniques, which have limitations including low sensitivity and high cost.Highly
 sensitive diagnostic technique is needed for more accurate rapid diagnosis of tuberculosis to
 aid earlier initiation of antituberculous therapy. Detection of Mycobacterium tuberculosis
 (MTB) antigens in the bloodstream can potentially allow early diagnosis of tuberculosis. This
 study aims to evaluate the diagnostic performance of a novel assay using nanotechnology to
 detect MTB antigens in patients admitted to hospital with suspected pulmonary and/or
 extrapulmonary tuberculosis. Blood will be taken from eligible patients, and will be sent to
 the School of Biological and Health Systems Engineering, Arizona State University, for
 detection of 10-kDa culture filtrate protein (CFP-10) and the 6 kDa early secretory antigenic
 target (ESAT-6), two antigens specific for MTB, using the Nanodisk-MS assay. Investigations,
 including microscopy, culture, MTB polymerase chain reaction (PCR), and imaging, will be
 performed for diagnosis of tuberculosis. The diagnostic performance of Nanodisk-mass
 spectrometry (MS) assay will be evaluated.
Inclusion Criteria:

 -  Adult patients aged 18 or above,

 -  Assessed by an Infectious Diseases physician to have clinical and/or radiological
 suspicion of pulmonary and/or extrapulmonary TB.

 Exclusion Criteria:

 -  Refusal to consent from patients or next of kins for incompetent patients.