Tuberculosis Diagnosis by Flow Cytometry

Reagent Evaluation Plan: Tuberculosis Diagnosis by Flow Cytometry (Project Orion)

Tuberculosis and HIV continue to be major public health problems in resource constrained settings like Zambia. Zambia is among the top 30 highest burden countries globally. The major drivers of TB in the Africa region is the HIV epidemic. Inadequate TB diagnostic tools with failure to make a timely diagnosis and start appropriate treatment are the major impediments to TB control in Zambia and globally.

Project Orion is focused on utilizing Flow Cytometry Technology to screen and diagnose tuberculosis. There are two assays being tested under this Project:

1. Activated TB assay for differentiation of latent and active TB infection using blood samples and
2. Direct TB assay (DTA) for rapid detection and DST of Mycobacterium tuberculosis (Mtb) using sputum specimens.)

Inclusion Criteria:

• Presumptive TB patients (patients recommended for tuberculosis diagnostic testing and not on ATT)
• Patients with multi-drug resistant TB (MDR-TB)
• Paediatric patients (< 15 years old)
• Patients suspected of extra-pulmonary tuberculosis
• Patients with TB/HIV co-infection

Exclusion Criteria:

• Unable/unwilling to sign Informed consent