Tuberculosis Diagnosis by Flow Cytometry

Study Overview
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Brief Summary
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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.

Detailed Description
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Project Orion is focused on utilizing Flow Cytometry Technology to screen and diagnose tuberculosis. There are two assays being tested under this Project: Activated TB assay for differentiation of latent and active TB infection using blood samples and Direct TB assay (DTA) for rapid detection and DST of Mycobacterium tuberculosis (Mtb) using sputum specimens.)

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

Conditions
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Tuberculosis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blood Assay Phase - 1<br>TB Positive / HIV Positive: 65 participants | |
| Blood Assay Phase - 2<br>TB positive / HIV Negative: 65 participants | |
| Blood Assay Phase - 3<br>TB positive and negative Paediatric: 30 participants | |
| Blood Assay Phase - 4<br>TB Negative/HIV positive: 50 participants | |
| Blood Assay Phase - 5<br>Healthy controls: 30 participants | |
| Sputum Collection Phase - 1<br>TB Positive: Xpert Rif sensitive: 100 participants | |
| Sputum Collection Phase - 2<br>TB Positive: Xpert Rif resistant: 20 | |
| Sputum Collection Phase - 3<br>TB Negative: Other chest: unknown number | |
| Sputum Collection Phase - 4<br>TB Negative: Smear negative/Xpert negative: 20 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ATB assay for differentiation of latent and active TB infection using Blood samples | To evaluate the clinical utility of the test reagent(s) compared to diagnostic gold Standard: Culture and Xpert MTB/Rif along with clinical (empiric) diagnosis | The duration of this project is 9 months. | 
| DTB assay for rapid detection and drug sensitivity testing of Mtb using sputum specimens | To evaluate the clinical utility of the test reagent(s) compared to diagnostic gold Standard: Culture and Xpert MTB/Rif along with clinical (empiric) diagnosis | The duration of this project is 9 months. |