Phage-TB
Research type
Research Study
Full title
Evaluating the diagnostic utility of Actiphage® for active pulmonary TB in a low burden setting
IRAS ID
328778
Contact name
Pranabashis Haldar
Contact email
Sponsor organisation
Research Governance Office, Research & Enterprise Division,University of Leicester
Duration of Study in the UK
1 years, 1 months, 30 days
Research summary
Research Summary:
Tuberculosis (TB) disease still causes serious illness and death throughout the world. Diagnosis of TB relies on patient producing sputum and culturing bacteria from sputum which takes days to weeks, causing delay in the diagnosis. Some people do not produce sputum, and require procedure such as bronchoscopy. To help us fight TB, we need better tests to detect and treat it.
Actiphage test is a blood-based test that is being developed to detect bacteria that causes TB in blood, which is easily accessible. And, this new test has to be evaluated properly to see how well it performs in detecting TB.
The study will build on observations reported in a recent, small proof of concept single-centre study (Leicester) that demonstrated Actiphage based detection of Mtb in the blood of treatment naïve pulmonary TB patients, with a sensitivity of 73% and specificity of 100%. In that study, sensitivity of the assay associated with radiological and microbiological correlates of increased disease severity. The present study aims to extend these observations to provide supporting evidence for validation in an independent fully characterised cohort at Leicester (UK).
This study will gather evidence to determine the utility of the Actiphage assay as a blood-based TB diagnostic.
Summary of Results:
The study was successful in recruiting the target population, including 34 people that had TB and 69 people who presented to the service with a different diagnosis. Over the course of the study, we identified problems with the assay not working properly. To begin with, the causes for this were unclear, and the team tried changing different things in the process to see if this would help. Eventually, we identified there was a problem with the PCR test that is performed at the end to amplify the DNA that is used to determine whether a test is positive or not. Although we were unable to determine whether the assay can be effective as a new blood test for TB, the study provided useful information to guide how the assay should be developed for future studies.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
23/SC/0222
Date of REC Opinion
3 Jul 2023
REC opinion
Favourable Opinion