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Recruitment is underway in Papua New Guinea (PNG) for a trial supported by Burnet Institute and the National TB program of PNG of a new and potentially lifesaving rapid diagnostic for tuberculosis (TB).
The battery-powered and phone-operated device, called the Truenat, developed by Molbio Diagnostics India, can detect TB and antibiotic-resistant TB from sputum samples in 60 to 120 minutes.
It’s designed to address an urgent need for accurate, cheaper, point-of-care TB diagnostics for use in rural and remote settings in a country like PNG as an alternative to laboratory-based instruments such as the GeneXpert diagnostic, which is currently available only in district and provincial hospitals across the country, and less reliable microscopy tests.
Sponsored by FIND (The Foundation for Innovative New Diagnostics), the multi-national trial, which includes India, Ethiopia and Peru, will evaluate the sensitivity and specificity of the Truenat, and assess patient-important outcomes.
Burnet Institute is working in partnership with Port Moresby General Hospital (PMGH), Central Public Health Laboratory, National TB Program, Victorian Infectious Diseases Reference Laboratory, and PNG Institute of Medical Research.
PMGH will be the setting for the trial involving a target population of people attending general outpatients and/or the hospital’s TB clinic.
“Clinical trials are challenging but with the cooperation of the TB clinic staff and the laboratory staff as the main players, this Truenat trial can be done,“ Dr Evelyn Lavu, Director of the Central Public Health Laboratory at PMGH, said.
“Truenat could be a better option for TB diagnosis in rural health laboratories where power supply is unavailable or poor. This instrument could improve TB diagnosis in facilities where GeneXpert is not available, but needs to first be rigorously assessed in a trial before it can be introduced into programs”
TB is the second leading cause of death in PNG with a case notification rate of 378 per 100,000. The World Health Organization classifies PNG as a high-burden country for TB, TB/HIV and Drug-Resistant (DR)-TB.
Rapid and accurate diagnosis of TB is fundamental to achieving the ambitious targets set by the World Health Organization’s (WHO) new END TB strategy, and meeting the United Nations Sustainable Development Goal to end the global TB epidemic by 2030.
Burnet Infectious Diseases Specialist Dr Philipp du Cros is a Principal Investigator on the study with Dr Lavu.
Funding for the global trial has been provided by The Bill & Melinda Gates Foundation, the Indian Council for Medical Research, and the Australian government.
For more information in relation to this news article, please contact:
Infectious Diseases Specialist, TB Elimination and Implementation Science