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Ifakara features in new WHO guidelines for work on novel TB diagnostic tool
Ifakara Health Institute (IHI) has been featured in the latest World Health Organization (WHO) guidelines on tuberculosis (TB) diagnostics after its work on a novel technology for testing TB contributed to new consolidated guidelines on tuberculosis module 3 that was published by the WHO recently.
IHI senior researcher, Dr. Frederick Haraka, is amongst 12 scientists forming the WHO team which reviewed a range of new diagnostic technologies endorsed by WHO during the past 10 years. “Our review of the Impact of Xpert on patient important outcomes contributed particularly for recommendation 1.1, says Dr. Haraka, adding:
“Before our review, Xpert MTB/RIF was strongly recommended as initial diagnostic test in adults who are suspected for TB but also have either HIV or Multi drug resistant TB (MDR). Now it is strongly recommended for all adults with signs and symptoms of TB regardless of HIV or MDR status”.
A set of recommendations under Section 1 of the guideline, headlined “Molecular assays intended as initial tests for TB,’ provide for application of two novel technologies: Xpert MTB/RIF and Xpert Ultra as initial tests in adults and children with signs and symptoms of pulmonary TB. IHI work contributed in the review and adoption of the first one: Xpert MTB/RIF.
In their review Haraka and his team had shown those patients who were diagnosed using Xpert MTB/RIF had better chances of surviving and being cured compared to those diagnosed using the standard of care, smear microscopy.
The recommendation reads: “In adults with signs and symptoms of pulmonary TB, Xpert MTB/RIF should be used as an initial diagnostic test for TB and rifampicin-resistance detection in sputum rather than smear microscopy/culture and phenotypic DST. (Strong recommendation, high certainty of evidence for test accuracy; moderate certainty of evidence for patient-important outcomes)”
What does this mean? Dr. Haraka says, the new guidelines when adopted by national TB programs, will be applied by health care personnel to improve TB diagnostics. “The new recommendation means better access for TB diagnostic for all”
Commenting on his involvement and participation in the review of the testing technology along with top scientists from around the world, Dr. Haraka says, “It was a great learning opportunity on how WHO guideline development process occurs. We are happy to have been part of this great global effort and to learn that our ten years of TB research at our Institute gets global recognition in some way.”
Dr. Ally Olotu, Head of the Interventions and Clinical Trials department at IHI, who is Frederick’s peer, says, “It is indeed fulfilling to see your work is being recognized and considered in the development of the international guidelines. Congratulations to the entire TB research team!”
Below are some of the quick reactions to the news:
“Great milestone!” Dr. Robert Ndege, Head of IHI’s Chronic Diseases Clinic in Ifakara.
“We appreciate the effort made to contribute to the global recommendations,” Dr. Ester Elisaria, senior researcher at IHI.
“Great achievement!” Dr. Maja Weisser, an international public health researcher with IHI.
The political declaration at the first United Nations (UN) high-level meeting on TB held on September 26th, 2018 included commitments by Member States to diagnose and treat 40 million people with TB in the 5-year period 2018–2022. The approximate breakdown of the target is about 7 million in 2018 and about 8 million in subsequent years.
The traditional method for diagnosing TB using a light microscope, developed more than 100 years ago, has in recent years been challenged by several new methods and tools. These methods are based on either the detection of mycobacterial antigens or on the detection of mycobacterial DNA. The novel tools to detect presence of Mycobacterium tuberculosis and resistance to anti-TB drugs called for evidence-based policy recommendations.
The WHO published a number of guidelines developed by WHO-convened Guideline Development Groups (GDGs), using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to summarize the evidence and to formulate policy recommendations and accompanying remarks.
However, the growing number of published guidelines complicates the overview of recommendations for the intended audience (which includes health care personnel, national TB programs and policymakers), and WHO recognized the need to consolidate the recommendations into one document.
The recommendations in the new document, one of them being that on the use of ‘Xpert MTB/RIF’ tool which IHI contributed in reviewing, have been presented in five guidelines published by WHO between 2016 and 2020. Earlier guidelines on diagnostics that were not developed according to the GRADE approach have not been included in the consolidated document. #
Watch video here. View event photos here.
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