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[afro-nets] Diagnostic test Xpert MTB/RIF proven fast and effective in low-resource settings

Diagnostic test Xpert MTB/RIF proven fast and effective in low-resource settings

The Lancet published a significant development for TB diagnostics yesterday 
with concrete and encouraging study outcomes on the effectiveness of the new 
Xpert MTB/RIF test for TB and rifampicin resistance in realistic health care 
field conditions. One of the authors, Prof. Mark Nicol of the University of 
Cape Town (South Africa) who contributed to this study, is an EDCTP Senior 
Fellow. The article demonstrates that the test can effectively be used in 
low-resource settings to simplify early and accurate diagnosis of patients. The 
potential impact is a reduction in the morbidity associated with diagnostic 
delay, dropout and mistreatment. The article has appeared online on 19 April 
2011 and will be published in volume 377 on 30 April 2011.

Professor Mark Nicol of the University of Cape Town has conducted a study on 
the impact of the test at clinic and patient level: The impact of rapid 
genotypic detection of multi-drug resistant tuberculosis on treatment outcome 
in a semi-rural region of South Africa. In other studies the test showed high 
sensitivity in diagnosing TB in both smear-positive as well as smear-negative, 
culture-positive individuals including detection of the presence of rifampicin 
resistance. This cluster randomised study aimed to determine the impact of 
rapid testing with Xpert MTB/RIF when compared to the routine diagnostic 
algorithm. The primary impact outcomes to be assessed were the time between the 
first presentation to clinic of a patient with symptoms and the start of 
appropriate treatment for TB and, secondly, the proportion of patients in each 
arm with undiagnosed TB two months after the first TB test. One of the tests is 
a cartridge-based, automated diagnostic test that can identify Mycobacterium 
tuberculosis (MTB) and resistance to rifampicin (RIF) called the GeneXpert 
MTB/RIF. This test utilises a real time polymerase chain reaction (PCR) 
amplification system that processes an integrated specimen and is design ed for 
use at or close to the point of care.

Already, the preliminary results of this study formed a substantial component 
of a report submitted to the WHO Strategic and Technical Advisory Group (STAG) 
for Tuberculosis that endorsed the use of GeneXpert to diagnose TB in December 
2010. The National Health Laboratory Service of South Africa is evaluating the 
possibilities of rolling out GeneXpert testing for routine services. The data 
from this study will be central to informing this policy decision.

The project has established working relationships with the Foundation for 
Innovative New Diagnostics (FIND) and the grantee and his team are consortium 
members of the TB Clinical Diagnostics Research Consortium led from Johns 
Hopkins University of USA. The team are also co-investigators on the EDCTP 
sponsored TB-NEAT consortium led by Professor Keertan Dheda. Funding from the 
Wellcome Trust will allow extension of the project to a second laboratory site 
and, in particular, to the follow up period beyond the term of this EDCTP grant.

The overall study of the effectiveness of the test comprised sites in South 
Africa, Uganda, Azerbaijan, India, Philippines and Peru. It was funded by the 
Foundation for Innovative New Diagnostics, the Bill & Melinda Gates Foundation, 
the European and Developing Countries Clinical Trials Partnership, the Wellcome 
Trust and the UK Department for International Development.

Link to the article at The Lancet website:

The European and Developing Countries Clinical Trials Partnership (EDCTP) was 
created in 2003 as a European response to the global health crisis caused by 
the three main poverty-related diseases (PRDs) of HIV/AIDS, tuberculosis and 
malaria. Currently EDCTP is a partnership between 14 European Union member 
states plus Norway and Switzerland with 47 sub-Saharan African countries. The 
aim of the programme is to accelerate the development of new or improved drugs, 
vaccines and microbicides against HIV/AIDS, malaria and tuberculosis through 
promoting the integration of national programmes of EDCTP European Member 
States and development of a genuine partnership with African counterparts.


Note to the editor:
For further information, please contact:
Gert Onne van de Klashorst
Phone: +31 (0)70 344 0885

More information:
  *   Article: Achieving STOP TB Partnership goals: perspectives on development 
of new diagnostics, drugs and vaccines for tuberculosis
Tropical Medicine and International Health, April 2011

Daniela Pereira

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