9 December 2010
The South African Medical Research Council (MRC) has welcomed the approval of a new rapid test for tuberculosis (TB) that could revolutionise TB care and control. The test provides an accurate diagnosis in about 100 minutes, compared to current tests that take up to three months.
Endorsement of the fully automated Nucleic Acid Amplification Test (NAAT) by the World Health Organisation (WHO) followed 18 months of rigorous assessment of its field effectiveness in the early diagnosis of TB.
Its effectiveness has also been tested in cases of Multi-Drug Resistant TB (MDR-TB) and TB complicated by HIV infection, which are more difficult to diagnose.
Evidence to date indicates that implementation of the test could result in a three-fold increase in the diagnosis of patients with MDR-TB and a doubling in the number of HIV-associated TB cases diagnosed in areas with high rates of TB and HIV.
Testing for resistance
Welcoming the approval of the rapid test, MRC Acting President Dr Ali Dhansay noted that the test also allows for testing for resistance of the organism to one of the frontline TB drugs.
“The new test will certainly increase access to treatment and dramatically decrease treatment time for our patients, especially those with HIV co-infection,” said Dhansay. “We are also pleased that the issue of cost has been factored in. Once the test is implemented, the cost-benefit will have to be evaluated.”
He said, however, that the “gold standard” of TB culture remained, since the new test did not reveal sensitivity to other TB drugs.
WHO Stop TB Department Director Dr Mario Raviglione said the new test represented a major milestone for global TB diagnosis and care.
“It also represents new hope for the millions of people who are at the highest risk of TB and drug-resistant disease. We have the scientific evidence, we have defined the policy, and now we aim to support implementation for impact in countries,” said Raviglione.
The organisation has called for the fully automated NAAT to be rolled out under clearly defined conditions and as part of national plans for TB and MDR-TB care and control.
Policy and operational guidance are also being issued based on findings from a series of expert reviews and a global consultation held in Geneva last week, attended by more than 100 representatives from national programmes, development aid agencies and international partners.
Reduced prices for 116 countries
Foundation for Innovative and New Diagnostics (FIND) CEO Dr Giorgio Roscigno announced that the foundation had negotiated with the manufacturer, Cepheid, for a 75% reduction in the current market price for countries most affected by TB.
Roscigno noted that preferential pricing would be granted to 116 low- and middle-income countries where TB is endemic, with additional reductions in price once there was significant volume of demand.
The WHO is also releasing recommendations and guidelines for countries to incorporate the test in their programmes, including testing protocols to optimise the use and benefits of the new technology in those persons where it is needed most.
Though there have been major improvements in TB care and control, about 1.7-million people worldwide were killed by TB in 2009, with 9.4-million people developing active TB.
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