WHO approves new rapid TB test

The new rapid test, endorsed by the World Health Organisation (WHO) on Wednesday, 8 December 2010, could revolutionise TB care and control by providing an accurate diagnosis in about 100 minutes, compared to current tests that can take up to three months.

The rapid test approval, which is a fully automated Nucleic Acid Amplification Test (NAAT), follows 18 months of rigorous assessment of its field effectiveness in the early diagnosis of TB, as well as 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 this test could result in a three-fold increase in the diagnosis of patients with Drug-Resistant TB and a doubling in the number of HIV-associated TB cases diagnosed in areas with high rates of TB and HIV.

Welcoming the approval of the rapid test, MRC Acting President, Dr Ali Dhansay, noted 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. 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," said Dr Dhansay.

He said, however, that the 'gold standard' of TB culture remains since the test does not reveal sensitivity to the other TB drugs.

WHO's Stop TB Department Director, Dr Mario Raviglione, said the new test represents 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 Dr 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 last week in Geneva, which was attended by more than 100 representatives from national programmes, development aid agencies and international partners.

Foundation for Innovative and New Diagnostics (FIND) CEO, Dr Giorgio Roscigno announced that the foundation has negotiated with the manufacturer, Cepheid, a 75 percent reduction in the current market price for countries most affected by TB.

Dr Roscigno noted that preferential pricing will be granted to 116 low and middle- income countries, where TB is endemic, with additional reduction in price once there is significant volume of demand.

WHO is also releasing recommendations and guidelines for countries to incorporate the test in their programmes. These include testing protocols to optimize 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 were killed by TB in 2009, with 9.4 million people developing active TB.