Quick flu test fast-tracked by FDA

A new laboratory test to diagnose H5 strains of influenza in patients has been approved by the US Food & Drug Administration.

The test, developed by the Centers for Disease Control and Prevention (CDC), can give preliminary results on suspected H5 influenza samples within just four hours. Previous testing technology would require at least two to three days.

If the presence of the H5 strain is identified, then further testing is conducted to identify the specific H5 subtype (e.g., H5N1).

Since December 2003, some 160 human cases of avian flu have been reported in Thailand, China, Vietnam, Cambodia, Indonesia, Turkey and Iraq. More than half of the people infected with the H5N1 virus have died. The concern is that H5N1 will evolve into one capable of human-to-human transmission, leading to an influenza pandemic.

'Preparing for a possible flu pandemic is a top priority for our nation, and FDA acted quickly to evaluate and expedite CDC's request for approval of this test,' acting FDA commissioner Dr Andrew von Eschenbach said. 'Using flexible regulatory authorities, FDA was able to prioritise this expedited approval based on the clear critical need without compromising the quality or integrity of the FDA review process.'

The test will be distributed to designated laboratories to enhance early detection. CDC has also shared the test technology with the World Health Organization and its collaborating centres around the world.