FDA Clears Rapid Flu Diagnostic For Wider Use

By Chuck Seegert, Ph.D.

A new nucleic acid-based flu test has received an FDA waiver so that it may be used in a wider variety of settings. The test, which can deliver results in as little as 15 minutes, is manufactured by Alere Inc. and uses nasal swabs to test for influenza.

Influenza, or the flu virus, is a respiratory illness caused by two types of the virus — Type A and Type B. While infection can be mild in some cases, it can also be quite serious, leading to hospitalization and even death. Several hundreds of thousands of people are hospitalized for the virus every year, which has a seasonal cycle that culminates in the winter months.

To help with the diagnosis of the illness, a rapid test has been developed by Alere Inc., according to a recent story from Reuters. By detecting the nucleic acids of the flu virus, the test can confirm the presence of disease through the identification of its genetic material. The test uses a nasal swab sample and can be conducted in as little as 15 minutes. The test was first cleared by the FDA in June of 2014, but it was only available for prescription use since it was classified as moderately complex test.

The FDA recently granted a CLIA (Clinical Laboratory Improvement Amendments) waiver related to the Alere Inc. test, which is the first waiver of its kind for a nucleic acid test, according to a recent news release from the agency. The federal CLIA standards classify tests into three different levels of complexity, including waived tests, moderately complex tests, and high-complexity tests. Each CLIA laboratory is certified based on the complexity of test that it can perform. With this waiver, the Alere influenza test may now be distributed to many non-traditional laboratory sites, such as physician’s offices, health department clinics, emergency rooms, and other healthcare-related facilities.

The CLIA waiver was issued by the FDA after Alere submitted data showing that the ease-of-use for the test was very high. Even in the hands of untrained operators, the opportunity for false results was extremely low, which is key if the test will be used outside of moderate- or high-complexity laboratories. While the test maintains its accuracy when performed by inexperienced users, negative results do not necessarily rule out a flu infection. The evaluation of other risk factors is also required.

Flu vaccinations are also an important facet of battling the virus. Recently, a microneedle patch was introduced that may make these vaccinations easier.