As influenza continues to spread rapidly across the United States, a test has been needed that would be able to verify the presence of the influenza virus in patients. Today, the Food and Drug Administration (FDA) has cleared the use of a new influenza test for wider use.
The influenza test uses a nasal swab and enables medical staff to determine if the flu virus is present. It is referred to as a nucleic acid-based test. Officially it is called the Alere i Influenza A & B test.
Previously, the test was only allowed to be used in laboratory settings and required a prescription. Now it can be used in actual doctor’s offices. Other places that may use the flu test include emergency rooms, clinics, and other offices that provide some form of health care.
In order to give the “OK” on this particular test, the FDA issued a waiver on it. The waiver bypasses the Clinical Laboratory Improvement Amendments (CLIA). Allowing the Alere i Influenza A & B test to be used at this time will most likely open the door for other similar type tests to be developed, says the FDA’s Center for Devices and Radiological Health Director Alberto Gutierrez, Ph.D., part of the In Vitro Diagnostics and Radiological Health Office.
The FDA gave the all-clear on this device based on two factors. First, it was easy to learn how to use, and secondly, there was a low risk of getting false results even when used by people who are not well-trained in its use. The test was initially cleared for use only on a prescription basis this past June. Both of these factors were essential when considering opening up its use outside of more complex laboratories.
The influenza test is merely an additional aid in detecting the presence of the flu virus. Although it does have a high level of accuracy, obtaining a negative result does not mean that a flu virus is not present.
The advantage of this influenza test, which caused it to be cleared for wider use, is that it is the first device offering a molecular test that can deliver results in less than 15 minutes. It had been tested at eight trial sites previously within the United States.
The Alere device was tested on more than 580 patients who had flu-like symptoms. After the device produced its results, the test results were compared with the results from more standard tests. The device proved to be quite accurate in most cases.
The test becomes available just in time for doctors to be able to evaluate dozens of flu cases coming into their offices each week in some places. The flu epidemic continues to spread rapidly and a faster analysis enables a correct treatment to be given. The CDC reports that more than 200,000 people are hospitalized each year with the flu.
The Alere i Influenza A & B test device is made by Alere Scarborough, Inc., which is located in Scarborough, Maine. It is able to provide a highly accurate result when testing for influenza A or B. After the FDA cleared the influenza test for the much wider use, the New York Stock Exchange witnessed Alere stock rise 1.4 percent to close at $37.25.
By Mike Valles