During flu season, catching the flu is about as easy as counting to three, and a new device from 3M (St. Paul, Minnesota) may make detecting the highly contagious viral respiratory infection just as easy.

3M reported nationwide availability of its 3M Rapid Detection Flu A+B test. According to 3M, it is the first rapid flu test to provide automated results. The automated technology helps reduce user interpretation errors, which can lead to both false negative or false positive results, the company said. The 3M Rapid Detection Flu A+B test will be able to deliver hospital and physician office laboratories “reliable and objective” electronic results in 15 minutes, 3M noted.

“Bringing automation to the interpretation of influenza tests is a key factor for the next generation of rapid flu tests,” said Brian Anderson, marketing manager, 3M Health Care. “Automating and storing the objective result of a flu test will help increase laboratory productivity and minimize the potential for human error, which can contribute to improving patient outcomes.”

Anderson told Medical Device Daily that the new flu test is a lateral flow immunoassay with the same core technology as other rapid flu tests on the market, except that the new test uses a small instrument – the 3M Rapid Detection Reader – that actually interprets the test results. All other rapid flu tests are visual read tests, like a pregnancy test, he said, with a blue or red line and the laboratory technician interprets the results visually.

With traditional lateral flow tests, the lab technician has to set a timer and go back and read the results, Anderson said. “A lot of times in a busy laboratory that can be a challenge. Technicians are spread thin ... it’s not unusual to get sidetracked and be late in reading a test result,” he said.

Requiring less than three minutes of prep time, 3M says its flu test is designed to detect positive or negative results, and differentiate influenza A and influenza B with results clearly displayed on the reader.

The technology also is intended to enable labs to export data through laboratory information systems, further reducing the potential for reporting error by eliminating the need for manual recording and transferring of patient results. The test also reads and stores lab results, giving lab technicians more flexibility in time and test management, 3M said.

“In the flu season hospitals are inundated with tests, especially at the peak of flu season, because of needing to time the results and interpret the results, this system really automates and simplifies the running of the assay,” Anderson said.

He said influenza diagnostics is estimated to be more than a $100 million market and is “growing very rapidly.”

The 3M Rapid Detection Flu A+B test uses the RAMP technology platform from Response Biomedical (Vancouver, British Columbia). In late 2006 the two companies formed a collaboration to sell rapid infectious disease tests worldwide. The Flu A+B test is the first product to come out of that agreement.

“Properly interpreting test results is critical, especially considering that most flu antiviral medications have a 48-hour recommended therapeutic window for prescribing, so false-positives or even delayed test results may result in misapplication of therapy or may reduce its effectiveness,” said Christine Ginocchio, PhD, director of microbiology, virology and molecular diagnostics at North Shore Long Island Jewish Health System. “Having an automated reader almost eliminates the potential for misinterpreting results, leading to a faster and more informed treatment decision, which results in better patient outcomes.”

Anderson said a recent study evaluated the new flu diagnostic against what 3M referred to as “the leading hospital brand” and two conventional methods of diagnosing influenza A and B, direct fluorescent antibody staining (DFA) (1.5 to 3 hours for results) and rapid cell culture (R-Mix) (24 to 48 hours for results). Compared to the leading hospital brand, 3M’s flu test demonstrated superior analytical and clinical sensitivity for the detection of both influenza A and B, the company said. Further, the study concluded that the automated reading of test results eliminated the potential for user misreading or misinterpretation of test results.