The latest report from the national Centers for Disease Control and Prevention indicates that the majority of states, 43 in all, are experiencing either “high or widespread flu activity” this winter, mostly resulting from circulation of the H3N2 family of viruses.

That report is corroborated by the latest statistics from the Maine Center for Disease Control and Prevention, which shows that nearly 700 people statewide have tested positive for the flu so far. Cumberland and Penobscot counties are the hardest hit, with 160 people in Cumberland County testing positive for the flu as of last week.

Now comes word that a new, highly accurate influenza test, created by a research and development team in Scarborough, has received approval from the U.S. Food and Drug Administration for wide use.

The test, officially called the Alere i Influenza A & B test, uses a nasal swab that allows medical staff to determine within about 15 minutes if a patient has a flu virus, halving other rapid test times.

Previously the test was only allowed in laboratory settings and required a prescription. Now, though, it can be used in doctors’ offices, hospital emergency rooms, urgent care clinics and other places that provide health care.

According to a press release from Alere, the Food and Drug Administration cleared the way for wider use of the company’s new flu test based on the fact that it’s easy to use and there is a low risk of getting false results.

In the press release, Alere said its new flu device was tested on more than 580 patients who had flu-like symptoms.

“The flu continues to spread rapidly and a faster analysis enables a correct treatment to be given,” the company said.

In all more than 200,000 people are hospitalized each year with the flu, according to the national Centers for Disease Control and Prevention.

Alere, which is headquartered in Waltham, Mass., also has facilities in Florida, Arizona, California, New Jersey, Kansas, Louisiana and Virginia, as well as various locations in Europe, the Middle East and Asia.

It bills itself as a leader in “creating breakthrough, cost-effective diagnostic solutions that address the most intractable diseases for all populations in all corners of the world, including infectious disease, cardio-metabolic disease and toxicology,” according to the company’s website.

At the Scarborough facility, there are both a research and development team of about 32 people, as well as a manufacturing plant. In all, 191 people work for Alere at the Scarborough location, according to Carrie Hollis, the onsite human resources manager.

KC McGrath, the respiratory product manager for Alere, said the goal of the new flu test was to allow health-care providers to get an “actionable result” while the patient is still on site.

The Alere i is the first handheld diagnostic test of its kind, according to McGrath. And, Hollis said, the platform could soon be used to detect other infectious diseases, not just the flu.

The benefit of the Alere i Influenza test is that it allows health-care providers to “better use antiviral (drugs), reduce the overuse of antibiotics and reduce the potential spread of influenza,” McGrath said.

The flu, he said, “can cause severe illness and life-threatening complications in many people.” It is estimated that in the United States, on average, 5 to 20 percent of the population gets the flu each year.”

In addition, according to McGrath, the flu can be “unpredictable and severe.” It’s estimated that flu-associated deaths in the U.S. range from a low of about 3,000 to a high of about 49,000 for the 30-year period between 1976 and 2006.

He said the Alere i analyzes nasal swab samples to detect influenza A and B and is also able to distinguish between the two types of infections. McGrath said the test’s sensitivity exceeds 90 percent for both viruses, which is “substantially higher” than that of older rapid influenza detection tests that rely on enzyme technology.

“The timely result (from the Alere i) allows the clinician to treat the patient during the course of a visit. Allowing for timely use of antivirals, if appropriate,” McGrath said. “The sooner that patients can know about their medical condition or status, the sooner they can begin the appropriate treatment.”

According to the Centers for Disease Control and Prevention, the best way to prevent the flu is to get a flu vaccine each year.

Those most at risk from the flu are children younger than 2, adults 65 and older and pregnant woman, along with those who have asthma, heart disease, various types of blood disorders, various types of kidney or liver disorders and the morbidly obese.

As of last week, according to the Centers for Disease Control and Prevention website, “Anyone who has not gotten vaccinated yet this season should do so now. This includes people who may already have gotten the flu this season because flu vaccines protect against three or four different viruses and it’s possible that other viruses will circulate later,”

As of Dec. 5, the site said, 145.4 million doses of seasonal flu vaccine had already been distributed nationwide.

Alere, a research and development facility in Scarborough, has created a new way of detecting the flu virus. Here, the members of the research team pose with the new product. From left are, Abby Bolduc, Kristen Cyr, Maddie Valentine, project director, Sami Gardner, Beth Dennis and Kerri Burns. Staff photo by Kate Irish Collins


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