SCARBOROUGH — As another flu season is about to begin, a company in Scarborough that makes rapid diagnostic tests to determine in minutes whether a patient has the flu is ready.

Maine and the nation recently suffered through one of the worst seasons for influenza – perhaps since the H1N1 flu outbreak in 2009 – with 9,018 reported cases and 82 deaths in the state in the 2017-18 flu season. Cases were up more than 50 percent in Maine from the previous season. Although the flu season runs from October to May, with peak months typically January through April, it is notoriously unpredictable.

Nationwide, there were 223,487 positive tests for the flu last season. Many of those tests used kits produced by Abbott, a health care services company in Scarborough.

Andy Wilkinson, left, is site manager at Abbott, which employs more than 300 in Maine, and Norman Moore is scientific affairs director. “We feel very proud that what we’re doing can save people’s lives,” Moore said. Staff photo by Jill Brady

Located off Southgate Drive, Abbott is part of a Chicago-based multinational corporation that had $27.4 billion in sales last year. From its Scarborough facility, the company makes more than 1 million flu tests per year that are distributed to more than 130 countries, and “tens of millions” of other diagnostic tests, company officials said. More than 300 Abbott employees work in Maine.

Because the tests must meet rigorous standards to gain U.S. Food and Drug Administration approval, and production requires custom-designed manufacturing equipment, there’s only a handful of competitors. That makes Abbott a major player in the marketplace.

“Whatever the demand is, we will meet it,” said Andy Wilkinson, site manager at Abbott.

EASE OF USE IS CRUCIAL

Abbott makes rapid tests not only for influenza, but also to detect other common infectious diseases, such as pneumonia, strep, a respiratory virus and HIV.

Its Maine location works on the tests from research and development to logistics, manufacturing and customer service until they are sent to distribution centers in New Jersey or in Europe. From there, they are sent to doctor’s offices, hospitals, urgent care clinics and similar health service locations around the world.

The goal, Wilkinson said, is to make the tests so easy to use that a seventh-grader could reliably administer the test and read the results. That “ease of use” opens up administering the tests to a wide swath of health professionals, which is essential during peak times when there’s a flu outbreak.

“When there’s 50 people coming through the door, you want many people at the office to have the ability to administer and read the test results,” said Norman Moore, scientific affairs director at Abbott.

A sample swab is inserted into an ID NOW diagnostic machine made by Abbott. It takes five to 13 minutes to produce a result, and if positive, the test can tell what strain of influenza a patient has. Staff photo by Jill Brady

A white rectangular machine called the “ID NOW” sat on the conference room table inside Abbott’s sprawling 115,000-square-foot complex. To conduct a test, a nose is swabbed and the sample is inserted into a designated spot in the “ID NOW” machine.

A few clicks and whirs later, the machine makes a sound similar to a dial tone to indicate that it’s done. It takes five to 13 minutes to produce a result, and if positive, the test can tell what strain of influenza patients have, influenza A or B.

Moore said the test has a number of public health benefits. If patients are accurately diagnosed early in the disease’s cycle, they can start taking anti-viral medications that are not as effective in later stages of the flu.

“If people know they have the flu, they stay home and don’t go to work and school, and stay away from other people, helping to prevent it from spreading to others,” Moore said. “They can get the correct treatment right away, preventing overuse of antibiotics.”

Moore said when doctors don’t know whether it’s the flu or, say, a bacterial infection, they may give patients antibiotics, which is counterproductive. Antibiotics do not work on viral infections like influenza, and overuse of antibiotics can lead to antibiotic-resistant bacteria.

On the flip side, misdiagnosing patients with the flu when they actually have pneumonia can also be deadly, because the course of treatment is different. Most forms of pneumonia are caused by bacterial infections that are treated with antibiotics.

Another benefit is keeping people who don’t need to be in emergency rooms out of the ER if they can get a rapid test at their doctor’s office or an urgent care center. During peak flu season, ERs can become overwhelmed with flu patients.

Test swabs are stored at Abbott, which makes flu diagnostic tests that are distributed around the world. Staff photos by Jill Brady

The rapid flu tests, combined with preventive flu vaccines, are some of the better resources that public health officials have for reducing the severity of an outbreak, Moore said.

“How much better job satisfaction can you have knowing what impact we are having? We feel very proud that what we’re doing can save people’s lives,” Moore said.

The diagnostic testing company formed in Portland in 1986 as Binax. In 2005, it was bought by Alere, and Alere was purchased by Abbott in 2017.

TIMING OF TESTING IMPORTANT

Dr. Kolawale Bankole, director/administrator of the Portland Public Health Department, said the rapid tests are valuable, but not perfect. Bankole – speaking generally about the rapid tests and not specifically about Abbott’s products – said some of the rapid tests generate false positives and false negatives during early- and late- flu season. But he said even though some of the tests have shortcomings, they are extremely helpful.

“These tests work best during the peak of the season,” Bankole said. “If you catch people in the early stages of when they have the flu, that’s when these tests can really do well.”

Bankole said treatment for flu is most effective if it can be detected early, because patients rest more and anti-viral medications work better.

Cliff Seymour, Abbott’s team leader for production, said it’s nice to know the tests they produce in Maine can help alleviate outbreaks of infectious diseases around the world.

“When you go home for the night, it gives you a great feeling knowing what we’re doing,” he said.

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