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More than a year into the COVID-19 pandemic the rollout of vaccines has taken center stage, but the rapid tests that have been developed to determine who is infected remain critical to reducing the spread and beating the pandemic.
Getting enough people vaccinated will take time, and there is still much to learn about the length of immunity, and efficacy against emerging variants. Rapid COVID-19 tests can help determine who is infected so they can quarantine and not spread the virus to their family and friends.
Leading the charge on the testing front is Chicago-based Abbott. They developed eight COVID-19 tests that have received Emergency Use Authorization from the Food and Drug Administration (FDA). Their technologies and approaches—from highly accurate lab-based tests to inexpensive at-home products—offer flexibility and options to doctors, public health officials, and the public.
By March 18, 2020, Abbott received Emergency Use Authorization for its first molecular test for the identification of SARS-CoV-2, the virus that causes COVID-19, and immediately deployed 150,000 tests to medical centers across the country. It scaled up production at its U.S. manufacturing location to reach capacity for one million tests per week by the end of March 2020.
A few days later came approval for a smaller, toaster-sized device for fast portable tests. The ID NOW system delivers results in 13 minutes and can be done in a doctor’s office. Abbott immediately ramped up production to deliver 50,000 ID NOW COVID-19 tests per day to the U.S. healthcare system.
Over the next several months Abbott developed eight COVID-19 tests critical to helping frontline workers diagnose COVID-19 and better understand it.
Technologies and Tests
Tests, developed by Abbott and other companies, look for viral RNA, antigens, or antibodies to determine if a person is currently infected or previously had the virus.
Viral RNA is the genetic material a virus produces when it multiplies in the body. Antigens are the invader–the virus. Antibodies are the proteins the immune system produces to stop the virus and remove it from the body.
Molecular tests: Molecular tests look for viral RNA. By taking a mucus sample—from those infamous nasal swabs and less invasive throat swabs—molecular tests can determine if a patient has viral RNA and the COVID-19 virus. Testing equipment like Abbott’s Alinity m system can run up to 1,080 tests a day and are available in hospitals and testing labs.
Antigen tests: To test to see if a person has COVID-19 antigens, Abbott developed the BinaxNOW test. It’s the size of a credit card, can be used at home with a prescription, and can deliver results in 15 minutes with a nasal swab.
What’s more, by using an Abbott-developed app, the test can issue a temporary digital health pass certificate that organizations can use to ensure someone tested negative. It can be incorporated with other preventatives measures in the workplace like social distancing, mask-wearing, and hand-washing.
Inexpensive and fast antigen tests—while not as accurate as ones performed in labs—play an important role.
“In terms of what we’re trying to do—preventing the spread of infection—the antigen test, particularly when it’s applied multiple times, seems to work great,” said Dr. David Harris, a stem-cell researcher running the University of Arizona’s mass testing program.
“Our rapid antigen BinaxNOW test and our ID NOW molecular rapid test are effective at identifying the virus when you're most likely to transmit it. Which is to say, when you're contagious. They determine: Do you have active virus in you right now? And are you contagious? Those are really important questions that you need to answer in the middle of a pandemic,” said Chris Scoggins, Abbott's senior vice president of Rapid Diagnostics.
Blood (serology) tests: Molecular and antigen tests can determine if someone currently has the virus. But how do you find out if you had it in the past but never had any noticeable symptoms? That’s where serology (blood) tests come in. It helps determine if someone has previously been infected.
Using a blood sample, a testing instrument like Abbott’s Alinity i system can determine if a patient has produced COVID-19 antibodies.
Blood tests are useful in understanding the spread of the virus. "The new serology tests can help public health officials and policymakers make critical decisions based on how prevalent the virus is in their community,” said Dr. Robert Hart, Executive Vice President and Chief Medical Officer, Ochsner Health, Louisiana.
While it’s hard to see beyond the pandemic, Abbott’s work on testing will pay dividends in the future.
“Eventually, a few years from now, when COVID testing ramps down and becomes more like flu testing, the infrastructure put in place because of COVID-19 will remain and play an important role in healthcare,” Scoggins explained. “Abbott will have built this new platform outside labs and hospitals that can bring all kinds of rapid tests to people when and where they need them.”
Going from no tests to eight in less than a year shows how Abbott’s focus on innovation can pay off—and is one example of how businesses have stepped up to fight the pandemic.