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FDA Allows First Rapid Virus Testing to Get Results at Home

To date, the FDA has approved approximately 300 tests for the coronavirus. The majority require nasal swabs performed by medical professionals and must be processed in the laboratory using high-tech equipment. Some tests allow people to collect their sample (nasal swab or saliva) at home and send it to the lab. This usually means waiting for the result.

Health professionals are looking for options that allow people to test themselves at home, reducing turnaround times and reducing the chances of the virus spreading to others, including healthcare professionals. Prompt test results are important for quickly isolating infected people and tracking contacts. But for months, US testing has been plagued by slow results due to bottlenecks in test labs. There are other quick tests, but most often require a small special machine operated by a medical professional to produce results.

In a statement, Dr. Jeff Schlen, director of the FDA’s Device Center, said, “Now, more Americans who may have COVID-19 are, based on the results, themselves and their surroundings. We will be able to take immediate action to protect people. “

According to Lucilla, the test costs $ 50 and will be available nationwide by next spring.

The Lucira COVID-19 test was born out of the research the company was doing to develop a flu test at home, according to the company’s website. Founded in 2013, Lucira adopted the technology to detect COVID-19 after an outbreak.

This test uses techniques similar to genetic test-based testing, which is the standard tool for COVID-19 screening. This is different from the fastest test currently used in the United States, which looks for viral proteins called antigens, not the virus itself. These are usually less accurate than lab-based tests.

According to Lucilla, the test results were 94% likely to match the results of laboratory-based tests when screening for viruses.

Anyone who uses the test and tests positive should seek care in isolation from medical professionals, the FDA said in its release. Talk to your doctor if your test is negative but you still have coronavirus symptoms. Negative results do not rule out COVID-19 infection.

The FDA said Lucilla’s tests are also permitted for use in clinics and laboratories. Currently, all US test sites need to report results to state and federal health authorities tracking pandemics. Your doctor will need to report the results of your home exam.

“If the results aren’t reported, it can be difficult to understand what’s happening across the community,” said Dr. Albert Gutierrez, a former head of the FDA’s test office, in a pre-announcement interview. I did.

Over 20 companies have been competing for months to develop the first rapid home test for COVID-19. However, the FDA has outlined many research requirements for manufacturers.

These hurdles have nothing to do with COVID-19 in particular, but with decades of concern about whether non-medical people can accurately screen themselves and interpret the results.

The FDA has approved only one home test for infectious diseases. It’s an HIV test. Also, even common commercial tests, such as home pregnancy kits, were subject to years of scrutiny before the FDA approved them for use in the 1970s.

Experts say that the coronavirus requires a careful approach.

In a pre-announcement interview, Mayo Clinic’s Dr. Robin Patel said, “I think increasing testing near patients, including at home, is the way forward.” “But there are considerations that must be addressed to ensure that this is done in a safe and effective way.”

FDA regulators have approved new tests using emergency authority to expedite the availability of experimental products in the event of a public health crisis. The FDA typically requires proof of safety and effectiveness before passing a new test. However, during public health emergencies, authorities can lower those standards if the benefits of the test appear to outweigh the risks.


Follow Matthew Perrone on Twitter: @AP_FDAwriter


The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at Howard Hughes Medical Institute. The Associated Press is solely responsible for all content.

FDA Allows First Rapid Virus Testing to Get Results at Home

Source link FDA Allows First Rapid Virus Testing to Get Results at Home

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