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A12 HEALTH
Friday 20 November 2020

FDA allows 1st rapid virus test that gives results at home

By MATTHEW PERRONE for COVID-19. However,
AP Health Writer the FDA outlined a number
WASHINGTON (AP) — U.S. of study requirements for
regulators on Tuesday al- manufacturers.
lowed emergency use of These hurdles have less to
the first rapid coronavirus do with COVID-19 specifi-
test that can be performed cally, and more to do with
entirely at home and deliv- decades-long concerns
ers results in 30 minutes. about whether people
The announcement by the without any medical train-
Food and Drug Administra- ing can accurately screen
tion represents an impor- themselves and interpret
tant step in U.S. efforts to the results.
expand testing options for The FDA has only ever ap-
COVID-19 beyond health proved one home test for
care facilities and testing an infectious disease — an
sites. However, the test will HIV test. And even com-
require a prescription, likely monplace over-the-coun-
limiting its initial use. ter tests— such as home
The FDA granted emer- pregnancy kits — were sub-
gency authorization to the ject to years of scrutiny be-
single-use test kit from Lu- This image provided by Lucira Health shows the Lucira COVID-19 all-in-one home test kit. fore FDA allowed their use
cira Health, a California Associated Press in the 1970s.
test developer. The com- Experts say that careful
pany's test allows users to virus to others, including search the company was FDA said in its release. approach is warranted for
swab themselves to collect health care workers. Rapid doing to develop an at- Those who test negative coronavirus.
a nasal sample. The sam- test results are critical to home flu test, according but still have coronavirus "I think increased testing
ple is then swirled in a vial quickly quarantining those to the company's website. symptoms should consult closer to patients, including
of laboratory solution that who are infected and trac- Founded in 2013, Lucira a doctor; a negative result in the home, is the way of
plugs into a portable de- ing their contacts. But for adapted its technology does not rule out COVID-19 the future," said Dr. Robin
vice. Results are displayed months, U.S. testing has to detect COVID-19 after infection. The FDA said Lu- Patel of the Mayo Clinic, in
as lights labeled positive or been plagued by slow re- the outbreak. The test uses cira's test was also autho- an interview before the an-
negative. sults due to bottlenecks at technology similar to ge- rized for use in doctor's of- nouncement was made.
To date, the FDA has au- testing laboratories. There netic laboratory-based fices and testing sites. Cur- "But there are consider-
thorized nearly 300 tests for are other rapid tests but tests that are the standard rently all U.S. testing sites ations that have to be ad-
coronavirus. The vast ma- most require a small, spe- tool for COVID-19 screen- must report results to state dressed to make sure that
jority require a nasal swab cial machine operated by ing. That's different than and federal health authori- this is done in a safe and ef-
performed by a health pro- a health professional to de- most rapid tests currently ties tracking the pandemic. fective way."
fessional and must be pro- liver results. used in the U.S., which look Doctors will be required to FDA regulators authorized
cessed at laboratories us- "Now, more Americans who for viral proteins called an- report the home test results. the new test using their
ing high-tech equipment. may have COVID-19 will be tigens — not the virus itself. "If the results are not report- emergency powers to
A handful of tests allow able to take immediate They typically have lower ed back, it may be difficult quickly speed the availabil-
people to collect their own action, based on their re- accuracy for detecting the to figure out what is hap- ity of experimental prod-
sample at home — a nasal sults, to protect themselves virus than lab-based tests. pening in the community ucts during public health
swab or saliva — that's then and those around them," Lucira said its test results at large," said Dr. Alberto crises. In normal times, the
shipped to a lab, which Dr. Jeff Shuren, director of matched those of a lab- Gutierrez, former head of FDA requires evidence of
usually means waiting days the FDA's devices center, oratory-based test 94% of the FDA's testing office, in safety and effectiveness
for results. Health experts said in a statement. the time when screening an interview before the an- before clearing a new test.
have called for options to Lucira said it expects the for the virus. nouncement. But during public health
allow people to test them- test to cost $50 and to be Anyone that tests positive More than two dozen com- emergencies the agency
selves at home, reducing available nationwide by using the test should iso- panies have been racing can lower those standards
turnaround times and the next spring. The Lucira CO- late and seek care from for months to develop the if the test's benefits appear
potential spread of the VID-19 test grew out of re- a health professional, the first, rapid home-based test to outweigh its risks.q

Will social distancing weaken my immune system?

In short, no. "We're constantly exposed Experts say anyone look-
Some worry a lack of con- to microbes," said Akiko ing to boost their immune
tact with others will weak- Iwasaki, an immune sys- health during the pan-
en their immune system by tem researcher at Yale demic should practice
reducing its active con- University. "Our immune habits such as stress man-
tact with germs. system is always being trig- agement, healthy eating,
But even when we're stay- gered." regular exercise and get-
ing 6 feet from others or The effects of childhood ting enough sleep.
spending most of our time vaccines and other built- "These are the things that
at home, our bodies are up immunity are also long- actually affect the im-
continuously responding lasting, Iwasaki said, and mune system," Iwasaki
to plenty of bacteria and won't disappear overnight said.
Associated Press Illustration/Peter Hamlin
other germs that inhabit because we're keeping A seasonal flu shot will also
By The Associated Press weaken my immune sys- indoor and outdoor envi- our distance from others help protect you from one
Will social distancing tem? ronments. during the pandemic. more potential illness. q