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                                                                                                      SCIENCE Thursday 14 May 2020
            New coronavirus test is imperfect step toward mass screening




            By MATTHEW PERRONE
            AP Health Writer
            WASHINGTON  (AP)  —  A
            new  type  of  coronavi-
            rus  test  offers  a  cheaper,
            quicker  way  to  screen  for
            infections,  moving  the  U.S.
            toward  the  kind  of  mass
            screening  that  experts  say
            is essential to returning mil-
            lions of Americans to school
            and work.
            But  the  first  so-called  an-
            tigen  test  —  announced
            Saturday by the Food and
            Drug  Administration  —  is
            not  quite  the  kind  sought
            by top government health
            officials.  It  is  less  accurate
            than the current gold stan-
            dard  for  testing  and  can
            only be run on specialized
            equipment.
            "It  is  too  early  to  tell,"  said
            lab researcher Patricia Sim-
            ner  of  Johns  Hopkins  Uni-
            versity,  assessing  the  test's
            impact.  "It  certainly  has
            the potential to aid in more
            widespread testing."
            Some  questions  and  an-
            swers about the new test:
            WHAT'S  DIFFERENT  ABOUT
            THIS TEST?
            The test from Quidel Corp.
            screens  for  new  infections
            but  in  a  different  way.  It   This undated electron microscope image made available by the U.S. National Institutes of Health in February 2020 shows the Novel
            looks  for  protein  traces  of   Coronavirus SARS-CoV-2, the virus causes COVID-19.                                           Associated Press
            the virus — known as anti-
            gens.  The  same  approach
            is used in rapid tests for flu,  machine,  but  it  only  does  performed  without  profes-  seasonal flu.          be  more  accurate,  easier
            strep  throat  and  other  in-  one sample at a time.     sional  oversight  or  special  "They  are  going  to  pick  to  use  and  more  suitable
            fections that are run at the  WHY  IS  ANTIGEN  TESTING  equipment.  While  an  im-    up  fewer  people  that  are  for mass screenings.
            hospital  or  doctor's  office.  IMPORTANT?               portant stepping stone, the  infected,"  said  Simner  of  OraSure  Technologies  has
            They represent a trade-off,  The  U.S.  is  still  struggling  to  Quidel test isn't there yet.  Johns  Hopkins.  "So  that's  a $710,000 federal contract
            sacrificing some of the ac-  increase testing to the lev-  HOW DOES IT WORK?           where you see a lot of skep-  to  develop  a  saliva-based
            curacy  of  more  rigorous  els that most public health  The  new  test  uses  a  nasal  ticism around using antigen  antigen test that could be
            tests  for  quicker  results  at  experts  say  are  essential.  swab  like  other  screening  tests  for  the  diagnosis  of  performed  at  home.  The
            a  lower  cost.  "They  allow  Harvard  researchers  have  tests, and delivers results in  COVID-19."               company has antigen tests
            you  to  dramatically  ex-   projected  that  the  nation  about 15 minutes.           For now, Simner and other  for  other  viruses  —  includ-
            pand  testing  and  they're  needs  to  be  able  to  do  The sample is put in a tube  experts  say  negative  test  ing  HIV  and  Ebola  —  and
            very cheap," said Dr. Scott  900,000  daily  tests    to  be  with testing chemicals and  results  for  people  showing  those have accuracy rates
            Gottlieb,  the  former  FDA  able  to  track  new  cases  then  into  a  cassette  that  symptoms  should  be  con-  of over 95%. Along with ac-
            commissioner,  in  an  inter-  and  contain  new  out-    goes  into  the  company's  firmed with the more accu-    curacy,  the  company  is
            view Sunday with CBS. But  breaks  as  the  country  re-  electronic reading device.  rate genetic test.            focused  on  speed,  aiming
            he acknowledged antigen  opens.  That's  more  than  There, it's exposed to a test-    "But as you might imagine,  to delivers results in 20 to 30
            testing's  reduced  accu-    three  times  the  country's  ing  strip  embedded  with  that's not a perfect scenar-  minutes.
            racy: "They're going to miss  current daily testing rate of  laboratory-made  antibod-  io because you have to do  "If  you  are  going  to  test
            some  patients  who  have  about 275,000.                 ies, the specific blood pro-  twice  as  many  tests  when  people  coming  into  work
            COVID." Previously, the only  White  House  adviser  Dr.  teins  made  by  the  body's  the result isn't positive," said  you  can't  make  them  line
            way to diagnose active in-   Deborah  Birx  and  other  immune  system  when  it  Dr. Robin Patel of the Mayo  up at 3 a.m." OraSure CEO
            fections was a test that de-  federal  officials  have  said  detects an infection. If the  Clinic.                 Stephen  Tang  said.  "You
            tects  the  genetic  material  a  "breakthrough"  in  anti-  antigens and antibodies in-  WHAT'S NEXT?              need  to  be  able  to  get
            of the virus. While highly ac-  gen testing could open the  teract, the test is positive.  Many companies are work-  their results quickly."q
            curate, most of those tests  way to daily testing before  HOW  ACCURATE  IS  THE  ing  on  versions  that  would
            take  hours  to  develop  on  going  to  back  to  work  or  TEST?
            machines  mainly  found  at  school.                      The  new  test  is  expected
            commercial  labs,  hospitals  The  National  Institutes  of  to detect about 80% of ac-
            or  universities.  Abbott  Lab-  Health  is  pouring  $1.5  bil-  tive  COVID-19  infections,
            oratories  makes  a  15-min-  lion  into  efforts  to  develop  according to the FDA. That
            ute  version  of  the  genetic  highly  accurate,  easy-to-  accuracy  rate  is  similar  to
            test that runs on its portable  use  tests  that  could  be  other rapid antigen tests for             linda.reijnders@cspnv.com
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