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A26    U.S. NEWS
                      Monday 15 June 2020
            Accuracy still unknown for many coronavirus tests rushed out



            WASHINGTON (AP)  — How                                                                                              ed  to  assess  a  test's  true
            accurate are the coronavi-                                                                                          performance.
            rus tests used in the U.S.?                                                                                         Lab  testing  bears  little  re-
            Months  into  the  outbreak,                                                                                        semblance  to  actual  —
            no  one  really  knows  how                                                                                         sometimes  imperfect  —
            well many of the screening                                                                                          conditions at hospitals, clin-
            tests  work,  and  experts  at                                                                                      ics  and  testing  sites  noted
            top  medical  centers  say  it                                                                                      Dr.  Robert  Kaplan  of  Stan-
            is time to do the studies to                                                                                        ford University.
            find out.                                                                                                           "You're  testing  people  in
            When the new virus began                                                                                            parking  lots,  the  patients
            spreading,  the  Food  and                                                                                          themselves  are  extremely
            Drug Administration used its                                                                                        anxious  and  often  unable
            emergency  powers  to  OK                                                                                           to  follow  instructions,"  said
            scores  of  quickly  devised                                                                                        Kaplan, a former associate
            tests,  based  mainly  on  a                                                                                        director of the National In-
            small  number  of  lab  stud-                                                                                       stitutes of Health.
            ies showing they could suc-                                                                                         Kaplan  and  others  say
            cessfully detect the virus.                                                                                         those  differences  could
            That's  very  different  from                                                                                       explain why some tests are
            the  large  patient  studies                                                                                        not  performing  as  expect-
            that  can  take  weeks  or    In this Friday, June 12, 2020 file photo, a nurse uses a swab to perform a coronavirus test in Salt   ed.
            months,  which  experts  say   Lake City.                                                                           Last   month,   the   FDA
            are  needed  to  provide  a                                                                        Associated Press  warned  doctors  of  a  po-
            true sense of testing accu-                                                                                         tential  accuracy  problem
            racy.                        tential problems with some  110  authorized  screening  available, according to an  with  Abbott  Laboratories'
            The FDA's speedy response  COVID-19  tests,  including  tests. The agency also said  Associated Press review.       rapid  ID  Now  test,  which
            came  after  it  was  initially  one used daily at the White  it is tracking reports of prob-  The  government's  emer-  delivers  results  in  roughly
            criticized  for  delaying  the  House.  Faulty  tests  could  lems.  Accuracy  has  also  gency  authorization  pro-  15  minutes.  The  test  has
            launch of new tests during  leave  many  thousands  of  been  an  issue  with  blood  cess "requires a lower level  been  lauded  by  President
            a  crisis  and  after  the  Cen-  Americans  with  the  incor-  tests  that  look  for  signs  of  of  evidence,"  the  agency  Donald  Trump  and  used
            ters  for  Disease  Control  rect  assumption  that  they  past infections.            said.  Makers  need  only  to  screen  the  president,
            and  Prevention  stumbled  are  virus-free,  contribut-   No  screening  test  is  100%  show  that  a  test  "may  be  his  staff  and  visitors  to  the
            in getting its own test out to  ing to new flare-ups of the  accurate. So details on ac-  effective"  instead  of  the  White House.
            states.                      disease as communities re-   curacy  are  routinely  pro-  usual requirement to dem-   The  FDA  alert  followed  a
            But  with  the  U.S.  outbreak  open.                     vided  for  tests  of  all  types,  onstrate "safety and effec-  preliminary  report  by  New
            nearly certain to stretch on  "In  the  beginning,  the  FDA  including seasonal flu, hep-  tiveness." They would have  York  University  that  found
            for  months  or  even  years,  was under a lot of pressure  atitis, HIV and cancers. For  to meet that higher thresh-  Abbott's  test  missed  be-
            some  experts  want  the  to get these tests onto the  example, rapid flu tests are  old  once  the  U.S.  govern-  tween a third to one-half of
            FDA to demand better evi-    marketplace," said Dr. Ste-  known to miss 20% or more  ment  declares  the  emer-     infections caught by a rival
            dence  of  the  tests'  accu-  ven Woloshin of Dartmouth  of  all  cases,  a  factor  doc-  gency over.             test in patients screened for
            racy so doctors know how  College, who wrote about  tors  weigh  when  treating  Many  of  the  commercial  the virus.
            many  infections  might  be  the  issue  in  the  New  Eng-  patients  who  have  symp-  test  makers  submitted  re-  Abbott  rejected  the  find-
            missed.                      land  Journal  of  Medicine  toms but test negative.      sults  from  60  samples,  the  ings,  saying  the  research-
            There  have  been  more  last  week.  "But  now  that  For  now,  most  COVID-19  minimum  number  required  ers  did  not  follow  the  in-
            than  2  million  confirmed  there are plenty of tests out  tests  in  the  U.S.  don't  give  and  mostly  used  lab-pro-  structions  for  using  its  test.
            coronavirus  cases  in  the  there,  it's  time  for  them  to  data  on  real-world  perfor-  duced  specimens  of  the  The  company  pointed  to
            U.S. and more than 115,000  raise the bar."               mance,  including  how  of-  virus. The FDA now recom-    alternate  patient  studies,
            deaths, according to data  The FDA said in a statement  ten  the  tests  falsely  clear  mends  the  use  of  nasal  including its own, that have
            compiled by Johns Hopkins  that  it  has  already  asked  patients  of  infection  or  swabs or other real samples  found  the  test  successfully
            University.  Cases  in  nearly  multiple  test  makers  to  do  falsely detect the virus. That  from  people  screened  for  detects between 91% and
            half of U.S. states are rising.   follow-up  accuracy  stud-  information is lacking for all  coronavirus.          95% or more of virus cases
            In recent weeks, preliminary  ies, although it didn't say for  but a few of the roughly 80  Experts  say  larger  patient  when  compared  to  other
            findings  have  flagged  po-  how many of the more than  commercial screening tests  studies  patients  are  need-  tests.q


            Report: 40,000 cruise ship workers still trapped at sea




            MIAMI  (AP)  —  More  than  Cruise lines stopped sailing  Some  cruise  ship  workers  America.    Royal   Carib-   Barbados  has  allowed  for
            40,000  cruise  ship  workers  in  mid-March  after  several  have started being repatri-  bean  also  flew  more  than  crew  repatriation  flights
            are  still  stuck  at  sea  be-  high-profile  outbreaks  at  ated  to  their  home  coun-  1,200  Filipino  crew  mem-  from its airports.
            cause  of  concerns  about  sea.  More  than  600  peo-   tries.                       bers  home  last  week  from  For most people, the coro-
            the coronavirus.             ple  fell  ill  aboard  Carnival  About   3,000   Carnival  Greece, Dubai, the United  navirus causes mild or mod-
            The  Miami  Herald  reports  Corp.'s  Diamond  Princess  Cruise  Line  workers  got  off  States  and  Barbados,  ac-  erate symptoms that clear
            that at least 42,000 workers  while it was quarantined off  in Croatia earlier this month  cording to the Herald.   up within weeks.
            remain  trapped  on  cruise  Japan,  for  example.  Four-  to  catch  rides  and  flights  Several  Caribbean  coun-  But  for  others,  especially
            ships  without  paychecks,  teen passengers died.         home  across  Europe.  MSC  tries haven't allowed cruise  older  adults  and  people
            and  some  still  are  suffer-  The  U.S.  Centers  for  Dis-  Cruises has flown more than  ships  to  dock  in  their  ports  with  existing  health  prob-
            ing  from  COVID-19,  three  ease  Control  has  prohib-  1,000 Indian crew members  out  of  concerns  that  they  lems,  the  virus  can  cause
            months  after  the  industry  ited  cruises  in  U.S.  waters  home  on  charter  flights  would  cause  spikes  in  the  severe  symptoms  and  be
            shut down.                   through July 24.             from  Europe  and  South  number of virus cases. Only  fatal.q
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