The New York Times - USA (2020-10-26)

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THE NEW YORK TIMES, MONDAY, OCTOBER 26, 2020 N A

In the high-stakes world of co-
ronavirus testing, one mistake
has taken center stage: the
dreaded false negative, wherein a
test mistakenly deems an infected
person to be virus-free.
These troublesome results, ex-
perts have said, can deprive a per-
son of treatment and embolden
them to mingle with others, has-
tening the spread of disease.
But false negatives are not the
only errors bedeviling coronavi-
rus diagnostics. False positives,
which incorrectly identify a
healthy person as infected by the
virus, can have serious conse-
quences as well, especially in
places where the virus is scarce.
Although false positives may
seem relatively harmless in com-
parison with their false-negative
cousins, “people can absolutely
get hurt,” said Dr. Benjamin Ma-
zer, a pathologist and diagnostics
expert at Johns Hopkins Univer-
sity.
False positives are generally
very rare among tests that have
been vetted by the Food and Drug
Administration. But any test can
be plagued by contamination,
mishandling or technical glitches,
leading a device to spot the co-
ronavirus where it is not.
Some rapid tests, which forgo
sophisticated laboratory equip-
ment and can deliver results in un-
der an hour, have been criticized
for returning high numbers of
false positives, especially when
used to screen people without
symptoms. Even laboratory tests
that rely on a very reliable tech-
nique called polymerase chain re-
action, or P.C.R., have been known
to return the occasional false pos-
itive.
In places where the virus is rel-
atively scarce, false positives may
even outnumber actual positives
— eroding trust in tests and, un-
der some circumstances, prompt-
ing outbreaks of their own.


Unnecessary Isolation


A positive result on a coronavirus
test sets off a cascade of conse-


quences. According to guidelines
published by the Centers for Dis-
ease Control and Prevention, peo-
ple who test positive should im-
mediately isolate for at least 10
days after their symptoms start
(if they experience symptoms at
all).
That is 10 days spent away from
friends and family, and 10 days of
potential productivity in a school
or workplace lost.
The ever-increasing availabil-
ity of virtual platforms might
make that transition easy for
some, Dr. Mazer said. But for peo-
ple whose work can only be done
in person, or who lack a financial
buffer, “this could be a huge deal,”
he said. “They could lose their
paycheck. They could lose their
job.”
Caregivers, too, may find them-
selves put in a precarious position
by false positives, which could
force them to separate from chil-
dren, older family members or
other vulnerable contacts. Should
another person need to come in
and take their place, the risks of
exposure to the virus could in-
crease for all involved.

And for facilities with limited
space, placing a person in unnec-
essary isolation could shift equip-
ment, medical care and even fol-
low-up tests away from someone
who might need those resources
more.

New Outbreaks
Under certain circumstances, a
false positive could seed new co-
ronavirus cases. Crowded facili-
ties, such as nursing homes, pris-
ons or hospitals, might isolate co-
ronavirus-positive people togeth-
er.
In a worst-case scenario, “if
someone isn’t actually positive,
we could be sending them to their
death,” said Dr. Valerie Fitzhugh,
a pathologist at Rutgers Univer-
sity.
In early October, officials in Ne-
vada ordered the state’s nursing
homes to halt the use of two rapid
coronavirus tests until further no-
tice, citing concerns about accura-
cy. (Nearly 40 percent of the coun-
try’s known Covid-19 deaths have
come from nursing homes, ac-
cording to an analysis by The New
York Times.) A rash of false pos-

itives had been uncovered, ac-
cording to the directive, which had
risked placing uninfected resi-
dents into units with infected peo-
ple, creating a situation that gives
the coronavirus a greater oppor-
tunity to spread. Such a scenario
“could result in causing harm to a
population that we have col-
lectively worked so hard to pro-
tect,” officials noted in a follow-up
directive. Under pressure from
the federal government, Nevada
officials revoked the rapid testing
prohibition on Oct. 9.

Missed or Inappropriate Treatment
False positives can also be disas-
trous from a treatment stand-
point, said Linoj Samuel, a clini-
cal microbiologist at Henry Ford
Health System in Detroit. People
with the flu or Covid-19, for exam-
ple, often show similar symp-
toms, but may only be tested for
one of them at a time. If a patient
is given an incorrect diagnosis of
Covid-19, that person could be de-
prived of treatment that could al-
leviate their illness, or be given a
costly therapy that does little to
speed their recovery.

“That’s definitely a price you
pay,” Dr. Samuel said.

A False Sense of Security
Mounting evidence suggests that
most people who have fought off
the coronavirus once retain a de-
gree of immunity that can thwart
the virus a second time. Scien-
tists do not know how long this
immunity lasts, or how it varies
from person to person, but the
C.D.C. has issued guidelines that
note that reinfection is unlikely
within 90 days. People who don’t
have symptoms within this time
window do not need to be tested
again, the agency has said.
That could be helpful advice for
people who actually contracted
the coronavirus. But people who
unknowingly receive a false pos-
itive on a test might be misled
into thinking that they are invin-
cible, said Saskia Popescu, an in-
fection prevention expert at
George Mason University.
However, if these people never
actually encountered the virus,
they would be just as vulnerable
as before — if not more, should
they choose to forgo masks or
physical distancing after assum-
ing their bodies are already bol-
stered against the virus.
Dr. Catherine O’Neal, an infec-
tious disease specialist at Louisi-
ana State University, expressed
similar concerns when discussing
a false-positive result given to the
University of Alabama football
coach Nick Saban this month.
Should someone be dropped from
routine testing, Dr. O’Neal said,
they would not just imperil their
own health. A false positive could
put an entire group of close con-
tacts at risk.

Undue Stress
With so many of the long-term
consequences of coronavirus in-
fections unknown, a positive re-
sult can understandably take an
emotional toll on the person who
receives it, Dr. Fitzhugh said.
“You hear that news and the first
thing you think is, ‘I could die,’ ”
she said.
On a recent call with Adm.
Brett Giroir, who has led the na-
tion’s testing efforts, Ruth Katz,
senior vice president of policy at
LeadingAge, an association of
nonprofit providers of aging serv-
ices, noted that the repercussions

of false positives had been a
source of extra heartache among
residents and staff members.
Dr. Mazer noted that false pos-
itives on coronavirus tests were
likely to evoke some of the same
stressful reactions as when other
types of clinical screens like
mammograms, which search for
signs of breast cancer, return in-
correct results. “We see the anxi-
ety, the frustration,” he said.

Loss of Trust in Testing
As testing in the United States
continues to increase, experts
have expressed concerns that fre-
quent and high-profile diagnostic
errors could seed disillusionment
among the general public.
Tests with a reputation for spit-
ting out incorrect results of any
kind might struggle to gain wide-
spread traction. People who are
wary of coronavirus tests might
even become more hesitant to
take other types of tests, for fear
that they will not be given the an-
swers they require.
More frequent and accessible
testing is needed — but putting it
in effect could be more challeng-
ing if the public is less willing to
engage, Dr. Mazer said. “That
could have long-term conse-
quences.”
These concerns and more have
prompted several experts to call
for more data evaluating how dif-
ferent types of tests perform out-
side of laboratories and clinics, in
places where most sick people go
to get a diagnosis. Some tests
may be able to effectively screen
the healthy and quash outbreaks
before they spin out control,
while others are ill-suited to for
this purpose. Depending on the
circumstances, certain tests
might need their results to be
confirmed with a second, more
accurate test.
As testing efforts ramp up na-
tionwide, experts said, people
taking tests will need to be well
versed not only in the benefits of
tests but in their limitations as
well.
No test is perfect, Dr. Fitzhugh
said. But tests, and the ways in
which they are deployed, must
still be vetted thoroughly before
they are rolled out in large num-
bers, she said. “People need to
know that the tests they receive
are the best we have to offer.”

DIAGNOSTICS


A False Positive Test Result Can Set Off a Cascade of Other Consequences


Testing for the coronavirus in San Francisco. It may seem harmless, but a false positive test result
can become a source of stress for the person diagnosed, or lead them to a false sense of immunity.

JIM WILSON/THE NEW YORK TIMES

By KATHERINE J. WU

Tracking an OutbreakScience and Research


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