The Wall Street Journal - 03.04.2020

THE WALL STREET JOURNAL. Friday, April 3, 2020 |A

THE CORONAVIRUS PANDEMIC

tients return to the emergency

department where he works

with worsened symptoms, in-

cluding fevers and coughs. Af-

ter being admitted to a hospi-

tal, they tested positive.

“You kind of figure, yeah,

that’s a false negative,” Dr.

Brokish said.

Linda Girgis, a New Jersey

primary-care doctor, saw the

same pattern with a test run

for a health-care worker by

Quest Diagnostics Inc., a find-

ing that made her fear that

front-line workers might re-

port for duty thinking they

weren’t contagious.

“Our materials for providers,

including our test reports, make

clear that while these tests are

designed to minimize false neg-

atives and false positives, such

results can occur,” said Wendy

Bost, a Quest spokeswoman.

A Labcorp spokesman said

that while a positive result is a

definitive sign of coronavirus

infection, “a negative result

does not definitively rule out

infection.” He said test accu-

racy can be affected by how a

specimen is collected, and how

long an individual has been in-

fected before testing.

In New York City, “a nega-

tive is not clearing anybody

who is symptomatic,” said

Dara Kass, an emergency-room

doctor at NewYork-Presbyte-

rian, a hospital system. Dr.

Kass said all patients with

symptoms are being treated as

coronavirus-positive.

A continuing scarcity of

testing materials is probably

obscuring the true rate of in-

correct results, doctors say.

Few say they are willing to

waste specimen-collection kits

double-checking a patient who

already tested negative.

They say incorrect results

could be caused by differences

in how samples are collected

and transported, as well as un-

derlying problems with testing

platforms.

Swabs taken from the front

of patients’ noses, for in-

stance, tend to have fewer

copies of the virus mixed into

the mucus than those taken

from the nasopharynx, the in-

tersection of the nasal cavity

and throat.

Last week, a 16-month-old
boy in Florida tested positive
for the new coronavirus, a lab
report shows. A few days later,
he tested negative at a second
lab.
The chief medical officer at
the practice where the tests
were ordered is betting that the
positive result is the right one.
“A false negative is prob-
lematic because it tells the pa-
tient they don’t have the vi-
rus,” said the doctor, Craig
Deligdish, an oncologist at
Omni Healthcare, a Melbourne,
Fla., medical group. Mean-
while, that patient can unwit-
tingly spread it, he said.
Health experts say they
now believe nearly one in
three patients who are in-
fected are nevertheless getting
a negative test result. They
caution that only limited data
is available, and their esti-
mates are based on their own
experience in the absence of
hard science.
That picture is troubling,
many doctors say, as it casts
doubt on the reliability of a
wave of new tests developed
by manufacturers, lab compa-
nies and the U.S. Centers for
Disease Control and Preven-
tion. Most of these are operat-
ing with minimal regulatory
oversight and little time to do
robust studies amid a desper-
ate call for wider testing.
“The whole testing field is
in flux,” said Bill Miller, a phy-
sician and epidemiologist at
the Ohio State University. “The
thing that is different this time
is most of these tests are go-
ing through a really rapid vali-
dation process. As a result we
can’t be completely confident
in how they will perform.”

BYCHRISTOPHERWEAVER

Michele Hickle, of Lubbock, Texas, initially tested negative for coronavirus, but a later test was positive.

SEAN ALEXANDER

The unknown rates of false-

negative results could leave

patients with unjustified confi-

dence that they can return to

business as usual and could

show that the nation’s view

into the spread of the disease

has a blind spot, Dr. Miller

said.

All lab tests have some

margin of error, measured in

terms of sensitivity—the per-

cent of positive cases a test

accurately detects—and speci-

ficity, the percent of negative

cases it accurately detects.

The sensitivity of the cur-

rently available coronavirus

tests seems to be lower than

other similar tests, said Mike

Lozano, a Tampa, Fla.-based

executive at Envision Health-

care Corp., a medical group

that contracts to provide care

at hospitals. Dr. Lozano said

he estimates that the sensitiv-

ity of the tests is in the neigh-

borhood of 70%, meaning

nearly one in three positive

patients walks away with a re-

assuring negative result.

Chris Smalley, a primary-

care doctor at Louisville, Ky.,-

based Norton Healthcare, said

the 70% estimate was gaining

traction with doctors finding

out how well the tests work in

the real world, absent better

data. He said several of his pa-

tients with negative tests went

on to develop highly suspicious

coronavirus symptoms and re-

quire long hospital stays.

Dr. Smalley said a negative

result is more likely to be ac-

curate in places like Louisville

where the prevalence is low,

but could be virtually useless

in New York, where it is high.

A February study of about

1,000 patients in Wuhan,

China, who were hospitalized

with suspected coronavirus

there, where the pandemic be-

gan, found that about 60%

tested positive using lab tests

similar to those available in

the U.S. But, almost 90%

showed telltale signs of the vi-

rus in CT scans of their chests,

the article, published in the

journal Radiology, found, sug-

gesting many patients in the

group were testing negative

despite active coronavirus in-

fections.

The technology that under-

pins the new coronavirus tests

so far available, a genetic

method called polymerase

chain reaction, typically de-

tects over 90% of positive

cases accurately, said Tom

Taylor, a professor and former

CDC statistician. In less dire

circumstances, he said, the

CDC would typically do a study

to verify the accuracy of such

tests, which might take a year.

The U.S. Food and Drug Ad-

ministration initially required

testing companies to submit

applications for new tests, a

move the agency said was re-

quired by law. Critics said that

deterred private companies

from moving quickly to de-

velop badly needed tests.

As demand surged in late

February, the agency relaxed the

requirements, saying labs could

start testing without approval

and submit their internal stud-

ies later. Published details of

those studies are often limited.

In a statement Monday, the

FDA said it is balancing the

need for more testing with its

prerogative to ensure tests are

accurate. Right now, the FDA’s

priority remains getting more

tests into the field, an agency

spokeswoman said.

A Dallas-area emergency-

room doctor, Peter Brokish,

said several lab results he had

sent to Laboratory Corp. of

America Holdings came back

negative, only to have the pa-

Questions of Test

Accuracy Sow Worry

Experts believe nearly

one in three infected

patients are getting

negative test results

Patients with false

negatives can

unwittingly spread

the coronavirus.

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