https://www.nytimes.com/2020/08/29/health/coronavirus-testing.html?fbclid=IwAR2jjwfoZohotya_OIfpU3vjB86lL_uY6ZeVaZ9r1YH3dAT9WrXwKdcQVE8

Your Coronavirus Test Is Positive. Maybe It Shouldn’t Be.

The usual diagnostic tests may simply be too sensitive and too slow to
contain the spread of the virus.
[image: Tests authorized by the F.D.A. provide only a yes-no answer to
infection, and will identify as positive patients with low amounts of virus
in their bodies.]
Tests authorized by the F.D.A. provide only a yes-no answer to infection,
and will identify as positive patients with low amounts of virus in their
bodies.Credit...Johnny Milano for The New York Times

By Apoorva Mandavilli <https://www.nytimes.com/by/apoorva-mandavilli>

   - Aug. 29, 2020
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Some of the nation’s leading public health experts are raising a new
concern in the endless debate over coronavirus
<https://www.nytimes.com/2020/09/01/world/coronavirus-covid-19.html> testing
in the United States: The standard tests are diagnosing huge numbers of
people who may be carrying relatively insignificant amounts of the virus.

Most of these people are not likely to be contagious, and identifying them
may contribute to bottlenecks that prevent those who are contagious from
being found in time. But researchers say the solution is not to test less,
or to skip testing people without symptoms, as recently suggested by the
Centers for Disease Control and Prevention
<https://www.nytimes.com/2020/08/27/us/politics/trump-coronavirus-testing.html>
..

Instead, new data underscore the need for more widespread use of rapid tests
<https://www.nytimes.com/2020/08/06/health/rapid-Covid-tests.html>, even if
they are less sensitive.

“The decision not to test asymptomatic people is just really backward,”
said Dr. Michael Mina, an epidemiologist at the Harvard T.H. Chan School of
Public Health, referring to the C.D.C. recommendation.

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“In fact, we should be ramping up testing of all different people,” he
said, “but we have to do it through whole different mechanisms.”

In what may be a step in this direction, the Trump administration announced
on Thursday that it would purchase 150 million rapid tests.

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The most widely used diagnostic test for the new coronavirus, called a PCR
test, provides a simple yes-no answer to the question of whether a patient
is infected.

But similar PCR tests for other viruses do offer some sense of how
contagious an infected patient may be: The results may include a rough
estimate of the amount of virus in the patient’s body.

“We’ve been using one type of data for everything, and that is just plus or
minus — that’s all,” Dr. Mina said. “We’re using that for clinical
diagnostics, for public health, for policy decision-making.”
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But yes-no isn’t good enough, he added. It’s the amount of virus that
should dictate the infected patient’s next steps. “It’s really
irresponsible, I think, to forgo the recognition that this is a
quantitative issue,” Dr. Mina said.
The PCR test amplifies genetic matter from the virus in cycles; the fewer
cycles required, the greater the amount of virus, or viral load, in the
sample. The greater the viral load, the more likely the patient is to be
contagious.

This number of amplification cycles needed to find the virus, called the
cycle threshold, is never included in the results sent to doctors and
coronavirus patients, although it could tell them how infectious the
patients are.

In three sets of testing data that include cycle thresholds, compiled by
officials in Massachusetts, New York and Nevada, up to 90 percent of people
testing positive carried barely any virus, a review by The Times found.

On Thursday, the United States recorded 45,604 new coronavirus cases,
according to a database maintained by The Times. If the rates of
contagiousness in Massachusetts and New York were to apply nationwide, then
perhaps only 4,500 of those people may actually need to isolate and submit
to contact tracing.

One solution would be to adjust the cycle threshold used now to decide that
a patient is infected. Most tests set the limit at 40, a few at 37. This
means that you are positive for the coronavirus if the test process
required up to 40 cycles, or 37, to detect the virus.

Tests with thresholds so high may detect not just live virus but also
genetic fragments, leftovers from infection that pose no particular risk —
akin to finding a hair in a room long after a person has left, Dr. Mina
said.
Any test with a cycle threshold above 35 is too sensitive, agreed Juliet
Morrison, a virologist at the University of California, Riverside. “I’m
shocked that people would think that 40 could represent a positive,” she
said.
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A more reasonable cutoff would be 30 to 35, she added. Dr. Mina said he
would set the figure at 30, or even less. Those changes would mean the
amount of genetic material in a patient’s sample would have to be 100-fold
to 1,000-fold that of the current standard for the test to return a
positive result — at least, one worth acting on.
Image[image: “It’s just kind of mind-blowing to me that people are not
recording the C.T. values from all these tests, that they’re just returning
a positive or a negative,” one virologist said.]
“It’s just kind of mind-blowing to me that people are not recording the
C.T. values from all these tests, that they’re just returning a positive or
a negative,” one virologist said.Credit...Erin Schaff/The New York Times

The Food and Drug Administration said in an emailed statement that it does
not specify the cycle threshold ranges used to determine who is positive,
and that “commercial manufacturers
<https://www.fda.gov/media/135900/download> and laboratories
<https://www.fda.gov/media/135658/download> set their own.”

The Centers for Disease Control and Prevention said it is examining the use
of cycle threshold measures “for policy decisions.” The agency said it
would need to collaborate with the F.D.A. and with device manufacturers to
ensure the measures “can be used properly and with assurance that we know
what they mean.”

The C.D.C.’s own calculations suggest that it is extremely difficult to
detect any live virus in a sample above a threshold of 33 cycles
<https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html>.
Officials at some state labs said the C.D.C. had not asked them to note
threshold values or to share them with contact-tracing organizations.

For example, North Carolina’s state lab uses the Thermo Fisher coronavirus
test, which automatically classifies results based on a cutoff of 37
cycles. A spokeswoman for the lab said testers did not have access to the
precise numbers.

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This amounts to an enormous missed opportunity to learn more about the
disease, some experts said.

“It’s just kind of mind-blowing to me that people are not recording the
C.T. values from all these tests — that they’re just returning a positive
or a negative,” said Angela Rasmussen, a virologist at Columbia University
in New York.

“It would be useful information to know if somebody’s positive, whether
they have a high viral load or a low viral load,” she added.
The Coronavirus Outbreak ›
<https://www.nytimes.com/news-event/coronavirus?action=click&pgtype=Article&state=default&module=styln-coronavirus&region=MAIN_CONTENT_3&context=storylines_faq>Frequently
Asked Questions

Updated September 4, 2020

   - What are the symptoms of coronavirus?
      - In the beginning, the coronavirus seemed like it was primarily a
      respiratory illness
      
<https://www.nytimes.com/article/coronavirus-facts-history.html?action=click&pgtype=Article&state=default&module=styln-coronavirus&region=MAIN_CONTENT_3&context=storylines_faq#link-6817bab5>
—
      many patients had fever and chills, were weak and tired, and
coughed a lot,
      though some people don’t show many symptoms at all. Those who seemed
      sickest had pneumonia or acute respiratory distress syndrome and received
      supplemental oxygen. By now, doctors have identified many more
symptoms and
      syndromes. In April, the C.D.C. added to the list of early signs
      
<https://www.nytimes.com/2020/04/27/health/coronavirus-symptoms-cdc.html?action=click&pgtype=Article&state=default&module=styln-coronavirus&region=MAIN_CONTENT_3&context=storylines_faq>
sore
      throat, fever, chills and muscle aches. Gastrointestinal upset, such as
      diarrhea and nausea, has also been observed. Another telltale sign of
      infection may be a sudden, profound diminution of one’s sense of
      smell and taste.
      
<https://www.nytimes.com/2020/03/22/health/coronavirus-symptoms-smell-taste.html?action=click&pgtype=Article&state=default&module=styln-coronavirus&region=MAIN_CONTENT_3&context=storylines_faq>
Teenagers
      and young adults in some cases have developed painful red and purple
      lesions on their fingers and toes — nicknamed “Covid toe” — but few other
      serious symptoms.
   - Why is it safer to spend time together outside?
      - Outdoor gatherings
      
<https://www.nytimes.com/2020/05/15/us/coronavirus-what-to-do-outside..html?action=click&pgtype=Article&state=default&module=styln-coronavirus&region=MAIN_CONTENT_3&context=storylines_faq>
lower
      risk because wind disperses viral droplets, and sunlight can kill some of
      the virus. Open spaces prevent the virus from building up in concentrated
      amounts and being inhaled, which can happen when infected people
exhale in
      a confined space for long stretches of time, said Dr. Julian W. Tang, a
      virologist at the University of Leicester.
   - Why does standing six feet away from others help?
      - The coronavirus spreads primarily through droplets from your mouth
      and nose, especially when you cough or sneeze. The C.D.C., one of the
      organizations using that measure, bases its recommendation of six feet
      
<https://www.nytimes.com/2020/04/14/health/coronavirus-six-feet.html?action=click&pgtype=Article&state=default&module=styln-coronavirus&region=MAIN_CONTENT_3&context=storylines_faq>
on
      the idea that most large droplets that people expel when they cough or
      sneeze will fall to the ground within six feet. But six feet has
never been
      a magic number that guarantees complete protection. Sneezes, for
instance,
      can launch droplets a lot farther than six feet, according to a
      recent study
      <https://jamanetwork.com/journals/jama/fullarticle/2763852>. It's a
      rule of thumb: You should be safest standing six feet apart outside,
      especially when it's windy. But keep a mask on at all times,
even when you
      think you’re far enough apart.
   - I have antibodies. Am I now immune?
      - As of right now, that seems likely, for at least several months.
      
<https://www.nytimes.com/2020/07/22/health/covid-antibodies-herd-immunity.html?action=click&pgtype=Article&state=default&module=styln-coronavirus&region=MAIN_CONTENT_3&context=storylines_faq>
There
      have been frightening accounts of people suffering what seems to be a
      second bout of Covid-19. But experts say these patients may have a
      drawn-out course of infection, with the virus taking a slow toll weeks to
      months after initial exposure. People infected with the coronavirus
      typically produce
<https://www.nature.com/articles/s41586-020-2456-9> immune
      molecules called antibodies, which are protective proteins made in
      response to an infection
      
<https://www.nytimes.com/2020/05/07/health/coronavirus-antibody-prevalence.html?action=click&pgtype=Article&state=default&module=styln-coronavirus&region=MAIN_CONTENT_3&context=storylines_faq>.
      These antibodies may
      
<https://www.nytimes.com/2020/05/07/health/coronavirus-antibody-prevalence.html?action=click&pgtype=Article&state=default&module=styln-coronavirus&region=MAIN_CONTENT_3&context=storylines_faq>
last
      in the body only two to three months
      <https://www.nature.com/articles/s41591-020-0965-6>, which may seem
      worrisome, but that’s perfectly normal after an acute infection subsides,
      said Dr. Michael Mina, an immunologist at Harvard University. It may be
      possible to get the coronavirus again, but it’s highly unlikely that it
      would be possible in a short window of time from initial
infection or make
      people sicker the second time.
   - What are my rights if I am worried about going back to work?
      - Employers have to provide a safe workplace
      <https://www.osha.gov/SLTC/covid-19/standards.html> with policies
      that protect everyone equally. And if one of your co-workers tests
      positive for the coronavirus, the C.D.C.
      
<https://www.nytimes.com/article/coronavirus-money-unemployment.html?action=click&pgtype=Article&state=default&module=styln-coronavirus&region=MAIN_CONTENT_3&context=storylines_faq>
has
      said that employers should tell their employees
      
<https://www.cdc.gov/coronavirus/2019-ncov/community/guidance-business-response.html>
--
      without giving you the sick employee’s name -- that they may have been
      exposed to the virus.

Was this helpful?

Officials at the Wadsworth Center, New York’s state lab, have access to
C.T. values from tests they have processed, and analyzed their numbers at
The Times’s request. In July, the lab identified 794 positive tests, based
on a threshold of 40 cycles.

With a cutoff of 35, about half of those tests would no longer qualify as
positive. About 70 percent would no longer be judged positive if the cycles
were limited to 30.

In Massachusetts, from 85 to 90 percent of people who tested positive in
July with a cycle threshold of 40 would have been deemed negative if the
threshold were 30 cycles, Dr. Mina said. “I would say that none of those
people should be contact-traced, not one,” he said.

Other experts informed of these numbers were stunned.

“I’m really shocked that it could be that high — the proportion of people
with high C.T. value results,” said Dr. Ashish Jha, director of the Harvard
Global Health Institute. “Boy, does it really change the way we need to be
thinking about testing.”

Dr. Jha said he had thought of the PCR test as a problem because it cannot
scale to the volume, frequency or speed of tests needed. “But what I am
realizing is that a really substantial part of the problem is that we’re
not even testing the people who we need to be testing,” he said.

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The number of people with positive results who aren’t infectious is
particularly concerning, said Scott Becker, executive director of the
Association of Public Health Laboratories. “That worries me a lot, just
because it’s so high,” he said, adding that the organization intended to
meet with Dr. Mina to discuss the issue.

The F.D.A. noted that people may have a low viral load when they are newly
infected. A test with less sensitivity would miss these infections.

But that problem is easily solved, Dr. Mina said: “Test them again, six
hours later or 15 hours later or whatever,” he said. A rapid test would
find these patients quickly, even if it were less sensitive, because their
viral loads would quickly rise.

PCR tests still have a role, he and other experts said. For example, their
sensitivity is an asset when identifying newly infected people to enroll in
clinical trials of drugs.

But with 20 percent or more of people testing positive for the virus in
some parts of the country, Dr. Mina and other researchers are questioning
the use of PCR tests as a frontline diagnostic tool.

People infected with the virus are most infectious from a day or two before
symptoms appear till about five days after. But at the current testing
rates, “you’re not going to be doing it frequently enough to have any
chance of really capturing somebody in that window,” Dr. Mina added..

Highly sensitive PCR tests seemed like the best option for tracking the
coronavirus at the start of the pandemic. But for the outbreaks raging now,
he said, what’s needed are coronavirus tests that are fast, cheap and
abundant enough to frequently test everyone who needs it — even if the
tests are less sensitive.

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“It might not catch every last one of the transmitting people, but it sure
will catch the most transmissible people, including the superspreaders,”
Dr. Mina said. “That alone would drive epidemics practically to zero.”

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-- 
*Brianna Ho Delott, MBA, BBA-PSYC*
*Certified Spiritual Counselor*


*Attachment, Relational & Developmental Trauma-Informed641-233-7688
(cell/text)*
*www.BriannaHoDelott.com <http://www.briannahodelott.com/>*

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