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Blood tests not yet reliable, public health laboratories warn

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A Los Angeles County test looks for essential information about people’s ability to develop immunity that helps them fight future infections.

USA TODAY

Companies are lining up to market a new type of blood test to detect if someone has ever had the new coronavirus. These antibody tests could be essential to the reopening of the United States, informing public health and state officials on how and when Americans can resume their daily activities.

Some laboratory experts warn that the relaxed rules of the Food and Drug Administration allow unproven and potentially unreliable tests on the market. Companies that market 90 antibody tests have notified the federal agency of its intention to offer tests to assess whether someone has ever been infected with SARS-CoV-2, the virus responsible for COVID-19.

The FDA will review the antibody tests in light of the accuracy concerns raised by the Association of Public Health Laboratories, but the tests remain on the market.

APHL officials have recognized that accurate and reliable antibody tests are an important tool in responding to the country’s pandemic, but the wave of unproven tests sold in doctors’ offices or elsewhere could do more harm. only good.

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“We now have at least 90 tests on the market, and we don’t know the accuracy of the results,” said Kelly Wroblewski, director of infectious disease programs at the APHL. “Having many inaccurate tests is worse than not having any at all.”

Blood tests measure the antibodies that are part of the immune system’s response to fight infection. The test differs frommolecular versions administered with a nasal swab to diagnose a person infected with the virus.

Because these blood tests measure antibodies, even in people who have little or no symptoms and are not looking for treatment, the scientists said they would more accurately reflect the number of people infected. Tests could reveal if someone develops immunity that protects against infection.

Marc Lipsitch, professor of epidemiology at Harvard T.H. Chan School of Public Health, said the data from these serological tests, as they are called, are absolutely necessary.

Medical staff gather as antibody tests begin in Los Angeles County. (Photo: Kit Karzen, Los Angeles County Department of Health and USC Sol Price School of Public Policy)

“What we really, really need are serological studies to determine what proportion of the population has (immunity),” said Lipsitch. “And then there is another question of how protective this immune response is. “

A better scenario would produce studies based on specific tests that inform public health and elected officials when to loosen state home orders. A test that reveals that a nurse recovered from COVID-19, for example, could allow this person to work floors filled with patients with coronavirus and are not afraid of being infected. Or, random tests could tell superintendents when to reopen schools or workers in food processing plants when to return to work.

Unreliable tests could fuel a second wave of infections if federal and state leaders reopen the economy too soon or base their decisions on inaccurate data.

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The FDA’s relaxed policy aims to accelerate access by allowing private companies to market serological tests after companies have determined that the products are accurate and reliable. Companies or laboratories cannot claim that the FDA has authorized the tests and should include disclaimers such that the tests could falsely conclude if a person has ever had an infection.

“This policy has given labs and other healthcare professionals quick access to these tests to perform their own validation and determine if they are warranted for use by this lab or healthcare facility,” the FDA said in a statement. .

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Test developers have the option to pursue a more rigorous review through the agency’s emergency clearance. Only one company, Cellex, had emergency clearance from the FDA to market a serological test for SARS-CoV-2 until Tuesday, when the FDA authorized two additional tests.

APHL representatives met with FDA Commissioner Stephen Hahn twice in the past two weeks and warned of a flow of antibody tests “which was frankly of questionable quality,” said Scott Becker, CEO of APLL.

The FDA has agreed to assess serological tests and has promised to strengthen the enforcement of companies fraudulently marketing the tests, said Becker.

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FDA officials confirmed in a statement that the agency would join the Centers for Disease Control and Prevention, the National Institutes of Health and the Biomedical Advanced Research and Development Authority to “quickly assess the performance characteristics of these tests.”

The FDA cited the need to balance the “value of serological tests in reopening the economy” while ensuring that healthcare providers have access to accurate tests.

APHL wants serology tests to be verified through more rigorous FDA emergency clearance review, which requires labs to show validated data before getting approved, Becker said .

Eric Blank, director of the APHL program, said public health labs were working to develop reliable tests. A rush to allow commercial tests on the market could confuse the scientific community with tests that produce poor results.

“If you have bad data, you can’t make good decisions,” said Blank.

Reliable antibody tests could “reduce anxiety” in healthcare workers

There are large-scale pilot programs using serological testing at the CDC and NIH, as well as efforts in Los Angeles County and New York. These studies could provide crucial information about the number of people infected, the severity of the virus and whether people can develop immunity to fight infections.

The NIH study will collect blood samples from 10,000 volunteers who have no known history of SARS-CoV-2 infection and test for antibodies. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the results “will help us measure the impact of our public health efforts now and guide our COVID-19 response in the future. “

More than 200,000 Americans have asked about volunteering for the NIH study, which could extend beyond the figure of 10,000, according to study investigators.

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The study will seek to answer a key question about the accuracy of serological testing. Simple antibody tests targeting COVID-19 could cross-react with other pathogens, such as the coronavirus that causes colds. This will create “false positives” that are inaccurate.

Large government and university laboratories can monitor this problem and retest the samples to ensure accurate testing, said Kaitlyn Sadtler, section chief at the National Institute for Biomedical Imaging and Bioengineering.

Anthony Harris, professor and epidemiologist at the University of Maryland School of Medicine medical center, said accurate serological tests could reveal whether healthcare workers have developed immunity. This would lighten the country’s health care system, he said.

Immunized workers would be assigned to hospital units treating COVID-19 patients. Unimmunized workers would take care of uninfected patients, said Harris.

“It would significantly reduce the anxiety of my healthcare workers,” said Harris.

Los Angeles County Finds “Global” Coronavirus Infection Rate

The County of Los Angeles launched the first phase of its pilot project with samples taken from 1,000 people from April 10 to 11. The test, produced by Minnesota-based Premier Biotech, is designed to produce results in 10 minutes from a few drops of blood taken from a stick.

Donors, selected from a market research company’s database, were selected as a statistical sample reflecting age, race, geographic distribution and other county markers.

(Photo: Getty Images)

A second test of an additional 1,000 people is planned in two to three weeks. The researchers hope to continue testing if they can get additional funding.

One of the goals of the tests is to determine “how many people in the community have (have had or have been exposed to),” said the coronavirus, Dr. Neeraj Sood, vice-dean for research at the University of Southern California Sol Price School of Public Policy.

“It is important because before, we only tested the sick. So we don’t know what the overall infection rate is for the county, “said Sood.

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Tracking infections over time will allow researchers to determine whether California’s home stay policy has helped limit the spread of the disease, said Sood.

Tests may help researchers determine whether those who survived exposure to the coronavirus obtained immunity, as well as the strength and duration of that immunity, said Dr. Paul Simon, Scientific Director at the Los Angeles County Department of Health.

He acknowledged that he and other researchers were concerned about the potential for false negative and false positive test results. Simon said Sood approved Premier Biotech before choosing the company. The researchers performed preliminary checks that produced accurate results before the blood was drawn.

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“We will adjust our result to account for it (potential false negatives or positives),” said Sood.

Simon said a small percentage of false negatives or positives would not have a major impact on the results at the county level. However, he acknowledged that false reports “could have catastrophic results” for a person who had been tested.

“If we find that the infection rate is very low, and it is not increasing at all, it would suggest that our efforts (staying at home) are working,” said Simon. “But we can’t close everything forever. “

Reopening the county’s economy to certain normal operations may increase the number of COVID-19 cases and hospitalizations, said Simon.

“Some have called it a kind of dance, as you try to strike a balance. Maybe you open things up a little bit, maybe you go back a little bit, ”he said. “The change is that if we open everything, our healthcare system would be overwhelmed like in New York. But we recognize that we cannot close everything completely. We recognize that people really suffer. ”

New York Governor Andrew Cuomo: “We have to be smart” about the reopening

New York government Andrew Cuomo predicts testing will be a key part of the state’s strategy to restart civic life.

“The answer is that we want to reopen as soon as possible … end this nightmare,” Cuomo said at a press conference on Easter Sunday. “The caveat is that we have to be smart in how we reopen. We need a safe public health strategy that is consistent with an economic strategy. ”

To this end, Cuomo said that the reopening of schools, businesses and public transportation should be coordinated in a plan that covers not only New York City and the rest of the state, but also New Jersey and the Connecticut.

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The plan will require antibody testing, “more testing, faster testing than we have now, and we’re going to need federal help,” said Cuomo.

He announced plans to sign a decree to allow labs to test if New Yorkers also have COVID-19 for antibody testing.

The state has provided laboratories with the flexibility to allow more workers to test for COVID-19; the executive decree extends this authority, so that the same workers can perform antibody tests, the Cuomo office said in a written statement.

Testing can be difficult. San Miguel County, Colorado has suspended a program to test almost everyone in the community, which includes the Telluride ski resort.

County analysis partner United Biomedical took blood samples from 5,500 people last month, but provided fewer than 2,000 results on Tuesday. A dozen people have tested positive for past infections, said Susan Lilly, county news chief.

The company has told the county that its New York testing laboratory has been “very badly hit by COVID,” which slows down processing of the tests, said Lilly. The county’s highest health official wants to assess the test data, including its accuracy, as well as the results. United Biomedical did not return messages from the US TODAY.

“Certainly, with any test, we will be looking for that data (on test accuracy),” said Lilly.

The importance of accurate antibody testing in a region trying to recover from an epidemic is illustrated by the Ebola epidemic in 2014-2016 in West Africa, said Christopher Kirchhoff.

The former head of the National Security Council wrote the after action report on the US response to the Ebola crisis. In Guinea, Sierra Leone and Liberia, people tested positive for Ebola antibodies have been placed in healthcare and other jobs.

“It was doubly useful because they were able to hold essential jobs,” said Kirchhoff. “It was also a great source of income for those who supported their families. In some cases, they worked side by side with the doctors and nurses who saved their lives. “

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