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FDA: Mistakes made in the US by releasing unreliable antibody tests

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What went wrong and what steps the FDA “took”?

Two executives of the US Food and Drug Administration (FDA), Jeffrey Shuren and Timothy Stenzel, recently published in the journal New England Journal of Medicine article titledThe FDA’s Experience with Covid-19 Antibody Tests“. Analyzing their experience of the policy implemented by the FDA of approving antibodies to the new coronavirus, the two directors admit that it has had many problems and imperfections, but it will be an important “lesson” for better management of future pandemics.

Revyuh team summarizes the main points of the article.

In February 2020, following the outbreak of the pandemic, the FDA began approving diagnostic tests for SARS-CoV-2 infection.  The already known emergency use authorization (EUA) procedure for medical products has significantly accelerated the access of medical staff to the new coronavirus tests. However, the FDA did not initially take into account two parameters, (1) during earlier pandemics, antibody tests had not been developed or were of limited use, and (2) many people infected with the new coronavirus were asymptomatic.

The antibody tests detect the body’s immune response to an earlier infection, but can not determine whether a person is currently infected with the virus. In addition, it was not known for SARS-CoV-2 whether the presence of antibodies and at what level protected the individual from re-infection and how long this immunity lasted.

Due to pressure from the rapid spread of cases, the FDA on March 16, 2020, allowed companies to market their tests without EUA, as long as they showed good results from the control trial, they had done in their own laboratories. These tests were required to indicate that they had not received a EUA and that their results could not rule out coronavirus infection. For safety, the FDA restricted the use of antibody tests only by certified laboratories with experienced staff. By the end of March 2020, 37 commercial companies had notified the FDA of the sale of antibody tests in the United States.

But the first EUA approvals began in April, under pressure from US government officials to open up the economy. Thus began the widespread use of antibody tests, bypassing the restrictions set by the FDA. As a result, the market was flooded with antibody tests, several of which were unreliable, and had low accuracy and sensitivity. 

By the end of April, 164 trading companies informed the FDA that they were marketing antibody tests, some falsifying their results. On May 4, the FDA changed its policy, and in collaboration with the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the National Cancer Institute (NCI), began testing antibodies more systematically, testing their reliability in a series of positive and negative COVID-19 samples available at the Institutes. 

This effort marked, for the first time, the direct involvement of government agencies in the evaluation of the tests and the subsequent notification of the FDA for the grant of the EUA. The NIH even took advantage of its collaboration with many academic centers that participated in test evaluations as part of an initiative called RADx (Rapid Acceleration of Diagnostics).

The above facts helped the FDA to “learn” how to handle such emergencies. Both executives emphasize that:

Experience with SARS-CoV-2 antibody tests that have literally shut down the market has shown that unauthorized testing will not be allowed in the future. The FDA policy announced late on March 16, 2020, unfortunately, allowed this to happen in the case of the current pandemic.

Governments should coordinate the preparation of a research plan for the rapid epidemiological assessment of an emergency at the onset of a pandemic (eg dispersal, population immunity) as part of the state preparedness plan. The coordinated effort of many states can ensure that large-scale studies are conducted in a timely manner and individual objectives are shared so that they are not duplicated.

The way of independent and reliable testing should be defined and formally established before a pandemic is declared or very quickly with its occurrence. For example, the FDA’s successful collaboration with the NIH.

The rapid and objective assessment of the accuracy of molecular diagnostic tests, antigen tests, and antibody tests by national bodies minimizes the need for companies to find patient samples or other clinical samples to validate their tests and accelerate the availability of validated tests on the market. In fact, it is proposed that the NIH RADx initiative should continue and extend beyond COVID-19.

The scientific and medical community should understand from the outset the clinical use of antibody tests and how they will use the results to better care for patients. Continuing scientific and medical education is paramount in any public health emergency, given the misuse of antibody tests for diagnosis, the possibility of false-positive results when a single test is used in populations with low infection rates and the achievement of adequate immunity. The correct use of tests must always be based on valid scientific data.

In order to deal with a public health emergency, the correct and appropriate information must be provided more quickly. As doctors quickly tried to figure out how best to treat covid-19 patients, so the FDA had to adapt with little available and constantly changing information, especially in the early days of the pandemic.

The creation of coordinated national and international mechanisms for the collection, sharing, and dissemination of information is also critical to ending the current pandemic but and to address future public health emergencies.

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