The present White House loosened up regulatory guidance to make it easier for companies to flood the market with subpar COVID-19 tests, reports the CEO of the Association of Public Health Laboratories. Scott Becker reports, “It’s like the wild, wild, West out there—or wild East,” a reference to the fact that many of the testing products are produced in China.  As the ability to undertake antibody tests for COVID-19 becomes ever more important, some have growing concern about the quality of testing products coming on the market.

TrialSite News offers a breakdown of this situation involving allegations that many shoddy antibody tests are in fact flooding the market.

What is the Association of Public Health Laboratories?

The Association of Public Health Laboratories are an association that represents 125 state, county, and municipal public health labs in the United States.

What is association’s interest with COVID-19 antibody testing?

The association’s labs, along with private ones, reports CNN’s Elizabeth Cohen, seek to test people to determine if they have developed the antibodies to SARS-CoV-2. If affirmative, then that indicates that they have recovered from the novel coronavirus and their body has developed some form of immunity to the virus.

Why is this so important?

Well for strategies to “turn on” society, for example, in waves will require governments, employers, and the like to determine if individuals have already recovered, have developed the antibody, and hence can go back to work for example.

What is the Association of Public Health Laboratories issue with current tests on the market?

CEO Scott Becker reports that most of the labs that are members won’t use the tests on the market because they are concerned about bad results. For example, what if people get an incorrect result and mistakenly believe that they are immune to the novel coronavirus and return to work while not practicing social distancing? Well Becker suggests, according to Ms. Cohen’s article, “It could be quite dangerous.”

Has CEO Becker shared his concerns with government officials? Regulators?

Yes , Mr. Becker met with Dr. Brett Giroir, assistant secretary at the U.S. Department of Health and Human Services, and Dr. Stephen Hahn, commissioner of the U.S. Food and Drug Administration.

What did the top government executives have to say about this allegation?

According to Becker, they were attentive and were “very gracious.” However, their office spokespersons haven’t responded.

What is Becker’s key point?

Becker wrote recently in a follow-up email to the government officials: “The public needs to understand that all tests are not created equal and that these tests could create dangerous scenarios by giving people a false sense of security.”

Why is this even a possibility of happening?

Well according to one hypothesis, it could be because the FDA recently relaxed test rules last month. Due to the pandemic, the FDA changed its regulations to streamline the process for companies to market COVID-19 antibody tests.

Where did this mandate come from?

Probably from President Trump. He has talked about relaxing regulations. For example, on March 4 he stated during a briefing: “The Obama administration made a decision on testing that turned out to be very detrimental to what we’re doing. And we undid that decision a few days ago so that the testing can take place in a much more accurate and rapid fashion.”

No need to have the FDA directly validate the quality of the test—Could this be true?

Yes. According to CNN’s interpretation, companies that seek to market antibody tests can seek FDA approval if they desire to do so. However, they don’t have to. Thus far, as of last Sunday, April 5, 2020, only one company called Cellex, Inc. received FDA approval for their test, according to Ms. Cohen.

The Trends: A lot of Unregulated Product on the Market

According to a CNN review, the FDA reports at least 54 companies are able to peddle their wares just by letting the FDA know that they intend to market the test and that it has been validated. But they don’t have to go through a formal validation or inspection where the test’s maker must prove that the product works as intended. Consequently, Becker and other critics allege that these companies are marketing test products that have been reviewed or recommended by FDA and this isn’t true.

Independent Efforts to Verify the COVID-19 Antibody Tests

According to Becker, some members’ labs have sought to verify for themselves that the tests actually perform as intended. Several of the companies were asked if they could share the validation data. Some companies refused to share such information while others, according to the CNN report, revealed poor accuracy rates.

Local Health Officers are Stepping in: The Orange County, CA Example

So some health officers aren’t standing for this and speaking up. For example, the health lead for Orange County, California, has warned against using tests that have not been approved by the FDA. Dr. Nicole Quick reported in a March 26 statement, “These nonapproved tests can produce false results and lead to untended negative consequences for the individual and the broader community.” She continued, “For example, a negative result from a nonapproved testing kit may lead an individual who in fact has COVID-19 to think they are healthy and not capable of spreading the virus.”

What is the FDA’s comment thus far?

Stephanie Caccomo, a spokeswoman, suggested the news agency review an agency statement that mentions policy changes “in order to achieve more rapid testing capacity in the U.S.”

Has the CDC created an antibody test?

Not yet, but they are working on one. However, it is not quite ready as of yet.

Conclusion

In the world of healthcare products and services, quality is of the utmost concern. Hence why the FDA was created many years ago—to ensure that all kinds of peddlers and hucksters wouldn’t take advantage of the American public. Now of course we are in a totally different age and in the midst of a pandemic, it surely may make sense to streamline antibody test product development. But it doesn’t have to be an either/or situation; that is called a false dilemma. What do we mean? Well, the agency can streamline regulatory requirements but still require a stringent validation process. After all, this is how the FDA can assure that the product does what it is supposed to do and hence is made with quality. If this position by CNN is nearly 100% accurate, it represents a real problem. On the other hand, Trump was correct to work with the FDA to shake things up and make it easy to drive product development through the regulatory system. They should just ensure that a sufficient quality enforcement stage gate is in place to ensure a higher probability of quality—the stakes are too high with this deadly virus.

Source: CNN

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