FDA Replaces March 16 Serology COVID-19 Rules

Before issuing new guidance on May 4, the FDA okayed more than 200 tests, some were fraudulent

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CEO SUMMARY: In the rush to allow companies and clinical laboratories to develop, validate, and bring to market serological tests for COVID-19, the federal Food and Drug Administration issued rules on March 16 that eased its requirements for these new assays. Because of the lack of oversight under the March 16 rules, the market was flooded with tests, including some that were unproven and some that were fraudulent. On May 4, the agency reversed course and issued more rigorous requirements.

ON MARCH 16, THE FEDERAL FOOD AND DRUG ADMINISTRATION (FDA) issued rules allowing lab test manufacturers to market COVID-19 serological tests with little or no agency review.

Yet, on May 4, just seven weeks later, the FDA issued another set of rules that essentially replaced the earlier rules with more rigorous requirements that test developers must meet to register their COVID-19 antibody assays and obtain emergency use authorizations (EUAs).

When it issued its March 16 policy, the agency said it was granting “regulatory flexibility for developers offering such tests without FDA review and without an EUA.” Test manufacturers only needed to notify the agency that they had validated their serological tests and provide disclaimers about the limitations of the tests.

“The FDA does not review the validation or accuracy of the data for these tests unless an EUA is submitted,” the agency stated at that time.

Without any meaningful oversight, the FDA was flooded with notifications from test manufacturers ready to offer serology COVID-19 tests to labs and providers. At one point in early May, the FDA had listed more than 200 COVID-19 serology tests submitted under the March 16 rules. However only about a dozen of these tests obtained an EUA, according to published reports.

The rules issued on March 16 caused a cascade of problems, including the introduction of faulty and fraudulent tests that were not approved or authorized, but rather were introduced without review.

Following the FDA’s easing of rules requiring agency review for COVID-19 serology tests on March 16, criticism came from clinical pathologists, lab administrators, and others who said the rules would allow substandard serology tests to flood the market. That flood of unproven tests established “a wild west show” in the market, said Eric Blank, DrPH, Senior Director of Public Health Systems and Programs for the Association of Public Health Laboratories. “It really has created a mess that’s going to take a while to clean up,” he told the Associated Press.

Confidence in Test Accuracy

Regardless of whether tests undergo FDA review, clinical laboratories are responsible for validating the performance of all tests they provide. However, because the FDA was allowing these serology tests into the market without appropriate regulatory review, laboratories lacked the data to give them confidence the COVID-19 serology tests they were buying would produce accurate, reliable, and reproducible results. Would lack of FDA review, and the data it publishes after it reviews a test, affect how these laboratories evaluate and select COVID-19 serological tests?

At all levels in the healthcare system,the goal in early March was to encourage new COVID-19 antibody tests to quickly become available in the market. The FDA was under pressure from the administration, members of Congress, and the public to speed up the process of getting diagnostic tests for COVID-19 developed and into clinical use.

Pressure to Acquire, Validate

But any rush to push new diagnostic tests into clinical use has significant implications for clinical laboratories. These labs were under equally intense pressure to acquire, validate, and offer large numbers of COVID-19 serology tests to physicians and patients as soon as possible.

Facing an obvious and pressing need, FDA officials thought the most important goal was to get more tests onto the market quickly, according to published reports. At the time, clinical laboratories were introducing the reverse transcription- polymerase chain reaction (RT-PCR) test—considered to be among the most accurate ways to detect the SARS-CoV-2 that causes the COVID-19 illness. But those tests were coming to market slowly after the federal Centers for Disease Control and Prevention botched the introduction of the first RT-PCR test that it offered to labs.

Then, the FDA required manufacturers and clinical labs seeking to run these RT-PCR COVID-19 tests to submit requests for EUAs before they could run these tests. While the agency okayed many of these requests, review came slowly, often taking a few days but sometimes stretching out for several weeks.

Meanwhile, government scientists—including members of President Trump’s Coronavirus Task Force—stressed that the nation needed serology tests designed to identify antibodies for the virus. They urged labs to validate COVID-19 serology tests quickly so they could perform these tests in volume.

Recipe for Failure

But as with so many processes in clinical lab testing, moving quickly and eliminating rigorous review of new COVID-19 serology tests is a recipe for failure, clinical lab experts told The Dark Report. (See, “Expert Offers Comments on FDA and Revised Serology Test Rules.”)

Following weeks of criticism, the agency changed course, issuing new guidelines on May 4. When it announced the new rules, the FDA said the regulations it issued in March led to criticism and the need for more rigorous standards on commercial test companies, as well as the need to crack down on fraudulent test manufacturers.

In commenting on the May 4 rules, the FDA said all serological test manufacturers would need to apply for an EUA, and all tests would need to have at least a 90% level of sensitivity to detect coronavirus antibodies and have a sensitivity level of 95% to avoid false positive results.

Also, on May 4, the agency assured the public that it would act against companies that do not follow the new rules. “We have and will continue to take appropriate action against firms unlawfully marketing their tests,” the agency wrote. It would do so, for example, by detaining illegitimate test kits at the border and refusing to let them into the country.

Faulty Serological Tests

In addition, the FDA said it is educating states and healthcare systems about the need to be vigilant about faulty tests. “If particular commercial manufacturers that are currently marketing tests under our March 16 policy fail to submit an EUA within 10 business days, we intend to share this information publicly,” the agency said. “We will keep up our work to stop illicit tests from entering the U.S.,and we encourage states, hospitals, and consumers to be on high alert and to make informed purchasing decisions regarding these tests.”

Under new guidance the FDA issued on May 4, the agency required all developers of serological tests for the novel coronavirus to submit requests for EUAs. Also, the agency said test developers needed to submit validation data within 10 business days from the date they notified the FDA of their validation testing or by May 14, whichever is later. The agency also set performance standards for specificity and sensitivity for all serology test developers.

In addition, the FDA said, each high-complexity lab developing a laboratory-developed test (LDT) to identify antibodies for the coronavirus must have a valid CLIA certificate from the federal Centers for Medicare and Medicaid Services to develop these serology tests.

These labs also will need to notify the FDA about the results of their validation studies and meet other labeling recommendations that the agency issued in its March 16 policy. “Developers of LDTs are still encouraged to seek authorization through an EUA,” the agency concluded.

FDA Explains Why It Issued New Test Rules

IN A STATEMENT THE FEDERAL FOOD AND DRUG ADMINISTRATION published on its website on Monday, May 4, the agency explained the reasons it needed to change the regulatory review process for serological tests for the novel coronavirus.

“In mid-March, it was critical for the FDA to provide regulatory flexibility for [COVID-19] serology test developers, given the nature of this public health emergency and an understanding that the tests were not to be used as the sole basis for COVID-19 diagnosis, a fact that remains true today,” the FDA said in a statement, titled, “Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy.”

“However, flexibility never meant we would allow fraud,” the agency added. “We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety.

“Some test developers have falsely claimed their [COVID-19] serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance,” the FDA said.

“Also, since that time, the FDA has become aware that a concerning number of commercial serology tests are being promoted inappropriately, including for diagnostic use, or are performing poorly based on an independent evaluation by the NIH,” said the agency.

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