FDA giving White House new guidance on rapid COVID-19 test

WASHINGTON —
President Donald Trump expressed no concerns Friday about a rapid coronavirus test that the White House has been relying on to ensure his safety, despite new data suggesting the test may return an inordinate share of false negatives.

Trump expressed his confidence in the test from Abbott Laboratories after a preliminary study by New York University researchers reported problems with it. Trump and his deputies have have promoting the 15-minute test as a “game changer.”

The Food and Drug Administration announced late Thursday it was investigating preliminary data suggesting the Abbott test can miss COVID-19 cases, falsely clearing infected patients.

“Abbott is a great test; it’s a very quick test,” Trump said at a Rose Garden event to highlight his administration's efforts to develop a vaccine for the virus. “And it can always be very rapidly double checked.”

The test is used daily at the White House to test Trump, key members of his staff as well as any visitor to the White House complex who comes in close proximity to the president or Vice President Mike Pence.

“We’ve got to get to the bottom of it, but we still have confidence in the test or we wouldn’t have it on the market,” Health and Human Services Secretary Alex Azar told Fox Business Network.

White House officials on Friday continued using the Abbot ID Now test. Reporters at the White House underwent the test before Trump's Rose Garden event. The president noted that the administration officials and staff around him, not all of whom were wearing masks, also had undergone testing Friday.

Trump, who also did not wear a mask, was asked why not everyone was wearing a face covering.

“I’ve been tested, we’ve all been tested and we're quite a distance away, and we're outdoors,” said Trump. “I told them I gave them the option they can wear it or not.”

Azar described the FDA warning as a routine announcement that comes after medical manufacturers submit any type of negative information about their product.

Trump has praised the Abbott test as “very quick, very good” and alluded to the tests helping keep him safe.

FDA commissioner Steve Hahn said that if a person is suspected of having the disease caused by the coronavirus, “it might be worth, if the test is negative, getting a second confirmatory test. That’s what our guidance is about.”

Hahn, asked on CBS on Friday whether he'd continue to recommend using the test at the White House, said, “That will be a White House decision.” But he said the test is on the market and the FDA continues to “recommend its use or to have it available for use.”

Federal health officials have been alerting doctors to the potential inaccuracy in the test, which is used at thousands of hospitals, clinics and testing sites across the United States.

The FDA warning came a day after New York University researchers reported results suggesting Abbott's test can miss up to half the infections caught by a rival test made by Cepheid. The research has not been peer-reviewed or published in a medical journal and was based on about 100 patients.

The researchers found that Abbott's test, run on the company's portable ID NOW system, missed one-third of the infections caught by Cepheid's test when swabs were stored in liquid used to transport laboratory samples. When the samples were kept dry the test missed 48% of the cases flagged by Cepheid's test.

The researchers called the test's performance “unacceptable,” due to the risk of falsely clearing patients who could spread the infection to others. They acknowledged shortcomings of the study, including the time needed to transport patient samples to the device for processing.

Abbott rejected the findings, saying the researchers used the test “in ways that it was not designed to be used.”

“ID NOW is intended to be used near the patient with a direct swab test method,” the company said in a statement.

The company pointed to other independent study results that found the test accurately detected 90% or more infections.

Last month Abbott changed the instructions for its test to explicitly warn against putting patient samples in transport chemicals. The update came after researchers at the Cleveland Clinic reported a 15% false negative rate for samples stored in the chemicals.

The FDA said it was reviewing the data with Abbott and was working on a letter to health care providers about potential accuracy issues. The agency said physicians may need to confirm the results of a negative Abbott test if patients have symptoms of the virus. Regulators said they are requiring Abbott to conduct follow-up studies on the test's accuracy.

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Federal contracting data show the White House spent $140,666 on the Abbott rapid test kits in April. The Department of Heath and Human Services also paid more than $27.3 million last month for the problematic Abbott tests.

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Madhani reported from Chicago. AP Writer Michel Biesecker contributed to this report.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.