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

head of Food and Drug Administration said Friday his ncy has provided new guidance to White House after data suggested that a rapid COVID-19 test used by President Donald Trump and ors every day may provide inaccuracies and false negatives.

Commissioner Steve Hahn said that if a person is suspected of having disease caused by

test, by Abbott Laboratories, is used daily at White House to test Trump and key members of his staff, including coronavirus task force.

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

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

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

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

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

Abbott rejected findings, saying researchers used test “in ways that it was t designed to be used.”

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

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

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

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

FDA first cleared Abbott's test in late March under emergency powers used to quickly accelerate review of tests and treatments during a public health crisis. ncy has authorized more than 90 tests, effectively flooding market with testing options amid persistent problems ramping up testing levels.

For weeks, Trump has promoted Abbott's test as a “game changer.” On Monday, company's ID W system and test cartridges were displayed prominently at

“se tests are highly sophisticated — very quick, very good,” Trump told reporters.

administration has shipped more than 235,000 of tests to state public health laboratories. And Abbott has separately said it has distributed 1.8 million tests to health care facilities in all 50 states.

A White House spokesperson did t immediately respond to a request for comment Thursday night.