FDA says rapid at-home tests not as sensitive to Omicron variant, causing ‘false negative’ results

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Only days after President Joe Biden announced that he’s ordered 500 million rapid at-home COVID tests for the federal government to distribute to the American people free of charge, a report emerged confirming that these tests have some issues.

In an announcement published Tuesday, the Food and Drug Administration reported that “early data” from a study, the RADx program, doesn’t look entirely great.

“RADx recently performed preliminary studies evaluating the performance of some antigen tests using patient samples containing live virus, which represents the best way to evaluate true test performance in the short-term. Early data suggests that antigen tests do detect the omicron variant but may have reduced sensitivity,” according to the FDA.

The good news for the Biden administration is that this was expected. It was known that these tests are less reliable than laboratory tests. They were ordered anyway to provide Americans an easy way to obtain confirmation that they’ve contracted the virus.

Unlike laboratory PCR tests, rapid tests provide immediate results. Moreover, they’ll ostensibly be easier to obtain, in that you’ll be able to get the test mailed to you versus having to wait in long lines such as the following:

The FDA notes that those who do test positive “should self-isolate and seek follow-up care with a health care provider to determine the next steps.”

For those who test negative, however, they have a choice. They can either trust the result or, if they’re “experiencing symptoms or have a high likelihood of infection due to exposure,” they can seek out a laboratory test.

“So if you feel any symptoms but test negative, it’s not a get-out-of-jail-free card. You may need to test again and hold off a little bit on assuming that you’re negative,” Gigi Gronvall, a senior researcher at the Johns Hopkins Center for Health Security, explained in an emailed statement to NBC News.

Despite this issue, the FDA “continues to authorize the use of these tests as directed in the authorized labeling and individuals should continue to use them in accordance with the instructions included with the tests.”

The only real issue at this point, as previously reported, is that the president took so long to order these at-home antigen tests.

Vanity Fair magazine reported last week that the idea of distributing free rapid tests to the American people had been proposed to the president months ago yet ignored for what some now suspect were political reasons.

“On October 22, a group of COVID-19 testing experts joined a Zoom call with officials from the Biden administration and presented a strategy for overhauling America’s approach to testing,” Vanity Fair reported.

They presented the administration with a 10-page plan that called for putting “rapid at-home COVID-19 testing into the hands of average citizens, allowing them to screen themselves in real time and thereby help reduce transmission.”

“The plan called for an estimated 732 million tests per month, a number that would require a major ramp-up of manufacturing capacity. It also recommended, right on the first page, a nationwide ‘Testing Surge to Prevent Holiday COVID Surge,’” according to Vanity Fair.

But the Biden administration reportedly punted and so now, months later amid the current omicron surge (versus before the surge hit), the administration is rushing to distribute tests to the American people.

All this comes as the number of COVID cases in the United States continues to hit record highs, despite the widespread availability of multiple coronavirus vaccines and booster shots.

“The US hit a seven-day average of 265,427 new Covid-19 cases on Tuesday, blowing past the country’s previous record of about 252,000 daily cases, reported nearly a year ago on January 11,” CNN reported early Wednesday morning.

“The new peak, according to Johns Hopkins University data, comes amid a rapid acceleration of infections in the United States — and across the world — since last month,” according to the left-wing network.

Furthermore, it appears that the states with the highest percentage of vaccinated residents are seeing the largest spikes in COVID cases.

Similarly, the majority of Americans afflicted by the Omicron variant are vaccinated and boosted, according to Reuters: “Most of the 43 COVID-19 cases caused by the Omicron variant identified in the United States so far were in people who were fully vaccinated, and a third of them had received a booster dose.”


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