Covid-19 Home Test Helps Unlock US

Ahs A government struggle to help Americans move from lockdowns and on-the-fly evacuation orders to a “new normal”, home testing of Covid-19 is an important part of any plan. Must be

The required home test is a combination of rapid and highly effective antigen-antibody testing and embedded technology that enables seamless and sensitive contact tracking. The antigen assay informs the user if they are currently infected with SARS-CoV-2, the virus that causes Covid-19. Antibody assays probably let them know if they have been infected in the past, perhaps without knowing it.

The technology for creating rapid combination tests in the home is well established. You can also quickly add contact tracking by using existing technology. The United States has the world’s most innovative healthcare companies, creative technology companies, and the strongest medical and academic centers. There is no doubt that they can create the home tests that our country needs.

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However, implementing Covid-19 testing strategies for the home requires the government to focus on science and data over politics.

It is essential that all tests be verified before they are approved by the market. Sadly, the Food and Drug Administration was broken with its mission to make a decision informed by this kind of data for the Covid-19 test. Instead under it Emergency use permit, The FDA allows all suppliers of Covid-19 testing to sell them without providing performance data.

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The FDA is working on what appears to be a bit obfuscated, as it is becoming apparent that some of these tests are not working well. At the White House’s daily afternoon briefing on Tuesday, FDA Commissioner Stephen Hahn Performed “self-verification” of the test (This reminded me of my third year time self-scoring history test).

The FDA’s decision was to use tests that were less than 95% reliable, Recent Performance Survey. In highly contagious diseases like Covid-19, a test that tells some individuals that they are virus-negative when they are actually infected can have disastrous results.

The FDA’s reckless and risky policy of allowing market testing without the need for verification was undoubtedly based on political pressure. Tragically, this is not the first time the FDA has taken politics over science in the face of a fashion.

In 1987, a company I founded applied to the FDA and approved the first home HIV test. Clinical trials involving more than 5,000 participants have shown results to be 100% consistent with the best lab tests. There was a clear need for this product. At that time, one-third of Americans who wanted to test for HIV only tested at home. Still, there were opposition to HIV testing at home, even from laboratories, clinics, and even AIDS activists, all of whom were involved in the current status of testing.

Therefore, although HIV is incurable and apparently asymptomatic for the first 10 years after infection, the FDA has banned home-use HIV tests lasting 25 years. It wasn’t Until 2012 The FDA has approved the first rapid home testing kit for HIV. And under the leadership of the FDA, the World Health Organization did not approve home testing until 2018.

Even today, there are no large HIV testing programs, 1.3 million worldwide Is newly infected with HIV every year, of which 40,000 live in the United States, with AIDS spending accounting for over 1% of US federal tax income.

A lesson learned from the US government’s opposition to domestic HIV testing is that politics takes precedence over common sense, science, and the public good. As Mark Twain Once observed, “It’s worth noting that history doesn’t repeat itself. Because the human character always makes it impossible to prevent repetition.” Translation: Because the character of the people of government is to focus on politics. , It is the responsibility of the Americans to support the widespread distribution of home tests and require them to function reliably.

While the competition for the development and validation of household Covid-19 tests is likely to yield better, more effective and cheaper products, once the FDA approves the most effective tests, the industry will work together. Need to work. Share production details among a consortium of talented manufacturers with the experience and resources to manufacture or purchase the components needed to expand the production and distribution of tens of millions of high quality, low cost Covid-19 tests each week need to do it. world.

Written by Robert Frost A comparison of two roads branching in the woods and one lesser road. Even in the midst of the epidemic, America is as politically divided as it is today. In this environment, low-traffic roads provide a route out of government for solutions to the Covid-19 epidemic. Age and age will make all the difference, as Frost wrote.

Elliott Millenson was the founder and CEO of Johnson & Johnson, the company that developed the first home tests for HIV.