Demand FDA Approval for At-Home Coronavirus Testing

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WHY WE NEED TESTING

The most important aspect to control a pandemic is to know where a virus is spreading. Directly from the head of the WHO: “Test, test, test. We cannot fight this pandemic blindfolded.”

South Korea is emblematic of that policy, quickly ramping up test deployment to detect, quarantine and control the spread of the virus. The country now produces over 100,000 tests daily and conducted over 300,000 tests, more than 40 times the per capita rate of the US and has completely controlled the spread of the virus.

Broadly speaking there are three categories of testing for COVID19:

  1. In-house lab-based diagnostic testing (lengthy, up to several days for a test, often used for clinical confirmation and clinical decision-making)
  2. In hospital clinical diagnostic tools (fairly fast, but detect the symptoms, not the virus itself) and require secondary lab confirmation.
  3. On the spot rapid diagnostic testing (RDT) (provides results within a few minutes to hours, often used for decision-making by healthcare and public workers)

So far we've only been using #1 and #2 to test in the United States. We need access to #3 to get rapid testing now.

These rapid tests are known as serological or antibody-based tests. They can be taken from a tiny finger prick of blood, similar to a diabetes glucose test. This is safer than current nasal swabs, rapid (15 minute readouts) and can be deployed quickly in the home with no need for a lab. Additionally, they can provide useful information for the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) on immune response.

These tests are widely in use by the Chinese and Korean CDC. The UK has already enabled home testing using these kits.

The US FDA allows for serological tests to be used in a clinical setting. However, the US FDA does not current allow for these rapid tests to be used in the home.

Sign this petition to make the US FDA allow for home testing for coronavirus. Do it now. Lives are at stake.