The FDA amended its emergency policy regarding diagnostic testing for SARS-CoV-2 (the virus that causes COVID-19). Several specific private entities and labs will be allowed to develop and distribute tests that can provide results in as little as 5-15 minutes.
So far, after relaxing some policy guidelines, FDA named 29 companies that provided notification to the agency as required and are now therefore able to distribute their tests.
Since the explosion of coronavirus pandemic, FDA has changed, suspended, or amended many laws and regulations to make the fight with the virus easier and more effective. To bad that almost all those changes are temporary. They will expire or are going to be changed back to what it was before the outbreak after the virus is gone.
You’ll know it in 15-minutes.
One of the test’s makers is Abbott Laboratories. Abbott expects to deliver 50,000 tests per day beginning next week and plans to produce about 5 million tests per month when fully operational.
Another 15 min-test is coming from Henry Schein. The firm said that several hundred thousand tests would be available by March 30, with many more expected in April.
The company that comes the closest to an at-home or direct-to-consumer test kit is called Coris BioConcept, which recently announced a DIY test that can deliver results in just 15 minutes. It works kind of like a pregnancy test. Unfortunately, the FDA had not authorized any test that is available to purchase for self-testing at home. The FDA took that action to protect consumers from fraudulent test kits – scammers selling fake products.
The rapid tests kits are serological, meaning they identify the presence of antibodies in a person’s blood.
Serological vs. molecular.
Serological testing is different from the molecular testing that is currently in use by labs and drive-through testing sites.
The serological tests show that a person has developed antibodies to SARS-CoV-2, which means very likely came into contact with it (and either has it or has already recovered from having it).
The molecular tests detect the presence of viral DNA in the bloodstream, which is a much more definitive indicator that they currently have an active infection
At-home test kits.
The benefit of at-home-collection kits is that the contact of potentially infected people with health professionals is kept to a minimum. Unfortunately, FDA can’t aloud the sale of DIY test kits online till there is a system in place, providing a safe and secure platform for people to buy those test kits without the risk of getting a fraudulent product.
The last thought.
Maybe it would be a good idea to create a simple government-run website (let’s say, virustestkits.gov), where legitimate test kit producers could sell their product to the general public. There’s probably a little more to it than that, but I like to keep things simple.
COVID-19 CORONAVIRUS PANDEMIC TRACKER
I decided to drop the Johns Hopkins corona tracker and switch to Worldometer’s COVID-19 CORONAVIRUS PANDEMIC tracker. It’s not as good looking as the one from Johns Hopkins but provides more information.
- Currently Infected Patients (Active Cases)
- Patients in Mild Condition
- Patients in Serious or Critical Condition
- Closed Cases (Recovered / Discharged and Deaths)
Data on testing at The COVID Tracking Project. (US totals and state by state numbers.)
If you rather use tracker from Johns Hopkins, use this link. Remember, however, that in order to get the number of people presently infected (active cases) you must subtract “Total Deaths” and “Total Recovered” from “Total Confirmed”.
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