BMEWS
 
Death once had a near-Sarah Palin experience.

calendar   Thursday - April 16, 2020

New Jersey To The Resue Again?

Good news, everyone!

FDA Gives EUA To Rutgers Developed COVID Saliva Test

Our community college is opening a drive through coronavirus testing facility that uses this brand new test. You need a prescription and an appointment, but there is no charge. Spit in the tube, or use a swab in your mouth. And they’ll contact you and your doctor and the CDC with the results. I don’t yet know how long it takes to get the results. But I do know that if this works, the hope is that it could ramp up 10000% and be used for DIY mail-in universal testing.

It is much less invasive than the deep nasal swab or the lung fluid sample test. There is no need for a blood sample. If this works, this will be the Big One.

And it was developed at Rutgers University, right here in the state everyone loves to hate on, New Jersey. They took the home ancestry DNA test concept and applied it to COVID. Awesome: standing on the shoulders of giants.


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Minor update because I try to be a responsible journalist: FDA granted EUA on April 10, not April 15. Even with a game changing bit of news like this the MSM is at least 4 days behind the curve. WTF.
Also the first site to use this test is the existing testing site in Edison. I don’t know of any other test sites, so these two are probably the first in the nation.

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Rutgers University researchers have received U.S. government clearance for the first saliva test to help diagnose COVID-19, a new approach that could help expand testing options and reduce risks of infection for health care workers.

The Food and Drug Administration authorized the test under its emergency powers to quickly clear new tests and therapies to fight the outbreak, the New Jersey university said Monday. [ “EUA” is Emergency Usage Approval ] The test initially will be available through hospitals and clinics affiliated with the school. The announcement comes as communities across the U.S. continue to struggle with testing to help track and contain the coronavirus.

The current approach to screening for COVID-19 requires health care workers to take a swab from a patient’s nose or throat. To lessen infection risks, many hospitals and clinics instruct staff to discard gloves and masks after close contact with anyone who may have the virus. And many institutions are struggling with shortages of basic medical supplies, including gloves, masks and swabs.

With the new saliva-based test, patients are given a plastic tube into which they spit several times. They then hand the tube back to the health care worker for laboratory processing.

“This prevents health care professionals from having to actually be in the face of somebody that is symptomatic,” said Andrew Brooks, who directs the Rutgers lab that developed the test.

An infectious disease expert not involved with the new test said it would help overcome some of the patient discomfort and difficulties in taking swab samples.

Rutgers tested the accuracy of its method by taking both saliva and swab samples from 60 patients. The results from patients’ saliva samples had a 100% match with results from the swabs.

Rutgers developed the laboratory method for the test using saliva collection kits from Spectrum Solutions, a Utah company that provides similar devices for DNA-based ancestry testing services. The Rutgers lab can currently process 10,000 patient samples per day, according to Brooks.

In its authorization letter to Rutgers, the FDA said the test should only be performed “in a health care setting under the supervision of a trained health care provider.” The FDA has not cleared any COVID-19 tests for use at home, though several companies have announced plans to make them available.

Additionally, the FDA said patients who test negative with the saliva-based kit should have their results confirmed with a second testing method.

Ok, that’s a bit of CYA from the FDA, but it’s additional risk abatement. It’s more of risk to the public to allow false negatives then it is to allow false positives.



“Nasal swabbing is an uncomfortable process for patients and can be associated with risk for the health care worker who is doing the swabbing,” said McNally, a physician and genetic expert not involved with the Rutgers test. “Another option like saliva makes it potentially easier and safer.”
...
McNally cautioned that both saliva-based and nasal swab tests aren’t always perfect because they depend on how much of the virus is actually present in the saliva or nasal sample; this is the biggest reason such tests could miss an infection.

“But overall these are still very helpful tests for knowing who has an active viral infection,” she said. “All tests are imperfect, but they are still very, very useful.”
...
“In the ideal situation, we would be able to test and identify every person who has infection with the virus,” McNally said. “We know the testing system missed a lot of people, especially those with mild symptoms or those who did not have any symptoms. We have so much more to learn about how many people were infected and what the state of active infection looks like going forward.”

The US Food and Drug Administration has authorized a saliva test for “emergency use” for diagnosing Covid-19. Rutgers University, where the test was developed in collaboration with other groups, announced the FDA authorization on Tuesday [ April 14 ] after formally receiving it over the weekend.



The Rutgers University scientist who oversaw the development of a saliva test to detect coronavirus said he believes this new way to collect patient samples could serve as a bridge to widespread national testing—modeled off the kits used by familiar commercial genealogical brands like Ancestry.com and 23 and Me.

“It opens up a lot of doors,” Andrew Brooks, the chief operating officer and director of technology development at the Rutgers lab, told ABC News.

Brooks painted a picture of what a future with large-scale, nationwide testing could look like, and it is very similar to the method commercial genealogy firms use to collect their DNA samples from their of customers. As with genealogy tests, he said a testing company could ship a kit to the patient, they can spit into a vial and then the vial is sent to a lab for analysis.



From the email sent out by my county the same day as the FDA approval was granted:

Who can get tested at the clinic?

Individuals who meet ALL of these criteria are eligible for testing:

● Somerset or Hunterdon county residents
● Age 5 or older
● Have COVID-19 symptoms (fever, cough, shortness of breath)
● Have a written doctor’s orders or prescription
● Have an appointment

What do I need to bring

Paper copy of doctor’s orders/prescription
Government issued ID
Pen

What are the dates and hours of the clinic?
The clinic will run Thursday 4/16, Friday 4/17, and Monday 4/20 from 10am to 1pm.

Do I need an appointment?
Yes. Only individuals with an appointment will receive testing.

Kudos to our local government. Obviously they knew about this ahead of time and had it all set up in advance. So they rolled it out the instant that EUA was granted, and it opened the next day. I expect there to be screwups in the process for the first few days, but that will quickly smooth out. And if preliminary testing works out, I fully expect twenty dozen other testing facilities to open up nearly overnight. This will cut down the processing time and ramp up the scale of testing by orders of magnitude. Imagine if 10 million people could be tested every day. From home. Why, this could even save the US Post Office, giving them lots of work delivering all the little “red bag” packages. Get them some PPE too, have a special test kit drop off mailbox and get those selected postmen some PPE. And get them all on HCQ + Zn, just to play it safest.

extra info: https://www.livescience.com/how-coronavirus-tests-work.html


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Posted by Drew458   United States  on 04/16/2020 at 10:37 AM   
Filed Under: • Health-Medicinepandemic and epidemic diseases •  
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