FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect, Which Uses a New Method of Saliva Sample Processing
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2. FDA NEWS RELEASE …. For Immediate Release: 8-20-20
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection.
“The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another testing innovation game changer that will reduce the demand for scarce testing resources,” said Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, M.D. “Our current national expansion of COVID-19 testing is only possible because of FDA’s technical expertise and reduction of regulatory barriers, coupled with the private sector’s ability to innovate and their high motivation to answer complex challenges posed by this pandemic.”
“Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s authorization is another example of the FDA working with test developers to bring the most innovative technology to market in an effort to ensure access to testing for all people in America. The FDA encourages test developers to work with the agency to create innovative, effective products to help address the COVID-19 pandemic and to increase capacity and efficiency in testing.”
SalivaDirect does not require any special type of swab or collection device; a saliva sample can be collected in any sterile container. This test is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past. Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources. Additionally, the SalivaDirect methodology has been validated and authorized for use with different combinations of commonly used reagents and instruments, meaning the test could be used broadly in most high-complexity labs.
Yale intends to provide the SalivaDirect protocol to interested laboratories as an “open source” protocol, meaning that designated laboratories could follow the protocol to obtain the required components and perform the test in their lab according to Yale’s instructions for use. Because this test does not rely on any proprietary equipment from Yale and can use a variety of commercially available testing components, it can be assembled and used in high-complexity labs throughout the country, provided they comply with the conditions of authorization in the EUA.
This is the fifth test that the FDA has authorized that uses saliva as a sample for testing. Testing saliva eliminates the need for nasopharyngeal swabs, which have also been prone to shortages, and alleviates the patient discomfort associated with these swabs. Since the saliva sample is self-collected under the observation of a healthcare professional, it could also potentially lower the risk posed to healthcare workers responsible for sample collection. While FDA has seen variable performance in tests using saliva, Yale School of Public Health submitted data with its EUA request from which the FDA determined that Yale’s test meets the criteria for emergency authorization when used to test saliva samples for SARS-CoV-2, the virus that causes COVID-19 infection.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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3. From Dr.Michael Mina: [These are a series of tweets Dr. Mina which I attempted to capture and put in sequence.. any failure is that of the editor not having sufficient skill to satisfactorily accomplish this objective.]
Terrific news that SalivaDirect gained @US_FDA approval today! A major step forward for lab based #COVID19 diagnostics.
SalivaDirect is a wonderful and hugely needed addition to the arsenal of laboratory based diagnostics. It will improve capacity to test in other CLIA labs too! It is however not a rapid test that's going to be done at home with an answer in minutes. These are different. I'll explain why this is good for DIAGNOSTICS but also why this is not widescale RAPID testing. Both are needed. Saliva use does not equal rapid testing.
If a test needs a lab, it will necessarily not be rapid and will hit limits in volume. Only a certain number of tests fit through a doorway each day and onto a robot. With the right technology, a lab based test can get to very high numbers...But it will necessarily not return a result in minutes (must travel to the lab) and the lab will hit its limits in terms of volume.So rapid tests are a whole different idea. It is distributed testing - with results back in minutes, on the spot. There are different kinds of tests.
Some rapid tests are true diagnostics - they need some healthcare involvement, including doctors prescription of some sort, and are going to hit high levels of sensitivity because they are for medical diagnostics.
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The tests with diagnostic labels will usually be more $$ too because they can be reimbursed by insurance (at least in US).
There is another kind of rapid test, which we have been calling for. These are first and foremost for public health - and can be done at home...
Non diagnostic rapid tests might use saliva or will use frontal nose swabs. They will hopefully not have a full diagnostic claim because they will serve to indicate if someone may be transmitting virus, but will not be used by a doctor to diagnose. These are different.
For more info on those kinds of rapidtests, you can check out http://rapidtests.org (linked below) or read this wonderful piece that covers all of this by @alexismadrigal in the Atlantichttps://theatlantic.com/health/archive/2020/08/how-to-test-every-american-for-covid-19-every-day/615217/…
[*******@SaadOmer3. Thanksfor reminding. By removing RNA extraction, SalivaDirect test can be made considerably cheaper than most lab based qPCR tests today. Likely <$5 vs $15-$50 in materials, making qPCR more accessible in low and middle income countries.]
First - why is this important for diagnostics?
First First though... what do I mean by diagnostics?
Diagnostics are what doctors use to know why someone is sick. They are a specific kind of test. Vs. a surveillance or public health test that indicates something.
A diagnostic that a doctor orders must be very good to do what it is meant to do - determine if someone is sick for a specific reason. So it needs to be high sensitivity and high specificity, there's little wiggle room. This is different than a public health indicator test.
I won't harp further on diagnostics. Why is the SalivaDirect a good step forward for DIAGNOSTICS?
Two main barriers have gotten in the way of diagnostics in this pandemic: Swabs/tubes/media for sample and importantly, RNA extraction kits that prepare the RNA for PCR test
The SalivaDirect uses saliva - abrogating need for a swab/tube/media. Simply spit in a plastic tube without any other buffer or diluent needed. Simple as that - but then it MUST GO TO A LAB (more later)
So removal of the need for a swab and transport media removes a crucial step that has plagued numerous testing efforts. While swabs haven't really been too limiting lately, the choice between a deep nasopharyngeal swab and a more convenient front of nose swab is a tradeoff.
the deep nasopharyngeal swabs are difficult to perform - require a healthcare provider to do it, and are uncomfortable. The anterior nare (front nose) swabs are easier to self-perform, don't hurt, but don't catch as much virus as the deep nasopharyngeal swabs.
Use of saliva is a nice intermediate. It seems to catch potentially more virus than a self-collected anterior nasal swab but it's up for debate still how well it does against a nasopharyngeal swab. Either way, it doesn't require a swab/media, can be self collected, and works.
So to sum up point 1, SalivaDirect is an improvement by removing the need for a swab/tube and removed need for a healthcare worker performed nasophayrngeal swab - although self-collected frontal nose swabs have also already been approved.
Now on to why it is good for the lab
A major hurdle in lab diagnostics for COVID19 has been a step in the qPCR process called RNA extraction. The RNA extraction kits were one of the first lab items in March to become limiting. Never did the world expect the number of RNA extraction kits that would be needed...
The RNA extraction process not only has proven to be a bottleneck in terms of supplies, but also adds an extra step in the laboratory that is almost as, or more burdensome as the qPCR test itself... so removal of it would be welcomed…
The RNA extraction process not only has proven to be a bottleneck in terms of supplies, but also adds an extra step in the laboratory that is almost as, or more burdensome as the qPCR test itself... so removal of it would be welcomed...
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To stop major outbreaks - we either need major behavioral change - seems unlikely - need to shutdown the economy again, vaccines (all of which problematic), or we need the federal government to approve and then mass produce simple at home #dailyquicktests
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