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Everything posted by BillsFanNC

  1. I'll take "Verbatim responses if report indicated Trump told Goodell that NFL season likely to be postponed/canceled" for $1000 Alex.
  2. I'm intimately familiar with both companies. Great partnership. FRANKLIN LAKES, N.J. MORRISVILLE, N.C., March 31, 2020 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and BioMedomics, a privately held, North Carolina-based clinical diagnostics company, today announced the release of a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. BD BioMedomics COVID-19 Test Procedures BD, BioMedomics announce the launch of a rapid serology test to detect exposure to COVID-19 at the point of care in 15 minutes. The test is completed in four, simple steps and will be available in April. The new test, developed and manufactured by BioMedomics, will be available through BD and distributed exclusively by Henry Schein, Inc. to health care providers throughout the United States. https://www.bd.com/en-us/company/news-and-media/press-releases/bd-biomedomics-announce-launch-of-rapid-serology-test-to-detect-exposure-to-covid-19 [Edit: this test is one of those described upthread as utilized widely in China and seeking FDA EUA in US, so Good that they've received permission to use it in USA. There is another company in CA, Bodysphere, that has just received FDA EUA for their test (it is a lateral flow immunoassay, also reacts with both IgM and IgG, 2-10 min) http://mybodysphere.com/sars2covid19.html https://www.businesswire.com/news/home/20200331005420/en/FDA-Authorizes-New-Two-Minute-Serological-Test-Kit To all, bear in mind the double-edged sword of serology testing: -It will react if you are far enough into an infection, usually 7-14 days, to produce antibodies against it. You can be infected and either not yet producing antibodies, or not producing enough to detect, so a negative test doesn't mean you're disease-free. -It also can't tell you if you're still INFECTIOUS - you could feel great (asymptomatic) or be recovered physically, but still be shedding virus from your nose and digestive track, and potentially able to infect others.] -What it can do is identify people who have had the disease, and are therefore at low risk for infection and also able to donate plasma to treat others
  3. The CDC bureaucracy dropped the ball with the initial roll out of failed kits. This is not disputable. Rolling out PCR testing on a mass scale was never, ever going to happen. Traditionsl PCR is not a high throughput test and with the testing infrastructure available at the CDC and public health labs even if the initial kits were good there would still be large gaps. Then you saw the partnership with private labs and EUAs for alternative molecular diagnostic technologies with higher throughput than traditional PCR and still you are seeing long time to results (days to weeks). The notion that this massive national testing infrastructure was going to magically appear indicates either a total lack of understanding of the logistics of sampling, transport and actually performing these tests, or you're latching on to a partisan talking point in the middle of a pandemic and national emergency.
  4. Tweet should say "monoclonal" antibodies, not microclonal. There are other therapies that use monoclonal antibodies as a passive immunization. There is one for RSV called Synagis. The researcher they are speaking to here from Distributed Bio appears in the Netflix docuseries Pandemic. They follow him and his company in their search for a universal flu vaccine.
  5. Early on I had read that the problem was with false positives in patient samples which would indicate a problem with primer design that might result in a test that lacked adequate specificity as you suggest. Later on I had read this article: https://www.technologyreview.com/s/615323/why-the-cdc-botched-its-coronavirus-testing/ As someone who has done a fair amount of PCR that suggested to me that the kits suffered from a negative control that had been contaminated with target sequence amplicons, something that can happen quite easily if routine PCR guidelines aren't followed. Without seeing the data we can only guess what the true failure was, but it was indeed a major failure by the CDC no matter how you slice it. I agree with the bolded, but my response in terms of IVD validation was based on my experience in dealing with both the CDC and FDA in the past. Having dealt with them specifically in developing a surveillance test for antiviral resistance, albeit when we weren't in the middle of a global pandemic, still gave me no reason to expect that they would react in a manner or with the appropriate speed that this situation required. With flu the the overall umbrella of surveillance is two pronged, diagnostic results (Flu A/B) are gathered from clinical labs in all states and territories to monitor how much flu is out there and where it is. These diagnostic data can be collected from rapid tests (both antigen and molecular based) and from traditional PCR. The rapid molecular and antigen based tests are something we did not have for covid19, although the Roche isothermal PCR test that was granted approval under the EUA should help in this regard. A smaller subset of samples are tested at public health laboratories for subtype (A/H1N1, A/H3N2, B) and lineage, which as you stated is primarily for identifying circulating strains to assess vaccine efficacy. And yes, they certainly do ramp up surveillance efforts when a novel strain appears such as in 2009. I think we are largely in agreement here that the CDC/FDA failed on both technical and bureaucratic levels in a big way. They clearly failed in rolling out enough tests that would have helped in giving an earlier picture on the spread of covid19. You can be certain that there will be congressional inquiries into this when all is said and done.
  6. Surveillance for flu is not done on a mass scale. If memory serves, they typically report about 2000 tests per week for surveillance purposes to drill down to influenza subtypes and lineages. Again I'll respond more fully later when I have time.
  7. I dont have time now to respond to the rest of your post now, but I'll instead ask a question, what is your experience in developing tests for viral diagnostics? I've spent 20 years developing tests mostly for influenza dealing with the FDA and CDC along the way. So I wont stop posting on this as my understanding is just fine.
  8. Absolutely they could have. I'm not absolving them of blame, but this was a perfect storm of a colossal reagent manufacturing ***** up teamed with the inability of stodgy government bureaucracies to be nimble when necessary. The first one most people didnt see coming, the second is like the sun rising in the east.
  9. Yes, but they didnt take them because regulations only allowed for them to use CDC validated tests, and the WHO tests hadn't been validated by CDC. It took lifting those regulations to allow for testing on the scale that seems to be now necessary.
  10. The CDC did do that. They rolled out the test kits in a short window and they were crap due to a contaminatefd negative control. The key word here is surveillance. The CDC conducts flu surveillance and is equipped to roll out other tests for surveillance, not to test on a mass scale or to manufacture enough tests to "test every american" as some journalists are ridiculously asking for. A rapid flu immuno diagnostic test helped dramatically in the H1N1 pandemic because while those tests are only able to tell you if you have flu A or B, they still allow for rapid screening of patients. In a pandemic situation with the 2009 flu, if a patient is flu A positive by the rapid test you just treat them as if it's the pandemic strain and you send a subset of the samples to CDC for surveillance confirmation by RT-PCR.
  11. Every single doctors office in the country has the ability to test for flu in the office with results in 10 minutes. Covid19 tests need to be sent out to a lab where the absolute best case scenario from sample collection to result might be 8-10 hours, but more likely 24-48 hours.
  12. I dont want Brady leaving NE. Father time comes for every NFL player eventually and I want it to happen to Brady while playing with all his cheating brothers in arms.
  13. Yep, detergents molecules have hydrophilic and hydrophobic ends. Basic kitchen chemistry.
  14. These questions about having a test available for every american are beyond stupid. If you have no symptoms you dont get tested. If you have mild symptoms, you stay at home. A drive through test is totally unnecessary even with mild symptoms. Beyond that, we are still in flu season, if you have symptoms you'll first get a flu test. If you're flu negative, then you get the test. If you're flu positive, you dont get the test.
  15. Tom Polen from BD just spoke, my old campany.
  16. The test that he mentioned by Roche is a quicker PCR test than is possible with normal PCR. My old company evaluated that platform and a few others for a rapid flu diagnostic. Having been involved in developing these types of tests over the years I can tell you with certainty that the speed at which they brought these tests forward and cut through the red tape is remarkable.
  17. That grayed area where there appears to be a drop on the right side of the graphic is labeled on the website as "illnesses that began during this time may not yet be reported"
  18. It shouldn't be available to everyone. If you come down with any of these symptoms your first response should be to go home and stay there, if your symptoms remain mild then you should remain at home and you'll never get tested. There are some small companies that are developing immunodiagnostics for Covid19 that will tell you qualitatively if you have produced an immune response to the virus. There's the potential then for people who had mild cases, recovered and were never tested by PCR who want to know if they had covid19 can get one of those tests once this all blows over.
  19. Trump is wrong for blaming Obama. You and the media are wrong in blaming Trump. In other words, there's no political axe to grind on this no matter how much anyone wants there to be one. The initial test kits produced by the CDC failed because of a contaminated negative control. You can't run a molecular diagnostic with valid results if the negative control doesn't work. In other words, if your internal assay control is positive when it's supposed to be negative, then how can you know if any of the patient sample results are real? You can't. All the initial tests manufactured by the CDC had to be scrapped because the tests were not reliable. This was a failure in manufacturing the kits and I'm sure that heads will eventually roll at the CDC for this. When the CDC realized that they had all these useless kits out there they had public health labs clamoring to be allowed to use their homebrewed, but not validated, PCR diagnostics to test for COVID19. The CDC initially did not allow this as the regulations as they stood did not allow outside labs to use unvalidated testing kits. Then they lifted that regulation a few weeks ago and have since shipped more kits with the negative control issue fixed. The kits exist in more than enough numbers, multiple state public health labs now have the ability to perform their own tests with their homebrewed tests. Why there isn't more testing being conducted or reported at this point is not due to lack of testing kits. In short this can be blamed on a failure in the initial manufacturing, as these assays are extremely sensitive to contamination ( I have used and developed PCR diagnostic assays), then it was a failure of federal agency bureaucracy, and now it seems to be a logistics failure in the collecting, processing and forwarding samples from the appropriate patient populations to the testing labs. If you want to blame Trump, then you have to blame Obama too since being prepared logistically for these scenarios should have taken precedence after 2009. But the CDC/FDA under Obama would have been caught with their pants down too in 2009 with a novel coronavirus pandemic. Rapid diagnostics for flu have existed for decades and were in place in every doctors office in the country with time to result in 10-15 minutes in 2009. I prefer to blame neither and put it solely on the CDC/FDA error and bureaucracy.
  20. Risk of reinfection in recovered patients is low due to immune response and circulating antibodies, yes.
  21. Of all the political BS with this pandemic, the calling it the Wuhan virus is racist theme is the most ridiculous. Viruses are other bugs are designated by where they originated from all the time. In influenza nomenclature, virus strains are always named according to their geographic origin. https://www.fda.gov/vaccines-blood-biologics/lot-release/influenza-vaccine-2019-2020-season
  22. It's you, focusing on one variable, seeing a correlation and concluding its the cause.
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