BillsFanNC

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 it. 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

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.

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.

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.

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.

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.

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.

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.

WHO offered kits and CDC did not take them.

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.

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.

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.

Yep, detergents molecules have hydrophilic and hydrophobic ends. Basic kitchen chemistry.