US FDA "Emergency" Fast Tracks COVID-19 Diagnostic Testing

[sharoncrayn]

As of February 29, 2020, In response to multiple complaints about the failure of current US test kits (let alone those used in China, Japan, South Korea, or Italy and Iran) to validate whether or not an individual actually has the COVID-19 virus, the FDA has gone to an emergency mode to allow all labs "certified" to perform "high complexity testing" (somewhere less than 100 in the US) without any bureaucratic delays such as prior public comment periods (can take months in most cases) and FDA oversight (further subsequent delays based on public comments). The purpose: develop a verifiable COVID-19 testing kit ASAP.

Given the 1st recorded US death from COVID-19, (Washington State), the "State of Emergency" in Santa Clara, CA and San Francisco, this action seems "better late than never'.

According to the several US virologists i have personally talked to, until we get reliable and longitudinal data out of Asia, it will remain difficult to determine who to test and who not to test even if we get improved testing kits. One puzzling cohort dichotomy is the under 40 age group versus the Chinese male (Ace2 dominant). Polar extremes in infection rates for some reason. Also, Why do we see a 15% "reinfection rate"? Does a "confounding" variable (i.e. COPD, immune system distress, smoking, diabetes, etc.) influence infection? Etc.

Whether claims to the effect by certain pharmaceutical firms about drugs or vaccines (generally "re-purposed" HIV-AIDS drugs or vaccines since apparently some virologists believe a link exists) are resulting in "cures" are questionable at this time.

Sharon

[sharoncrayn]

Update....

As of 4:00 PM, 02/29/2020. Washington State (US) has declared a "state of emergency" directly related to the COVID-19 death reported earlier and the distinct possibility of a so-called "community spread or outbreak" (certainly at the long term care facility where the incident occurred and where stringent anti-virus protocols are quite possibly not in place yet, or even understood or even possible).

It is all so similar to the S. Korea situation where 1557 out of 1900 in a church group tested positive according to BBC. How reliable that statistic really is seems questionable since it is far higher (81% in that very specific cohort) than encountered in SARS, Mers, or Ebola (using historical data), let alone CDC numbers for any US flu season since 2010 when they 1st began computer modeling to make estimates.

If S. Korea is a valid, complete canvass of all church members, coupled with valid, relevant indicators, that percentage is way beyond anything proposed by those virologists that I have personally talked to. It obviously implies the scenario where this virus is "asymptomatic". Does it also imply that the concept of a "super spreader" is possible? I don't think anyone knows at this time. Probably other factors at work in this S. Korean situation.

The 300 or so Wuhan evacuees and those from the Diamond Princess "allowed in" are definitely wild cards for the US.

Sharon

[Hidden in reply to sharoncrayn]

I wouldn't worry, Sharon. I read on here that ozone therapy cures basically everything.

[park_bear in reply to Hidden]

Perhaps you are joking to relieve stress but this is no laughing matter. The coronavirus patient in Solano County, California was in the hospital 10 days before being tested for the virus. Doctors had to beg for days on end to get a test kit. Meanwhile, 124 healthcare workers are known to have been exposed and are now on quarantine.

This patient most likely acquired coronavirus through chain of infection from Travis Air Force Base, where passengers from the Diamond Princess were repatriated. So there are some number of people out there who are infected and transmitting disease, while we are woefully short of test kits. Ideally healthcare workers would be testing everybody in sight and tracking this chain of infection down, but that is not happening.

On the other side of the country, a returnee from Asia had symptoms and was concerned he might have the coronavirus. He went to a hospital to get tested and ended up being charged $3500 for a flu test. 40% of this country is living paycheck to paycheck and can not afford such charges, nor to take unpaid sick leave. Are they going to self quarantine if they have symptoms?

We have got a disaster in progress going on here. As bad as things have been in China they ultimately responded efficiently. We had plenty of warning and yet are totally unprepared for this crisis. It is going to be a rough ride.

[Gioc in reply to park_bear]

Hi Park Bear and Sharon too

True, better not to joke. To better understand the problem and possible ways out, virologists and their mathematical models can help us. Here is an article unfortunately in Italian that explains it

maybe you have better ones in english.

google.it/amp/s/www.corrier...

I find it Also in english:

news1.news/2020/02/coronavi...

[LAJ12345 in reply to Gioc]

this is a very good explanation.

[PDConscience in reply to park_bear]

Rather than pretending to be privy to "facts" about COVID19 not yet announced by the thoroughly qualified US team currently tasked with addressing the matter, it may be best to refrain from feeding the hysteria.

Instead, tune in to the daily updates from the GENUINE experts as the situation evolves.

[park_bear in reply to PDConscience]

I have references for every fact cited. No "pretending".

I refer you to our code of conduct:

parkinsonsmovement.com/foru...

" We do not tolerate posts that insult the character, intelligence, honesty, or background of community members. "

[CaseyInsights in reply to PDConscience]

As of Feb 26 2020 -

U.K. conducted 7, 132 test.

The U.S conducted 445 test.

USA population is roughly 5 times U.K

The USA need to get its house in order. Just saying! No hysteria.

worldometers.info/coronavir...

[PDConscience in reply to CaseyInsights]

So... in your world quantity translates as quality?

[LAJ12345 in reply to PDConscience]

Not quality but accuracy. The more tests the greater the accuracy. If no tests are done we have no idea. If everyone is tested we have 100% accuracy (at that point of time, if the testing is accurate, which is a whole other story!)

[CaseyInsights in reply to PDConscience]

....and here - just in from the Washington Post

The novel coronavirus has probably been spreading undetected for about six weeks in Washington state, where the first U.S. death from covid-19 was reported this weekend. A genetic analysis of the virus from a newly diagnosed patient in Snohomish County closely matched that of a specimen from the first known coronavirus patient in the United States, who traveled from China in January.

washingtonpost.com/world/20...

[PDConscience in reply to CaseyInsights]

Uh huh... “spreading undetected” typically precedes detection in the case of viral disease. If you’ve found an alternative to this sequence it merits a Nobel. The point of your rant remains a mystery...

[CaseyInsights in reply to PDConscience]

They said ‘probably...’

The point to be made is the number of test has to go up. There were problems with the early test kits, and there is an all out effort to have more labs involved and to widen the criteria for testing.

I do believe it will be done, but it is not provoking hysteria to say that USA is behind the curve.

... and this from a bystander in the third world.

[PDConscience in reply to CaseyInsights]

US CDC is ahead of the curve in getting the secretive Chinese to open up their facilities in Wuhan and share their research (I live in Snohomish county site of first US death). I’m not aware of UK being involved in the process...

[park_bear in reply to PDConscience]

Here is the end result of failure to do proper testing:

threadreaderapp.com/thread/...

[PDConscience in reply to park_bear]

Are you suggesting parallels between the way the mullahs are handling the matter in Iran and that of the US??? Daft...

[park_bear in reply to PDConscience]

No not at all. I was pointing out to you the urgency of testing. Urgency that you seem to be dismissing.

[PDConscience in reply to park_bear]

“I have references for every fact cited. No ‘pretending’.” Yay!

RE China: “As bad as things have been in China they ultimately responded efficiently.”

RE US: “Ideally healthcare workers would be testing everybody in sight and tracking this chain of infection down, but that is not happening.”

Point made: China is “efficient“ whereas US is derelict.

At risk of interrupting your hyperventilation, I anxiously await your references for the above “facts“ cited.

[park_bear in reply to PDConscience]

With regard to the US failure to test patients, we failed to even test the hospitalized patient with suspicious symptoms in a timely fashion, never mind the community at large:

npr.org/sections/health-sho...

As to China, for example, we have this: How China Built Two Coronavirus Hospitals in Just Over a Week wsj.com/articles/how-china-...

[PDConscience in reply to park_bear]

Surely you’re not among the hyps who marvel at the fruits of China’s slave labor, while howling for a minimum wage increase stateside(?).

Still awaiting your references for US’s failures in “tracking this chain of infection down” (California’s practice of operating in direct opposition to the rest of the country is well-established - it doesn’t remotely qualify to represent ‘USA’).

Note: When Iran and China start to look better than the US, you may want to double check the “lens” through which you view things.

[park_bear in reply to PDConscience]

Are you claiming they built this hospital with slave labor? If so let us see your evidence. In any case I met your challenge regarding China and now you have nothing better to do than change the subject.

With regard to the US I met your challenge as well. It is absurd to blame California for the tardiness of the CDC to get them test kits. If you think California does not count as part of the US there is nothing further I have to say to you.

[PDConscience in reply to park_bear]

Unless you”re suggesting that the US model itself after China in order to produce similar results, such an example of “efficiency” falls a bit short.

And, if you re-read what I actually said, you’ll find that I stated that California “doesn’t remotely qualify to represent ‘USA’”. I suppose you’re ready to argue otherwise(?).

[PDConscience in reply to park_bear]

In any case, I’m sure patrons of HU Forum will sleep more soundly now that we have our very own CDC compliance officer.

[LAJ12345 in reply to park_bear]

Everyone should read this and decide themselves whether they trust your president with their life given he thinks its fake news.

[PDConscience in reply to LAJ12345]

Hopefully you’re able to provide a credible firsthand source for your claim that DJT “thinks its fake news“(and aren’t simply serving as a malleable shill for your favorite ‘real’ news source).

[LAJ12345 in reply to PDConscience]

No, I'm not in the US, its just what I read somewhere. I'm not that interested in him to be honest as I don't live there. Its just if I was deciding whether to trust my life on his competence lets just say I would err on the side of caution based on news that get reported here which may or may not be fake, who knows.

[PDConscience in reply to Hidden]

Horace99, you may be applying JC's recent "Quality Posts" declaration a bit TOO broadly.

[parkie13 in reply to sharoncrayn]

Dollar short and a day late. This was absolutely ridiculous having defective test kits less than 500 and US doing less than 500 test on suspected cases.

Here's a link to the Peak Prosperity video. They have done a lot of them, since the start of the virus. Very interesting explains a lot.

youtu.be/QVQC1hAYZBs(Not working as expected?)

Hope you can find some time to watch it. Mary

[PDGal4]

Anecdotal only, but my son lives in S Korea (fortunately he has been out of the country for the past six weeks and does not plan to return for a while). The COVID19-positive church group, according to my son, is a cultish type of church where members are encouraged to come to church sick and the membership is 'secret'. Instead of being quarantined, sick church members were encouraged to mingle in close quarters with healthy individuals. I don't think any reasonable conclusions can be drawn from this as applies to any other situation.

[LAJ12345]

Well this is all terrifying! Is it possible to get a home oxygen cylinder like they use for copd just in case it is impossible to get medical treatment? And how easy is it to use? Say worse case scenario you are on your own how can you be prepared for home treatment?

** Well I have just contacted my local oxygen supplier and if I can get my GP to issue a certificate saying what the recommended flow rate should be I am able to get my own portable oxygen tank pretty cheaply. Just waiting for the doctor's reply now. PS this is for my son who is asthmatic and who has landed up in hospital 3 times with bad post viral asthma. But it might be useful for everyone in the family and our neighbours in the event the GP and hospital are overrun. It is about $NZ 250 for the regulator, and 70c per day to hire the cylinder which is a bit larger than a fire extinguisher. At the moment they have them in stock, but I imagine there might be a run on them once people start to panic and everyone without any pre existing conditions decide they all need one .