New CV test with results in 45 minutes

[kingcat]

https://www.msn.com/en-us/health/hea...cid=spartandhp

This would appear to be very good news..

"The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems worldwide, of which 5,000 are in the U.S., the company said. The systems are already being used to test for conditions like HIV or tuberculosis.

The systems do not require users to have specialty training to perform testing, and are capable of running around the clock"

[CitizenBBN]

And this is why I don't panic.

Necessity is the mother of invention, and Americans are notorious for finding solutions to supposedly impossible problems very quickly. We'll get the testing ramped up, we'll find ways to treat those infected and we'll find a vaccine.

Now, it's a race, which is why flattening the infection rate is important, but we'll beat this just fine. I just hope it's quick enough we haven't lost so many small businesses that the economy suffers long term.

As I said elsewhere, the question that will remain will be how we change policy to insure we have the capacity in this country to produce the essentials we need. Drugs, critical equipment, etc. need to be made here. By law if necessary.

Within 2-3 weeks we'll have the testing problem fixed hopefully. Would have been better to have it licked weeks ago, but we needed to get a lot of bureaucracy out of the way.

[Doc]

There are advances on several fronts. I heard there is an ANTIBODY treatment close to being available. This is basically a treatment, not a preventative. You are giving the sick person that actual antibodies rather than the person making them themselves which is how a vaccine works. Antibody therapy starts almost immediately after infusion.

I also believe that they will "fast track" vaccines under the compassionate use criteria, so believe the 12-18 month estimate will be significantly shorter.

[PedroDaGr8]

This is pretty solid news, it appears their system is capable of handling most of the sample prep (which was why the samples normally need to be tested by a clinical lab). They are not the only one BioFire was approved for similar. That being said, it appears Cepheids largest system is an 80-sample unit, which only provides a throughput of around 2000-2500 tests per day for the 80-sample system. While this is around double the other systems, we still need a LOT more improvements to get ahead of this. The bigger thing is that is can be used in point-of-care situations. While they are unlikely to have the 80-sample device, there will be a lot more of the smaller devices around allowing for more distributed testing. This problem won't be solved by a single improved solution but rather the inverse of "death by a thousand cuts".

We'll get the testing ramped up, we'll find ways to treat those infected and we'll find a vaccine.

Now, it's a race, which is why flattening the infection rate is important, but we'll beat this just fine. I just hope it's quick enough we haven't lost so many small businesses that the economy suffers long term.

As someone who works in Clinical Diagnostics manufacture, building tests is the easiest part of the process. We are seeing tests that are good enough for now being rolled out in high capacity. The bigger problem now is the instrument capacity bottleneck, which the above only addresses slightly. Most labs simply don't have the need to perform tens of thousands of diagnostic assays a day (let alone that amount on top of their standard testing load) and as such aren't equipped to deal with this load. How do we get more instruments to the hospitals and/or health departments? We really need an order of magnitude (or two) increase in testing throughput to get ahead of this virus. Right now, most labs are testing 24/7 and still have a week or more back log.

Additionally, cures and vaccines are far from being ready. As I mention below, I can't foresee a situation where a vaccine is ready anywhere less than 10 months. I could see a cure being a bit quicker IF they quickly find one which works. That's the hard part about a cure, it is FAR harder to find a cure but once you find one it is normally easier to manufacture.

As I said elsewhere, the question that will remain will be how we change policy to insure we have the capacity in this country to produce the essentials we need. Drugs, critical equipment, etc. need to be made here. By law if necessary.

This is a BIG question right now, that governments AND companies are wrestling with. 3M had the capacity to produce the masks needed but they were made in China. China deemed all production to be for domestic use only basically nationalizing 3M's production capacity. On the testing side, most Clinical Diagnostic products are manufactured either in the USA or Europe which is why we have been able to scale up so quick.

Within 2-3 weeks we'll have the testing problem fixed hopefully. Would have been better to have it licked weeks ago, but we needed to get a lot of bureaucracy out of the way.

I think that is very ambitious and rat unrealistic. I think we will be in a better situation but far from fixed. I stated before, the main issue is sample throughput. So far ALL tests rely on the same fundamental technology (RT-qPCR). This is process cannot be made much quicker per sample than it currently is. The only options are either an alternate technology being approved or a huge number of these diagnostic instruments being built and deployed in a couple weeks.

The bureaucracy is not the issue here, it has already been trimmed WAY back. At this point, a failed vaccine or cure is actually far more damaging than not having a cure or vaccine at all (to me this is self-evident but I can expand on it if you wish). As such, the issue is the fundamental physical/time constraints of ensuring in a risk based manner that the cure/vaccine actually works with a reasonable certainty.

There are advances on several fronts. I heard there is an ANTIBODY treatment close to being available. This is basically a treatment, not a preventative. You are giving the sick person that actual antibodies rather than the person making them themselves which is how a vaccine works. Antibody therapy starts almost immediately after infusion.

I also believe that they will "fast track" vaccines under the compassionate use criteria, so believe the 12-18 month estimate will be significantly shorter.

Imunnoglobulin(Ig) treatments are seldom pleasant to say the least but for situations like this, they could represent an excellent front-line treatment. Ig treatments are used for a few other diseases like rabies and tetanus, so the technology is reasonably well understood. It has been attempted previously with H1N1 as well as the more releated SARS and MERS. The results were mixed in these tests with some showing great efficacy and some showing almost none. The FDA is currently allowing the use of Convalescent Plasma via emergency IND applications, so the option is available and is being actively investigated. On that note, if a successful Ig treatment is developed, in the longer term I expect it will be used in conjunction with the vaccine to mitigate outbreaks. Patients would be given the initial Ig treatment to fight the infection and prevent its spread and a vaccine to ensure lasting immunity.

As for vaccines, they will definitely fast track the vaccines. The first clinical trials have already started here in Washington. That being said, the earliest I can reasonably conceive a vaccine is 10 months from today (8-18 months for trials and 2-6 months for manufacturing). As a scientist, I would really love to see how they are determining efficacy in such a short amount of time. I am familiar with normal time frames but have never witnessed the accelerated form. Normally, it takes a decent amount of time to ensure the vaccine can provide any sort of immunity not just an immune response (you can't just inject patients with coronavirus). If they decide to lessen the bar to simply an immune response, I don't have much faith that the vaccine will be effective. If it is not effective, it would be worse than not having a vaccine at all.

From there, a fast scale-up will take around four-six months. This involves scaling up the production process, performing a limited validation on the scaled-up process, and manufacturing it in any significant quantities. We don't want a repeat of the SV40 contaminated polio vaccine fiasco if we can help it, so SOME validation of the manufacturing process will be mandatory. Depending on how the clinical data looks, I anticipate that manufacturing scale-up would start "at risk" before the trials are complete, which MIGHT get it down to two months before the first limited quantities roll out. If I were the government, I would be subsidizing the manufacturing scale-up of any promising vaccines well before clinical trials are complete. Scale-up is expensive and VERY risky and the "reward" on vaccines isn't that great. Some degree of subsidization would be helpful, DARPA/NIH/NASA could provide a great process for this a la their SBIR procedure (which is beyond the scope of this discussion but is a great program). Additionally, I could foresee a limited deployment in a shorter amount of time to the most vulnerable groups, then the data from said vulnerable groups being used to help justify the wider roll out.

[KeithKSR]

American ingenuity will find a way. Ford is ramping up to produce ventilators, heck, even homemaking and sewing clubs are making cloth masks for healthcare workers.

[CitizenBBN]

Pedro, curious if you know about the home test kit that's being touted. I'm sure it needs to then be sent to a lab to process? If the bottleneck isn't the kit but the instrumentation to get a result then no doubt we'll almost have to find other methods to ramp up very quick.

If this takes even 60 days to get to larger scale testing then we're in for a world of hurt.

[CitizenBBN]

American ingenuity will find a way. Ford is ramping up to produce ventilators, heck, even homemaking and sewing clubs are making cloth masks for healthcare workers.

Like WWII, I think salvation lies in private companies and a lot of invention of necessity.

It's not a panacea, but we will find solutions we never thought possible for things. Because we'll have to, and that's how it works.

[kingcat]

Like WWII, I think salvation lies in private companies and a lot of invention of necessity.

It's not a panacea, but we will find solutions we never thought possible for things. Because we'll have to, and that's how it works.

I'm praying that's the case.

[CitizenBBN]

We'll be fine in the end. It wont' be fun or pleasant but if we can carve a nation from nothing and defeat a world bent on fascist domination while fighting in every part of the globe then we can beat this thing.

[PedroDaGr8]

Pedro, curious if you know about the home test kit that's being touted. I'm sure it needs to then be sent to a lab to process? If the bottleneck isn't the kit but the instrumentation to get a result then no doubt we'll almost have to find other methods to ramp up very quick.

If this takes even 60 days to get to larger scale testing then we're in for a world of hurt.

I just saw a press release that the first IgG/IgM tests are starting to come online here in the USA. These will offer far faster turn-arounds and will allow much easier blood based testing. This will allow rapid and easy testing at point of care sites (like doctors offices). That being said, the IgG portion will trigger on people who were previously infected and have already recovered. This is actually a good thing because it can help us better understand mortality and hospitalization rates.

That being said, the company producing these is VERY small and they are only expected to ship around 100,000 in the short term. I imagine they will get a decent boost in funding if the tests show any signs of meeting the specificity and selectivity metrics.

Also, I ran the quick numbers on infections. I expect the number of positive cases to rise by 11000-14000 to somewhere between 62000 and 65000 positives since yesterday. Much of this is due to the 50,000-60,000 additional tests which were run since yesterday, but far from all. A lot is also due to the fact this virus is spreading rapidly in areas like Louisiana, Alabama, NYC, NJ, and Seattle.

[Doc]

I just saw a press release that the first IgG/IgM tests are starting to come online here in the USA. These will offer far faster turn-arounds and will allow much easier blood based testing. This will allow rapid and easy testing at point of care sites (like doctors offices). That being said, the IgG portion will trigger on people who were previously infected and have already recovered. This is actually a good thing because it can help us better understand mortality and hospitalization rates.

To clarify on Pedro's post for the nonscientist LOL:

IgG and IgM are antibody test. Means the person was been exposed/infected and produced antibodies, same as if you are vaccinated for tetnus and have immunity long term. The other tests, and what I think most tests that are used today, are antigen tests. These test for the actual virus, not antibodies to the virus. An antigen test says you have the bug per se, and hopefully will be positive before an antibody test. An antibody test will be positive long term. You want a positive antibody test. It says you were exposed and your is body doing what it is suppose to do. An antibody test will not be what is used to determine if you are "over the disease". A negative antigen means your body lacks the virus and are not shedding virus. You can have a negative antigen (no bugs) and a positive antibody (immunity). In fact that is ideal

[kingcat]

To clarify on Pedro's post for the nonsxientist LOL: IgG and IgM are antibody test. Means the person was been exposed/infected and produced antibodies, same as if you are vaccinated for tetnus and have immunity long term. The other tests, and what I think most tests that are used today, are antigen tests. These test for the actual virus, not antibodies to the virus. An antigen test says you have the bug pe se, and will be positive before an antibody test. An antibody test will be positive long term. You want a positive antibody test. It says you were exposed and your body doing what it is suppose to do. An antibody test will no be what is used to determine if you are "over the disease". A negative antigen means your body lacks the virus. You can have a negative antigen (no bugs) and a positive antibody (immunity). In fact that is ideal

Thanks for the clarification.

[Doc]

Thanks for the clarification.

Was a typo I fixed so if you reread it will make more sense, although you are likely able to figure out what I am saying despite my less than stellar typing

[kingcat]

I understood you.

[PedroDaGr8]

To clarify on Pedro's post for the nonscientist LOL:

IgG and IgM are antibody test. Means the person was been exposed/infected and produced antibodies, same as if you are vaccinated for tetnus and have immunity long term. The other tests, and what I think most tests that are used today, are antigen tests. These test for the actual virus, not antibodies to the virus. An antigen test says you have the bug pe se, and hopefully will be positive before an antibody test. An antibody test will be positive long term. You want a positive antibody test. It says you were exposed and your is body doing what it is suppose to do. An antibody test will not be what is used to determine if you are "over the disease". A negative antigen means your body lacks the virus and are not shedding virus. You can have a negative antigen (no bugs) and a positive antibody (immunity). In fact that is ideal

Thanks for clarifying that I actually messed up the IgG section! I was typing this post in two locations (one for friends with specific questions and this one) and forgot to include the clarification you provided.

They are actually doing nucleic acid tests (RT-qPCR) tests currently rather than antigen tests. It doesn't change your clarification, everything you said about an antigen test is also true for the nucleic acid test. Antigen (Ag) tests allow for the earliest detection. To explain why there are two different antibody tests: IgM tests go positive only a bit after Ag tests but will unfortunately will go back to negative as the body develops its immunity. IgG tests are the last to go positive, going positive as the immunity develops and remain positive even after the infection has cleared.