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Comment by bradly | Hacker News Reader

I still don’t understand this. Doesn’t WHO already have emergency tests ready to use? Is this just big gov funneling money to U.S. corporations or is there a less pessimistic explanation?

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Roche is a Swiss company [0]. My neighbor here in Canton Zürich works at a lab that uses these machines. She's been testing coronavirus, and she's having to go in on Saturdays now to deal with the backlog. Not Sundays though. Labor on Sundays cost an arm and a leg in Switzerland.

[0] https://en.m.wikipedia.org/wiki/Hoffmann-La_Roche

If I had those skills I'd volunteer.

This isn't even the same thing. Roche Cobas machines are industrial scale equipment used at hospitals to identify pathogens.

If a hospital is equipped with a Cobas and they have a Cobas test reagent/plan for a given virus, they can automate the testing process.

Other vendors in this space are doing the same thing. Abbott, Siemens, Biomerieux, etc. These companies are the backbone of clinical labs, not just in the US but globally.

Assuming the WHO stash has not already been depleted due to the global spike in cases, the number of WHO tests available to the US is probably insufficient to be helpful for its over 300 million people. Incentivizing the private sector to create tests on the other hand does have the potential to get enough tests for the whole population.

This is a global pandemic and there are many other affected countries around the world that do not have the ability to ramp up testing production the way the US does. Poorer countries should be the ones with access to the emergency test kits, not the US.

I think the existing kits are performed by hand. This new one can be done using high-throughput machines.

I thought the WHO kits are being used in mass in South Korea and Italy. Is the U.S. really developing something unique?

There are many RT-PCR LDTs. It does not take very much to create a real-time RT-PCR LDT for COVID-19; two weeks ago the CDC posted a comprehensive description of the process on their website, but it was not a secret before then. All you need is a clinical-grade RT-PCR machine, synthesized primer/probe DNA (which many labs are equipped to do), and quality reagents.

The difference here is that the Roche instrument is pre-approved for clinical use both (1) in the US and (2) outside "high complexity" CLIA labs; the instrument is already widely deployed to hospital labs; and the instrument is highly automated compared to the basic 96-well RT-PCR machine, with a robotic stage that allows it to run thousands of samples per day with less manual work.

The WHO does not have a massive stockpile of complete test kits, and to my knowledge the countries that have scaled up testing are not relying on the WHO for anything but information. Any kits the WHO provides would need to run on an existing RT-PCR machine anyway.

CDC's test instructions and (more importantly) the target RNA/DNA sequences were posted more like 6 weeks ago -- I think I first noticed them in early February, around the time CDC announced that they had applied for an emergency use waiver from the FDA.

They've been revised considerably since then (with a big "research use only" warning on them added).

Their protocol for clinical labs is a superset of the research protocol. (Clinical labs also have extensive prior experience in this kind of protocol, and many state DPH and other labs are in continuous touch with the CDC through CDC's lab network.)

At least one company in South Korea, Seegene, has produced many tests and it is this aggressive private sector production that is largely reasonable for South Korea's effective testing. There is also a large demand for Seegene's tests around the world indicating that WHO tests are definitely not in sufficient supply.

The private sector stepping in is the best way to get enough tests out to everyone who needs them.

https://www.cnn.com/2020/03/12/asia/coronavirus-south-korea-...

4 SK companies: https://news.ycombinator.com/item?id=22572121

See rest of that thread for background - maybe Seegene is doing better PR?

I read about 80% of the tests in S. Korea are done with Seegene test kits.

This is March 1st press conference from South Korea: https://news.v.daum.net/v/20200301162614985. It says Seegene accounts for 37.8% of test volume. The context is that Seegene (and only Seegene, other companies have other supply chains) had supply chain problem. As I understand problem is now resolved.

It is different than the test currently being used in the US, at least. It is going to speed up testing rates.

See: https://youtu.be/q_WM_pMp0Hg?t=7382

I have no clue about this, but to me it seems they just took the existing human workflow and built a robot to replicate it. Is there no more clean slate way of doing this (maybe with a lot of pipes like in a refinery?). How does one even keep one of those monsters clean?

The WHO is a coordination organization. They don't do health policy directly. And FWIW: Roche is a Swiss multinational.

This test is probably good. It's certainly good that it got rapid approval and reflects the fact that the US executive branch has turned the corner and is now taking things seriously (seven weeks later than it should have, but at this point recriminations will have to wait -- we have more serious problems).

Whether more testing should have been available much earlier (obviously it should have) isn't really relevant to this particular test product.

PCR and high-throughput are two things, testing kits are for PCR and aren't very accurate.

Roche says the machines that these tests run "automate the preparation and analysis of samples for quantitative and qualitative nucleic acid testing using real-time PCR technology. "

https://www.dialog.roche.com/pk/en_us/products_and_solutions...

Um, what? What is inaccurate about the PCR?

"Recent research found that the sensitivity of CT for COVID-19 infection was 98% compared to RT-PCR sensitivity of 71%."

https://www.sciencedaily.com/releases/2020/02/200226151951.h...

And this comment from a prior thread: https://news.ycombinator.com/item?id=22571588

Please read the sources you linked to. The problem is the disease model and how the disease presents itself, how and where the samples are taken, etc. The PCR test is not what is the problem. Its the gold standard. We use it daily at our company and rely on it for our vaccine development. Don't believe me, ask any scientist.

Also, a minor point but I don't get the idea of replying to someone with someone else's opinion. That way I can't really respond to you can I? I'm supposed to find the original person and reply to them? .. Sorry.. just a pet peeve.

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