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by mattmanser 2262 days ago
In the UK they're saying there's a shortage of swabs and pipettes even, do you not need these too?

Also, in the UK our independent and uni labs have been saying for almost a week they could extract the RNA differently but the NHS have a fixed approved way that they won't change.

- Are the chemicals you're using more common or would there just be a new shortage of different chemicals?

- Is there a risk you'd be creating a test that didn't work very well, and the US would end up with a bunch of useless tests (e.g. Italy had to abandon a bunch of Chinese sourced tests, UK's anti-body tests are ineffective)?

1 comments

Our technique would still be affected by shortages in specimen collection (like swabs).

Purely speculative, but I think if swabs remain an issue for too long, alternatives could start coming online, such as even using qtips + saline (no idea if it works, it's just an example). The current swab + Universal / Viral Transport Medium combo is optimized for flexibility; it is designed to work across a very broad range of viruses and bacteria that have different viral loads and shedding characteristics. The current pandemic is pretty much COVID-19 only, so I think it's a priori feasible that a specimen collection procedure can be found that uses common materials. We did try early on to see if saline or other buffers affected the performance of the assay, and it worked fine in those conditions.

We use fairly standard chemicals. I haven't heard from our suppliers about shortages for the chemicals we use. Chemicals and enzymes tend to be relatively fast to scale up for bulk manufacturing.

There's always manufacturing risk that a product will not work as expected. In fact, the first COVID-19 test developed by the CDC did not work as expected, and this delayed testing by several weeks. We de-risk this as much as possible by performing experiments as early as possible, akin to the fail fast mentality of checking for the highest risk failure modes first. Since we don't have a national healthcare system in the US, the manufacturer takes on the vast majority of the risk of a defective product.

There are companies out there working on swabs. e.g. Formlabs designed an autoclavable, 3D-printed nasopharyngeal swab using biocompatible Dental resin, in concert with local hospitals. They received FDA Class 1 Exempt status from the CDC and are printing some 150K per day.

https://formlabs.com/covid-19-response/covid-test-swabs/

https://www.plasticstoday.com/medical/formlabs-3d-printing-m...

https://formlabs.com/covid-19-response/

I'm not associated with the company, I just own some of their printers. They've also got some 2000+ volunteers who own printers or have CAD expertise signed up and looking for ways to contribute. Apparently we can't make medically-approved swabs (most of us aren't ISO 13485-certified or FDA-registered), but there's other stuff (e.g. hands-free doorknobs). I'm even contemplating shipping one of my printers back to them to help in the effort.

if the virus is known to live on cardboard or plastic for 48-72 hours, is the viral transport medium even necessary, assuming rapid shipping and processing?
Can live up to X hours != Will live up to X hours

Let’s say it’s 50/50 whether it lives 24h without help. That’s would be a pretty bad false negative rate for your test, but a 50/50 of potentially getting infected by your mail is pretty high.

To be more precise, last info I read modeled the virus with exponential decay, with half-life measured in minutes to hours. After an hour (or 3h or 0.5h), half of the virus is already inactive¹.

Even after ~6 half-lives, remaining 1% of viral load is still potentially dangerous, but it's not a good basis for a test if you want it to be sensitive.

¹ Inactive does not mean destroyed. It may be possible or even easier to detect a partially decomposed virus, even with the current tests. Or not.