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Comment by joezydeco | Hacker News Reader

They also cleared the Pinnacle BioLabs assay. You can order a 2-pack or a 25-pack.

https://www.pblabs.com/products/pinnacle-biolabs-covid-19-no...

Mine arrived in the mail this morning.

The kit looks very interesting. Unfortunately, it appears to me that the Pinnacle kit is not yet approved under the emergency fda authorization, yes? I'm using this web page for reference: https://www.fda.gov/medical-devices/emergency-situations-med....

The in-vitro EUA list on the FDA page only seems to cover PCR tests and not ELISA immunoassays (yet).

Pinnacle's webpage earlier this week said they were shipping to the EU but waiting on the FDA EUA for shipments to the US. The tracking on my order was marked as held up at the factory.

The EUA notice disappeared from their website on Wednesday, it shipped yesterday, and I got it this morning.

It's reasonable to believe Pinnacle obeyed the rules and waited. My plans weren't to use the kit unless absolutely necessary, so I can wait for the documentation to update.

Are there any reviews? Any third party verification? How do I know that this is legitimate? These are sincere questions, I'm not just being difficult.

Isn't FDA clearance the very definition of "third party verification"?

Looks like they got a CE seal on Feb 20, per their website. That's something at least.

Can we trust their website? Is it on another website somewhere?

Is it on the FDA website somewhere?

Did you buy it for some sort of industry use, or as a regular consumer for personal testing?

Personal use.

I ordered it weeks ago purely as a hypothetical. If I was home sick with a flu, was it seasonal or was it nCov? This was before all the lockdowns started.

I also bought a fingertip pulse oximeter for the same reason. I’m surprised those haven’t been hoarded...yet.

Seems to be a scam. If you look up their FDA registration number nothing shows up.

I’ve used some of their other home testing kits before, like their colon cancer screening kit. Detects globin at 50 ng/mL and is board approved by gastroenterologists. The company isn’t a scam.

Yeah, after digging into it more I saw that. Doesn't explain the missing FDA number though which is quite sketchy.

Their number is listed in the info brochure.

https://cdn.shopify.com/s/files/1/1010/0544/files/COVID19Bro...

Yeah, and it's not listed... in the actual FDA database.

Found it in 3 clicks. Maybe it's been recently updated?

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.c...

"Page Last Updated: 03/23/2020"

Strange indeed.

You said your test kit arrived already? What does it look like?

Well, pretty much like the picture. Package insert is the same. Not going to unwrap the LFA device unless it's really necessary.

Link already removed :-(

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