Why doesn’t the U.S. have at-home flu tests? | Hacker News Reader

Why doesn’t the U.S. have at-home flu tests?

statnews.com

25 pointsvwoolf19 comments

“It’s really rare, and it’s really new, that people are allowed to know about what’s happening inside their body without a physician in the middle,” said Michael Mina, a former assistant professor of epidemiology at Harvard.

We don't need a physician in the middle of every bit of knowledge. We need the knowledge to figure out when we need a physician.

IIRC one of the only useful things Theranos did was to lobby to remove the laws preventing people from ordering their own bloodwork without involving a physician.

That said, the two big lab companies are starting to offer more self-ordered tests which is cool: Labcorp has ondemand (formerly pixel): https://www.ondemand.labcorp and Quest has QuestDirect: https://questdirect.questdiagnostics.com/

The main beneficiary of cheap at-home disease tests is not the patient, but the patient's friends, family and coworkers.

They're the people who might avoid getting infected, and, for those vulnerable or unlucky it might save their lives.

From that point of view, these at home tests should not only be legal - they should be paid for by government and either strongly recommend or mandatory.

Or just avoid people when you aren't feeling well. No need for the government to give away more money.

> Yet no at-home flu tests are available for purchase in the U.S.

What about the LifeSign Status Flu A & B Test? That at least sounds good on their website...

https://www.lifesignmed.com/product-catalog/infectious-disea...

The FDA seems to at least know it exists... (and, so, hopefully it is legitimate).

https://www.fda.gov/media/145697/download

And it also seems I can buy it in the USA! (Hell: "USA" is literally in the name of the company selling it to me! ;P lol)

https://drugtestkitusa.com/products/lifesign-status-flu-a-b-...

OK: I've ordered a 25-pack. Let's see if they show up! (It could be that this product exists but I am not supposed to be allowed to buy it... that's happened to me before :/.)

https://mfimedical.com/products/lifesign-status-flu-a-b-test

FWIW, I saw them on this ^ other website that claimed they required a physician's license and are NOT an "at home test", but it seems like DrugTestKitUSA believes they are "CLIA waived"?

https://www.cdc.gov/labquality/waived-tests.html

> Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria.

I think the reason is - what would you do with the information?

If you’re sick you should isolate whether it’s flu or not.

In terms of treatment, you’d need a doctor for a prescription and you need to start treatment immediately.

So there isn't that much to be gained by having a positive flu test. I suppose if you were in a high risk category (old, respiratory disease, etc) it might be helpful to know if you should go to the doctor.

The doctor's office stands to lose the cost of their services from their patents' negatives.

Your insurer stands to lose their X% cut of all the money that passes through them on all their customers' negatives.

Follow the money. The System(TM) has a strong financial incentive to see to it that you interact with it as much as possible because that's how they make money.

Then why do we have other at-home tests? Why didn't insurance block those?

Why does it focus on US? I haven’t seen these in Europe either.

The website is a branch of an American newspaper so not surprisingly has a US focus. I think some of the challenges to get the tests in the US are uniquely American. In some cases the FDA has a tendency to drag its feet (case in point, the gray market of imported sunscreens that are approved in Europe or Asia but not the US)

There are likely more data points here than sunscreens. One study [1] seems to indicate that the EMA is typically slower to approve drugs that both the FDA and EMA end up approving.

Another article [2] seems to reach a similar conclusion, where the FDA typically approves faster than the EMA, but when this is not the case there tends to be a larger gap between EMA and FDA approval.

More to the point, perhaps, the at-home flu tests in question seem to have been approved in Europe, or at least received the CE mark which is some level of authorization. [3]

[1] https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.15...

[2] https://www.bioprocessonline.com/doc/first-in-line-fda-vs-em...

[3] https://www.lucirahealth.com/lucira-receives-ce-mark-for-bot...

For the proactive, there are at home strep throat tests.

Strep throat isn't influenza...

Oh wow look at captain obvious over here.

My point wasn't to refute the article because there's an at-home test for a completely different disease, but to point out that there are at-home tests of other kinds. Since companies and the FDA have done it before, and because they were able to bring a rapid at-home test for streptococcus to market, an at-home flu test is probably closer than the article makes it seem.

Detecting bacterial infections and viral infections isn't close to the same level of difficulty. The existence of a home strep test says nothing about the viability of a home flu test.

The existence of a home strep test says the FDA is capable of working with manufacturers to bring home test kits to market. The question then is: how much does the market want flu tests?

Not sure why you're attacking the viability. From the article:

>Yet no at-home flu tests are available for purchase in the U.S. That’s not for lack of technology — the rapid antigen flu tests at the doctor’s office are “virtually identical” to the Covid tests already in people’s homes

Yes, that's far more relevant than strep tests.

3 tests in one, Covid and Flu A/B

https://diagnostics.roche.com/global/en/products/params/sars...

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