First Smartphone-Enabled COVID-19 Rapid Antigen Test Awaits FDA Approval

[MacRumors]

Accurate and rapid COVID-19 testing has become a critical hallmark in the battle against the pandemic. Unfortunately, getting tested on a mainstream level currently requires a trip to a clinic or government instituted site.

However, in a possible breakthrough of what it means to get tested, Kroger Health today announced it's planning to obtain FDA approval for the first smartphone-enabled COVID-19 rapid antigen test.

According to a press release, patients will administer a nasal swab themselves and complete a rapid antigen test. Then, patients will scan the rapid test using the app on their iPhone, and using AI technology, the app will provide their results "within seconds."

What the app aims to do is remove any doubt of the actual results of the test by using AI to correctly determine the location of the results line. In COVID-19 rapid antigen tests, the presence and location of a line in different areas determines whether the patient tests positive or negative for COVID-19, and some patients may misinterpret the lines, leading to a false understanding of what their result actually is.

In compliance with U.S. law, the app will automatically share the results with appropriate public health agencies and abides by all HIPAA rules and regulations. The hope is that this new test will increase the number of people who can get tested for COVID-19 themselves with a higher level of accuracy.

The new test is awaiting FDA approval, and clinical trial results submitted to the agency shows the test has a "93% positive agreement and 99% negative percent agreement compared to high-sensitivity, emergency-use-authorized PCR tests," according to Kroger Health.

You can learn more about the test here.

Article Link: First Smartphone-Enabled COVID-19 Rapid Antigen Test Awaits FDA Approval

 

[johnmacward]

"Unfortunately, getting tested on a mainstream level currently requires a trip to a clinic or government instituted site."

Why is this "unfortunate"? It's normal, they're the experts, they know how to do it right (usually). What a strange point of view.

 

[peneaux]

"AI" for testing for virus? They forgot to add "quantum computing" in the mix. Add "nano-tech" for a trifecta!

 

[smoking monkey]

"Unfortunately, getting tested on a mainstream level currently requires a trip to a clinic or government instituted site."

Why is this "unfortunate"? It's normal, they're the experts, they know how to do it right (usually). What a strange point of view.

I think it just means it's less convenient and that means people are sometimes reticent to go.

within 20 years the things our smartphones and watches will be able to do for us medically will be incredible.

 

[hailey bee]

I'm all for rapid tests. But this one "smartphone enabled" on the level digital pregnancy test is https://www.bbc.com/news/technology-54025997 You can shed all the "smartphone" whistle, and sell detector strips a dozen a cent. Could have pushed to market months earlier.

 

[Taz Mangus]

The issue is the reliability of the rapid COVID-19 test:

if a person is asymptomatic, they might not have high enough levels of virus in their mucus to test positive.

And this is the real concern with using rapid testing:

Experts warn that you shouldn't treat rapid testing as a free pass to attend a party or wedding.

The New COVID-19 At-Home Rapid Test Gives You Results In 30 Minutes

It works a little bit differently than other tests.

www.womenshealthmag.com

 

[kiranmk2]

The overlooked factor is the self administered nasal swap. Having had a swab myself I know how uncomfortable it is (it feels like the swab is scraping your brain) and I would seriously doubt how reliably the average person would be able to self-administer this. Not going far enough up the nose likely won't gather the required antigens resulting in false negative results. In the UK dome doctors have esitmate that 1 in 3 negative test results may be invalid, presumably due to this.

 

[Rychiar]

The overlooked factor is the self administered nasal swap. Having had a swab myself I know how uncomfortable it is (it feels like the swab is scraping your brain) and I would seriously doubt how reliably the average person would be able to self-administer this. Not going far enough up the nose likely won't gather the required antigens resulting in false negative results. In the UK dome doctors have esitmate that 1 in 3 negative test results may be invalid, presumably due to this.

When I got tested they just swabbed the opening of my nose lightly

 

[JulianL]

I think it just means it's less convenient and that means people are sometimes reticent to go.

within 20 years the things our smartphones and watches will be able to do for us medically will be incredible.

Agreed. Plus if you're getting tested because you have reason to think you have the virus then even with masking and social distancing at test centres it would still be safer if you could start your self-isolation immediately you think you are infected and do the confirmation test at home rather than take your viral particles on a trip to a possibly crowded testing centre.

The overlooked factor is the self administered nasal swap. Having had a swab myself I know how uncomfortable it is (it feels like the swab is scraping your brain) and I would seriously doubt how reliably the average person would be able to self-administer this. Not going far enough up the nose likely won't gather the required antigens resulting in false negative results. In the UK dome doctors have esitmate that 1 in 3 negative test results may be invalid, presumably due to this.

So true. Every time I see an article about some new testing technology I always read it hoping that it is announcing some quick, affordable and reliable saliva test because the swabbing is definitely a big weak link in current testing. Sadly so far I always end up disappointed. Reliable spit-in/on-something tests will be a game changer if they can be perfected and made fast and affordable.

 

[Taz Mangus]

When I got tested they just swabbed the opening of my nose lightly

When I got tested, they inserted the swab far back in my nostril and twisted it in a circular motion for 10 seconds. To be sure they did both nostrils for the test. That was fun.

 

[contacos]

When I got tested, they inserted the swab far back in my nostril and twisted it in a circular motion for 10 seconds. To be sure they did both nostrils for the test. That was fun.

I actually like the feeling lol it tickles. I was joking like "can you do both sides? it reminded me of when you get your ears cleaned out

 

[ArtOfWarfare]

within 20 years the things our smartphones and watches will be able to do for us medically will be incredible.

If Apple has reliable glucose monitoring in the Apple Watch this year, that’ll be absolutely amazing.

But I’m thinking Neuralink is going to be the real medical game changer. Anything that reaches the brain will be measurable. I’m guessing it’ll be possible to tell the brain to tell the body to manufacture a response to a virus it’s never seen before, like vaccines minus being injected or feeling ill when your immune system encounters the vaccine. Just skip straight to it being a memory so your immune system is ready for it. Maybe the brain will be the wrong entry point for this, but the tech can probably get applied elsewhere to get this result.

 

[LV426]

How did they fit that cassette tape into the iPhone?

 

[Dan08]

There is definitely some great info in this article, but this one is by no means the first smartphone-enabled rapid antigen test approved. There is one from Ellume that has been approved by hasn’t become available yet, and there is another that is currently available and being distributed called BinaxNOW. This one looks more like ellume since your phone connects to another device. The Binax Now tests use a phone but don’t strictly need it, it’s more like a testing strip.

 

[VermontsFinest]

The overlooked factor is the self administered nasal swap. Having had a swab myself I know how uncomfortable it is (it feels like the swab is scraping your brain) and I would seriously doubt how reliably the average person would be able to self-administer this. Not going far enough up the nose likely won't gather the required antigens resulting in false negative results. In the UK dome doctors have esitmate that 1 in 3 negative test results may be invalid, presumably due to this.

There are different kinds of swabs - anterior nare or posterior nasopharynx. The self-admin tests are typically anterior nare.

 

[BvizioN]

"Unfortunately, getting tested on a mainstream level currently requires a trip to a clinic or government instituted site."

Why is this "unfortunate"? It's normal, they're the experts, they know how to do it right (usually). What a strange point of view.

Because it is time consuming. Decades ago you had to make a trip to the bank to do basic things such as cancel direct debit, apply for a loan and stuff like that, now you do it on your smartphone. Time changes everything.

 

[Confused-User]

I know it's hard to perfectly copyedit stories, given the short time you have to write and post them. But even by the relaxed standards of internet publishing, this is the worst article I've ever seen on this site.

The first three sentences, in particular, are amazing. While I'm pretty sure I can figure out what the author meant to say, what they actually wrote was virtually babble. "tested on a mainstream level"? "breakthrough of what it means to get tested"?

Use fewer words.

 

[benshive]

"Unfortunately, getting tested on a mainstream level currently requires a trip to a clinic or government instituted site."

Why is this "unfortunate"? It's normal, they're the experts, they know how to do it right (usually). What a strange point of view.

It's obviously not trying to imply that getting tested at those sites is a problem or that there's anything wrong with expert opinion. It's saying that requiring that trip is a barrier to getting everyone tested because not everyone can make the trip to a testing site or is located conveniently close to one and the testing sites have a certain capacity they can't exceed. The scale of testing required is not something that these sites were probably designed to accommodate.

 

[windywalks]

I'm confused. Why does the app even need AI again? Is the only variable it needs to analyze the "C" or "T" marker line on the test or does it account for something else too? If so, is it really that hard to read the instructions?

 

[deannnnn]

Sooo the app just looks at the test and tells you what it says? When you could just look at it with your eyes and also know?

 

[nikaru]

"Unfortunately, getting tested on a mainstream level currently requires a trip to a clinic or government instituted site."

Why is this "unfortunate"? It's normal, they're the experts, they know how to do it right (usually). What a strange point of view.

Well the pregnancy test that you can buy in the pharmacy and do it yourself is quite convenient. This is what this comment refers to. It is even more important for infectious diseases to have rapid test that you can order online and get tested without leaving home and potentially infecting other people.

 

[nikaru]

Sooo the app just looks at the test and tells you what it says? When you could just look at it with your eyes and also know?

Yes, the the test also has Bluetooth so that you can pair it with your phone and see the result on your screen.

 

[Romeo_Nightfall]

There are really people here, defending this madness.
this makes no sense - its just more inconvenient - it would only make sense if you can automatic store historic data - which makes no sense for a binary result which mostly is 0

 

[johnny1970]

Science and technology will get the world out of this.

 

[Miles Teg]

MIT is working on a smartphone app that will detect covid by recording a forced cough. It is even able to detect people who are asymptomatic. They are awaiting FDA approval.

Study: Smartphone App Detects Asymptomatic COVID-19 by Recording Forced Coughs

MIT team-developed app, derived from Alzheimer's research, expected to seek FDA approval

www.healthleadersmedia.com