10 ms·

FDA: Do Not Use Cue Health's Covid-19 Tests Due to Risk of False Results

59 points by resolutebat 2y ago

Olesya000 2y ago
[dead]
userbinator 2y ago
The FDA issued a Warning Letter to Cue Health on May 10, 2024, after an inspection revealed the company made changes to these tests and these changes reduced the reliability of the tests to detect SARS-CoV-2 virus. I'm almost certain those changes were to reduce production costs. This is a widespread endemic (no pun intended) across many industries.
- simonster 2y ago
  Per https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cue-health-inc-675673-05092024 https://www.fda.gov/inspections-compliance-enforcement-and-c..., it looks like the FDA is unhappy that Cue did something to identify whether the cartridge went outside of the allowed temperature parameters in transit (CP-4166 says that the seller is responsible if a device malfunctions due to damage in transit) and didn’t test each lot as much as they were supposed to or maybe used a lower accuracy threshold than stated in their claims.
  - DannyBee 2y ago
    For the last part: The accuracy authorized was 99.1%. They are now only trying to meet 96%.
shwaj 2y ago
The Cue tests may be unreliable, but at least they’re expensive! My company was providing Cue test cartridges for free. They always struck me as over engineered.
- jlund-molfese 2y ago
  Similarly, the only over-the-counter flu test you can buy in the US is disposable, requires AA batteries and costs $50. Feels wasteful throwing the whole thing away, but I guess that’s normal for medical devices. https://www.lucirabypfizer.com/ https://www.lucirabypfizer.com/
- z2 2y ago
  My company had us take the Ellume test, which was also over engineered as it was just a glorified one time use Bluetooth color sensor wrapped over a standard strip. I did start taking them apart and harvested several years' supply of CR2032 batteries though.
lotsofpulp 2y ago
I never understood why Covid 19 tests are easily available, but other corona/influenza/rhino/roto/nora/adeno/entero/etc are not. I have kids in daycare, and we’ve probably gone through most of them, but why is the focus on a single virus? I got laid out by influenza type A in 2022, and had to pay $175 to an urgent care to get tested for that.
- Arainach 2y ago
  >I never understood why Covid 19 tests are easily available, but other corona/influenza/rhino/roto/nora/adeno/entero/etc are not. Simplest answer: because due to the contagious nature of the virus there was a large economic incentive to being able to rapidly and accurately assess whether someone was sick, and because many businesses/governments had explicit rules around attending while infected with COVID. Similar resources and rules were not in place for other viruses. Full answer: because it's a novel, actively evolving virus that poses significant health risks and is significantly more contagious than the other viruses you mentioned.
  - kube-system 2y ago
    And I think diagnostic tests are generally regarded as requiring the interpretation of a professional.
  - maxerickson 2y ago
    Combo antigen tests have been available in other countries for quite some time (COVID, Flu and RSV), for pretty low cost. The FDA is concerned that we are stupid, so we aren't allowed to use them.
  - Ferret7446 2y ago
    I think the actual simplest answer can be understood if you take a look at the account statements of pharmaceutical companies around 2020.
- tedivm 2y ago
  Other countries have them, but for some reason they aren't approved in the US.
wannacboatmovie 2y ago
People are still taking Covid tests? It has become indistinguishable from a common cold at this point. Save your money and buy some chicken soup.
- sunshowers 2y ago
  I still regularly test before going to gatherings and events.
  - wannacboatmovie 2y ago
    How is having the knowledge of presence (or absence) of Covid-19 measurably different than having influenza, rhinovirus, or any of another dozen respiratory viruses? Are you testing for all of them? This is my opinion, but that sounds totally unnecessary and so singularly focused to render itself ineffective (I understand the altruistic part). There are people in my office that continue to wear N95 respirators, alone, in their cubicle on a daily basis. I feel sorry for their personal burden because at this point it's clear they are never going to stop. At some point you have to let go for life to have the ability to return to normal. This theater made sense when Covid was mostly lethal, which set it apart from other common illnesses. This is no longer the case.
    - refulgentis 2y ago
      No offense, trying to help: this is a whole lot of mind reading wrapped in condescension. You have absolutely no idea what their health status is, and COVID is still COVID. With wide vaccine availability and the likelihood of 0 exposure decreased, the rest of us can giggle about malformed psyches, but there's plenty of people who still need to avoid it like the plague. I empathize with you, my instinctual reaction when I see someone masking outdoors is to roll my eyes. Then I walk through "well gee maybe they have it and don't wanna spread it, or, or, or..."
    - adw 2y ago
      You don’t know their personal circumstances. Maybe they’re in the same situation as you (I’m assuming “generally in good health”), but they are just more anxious than you and you believe that’s unnecessary. On the other hand, some people - yes, in your workplace - are likely immunocompromised or caring for someone who is; disease risk is not evenly distributed and COVID did make this set of risks meaningfully and continuously worse. You can’t tell the difference just by looking at someone.
WheatMillington 2y ago
Who is still testing for Covid, and why? If you're sick, stay home. What useful information does a positive Covid test give you?
- adw 2y ago
  If you're at risk, you're probably better off taking the antivirals than not, and it lets you know whether you should ask your doctor for some?
- geor9e 2y ago
  If you live completely alone and don't leave home, sure, testing doesn't really apply. In my house, if someone is sick and visiting the kitchen every couple hours hacking up a lung, but won't spend 3 minutes to crack open one of those free government tests, that would be a bit rude. Catching any virus sucks, so I'd appreciate an FYI about if the air they're exhaling has the virility to infect an average of 6 people or an average of 1 person (or whatever the latest research has determined the wildly high R-value of infectiousness to be of covid vs a cold). The difference affects how active I need to be to avoid catching a bug.
- giraffe_lady 2y ago
  It still kills like a thousand people a week in the US and that is, still, almost certainly a dramatic undercount. It remains far far more dangerous than the illnesses it can resemble. I spend a lot of time around disabled people whose risk profiles can accept masked interaction with a cold, but not covid.
deleted 2y ago
[deleted]
galkk 2y ago
Damn, I had really high hopes for cue tests as an idea and company overall. In theory they could do big variety of various tests. They have mpox in the app, the promo materials we’re talking about STIs. But this, together with recent layoffs (50% of staff, https://www.sandiegouniontribune.com/business/story/2024-05-02/this-san-diego-maker-of-covid-19-tests-is-laying-off-half-its-workforce https://www.sandiegouniontribune.com/business/story/2024-05-...) seems like a death blow. Was it another theranos and the approach was not feasible from the beginning?
gleenn 2y ago
Ya know, it's horrible to suggest allowing a company giving out bad test results to continue operating is a good idea. But on the backdrop of the US having the most expensive health care in the world and getting some of the worst service, at least these people were probably mostly right? I wonder if we fall into this fallacy of "health care should be perfect" so they should be able to ask whatever price they want. People in the US don't get to see the bill until after the procedure, if that's the norm then of course we're getting screwed.

59 points by resolutebat 2y ago

[dead]

The FDA issued a Warning Letter to Cue Health on May 10, 2024, after an inspection revealed the company made changes to these tests and these changes reduced the reliability of the tests to detect SARS-CoV-2 virus. I'm almost certain those changes were to reduce production costs. This is a widespread endemic (no pun intended) across many industries.

simonster 2y ago
Per https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cue-health-inc-675673-05092024 https://www.fda.gov/inspections-compliance-enforcement-and-c..., it looks like the FDA is unhappy that Cue did something to identify whether the cartridge went outside of the allowed temperature parameters in transit (CP-4166 says that the seller is responsible if a device malfunctions due to damage in transit) and didn’t test each lot as much as they were supposed to or maybe used a lower accuracy threshold than stated in their claims.
- DannyBee 2y ago
  For the last part: The accuracy authorized was 99.1%. They are now only trying to meet 96%.

shwaj 2y ago

The Cue tests may be unreliable, but at least they’re expensive! My company was providing Cue test cartridges for free. They always struck me as over engineered.

jlund-molfese 2y ago
Similarly, the only over-the-counter flu test you can buy in the US is disposable, requires AA batteries and costs $50. Feels wasteful throwing the whole thing away, but I guess that’s normal for medical devices. https://www.lucirabypfizer.com/ https://www.lucirabypfizer.com/
z2 2y ago
My company had us take the Ellume test, which was also over engineered as it was just a glorified one time use Bluetooth color sensor wrapped over a standard strip. I did start taking them apart and harvested several years' supply of CR2032 batteries though.

lotsofpulp 2y ago

I never understood why Covid 19 tests are easily available, but other corona/influenza/rhino/roto/nora/adeno/entero/etc are not. I have kids in daycare, and we’ve probably gone through most of them, but why is the focus on a single virus? I got laid out by influenza type A in 2022, and had to pay $175 to an urgent care to get tested for that.

Arainach 2y ago
>I never understood why Covid 19 tests are easily available, but other corona/influenza/rhino/roto/nora/adeno/entero/etc are not. Simplest answer: because due to the contagious nature of the virus there was a large economic incentive to being able to rapidly and accurately assess whether someone was sick, and because many businesses/governments had explicit rules around attending while infected with COVID. Similar resources and rules were not in place for other viruses. Full answer: because it's a novel, actively evolving virus that poses significant health risks and is significantly more contagious than the other viruses you mentioned.
- kube-system 2y ago
  And I think diagnostic tests are generally regarded as requiring the interpretation of a professional.
- maxerickson 2y ago
  Combo antigen tests have been available in other countries for quite some time (COVID, Flu and RSV), for pretty low cost. The FDA is concerned that we are stupid, so we aren't allowed to use them.
- Ferret7446 2y ago
  I think the actual simplest answer can be understood if you take a look at the account statements of pharmaceutical companies around 2020.
tedivm 2y ago
Other countries have them, but for some reason they aren't approved in the US.

wannacboatmovie 2y ago

People are still taking Covid tests? It has become indistinguishable from a common cold at this point. Save your money and buy some chicken soup.

sunshowers 2y ago
I still regularly test before going to gatherings and events.
- wannacboatmovie 2y ago
  How is having the knowledge of presence (or absence) of Covid-19 measurably different than having influenza, rhinovirus, or any of another dozen respiratory viruses? Are you testing for all of them? This is my opinion, but that sounds totally unnecessary and so singularly focused to render itself ineffective (I understand the altruistic part). There are people in my office that continue to wear N95 respirators, alone, in their cubicle on a daily basis. I feel sorry for their personal burden because at this point it's clear they are never going to stop. At some point you have to let go for life to have the ability to return to normal. This theater made sense when Covid was mostly lethal, which set it apart from other common illnesses. This is no longer the case.
  - refulgentis 2y ago
    No offense, trying to help: this is a whole lot of mind reading wrapped in condescension. You have absolutely no idea what their health status is, and COVID is still COVID. With wide vaccine availability and the likelihood of 0 exposure decreased, the rest of us can giggle about malformed psyches, but there's plenty of people who still need to avoid it like the plague. I empathize with you, my instinctual reaction when I see someone masking outdoors is to roll my eyes. Then I walk through "well gee maybe they have it and don't wanna spread it, or, or, or..."
  - adw 2y ago
    You don’t know their personal circumstances. Maybe they’re in the same situation as you (I’m assuming “generally in good health”), but they are just more anxious than you and you believe that’s unnecessary. On the other hand, some people - yes, in your workplace - are likely immunocompromised or caring for someone who is; disease risk is not evenly distributed and COVID did make this set of risks meaningfully and continuously worse. You can’t tell the difference just by looking at someone.

WheatMillington 2y ago

Who is still testing for Covid, and why? If you're sick, stay home. What useful information does a positive Covid test give you?

adw 2y ago
If you're at risk, you're probably better off taking the antivirals than not, and it lets you know whether you should ask your doctor for some?
geor9e 2y ago
If you live completely alone and don't leave home, sure, testing doesn't really apply. In my house, if someone is sick and visiting the kitchen every couple hours hacking up a lung, but won't spend 3 minutes to crack open one of those free government tests, that would be a bit rude. Catching any virus sucks, so I'd appreciate an FYI about if the air they're exhaling has the virility to infect an average of 6 people or an average of 1 person (or whatever the latest research has determined the wildly high R-value of infectiousness to be of covid vs a cold). The difference affects how active I need to be to avoid catching a bug.
giraffe_lady 2y ago
It still kills like a thousand people a week in the US and that is, still, almost certainly a dramatic undercount. It remains far far more dangerous than the illnesses it can resemble. I spend a lot of time around disabled people whose risk profiles can accept masked interaction with a cold, but not covid.

deleted 2y ago

[deleted]

galkk 2y ago

Damn, I had really high hopes for cue tests as an idea and company overall. In theory they could do big variety of various tests. They have mpox in the app, the promo materials we’re talking about STIs. But this, together with recent layoffs (50% of staff, https://www.sandiegouniontribune.com/business/story/2024-05-02/this-san-diego-maker-of-covid-19-tests-is-laying-off-half-its-workforce https://www.sandiegouniontribune.com/business/story/2024-05-...) seems like a death blow. Was it another theranos and the approach was not feasible from the beginning?

gleenn 2y ago

Ya know, it's horrible to suggest allowing a company giving out bad test results to continue operating is a good idea. But on the backdrop of the US having the most expensive health care in the world and getting some of the worst service, at least these people were probably mostly right? I wonder if we fall into this fallacy of "health care should be perfect" so they should be able to ask whatever price they want. People in the US don't get to see the bill until after the procedure, if that's the norm then of course we're getting screwed.