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.
Per 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.
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.
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.
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.
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.
>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.
Because there was a significant time period in which the rest of the world had access to Covid-19 tests but the US didn't, and this created political that forced the FDA to allow them. There isn't any similar pressure for other viruses, so the FDA maintains its ban on their production and sale.
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.
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.
I make decisions around how I interact with other people based upon that information, yes. I also might decide not to avoid someone based on that information too, if for example, we are sick with the same thing.
For a recent family holiday, I decided to postpone because one group had covid and the other had flu, and we decided that having both viruses at the same event would not be fun. But if we both had the same thing, we wouldn't have avoided each other.
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.
COVID is still an order of magnitude more immediately deadly than the usual influenza strain. Furthermore, influenza basically either kills you or it doesn't; COVID continues to have a horrible habit of leaving young and perfectly healthy people permanently disabled.
Covid is significantly worse than other widespread respiratory viruses, in that it clearly leaves a significant chunk of people disabled for months at a time if not permanently. (I personally had terrible fatigue for around 3 months afterwards. I've had a lot of respiratory illnesses, but this was the only time I had symptoms lasting months.)
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.
The problem I've had with this argument is immunocompromised individuals existed before COVID but masking and obsessive testing was nearly nonexistent outside the elderly and infirm. Now that things have largely reverted back to normal, why have behaviors not followed?
You make valid points but COVID broke people's brains and caused widespread hypochondria. People in this category are likely making poorer long term health choices (e.g. N95 masks should not be worn for more than a few hours as it's hard on your heart).
"Obsessive" is pretty loaded language! Also: normal has shifted, as it always does, so you should expect permanent changes in behavior. It used to be normal to smoke indoors; one of the few good outcomes of Covid is that people are a lot more serious about building ventilation than they used to be, thankfully.
Anyway, the new normal _still_ includes Covid, and Covid is still a significant risk to the naive (un-or-insufficiently vaccinated or people who haven't had it yet). It's comparably risky to a bad flu, which is a pretty real thing.
Do you have a citation for the N95 risk? I'm sure a bunch of painters and woodworkers would be interested in that.
N95 respirators may make breathing more difficult and lead to increased breathing and heart rates. Individuals with heart and respiratory conditions should check with their doctor before wearing an N95 respirator.
N95 usage results in significantly elevated CO2 levels, reduced O2, and increased heart rate, with far more pronounced effects in overweight individuals. This is common knowledge and there have been plenty of medical articles published about this for years pre-COVID; Google them if you wish.
If anyone has done drywall or woodworking you know what a relief it is when you pull that mask off.
I am a strong believer in PPE. Wearing it when it's not necessary isn't a great idea.
> State of California says max of 8 hours. I assume this is over a 24 hour period.
From the page you point to about use for protection against wildfire smoke, it sounds like it is 8 hours use for a single mask, after which the mask should be discarded and replaced.
> N95 usage results in significantly elevated CO2 levels, reduced O2, and increased heart rate, with far more pronounced effects in overweight individuals.
In healthcare workers, only in heart rate, not CO2 or O2 [0]; the other factors may occur in the normal environment for non-medical N95 use (outside of the COVID pandemic) – i.e., dealing with particularly particulate-polluted environments, where the particulates will accumulated on the outside of the respirator (outside of the unique circumstances of the pandemic, healthcare N95 use has historically been either for a single encounter or perhaps a period – rarely more than a couple hours – in a diagnosis-segregated environment, since otherwise it would create an exposure risk more than protecting against it.)
Perhaps they discovered that wearing a mask wasn’t a particularly big deal for them and they don’t see a reason to stop. If I had the choice between wearing a mask in the office and getting one cold per year I would seriously consider the mask.
> The problem I've had with this argument is immunocompromised individuals existed before COVID but masking and obsessive testing was nearly nonexistent outside the elderly and infirm. Now that things have largely reverted back to normal, why have behaviors not followed?
My general hope from society is that we learn new things and improve over time. COVID completely changed the public and expert understanding of airborne illnesses.
While cloth masks don't work, N95-grade masks absolutely do.
I'm sure I'm going to get greyed for this reply, as well as for being a stickler for terms such as "vaccine" keeping their traditional meanings, but I may have an answer for you.
If you, like me, avoided the mRNA gene therapy injections, but still attend barbecues and other get-togethers, it's a good way of confirming that you were the recipient of spike proteins from one of the injected. Sunday before last (8 days ago), I was gifted Covid-19 a third time since Easter 2020 (took a test to be sure) from a bowl of spicy Fuego Takis at a barbecue, likely from licking my fingers clean of all the powder rather than washing them with soap and water.
The reason it was worth confirming that it was Covid was because of the irregular heartbeat I had during the first two days of the illness, and I wanted to make sure it wasn't something unrelated. Post-testing, I knew that 50mg daily zinc and vitamin C & D megadoses was all I needed for the rest of the week.
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..."
Uh, no, I had it a few months ago and it was a lot worse than a cold. Not to mention potential long-Covid symptoms.
More importantly, my 85-year-old father-in-law finally got it despite precautions, and he had quite a hard time. I really don’t want to be the one who brings him a second infection.
I'm almost certain those changes were to reduce production costs. This is a widespread endemic (no pun intended) across many industries.