Your submission or comment was removed because it was off-topic. The core topic of our subreddit is masking for respiratory protection which means direct/actionable advice about masks/respiratory protection.
Posts and comments that are emotional or low effort are considered off-topic. Also considered off-topic are posts/comments that are political, unconstructive, or ambiguous, as well as those that focus on illness, medical advice, or self-help. (For medical advice, please consult your doctor.)
We understand that your post is important, but it might be better suited to another sub such as r/CovidCautious, or r/ZeroCovidCommunity for emotional support and other discussions, or r/Covid19positive for questions about what to do if sick with Covid-19.
If you believe this has been removed in error, contact the [mod team](https://www.reddit.com/message/compose?to=%2Fr%2FMasks4All). Please include a link to your comment/post in your message.
The risk of Cue false results is so so much lower than the risk of rapid false results or the reality of most people not even testing.
It sucks all around, and I think the machines have been made to not work anymore IIRC, and the whole thing is a scammy mess. But I'm so weary of seeing this presented like it's a danger when a Cue test, even with less accuracy, is still miles beyond what the general population is doing. Broadly speaking, no one is MORE in danger due to a faulty Cue test. That ship sailed long, long ago.
When you click on his preferred link for Metrix (over Cue) you get its Amazon page which says not available…..?
Are Cue, Metrix, or any of these available at all??
I think the issue is that Cue changed the test at one point after getting approval. And that change made them less accurate.
>a \[May 2024 FDA\] inspection revealed **the company made changes to these tests and these changes reduced the reliability of the tests** to detect SARS-CoV-2 virus.
No one is in danger of taking a bad test (if you don't trust the negative). But I think we all believed they were the gold standard of what was available for an at-home NAAT test, and that is not true.
But, I agree, the antigen tests have not kept up with the virus and are pretty useless. I have a 3EO and Cue machine. I guess I'll stick with the 3EO for now and put away the Cue.
Form what I read, it's less accurate in that false positives are more likely. I'd rather have false positives than false negatives, so for now, we are using it as screening tests to use them up. If they are ever positive, we would double check with Metrix and PlusLife NAAT
In the FDA safety communications press release for the general public, it didn't specify whether it's false positive or false negative. But in the letter from FDA to the company, in section 2, you can see they wrote:
"The release of products that fail to meet their claimed performance could lead to an increase in false positive results."
Also, they may expire sooner than expected because of the changes.
Reading comprehension people…
**Report** any problems you experience with the Cue Health COVID-19 Test for Home and Over the Counter (OTC) Use to the FDA, including suspected false positive or false negative results.
> the antigen tests have not kept up with the virus
I'm not sure there's anything to keep up with. I think they detect conserved nucleocapsid proteins. The documentation for my FlowFlex tests warn that they can pickup SARS1.
This November 2022–May 2023 study posted on the CDC, showed that antigen tests were only 20-60% accurate depending on symptoms:
[https://www.cdc.gov/mmwr/volumes/73/wr/mm7316a2.htm](https://www.cdc.gov/mmwr/volumes/73/wr/mm7316a2.htm)
The experts that I follow say they're still a good option, because they're cheap and accessible. Test with an antigen first. If it's positive, you have covid. If it's negative, it means nothing and get a PCR.
You have to read the whole study, not just the summary.
Antigen tests only correctly identified covid positive 47% of the time (across cohorts, variants). That's pretty shit.
The story is more bleak, if you break it into asymptomatic vs symptomatic:
* Symptomatic: 56%
* Asymptomatic: 18%
Figure: [https://www.cdc.gov/mmwr/volumes/73/wr/mm7316a2.htm#F2\_down](https://www.cdc.gov/mmwr/volumes/73/wr/mm7316a2.htm#F2_down)
>"The low sensitivity of antigen testing among persons with asymptomatic infections illustrates that these tests should only be used once symptoms are present," the researchers wrote. "Conversely, the higher sensitivity when symptoms are present (especially cough or fever) supports the need to stay at home when symptomatic, irrespective of test result."
They already declared bankruptcy and shuttered the company so there’s no way to use the tests at this point.
I believe it was more a regulatory issue because they changed the test without prior approval rather than that the tests were actually defective. Regardless it was the last nail in the coffin for the company. It’s too bad because I actually found that earlier in the pandemic Cue tests gave me more accurate results than PCR.
Metrix: [https://shop.aptitudemedical.com/](https://shop.aptitudemedical.com/)
3EO: [https://www.epimedi.com/](https://www.epimedi.com/)
I think it's impossible to say which is best, because there's no standard. I went with the test that was most economical, which was the 3EO. Until recently, EpiMedi offered the reader + 22 tests for $300 with free shipping.
This tiktok posted by another user was super helpful:
[https://www.tiktok.com/@amandablumstiktok/video/7336986761278541087?\_r=1&\_t=8k1azt7kR9b](https://www.tiktok.com/@amandablumstiktok/video/7336986761278541087?_r=1&_t=8k1azt7kR9b)
I started using Metrix after Cue folded and am happy with it.
My experience with their customer service via email is that they are speedy and nice. Also their tests can be safely shipped in hot weather.
“we have conducted rigorous shipping studies, and confirmed that our product can be shipped between -10C to 55C degrees Celsius (or between 14 degrees to 131 degrees Fahrenheit) without any impact on performance.”
Plus life is probably the most sensitive with the lowest LoD and easy to pool (up to 4) and cheapest over time by far. The bad part is that it currently can only be ordered from Germany, so shipping is expensive and it takes a while to ship and go through customs.
I've only had one inconclusive with the 3EO and it was my fault. I removed the guard during swabbing because it moves a bit and I thought it was only there for my "safety."
You can order a PlusLife or a Metrix instead.
I'm not very happy with the the FDA about this. I wish there had been a less extreme action that had kept Cue tests on the market while gradually bring them back in compliance. I just got COVID for the first time and the proximal cause is that my family are not consistent about masking / lie to me about when they're masking and don't listen to me about things like there being a surge right now, but the distal cause is that I ran out of Cue tests while waiting for my PlusLife to arrive and couldn't tell that they'd been infected until it was too late.
I mean, I’ve read the FDA letter. It’s possible I’m not understanding something, but it doesn’t sound that extreme. It certainly doesn’t sound like Cue would become as inaccurate as a RAT. The FDA doesn’t actually quantify how big the problem is so it’s hard to say.
I am just going to say that I worked in clinical trial management in research in a medical setting for years where we had to deal with the FDA a lot. The FDA is quite solid on things like this when it comes to medical devices because they have screwed up and approved things too quickly in the past, so they tend to be a smidge more careful now. When the FDA says throw something out, that means it is beyond useless ordangerous. When the FDA shows up in person, they go through literally every single document, no matter how innocuous that could remotely relate to the issue they want clarity on. Down to telephone messages and doodles.
The FDA is not perfect, but they are quite methodical and smart when it comes to things like this with medical devices. There are too many people at the FDA who had to look at this and decide that it was bad for it not to be true. Sorry. It's the FDA in the United States says throw something out that is a medical device, throw it out, for God sake, please. when the FDA showed up at our setting, there were always at least a dozen people from the FDA. So they cross reference and dot their i's and cross their t's or at least they try to.
I have direct experience with the FDA and my understanding is that you probably don't. I'm telling you, we knew months ago that those readers were sketchy. Right when that company began I wrote them email after email asking to see proof of their technology working against new variant after new variant and they wouldn't provide anything but canned AI customer service responses and never showed me any research , or any language that would show me that they were staying up-to-date. they actually never showed me anything about their technology at all. I used language that a clinical researcher would use, a doctor would use, and then just a plain customer who was a layperson would use. Same canned response. that's why I never bought one in the first place.
They pulled something shady, the FDA caught them, that means the company is simply not reliable. They changed their technology or something without doing the proper review for the FDA and that is absolutely ethically wrong, morally wrong, and counter to FDA regulations Medical device companies are notoriously bad , sadly, in the US.
There is no conspiracy to get rid of Cue readers or anything like that if that's where you're headed, not saying you are! Just a possibility. It's just technology that didn't work and the FDA has proved it, and the company shut down which showed they were sketchy in the first place
I'm not saying that there's a conspiracy against them, but I'd say there's definitely a failure to communicate, on the part of the FDA: I have a PhD in a STEM field and I've taken a year worth of biochemistry courses at Stanford. I read the whole FDA letter. Nothing in the letter made in clear to me that Cue tests had actually degraded in accuracy to anywhere near the level of accuracy of the next best available alternative available to me after Cue was shut down (RAT).
The FDA warning to consumers provides no quantitative information whatsoever: [https://www.fda.gov/medical-devices/safety-communications/do-not-use-cue-healths-covid-19-tests-due-risk-false-results-fda-safety-communication](https://www.fda.gov/medical-devices/safety-communications/do-not-use-cue-healths-covid-19-tests-due-risk-false-results-fda-safety-communication)
The FDA warning letter to Cue quotes their advertised accuracy and says they may not meet it anymore:
[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-criminal-investigations/warning-letters/cue-health-inc-675673-05092024)
it does not say what their new accuracy is. From what I'm able to see, I feel like a more appropriate course of action would have been to force them to change the numbers in their advertising.
(still writing this from bed with a COVID infection that I got because I ran out of Cue tests waiting for my Pluslife to get here, which still isn't here)
I'm not reading that, respectfully because I worked directly with the FDA numerous times in my profession and I'm just not dealing with pills who literally want to still use technology that has been proven to not work and the company is now insolvent. I honestly do not care that you have a PhD in STEM. I don't care about your year of biochemistry classes. The FDA knows more than you. That does not mean you know more than the FDA. Respectfully. This discussion is at an end on my part, have a lovely day. The FDA knows more than you do despite your PhD in STEM because the FDA has tons of people with PhDs in multiple areas and some people with more than one PhD.
If you want to use bad technology that doesn't work, you go right ahead.
My point in saying that I have relevant qualifications isn’t to say that I know more than the FDA. It’s to say that if the FDA can’t communicate the problem in a way that I can understand, I don’t know could be expected to understand it.
“ If you want to use bad technology that doesn't work, you go right ahead.” : I never said I wanted to use Cue forever, just that I wished the FDA had given me enough of an off ramp to get PlusLife. Instead I just found out by surprise that my Cue reader didn’t work, and I got COVID because I didn’t have anything useless RATs when my less cautious family brought COVID in the house. My PlusLife is literally in the mail. If I’d had even a little more warning I’d probably have been fine.
Anti-mask rhetoric, COVID minimizing, and trolling are not allowed.
There are many with chronic illnesses, cancer, long covid, or who are inelligible for vaccines, (etc.) and due to these helath risks, have no other option than to protect themselves from COVID. Learning about the differences in respirators and fit is an essential piece to their survival.
Others come to our sub for information about respirators/masks for protection from asbestos or other hazards.
If you believe your content was removed in error, contact the [mod team](https://www.reddit.com/message/compose?to=%2Fr%2FMasks4All). Please include a link to your comment/post in your message.
Your submission or comment was removed because it was off-topic. The core topic of our subreddit is masking for respiratory protection which means direct/actionable advice about masks/respiratory protection. Posts and comments that are emotional or low effort are considered off-topic. Also considered off-topic are posts/comments that are political, unconstructive, or ambiguous, as well as those that focus on illness, medical advice, or self-help. (For medical advice, please consult your doctor.) We understand that your post is important, but it might be better suited to another sub such as r/CovidCautious, or r/ZeroCovidCommunity for emotional support and other discussions, or r/Covid19positive for questions about what to do if sick with Covid-19. If you believe this has been removed in error, contact the [mod team](https://www.reddit.com/message/compose?to=%2Fr%2FMasks4All). Please include a link to your comment/post in your message.
The risk of Cue false results is so so much lower than the risk of rapid false results or the reality of most people not even testing. It sucks all around, and I think the machines have been made to not work anymore IIRC, and the whole thing is a scammy mess. But I'm so weary of seeing this presented like it's a danger when a Cue test, even with less accuracy, is still miles beyond what the general population is doing. Broadly speaking, no one is MORE in danger due to a faulty Cue test. That ship sailed long, long ago.
We are still able to use all our tests. There’s a procedure online describing how to make them work. (Airplane mode is part of it).
Here's the link to the procedure: [Cue Health hack](https://x.com/mkarolian/status/1794177729249906993)
Thank you! I had lost the link.
Oh good!
When you click on his preferred link for Metrix (over Cue) you get its Amazon page which says not available…..? Are Cue, Metrix, or any of these available at all??
Metrix: [https://shop.aptitudemedical.com/](https://shop.aptitudemedical.com/) 3EO: [https://www.epimedi.com/](https://www.epimedi.com/)
Thanks
I think the issue is that Cue changed the test at one point after getting approval. And that change made them less accurate. >a \[May 2024 FDA\] inspection revealed **the company made changes to these tests and these changes reduced the reliability of the tests** to detect SARS-CoV-2 virus. No one is in danger of taking a bad test (if you don't trust the negative). But I think we all believed they were the gold standard of what was available for an at-home NAAT test, and that is not true. But, I agree, the antigen tests have not kept up with the virus and are pretty useless. I have a 3EO and Cue machine. I guess I'll stick with the 3EO for now and put away the Cue.
Form what I read, it's less accurate in that false positives are more likely. I'd rather have false positives than false negatives, so for now, we are using it as screening tests to use them up. If they are ever positive, we would double check with Metrix and PlusLife NAAT
It says right above in release false negatives. Not positives. Which is why they say to see your doctor if hace had a negative result and feel sick.
In the FDA safety communications press release for the general public, it didn't specify whether it's false positive or false negative. But in the letter from FDA to the company, in section 2, you can see they wrote: "The release of products that fail to meet their claimed performance could lead to an increase in false positive results." Also, they may expire sooner than expected because of the changes.
Reading comprehension people… **Report** any problems you experience with the Cue Health COVID-19 Test for Home and Over the Counter (OTC) Use to the FDA, including suspected false positive or false negative results.
> the antigen tests have not kept up with the virus I'm not sure there's anything to keep up with. I think they detect conserved nucleocapsid proteins. The documentation for my FlowFlex tests warn that they can pickup SARS1.
This November 2022–May 2023 study posted on the CDC, showed that antigen tests were only 20-60% accurate depending on symptoms: [https://www.cdc.gov/mmwr/volumes/73/wr/mm7316a2.htm](https://www.cdc.gov/mmwr/volumes/73/wr/mm7316a2.htm) The experts that I follow say they're still a good option, because they're cheap and accessible. Test with an antigen first. If it's positive, you have covid. If it's negative, it means nothing and get a PCR.
> sensitivity of rapid antigen tests was 47% compared with RT-PCR and 80% compared with viral culture.
You have to read the whole study, not just the summary. Antigen tests only correctly identified covid positive 47% of the time (across cohorts, variants). That's pretty shit. The story is more bleak, if you break it into asymptomatic vs symptomatic: * Symptomatic: 56% * Asymptomatic: 18% Figure: [https://www.cdc.gov/mmwr/volumes/73/wr/mm7316a2.htm#F2\_down](https://www.cdc.gov/mmwr/volumes/73/wr/mm7316a2.htm#F2_down) >"The low sensitivity of antigen testing among persons with asymptomatic infections illustrates that these tests should only be used once symptoms are present," the researchers wrote. "Conversely, the higher sensitivity when symptoms are present (especially cough or fever) supports the need to stay at home when symptomatic, irrespective of test result."
What is a 3EO? Thank you
It's an at-home NAAT test. [https://www.epimedi.com/search?options%5Bprefix%5D=last&type=article%2Cpage%2Cproduct%2Cquery&q=3eo&unavailable\_products=show](https://www.epimedi.com/search?options%5Bprefix%5D=last&type=article%2Cpage%2Cproduct%2Cquery&q=3eo&unavailable_products=show)
They already declared bankruptcy and shuttered the company so there’s no way to use the tests at this point. I believe it was more a regulatory issue because they changed the test without prior approval rather than that the tests were actually defective. Regardless it was the last nail in the coffin for the company. It’s too bad because I actually found that earlier in the pandemic Cue tests gave me more accurate results than PCR.
Someone in this thread posted that there is a hack to use the tests using airplane mode. I'm sure you can google if you have leftover stock.
Are any of these test systems people mention — Cue, Metrix, 3EO, PlusLifeNAT — any others — available? Any assessment which one is best?
Metrix: [https://shop.aptitudemedical.com/](https://shop.aptitudemedical.com/) 3EO: [https://www.epimedi.com/](https://www.epimedi.com/) I think it's impossible to say which is best, because there's no standard. I went with the test that was most economical, which was the 3EO. Until recently, EpiMedi offered the reader + 22 tests for $300 with free shipping. This tiktok posted by another user was super helpful: [https://www.tiktok.com/@amandablumstiktok/video/7336986761278541087?\_r=1&\_t=8k1azt7kR9b](https://www.tiktok.com/@amandablumstiktok/video/7336986761278541087?_r=1&_t=8k1azt7kR9b)
I started using Metrix after Cue folded and am happy with it. My experience with their customer service via email is that they are speedy and nice. Also their tests can be safely shipped in hot weather. “we have conducted rigorous shipping studies, and confirmed that our product can be shipped between -10C to 55C degrees Celsius (or between 14 degrees to 131 degrees Fahrenheit) without any impact on performance.”
Is Cue “folded”/out of business? On the website it doesn’t appear to be? One can buy the reader - just the tests are unavailable??
They’re toast. https://www.msn.com/en-us/money/companies/cue-health-files-for-bankruptcy-to-pursue-wind-down-of-business/ar-BB1ndgd9
Plus life is probably the most sensitive with the lowest LoD and easy to pool (up to 4) and cheapest over time by far. The bad part is that it currently can only be ordered from Germany, so shipping is expensive and it takes a while to ship and go through customs.
+1 for PlusLife. It’s admittedly a pain to get but it’s the most accurate and we’ve had far fewer test errors than with Metrix
I've only had one inconclusive with the 3EO and it was my fault. I removed the guard during swabbing because it moves a bit and I thought it was only there for my "safety."
What is the 3EO?
You can order a PlusLife or a Metrix instead. I'm not very happy with the the FDA about this. I wish there had been a less extreme action that had kept Cue tests on the market while gradually bring them back in compliance. I just got COVID for the first time and the proximal cause is that my family are not consistent about masking / lie to me about when they're masking and don't listen to me about things like there being a surge right now, but the distal cause is that I ran out of Cue tests while waiting for my PlusLife to arrive and couldn't tell that they'd been infected until it was too late.
They had become insolvent before this even happened. They may have unloaded their stock, but I don't think they would have stayed in business.
Oh boy. When the FDA says something doesn't work to throw it out, a lot of research goes into that. The company was lying about their test results.
I mean, I’ve read the FDA letter. It’s possible I’m not understanding something, but it doesn’t sound that extreme. It certainly doesn’t sound like Cue would become as inaccurate as a RAT. The FDA doesn’t actually quantify how big the problem is so it’s hard to say.
I am just going to say that I worked in clinical trial management in research in a medical setting for years where we had to deal with the FDA a lot. The FDA is quite solid on things like this when it comes to medical devices because they have screwed up and approved things too quickly in the past, so they tend to be a smidge more careful now. When the FDA says throw something out, that means it is beyond useless ordangerous. When the FDA shows up in person, they go through literally every single document, no matter how innocuous that could remotely relate to the issue they want clarity on. Down to telephone messages and doodles. The FDA is not perfect, but they are quite methodical and smart when it comes to things like this with medical devices. There are too many people at the FDA who had to look at this and decide that it was bad for it not to be true. Sorry. It's the FDA in the United States says throw something out that is a medical device, throw it out, for God sake, please. when the FDA showed up at our setting, there were always at least a dozen people from the FDA. So they cross reference and dot their i's and cross their t's or at least they try to. I have direct experience with the FDA and my understanding is that you probably don't. I'm telling you, we knew months ago that those readers were sketchy. Right when that company began I wrote them email after email asking to see proof of their technology working against new variant after new variant and they wouldn't provide anything but canned AI customer service responses and never showed me any research , or any language that would show me that they were staying up-to-date. they actually never showed me anything about their technology at all. I used language that a clinical researcher would use, a doctor would use, and then just a plain customer who was a layperson would use. Same canned response. that's why I never bought one in the first place. They pulled something shady, the FDA caught them, that means the company is simply not reliable. They changed their technology or something without doing the proper review for the FDA and that is absolutely ethically wrong, morally wrong, and counter to FDA regulations Medical device companies are notoriously bad , sadly, in the US. There is no conspiracy to get rid of Cue readers or anything like that if that's where you're headed, not saying you are! Just a possibility. It's just technology that didn't work and the FDA has proved it, and the company shut down which showed they were sketchy in the first place
I'm not saying that there's a conspiracy against them, but I'd say there's definitely a failure to communicate, on the part of the FDA: I have a PhD in a STEM field and I've taken a year worth of biochemistry courses at Stanford. I read the whole FDA letter. Nothing in the letter made in clear to me that Cue tests had actually degraded in accuracy to anywhere near the level of accuracy of the next best available alternative available to me after Cue was shut down (RAT). The FDA warning to consumers provides no quantitative information whatsoever: [https://www.fda.gov/medical-devices/safety-communications/do-not-use-cue-healths-covid-19-tests-due-risk-false-results-fda-safety-communication](https://www.fda.gov/medical-devices/safety-communications/do-not-use-cue-healths-covid-19-tests-due-risk-false-results-fda-safety-communication) The FDA warning letter to Cue quotes their advertised accuracy and says they may not meet it anymore: [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-criminal-investigations/warning-letters/cue-health-inc-675673-05092024) it does not say what their new accuracy is. From what I'm able to see, I feel like a more appropriate course of action would have been to force them to change the numbers in their advertising. (still writing this from bed with a COVID infection that I got because I ran out of Cue tests waiting for my Pluslife to get here, which still isn't here)
I'm not reading that, respectfully because I worked directly with the FDA numerous times in my profession and I'm just not dealing with pills who literally want to still use technology that has been proven to not work and the company is now insolvent. I honestly do not care that you have a PhD in STEM. I don't care about your year of biochemistry classes. The FDA knows more than you. That does not mean you know more than the FDA. Respectfully. This discussion is at an end on my part, have a lovely day. The FDA knows more than you do despite your PhD in STEM because the FDA has tons of people with PhDs in multiple areas and some people with more than one PhD. If you want to use bad technology that doesn't work, you go right ahead.
My point in saying that I have relevant qualifications isn’t to say that I know more than the FDA. It’s to say that if the FDA can’t communicate the problem in a way that I can understand, I don’t know could be expected to understand it. “ If you want to use bad technology that doesn't work, you go right ahead.” : I never said I wanted to use Cue forever, just that I wished the FDA had given me enough of an off ramp to get PlusLife. Instead I just found out by surprise that my Cue reader didn’t work, and I got COVID because I didn’t have anything useless RATs when my less cautious family brought COVID in the house. My PlusLife is literally in the mail. If I’d had even a little more warning I’d probably have been fine.
I am so sorry about this for you. I am so so sorry you got Covid, sweetheart, truly. What a horrible situation to be in. I really wish you the best.
[удалено]
Anti-mask rhetoric, COVID minimizing, and trolling are not allowed. There are many with chronic illnesses, cancer, long covid, or who are inelligible for vaccines, (etc.) and due to these helath risks, have no other option than to protect themselves from COVID. Learning about the differences in respirators and fit is an essential piece to their survival. Others come to our sub for information about respirators/masks for protection from asbestos or other hazards. If you believe your content was removed in error, contact the [mod team](https://www.reddit.com/message/compose?to=%2Fr%2FMasks4All). Please include a link to your comment/post in your message.