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LabCorp’s at-home Covid-19 test kit is the first to be authorized by the FDA
- techdevangelist 7y agoWhat is the expectation people will actually get the swab far enough back to collect a meaningful sample? Having been on the receiving end of a nasal collected flu test, it was a pretty deep probing. I’m kind of doubtful most people can do it to themself properly without some prompting to ‘go deeper’.
- James_Henry 7y agoThere's evidence that for Covid-19 it's not necessary to go as far back as people have been going. There's also evidence that self-collection works well. The FDA has acknowledged this before and allowed self-collection with physician oversight before they allowed this test.
- MikeAmelung 7y agoWhere is this evidence? How does this square with the evidence that RT-PCR tests are already coming back falsely negative, probably due to missing the virus while swabbing? Pardon me for being skeptical, but this is all from the same people who have bungled this every step of the way.
- cbhl 7y agoI'm having trouble finding the actual study, but UnitedHealth Group, working with the Bill & Melinda Gates Foundation, Quest Diagnostics, and the University of Washington did a study on the efficacy of self-swabbing. https://techcrunch.com/2020/03/25/study-behind-updated-fda-guidance-shows-self-swab-tests-are-as-effective-as-those-done-by-clinicians/ https://techcrunch.com/2020/03/25/study-behind-updated-fda-g...
- James_Henry 7y agoI found the paper. I haven't read through it so I can't say if it is actually any good, but it is good enough that the FDA changed their recommendations because of it (that might not mean much, of course). https://www.medrxiv.org/content/10.1101/2020.04.01.20050005v1 https://www.medrxiv.org/content/10.1101/2020.04.01.20050005v...
- MikeAmelung 7y agoThanks for tracking it down. Doesn't seem to be any problem with accepting their results that it's almost as good as a nasopharyngeal swab, so you won't see me complaining about it again.
- takeda 7y agoNot really an evidence, but looks like their instructions explicitly say to not insert it deep: https://www.pixel.labcorp.com/covid-19-sample-collection https://www.pixel.labcorp.com/covid-19-sample-collection
- biased_coin 7y agoPrompting to 'go deeper' could potentially be done over a video call. I hope LabCorp does some sort of beta testing to know how well people do with instructions.
- James_Henry 7y agohttps://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2#troubleobtainingviraltransport https://www.fda.gov/medical-devices/emergency-situations-med... The FDA doesn't think it is necessary to go that deep.
- throwaway55554 7y agoPut a mark on the swab, put a rubber band around the mark on the swab and say it has to go back that far. Have a test for adults and another for children. But, the video from the actual labcorp website someone else posted shows it does not actually have to go very deep.
- edoceo 7y agoEven adult noses are different sizes, the depth is a relative measure.
- jacobriis 7y agoYou only need to swab the edge of your nostril for this test. https://www.pixel.labcorp.com/covid-19-sample-collection https://www.pixel.labcorp.com/covid-19-sample-collection
- clumsysmurf 7y agoIt was my understanding, that its easy to get false negatives with this kind of test because the virus moves down the respiratory track as time goes on. Too early, its not sensitive enough. Too late, nothing there. It has to be in a specific window of opportunity. Can somebody jump in and correct me if I am wrong?
- fspeech 7y agoIt is now thought that the virus can also infect cells in the nose. Cough and nasal discharge could also bring virus from deeper parts of the body to the nasal passage.
- cypherpunks01 7y agoIt does move down the respiratory tract, but nasal epithelial tissue can still contain/produce the virus for awhile even after it "moves". For me, I was able to physically feel the inflammation move down from my throat to lungs to abdomen, but that was 5 weeks ago, and I just tested positive on a deep nose swab rtPCR given yesterday. A lot of people are testing positive for surprisingly long time. I wouldn't be surprised if a light nasal swab like being discussed here doesn't pick up anything post-symptoms, whereas PCR with the deep nasal swab may still be detectable for a longer time after primary symptoms have faded.
- LatteLazy 7y agoI think they're just assuming you will pay 119USD (Plus tax and shipping) for a box because coronavirus. What you do with it after your transaction clears really isn't their concern...
- MikeAmelung 7y agoAs a childhood sufferer of semi-regular strep throat infections, I have a hard time believing people are going to willingly jam the swab back to where it needs to go. To me, it seems like this will just generate false negatives.
- protomyth 7y agojacobriis pointed out you only have to swab to the edge of your nostril https://news.ycombinator.com/item?id=22935617 https://news.ycombinator.com/item?id=22935617 Strep tests are just a pain. Had one or two every year of high school.
- WoodenChair 7y agoIs there a possibility of us getting an FDA sanctioned OTC antibody test in the near future so we can find out if we already had the virus?
- James_Henry 7y agoI'm sure it will come, but it looks like the FDA is waiting until the big companies ask for an EUA because they don't trust the startups (or the startups aren't able to do what LabCorp does?)
- pmiller2 7y agoThere's one available in Richmond, CA for $125: https://www.sfgate.com/bayarea/article/COVID-19-antibody-testing-available-in-Richmond-15206098.php https://www.sfgate.com/bayarea/article/COVID-19-antibody-tes...
- renewiltord 7y agoIt's $199 (+taxes).
- pmiller2 7y agoIt literally says $125 in the opening paragraph of the article I linked. Do you have updated information?
- renewiltord 7y agoYes, the lab itself. https://app.acuityscheduling.com/schedule.php?owner=19381748 https://app.acuityscheduling.com/schedule.php?owner=19381748
- pmiller2 7y agoThat seems very odd considering the SFGate article was published yesterday, and I presume they asked the lab how much it costs. I sent the lab an email to clarify. Let's see what they send back.
- ck2 7y agoWell, it's three months and 40,000 deaths late but it's a start. But there needs to be anonymous antibody testing at home like a pregnancy test. BTW also needs the post office properly funded and saved from bankruptcy. WTF are we bailing out cruise ships and not the post office?
- throwaway55554 7y agoFollow the money. Who do the CEOs of the cruise ships know that are in Congress?
- renewiltord 7y agoWell considering it's been three months and 40k deaths and you have given us nothing, I'm going to go with the guy who gave me something.
- deleted 7y ago[deleted]
- needle0 7y agoSo this has you take a sample and ship it to their lab. How is this going to deal with the risk of biohazard for parcel delivery personnel?
- stronglikedan 7y agoIt's no more risky than anything else an already infected person may ship, which is why the parcel delivery companies likely already have sufficient mitigation efforts in place.
- pwg 7y agoLikely something like how this at home mail in test handles those exact same risks: https://www.cologuardtest.com/ https://www.cologuardtest.com/ The sample is sealed inside a heavy grade plastic container with a screw top lid. The plastic container is sealed inside a heavy weight zip-lock bag already form fitted to the inside of the shipping box. The shipping box itself is quite sturdy. I suspect something similar for this new LabCorp test, just customized for a swab.
- refurb 7y agoHow has 21 and Me been dealing with vials of saliva making it to their lab? Shipping biological hazards is a solved problem.
- stronglikedan 7y ago$119 [0], since it's not mentioned in the article. Also, not yet available to the masses: > With limited quantities of kits available, Pixel by LabCorp is currently prioritizing healthcare workers and first responders, consistent with guidance from the CDC. We plan to make kits more broadly available soon so please check back. [0]https://www.pixel.labcorp.com/ https://www.pixel.labcorp.com/
- fmakunbound 7y agoAnyone know if that $119 at cost? LabCorp is going to make a killing of this crisis...
- malandrew 7y agoMaybe, maybe not. Their other tests have almost no demand right now due to coronavirus. How much of a killing they make will depend on which tests have better margins.
- hbosch 7y agoI believe LabCorp's Men's Health Test is relatively popular amongst guys looking to check their testosterone levels. The results can be taken to a "men's health physician", or a "bio-identical hormone physician", or whatever else they are called and used to justify legal hormone therapies (typically testosterone injections and/or estrogen-blockers). Common for bodybuilders, or even just dudes closing in on 60 who want to stay good at golf.
- deleted 7y ago[deleted]
- stronglikedan 7y agoLikely not "at cost", since a for-profit company should be expected to be making a profit, but probably close, considering the herculean effort to get these things to market, despite the red tape.
- ianhawes 7y ago> Pixel by LabCorp™ is not available in NY, NJ, MD, or RI due to restrictions on how laboratory tests may be ordered. Please talk with your healthcare provider about options for getting tested. Ah wonderful, so this rules out states accounting for 45% of the confirmed cases.
- joncrane 7y agoI remember when they banned 23andme in MD, I researched it and it turns out the health insurance companies successfully lobbied against it with the argument that information asymmetry may lead to loss of profits. I'm still salty and I think this is part of the same scenario. Having said that, I think Governor Hogan is one of the best governors out there wrt state level response to Covid. Right up there with Newsom and Cuomo.
- chimeracoder 7y ago> Right up there with Newsom and Cuomo. Cuomo cut Medicaid funding by $6 billion during the pandemic. He dragged his feet on issuing a stay-at-home order for a week after the city government had asked for one (the governor has the sole authority to authorize one in NY). San Francisco beat Cuomo to the punch by nearly a week, even though New York had been hit earlier and harder with COVID-19 cases. Cuomo also fought against closing NYC schools even after the city and teachers were already on board with the idea. As a result of New York's sluggish response, community spread of COVID-19 happened much more rapidly than it did in other urbanized areas of the country (most notably San Francisco), so hospitals were already overloaded even before the stay-at-home order had been issued. On top of that, Cuomo also expanded pretrial detention for nonviolent drug offenders during the pandemic, which puts even more people in unnecessary close contact. https://nymag.com/intelligencer/2020/04/cuomo-has-learned-nothing-from-the-catastrophe-at-rikers.html https://nymag.com/intelligencer/2020/04/cuomo-has-learned-no... As of today, 1 in 1000 New Yorkers who were alive a month ago are now dead. Cuomo might not be the only person responsible for the current situation in New York, but it's clear that things would be better in New York had Cuomo taken action instead of fighting public health officials at every turn.
- mdszy 7y agoExpecting profit during a catastrophe is exactly why the sitaution is as shit as it is right now.
- TomatoTomato 7y agoeconomic profit, gross profit, operating profit, or net profit?
- Wowfunhappy 7y agoBut then, why would any company take the risk of developing a new test?
- mdszy 7y agoIf you can't see beyond monetary benefit when it comes to saving lives then I have news for you: you're a psycopath.
- whatshisface 7y agoI think a reasonable calibration would be charity=good, usual behavior=usual, and active malice=bad. Having a return around the cost of capital is usual behavior, so I think complaining about a company profiting off a disaster by selling the product that they usually make is kind of like complaining about a person not giving to a food bank.
- pmiller2 7y ago"Usual behavior" should not be "usual" in such an extraordinary situation as a deadly pandemic. Your premise is flawed.
- whatshisface 7y agoBecause of the way our system works, you and I will pay that 10% in the form of taxes and insurance premiums. I for one, am glad to reward companies who are contributing to the solution for this crisis. Profit is the reward we give to companies for good behavior, and wouldn't you agree that companies who are making tests are behaving well?
- nikofeyn 7y agohow does this help? if you can test at home, so what? how does that change anything? it's not being tracked, can you trust results, etc.
- SkyPuncher 7y agoIt won't do much for most people - which is why healthcare workers and first responders are being prioritized. My wife is a doctor and cared for our county's first COVID-positive patient before he was formally diagnosed (took 11 days to get test results). She was on self-isolation for 3 weeks for late March/early April. Two weeks for the initial exposure, 1 more week because of a low-grade fever. We're still not certain if she had it (I got symptoms about 5 days after she did) because it was extremely difficult to get her tested. The challenge now is monitoring her with likely exposure when she'll be working in-patient for the month of June. While these tests aren't perfect, they can give us some direction on how we need handle things at home. The price is reasonable enough that we can simply order the test for her directly without having to call 20 different people across 3 different hospital systems to get the sign-off on testing. A negative doesn't tell us much (as she could still have it), but a positive is a strong indication that she should be avoiding patient interactions and likely self-isolating at home.
- SketchySeaBeast 7y ago> A negative doesn't tell us much (as she could still have it), but a positive is a strong indication that she should be avoiding patient interactions and likely self-isolating at home. Doesn't it only tell you if you should now be immune once your sickness is over? Otherwise you have to act like you have it if you have the symptoms regardless of the test. Avoiding patient interactions and self isolating should happen regardless, shouldn't it?
- SkyPuncher 7y agoIn theory, yes. Sensitivity and Specificity should be considered. In practice, there's a lot of BS going on in the healthcare system right now - these tests are often taken at face value. It's unfortunate, but somewhat understandable given the extreme circumstances of our health care environment. If everyone with mild symptoms (likely not COVID related) had to self-isolate for two weeks, we wouldn't have any healthcare workers left to care for people. This seems to be a "good enough" approach for most healthcare systems.
- FootballMuse 7y agoSo if I get one of these tests, and it comes back negative, what does that mean?
- SketchySeaBeast 7y agoThat'll you need more testing through the rest of the pandemic until it's either over or you come back positive.
- FootballMuse 7y agoSounds like a positive test would be a relief then.
- gweinberg 7y agoYes. The best situation to be in is to have been through it and be immune. For those of us who aren't showing symptoms and aren't at high risk for exposure, there's no point in testing us unless the test becomes super cheap.
- macintux 7y ago> The best situation to be in is to have been through it and be immune. I think the jury's still out on the odds of achieving even temporary immunity after having caught it.
- grandmczeb 7y agoAll current evidence says infection confers temporary immunity to the vast majority of people infected. It’s not clear how long immunity lasts, but it’s most likely on the order of years. And even if you lose immunity, the reinfection will likely be more mild. https://www.wsj.com/articles/does-covid-19-infection-equal-immunity-11587314824 https://www.wsj.com/articles/does-covid-19-infection-equal-i...
- finaliteration 7y ago
- dznodes 7y agoI thought Theranos had those 5 years ago.
- btian 7y agoTheranos is a fraud
- LinuxBender 7y agoDoes "At Home" mean at home, or send the kit from your home to their lab? It looks like I have to ship my DNA to them. That is not "at home". LabCorp has been hacked enough times for me to stay far away from them. I was also not impressed with their Lab setup. I had to help other customers input their sensitive data into LabCorp's Kiosk systems because their 2 employees were overloaded. I am happy I left before giving them my data. No thanks.
- SparkyMcUnicorn 7y agoThe first paragraph mentions it's just a collection kit. Comes with a shipping label.
- drcode 7y agoYeah, I'm hoping we'll see serology tests soon that truly are 100% "at home", operating through a test strip. They already have had these tests available in China and other countries since February, but since the US is apparently a third world country in 2020 we will be lucky to see these tests before 2021.
- deleted 7y ago[deleted]
- chki 7y agoActually those test strips tests are basically useless at the moment because they have way too many false positives. But I think there is some interesting work, so maybe we will see these tests at some point in an accurate form which would be extremely helpful.
- vl 7y agoYou send your DNA to someone every time you post an envelope. LabCorp is the largest provider doing tests, when you are tested at hospital for example, most likely they will send your sample to them, so there is no difference with doing it at home.
- 7y ago
- tomohawk 7y agoAny idea what the false positive / false negative rate is?
- gshdg 7y agoYeah, haven't false negatives been a scourge of at-home testing kits released in other countries?
- LatteLazy 7y agoBefore people get excited that the FDA approved something, how much testing have the FDA done on this product and how many other tests have they declined to authorize? Right now, FDA approved means about as much as Probably not immediately lethal.
- tomohawk 7y agoFound this: https://www.fda.gov/media/136151/download https://www.fda.gov/media/136151/download > Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. Here's a brief article that explains why observed symptoms are more important than a test: https://asiatimes.com/2020/04/how-accurate-are-coronavirus-tests/ https://asiatimes.com/2020/04/how-accurate-are-coronavirus-t...
- tamaharbor 7y agoNo thanks, I will wait on the antibody test which could actually mean something.