132 Matching Annotations
  1. Jul 2021
    1. one day one dies an idiot

      .

    2. Such a machine can only do two things: convince or break down.

      I disagree with this as the machine can be copied in totality or partially and the parts without (or with?!) grit can be used for the original purpose or repurposed for something new.

    3. Hypertext likes give and take, snares and grottos, nets and knots. It lacks thrust. It will always lack thrust;

      Hypertext lacks thrust, it will always lack thrust... unless you use it as linear text.

      Hypertext is a superset of text.

    4. Hierarchies break down into chains of likenesses

      .

  2. Jun 2021
    1. the authors here calibrated the RT-PCR assay so that SARS-CoV-2 genome copy number could be determined

      A quick look at the Yang et al. ref 7 paper did not show any information regarding how they calibrated their genome copy number. The method / results did show high consistency and linearity for low Ct (<30).

      Also ref 14 is a great start but a very small sample size. And they're using different RNA extraction, primers, master mix, qPCR machines, etc.

      • TaqPath 1-Step Multiplex Master Mix (Thermo Fisher A28523) vs Platinum Taq Polymerase (Invitrogen) (supplementary info)
      • Bio-Rad CFX96 or CFX384 qPCR machine vs ?not specificed? -- they use LightMix-Modular Assays (Roche) for other pathogens.
    1. are statistical in nature

      This is putting the cart before the horse. All these measurements have uncertainty, and we have tried to develop tools i.e. statistics, ... which we also often abuse... to make sense of this uncertainty.

    2. P = .05 as a level determining statistical significance

      This is completely nonsense. 0.05000001 is not statistically significant? If this represented your chance of death from some mundane activity I'm certain most would not discount it as being (statistically) insignificant.

      I think the deeper point here is: give me the method, n (sample size) and distribution of results, and calculate the P value. Don't only say "significant or not significant".

    3. rarely

      Define rarely.

    1. Systems folks would say you change paradigms by modeling a system

      .

    2. system state called “room temperature”

      This is a system attribute which has a state of hot or cold or 30 degrees etc.

    1. From its very first appearance, it was well adapted to human cells. Researchers led by Alina Chan of the Broad Institute compared SARS2 with late stage SARS1, which by then was well adapted to human cells, and found that the two viruses were similarly well adapted. “By the time SARS-CoV-2 was first detected in late 2019, it was already pre-adapted to human transmission to an extent similar to late epidemic SARS-CoV,

      This might seem like double standards. And I thought this at first as the author of this article concluded it was not possible to measure how well a virus was adapted to human disease transmission from its sequence. But the quoted article uses the rate of viral mutation drift to conclude it is not under much pressure, i.e. it already seems like it could be well adapted to human disease transmission.

    2. BSL-2 or BSL-3 laboratories

      This is not good at all.

    3. but seemed unlikely in the circumstances, he said.

      Why unlikely? This is not scientifically robust / defensible language... is this not double standards given the earlier justified criticism of the two scientific papers referenced?

    4. preventing the SARS2 epidemic was zero

      Preventing, yes. Did that research reduce the pandemic's impact?

    5. within four months

      The virus was cultured from Civet cats but the original bat cave is thought to have been identified 14 years later in 2017 https://www.nature.com/articles/d41586-017-07766-9

    6. The wet market connection, the major point of similarity with the SARS1 and MERS epidemics, was soon broken: Chinese researchers found earlier cases in Wuhan with no link to the wet market. But that seemed not to matter when so much further evidence in support of natural emergence was expected shortly.

      Months and now years after these initial events, similar scenarios of cases with no link are still occurring in countries all around the world. NZ, Aus, UK etc.

  3. May 2021
    1. lay bare a spot of some twenty feet in diameter. Into one edge of this little area the trapper brought the females, directing Middleton and Paul to cover their light and inflammable dresses with the blankets of the party. So soon as this precaution was observed, the old man approached the opposite margin of the grass, which still environed them in a tall and dangerous circle, and selecting a handful of the driest of the herbage he placed it over the pan of his rifle. The light combustible kindled at the flash. Then he placed the little flame in a bed of the standing fog, and withdrawing from the spot to the centre of the ring, he patiently awaited the result. The subtle element seized with avidity upon its new fuel, and in a moment forked flames were gliding among the grass, as the tongues of ruminating animals are seen rolling among their food, apparently in quest of its sweetest portions.

      escape fire

    1. Hansson’s response to this employee took aback many of the workers I spoke with. He dug through old chat logs to find a time when the employee in question participated in a discussion about a customer with a funny-sounding name. Hansson posted the message — visible to the entire company — and dismissed the substance of the employee’s complaint.

      Would be wise not to take at face value and useful to hear Hansson's view of this but superficially this does not sound healthy or wise for their culture.

    2. To him, it escalated employees’ emotions past the point of being productive. 

      This is a valuable observation. But the preceding "had no place" is only one of the conclusions you could draw from this. Another, potentially mutually exclusive one, is that you should (if possible) invest more in the emotional awareness of your employees so that those impacted could understand and deal with it better, and thus effectively be impacted in a productive way.

  4. Apr 2021
    1. verbal churn

      The commenter is wondering if verbal churn, which has obvious downsides, is necessary or if it can be avoided.

    1. As you stir the coffee, the energy you inject into the system cascades down the spatial scales into smaller and smaller eddies, with the rate of the transfer of energy described by a universal exponential decay factor of −53 -\frac{5}{3}, which Kolmogorov deduced from the fluid’s dimensions. Kolmogorov’s “−53 -\frac{5}{3} law” always seemed mysterious, even as it served as a cornerstone of turbulence research

      Universal (magic) numbers in turbulence

    1. All too often, a doctor’s response to a patient with seemingly-incomprehensible symptoms is this, “Since I can’t find a typical reason for your symptoms, then you must not be physically sick at all. You are being dramatic. You are wasting my time, and you are wasting medical resources.”So. A better adage for medical schools might be, “When you hear hoofbeats and fail to find a horse -- suspect a zebra. Then refer that patient to a zebra doctor.”

      They often ask if you are anxious, which is fine. But they often then conclude you are just anxious, which is a lazy and potentially unhelpful conclusion.

    2. In my frustration with my head bobbling and sinking downward, I one day spontaneously pulled up on my head, forcing it higher and centering it away from my shoulders. I immediately noticed that I began to breathe normally. When I let go of my head, it sank back down, and my breathing became difficult again. I repeated this maneuver, several times, to make sure the effect on my breathing was actually happening. Sure enough, my breathing responded the same way each time.

      Interesting

    3. Despite my dramatic new symptoms, I did not want to seek medical attention. Aside from Dr. Kaufman, who was 2.5 hours away, no medical professional had ever understood that I was ill. I had actually faced outright hostility and ridicule from multiple doctors over the years. I am not alone in this. Nearly every patient with ME has shared similar stories on Phoenix Rising. There is an enormous, systemic problem.Reluctantly, I decided to go to the ER.In three trips to three different ERs for these new symptoms, I received three identical diagnoses: perfect health. The doctors noticed my elevated heart rate, but they dismissed that as being “just stress.”

      This is profoundly broken. It is idiopathic, it might be stress, it might be something else, you can not prove it is stress. I doubt we ever can. Do not diagnose stress with 100% certainty.

    1. and in some cases even accepting reduced returns

      If only Fearbook did this. Profits down 30%, accuracy up 80%, benefit of reducing fear and misinformation (almost) priceless.

    2. It's our food system that is unhealthy, and one result is overweight individuals.

      And it's also peoples' choices. It is both.

    3. Scaling fast is not necessarily a good thing.

    Annotators

    URL

    1. I think Steve killed it because it just didn't fit in with his worldview

      .

    Annotators

    URL

  5. Feb 2021
    1. What I find strange is that even people versed in causal analysis are still referring to this warning as a good "advice" passed to us by the sages, Cox, Rosenbaum, Rubin, but not as a fact in the real world out there, fact that everyone can see, verify and prove mathematically, if needed.

      .

    1. The winner was libertarianism

      .

    2. The World Wide Web in the mid-nineties was a beautiful thing.Idealism and utopian dreams pervaded the industry. The prevailingview was that the internet and World Wide Web would make the worldmore democratic, more fair, and more free. One of the web’s bestfeatures was an architecture that inherently delivered net neutrality:every site was equal

      .

    3. Despite what people tell you, the technology world does notactually change that much. It follows relatively predictable patterns.Major waves of technology last at least a decade, so the importantthing is to recognize when an old cycle is ending and when a new oneis starting. As my partner John Powell likes to say, sometimes you cansee which body is tied to the railroad tracks before you can see who isdriving the train.

      .

    4. I am not certain when Facebook first applied persuasive technologyto its design, but I can imagine that the decision was not controversial.Advertisers and media companies had been using similar techniquesfor decades. Despite complaints about television from educators andpsychologists, few people objected strenuously to the persuasivetechniques employed by networks and advertisers.

      .

    Annotators

    1. Fox Business was forced to run a fact-checking segment debunking some of its own anchor’s assertions.

      .

  6. Jan 2021
    1. Lo ng term o u tcome

      So their definition of "Long term outcome" differs from "Impact" along the dimension of causality they can ascribed to them (their interventions) as an actor.

  7. www.highspeeduk.co.uk www.highspeeduk.co.uk
    1. “HS2 modelling is shocking, biased and bonkers.” Margaret Hodge, Chair, Public Accounts Committee

      I can not find this quote on any other site but this site. I suspect it is fraudulent.

    1. Several new analyses are however consistent in reporting increased disease severityin people infected with VOC B.1.1.7 compared to people infected with non-VOC virusvariants.

      Is this an LD50 effect we're seeing? i.e. a hypothesis is that the mutation allows more virus to be shed which increases its transmission but it also means people get more of the virus so they get sicker...?

    2. PHIA probability yardstick –

      Interesting chart but why do the categories have spaces between them?

      Good Reddit post linking to: Perceptions of probability and police.uk which has a table with gaps but the chart with no gaps...?

    1. "He's a British Pakistani Irish Muslim, and I think that definitely ticked enough boxes for them to have been overjoyed," Farah says. So it wasn't the end of the world that he wasn't Bengali.

      So much overt racism and religious discrimination. Imagine if it said: "He's a British Germanic Christian" ... I think we need to start thinking about this more deeply and setting a level playing field. Obviously there are big differences cultural between these two scenarios... Farah's parents were angry and sad but came to accept it peacefully. I assume exceptions to this are rare. And I assume some white supremacist would likely not accept it peacefully and resort to violence.

    1. ○ Virology (2.0%)

      Percentage of labs with subspecialty in virology.

      Related microbiology subspecialties.

      • Bacteriology: 8.2%
      • Mycobacteriology: 1.3%
      • Mycology: 5.6%
      • Parasitology: 5.6%
      • Virology: 2.0%
    2. There are ∼172,000 total CLIA-certified high-complexity laboratories in the United States.

      Claimed approximate number of CLIA-certified high-complexity laboratories in the US

    1. Confirmatory Testing at CDC As of March 14, 2020, public health laboratories using the CDC assay are no longer required by FDA to submit samples to CDC for confirmation. CDC is maintaining surge capacity while focusing on other support to state public health and on improving options for diagnostics for use in the public health sector.

      Confirmatory Testing at CDC not needed

    1. Specifically, for obesity, it has been shown that obese mothers tend to have obese children [67], it has been shown that clinical intervention to cause maternal weight loss can have a positive effect on reducing risk of obesity in the offspring [68]

      .

    1. The FDA will continue to communicate with the public as we have additional information to share. The FDA encourages stakeholders to report any adverse events or suspected adverse events experienced with molecular tests for detection of SARS-CoV-2. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

      FDA supports "crowd sourcing" molecular test failures.

    1. What I want to see more of is senior researchers listening more to ECRs, to their experiences, their problems, their requests. I want them to embrace empathy for those who haven’t won the game, or refuse to play it.

      Good requests.

    2. A researcher would have to have a serious foot-shooting fetish to point out the flaws in their own achievements. But this means that the ‘elite’ by default choose ignorance over empathy

      Perhaps for mid stage, but if the elite hold the power, then they will not be threatened by changing the rules if they are going to retire soon?

    3. It will rarely be success based on individual prowess or skill, but a process of a thousand small events with a thousand different players that were leveraged at the right time, with just the right amount of luck, that manifests itself as personal achievement and results in acquisition of power.

      Really? I would like to see data and robust analyses supporting these assertions.

    1. Of the 14 FDA-approved commercial HSV typing assays [5], information on the target gene(s) is available for eleven. Seven out of these eleven assays target at least one HSV gene that contains a described HSV-1 × HSV-2 recombination event

      Poor degree of disclosing primer / probe sequences.

    1. If the Democrats win, there’s not going to be another fair, legal election in this country. We won’t have a democracy.

      This is obviously incredibly backwards: you’re trying to usurp democracy because you think that otherwise you won’t have democracy… I suspect this person thinks democracy means you get what you voted for, rather that it meaning the majority gets what they voted for so you sometimes, or often, does not deliver the result you want.

  8. Dec 2020
    1. Bezos has no hope of ever visiting one of these colonies, which wouldn’t arise until long after his death, but that fact does nothing to diminish the intensity of his efforts

      He's likely hoping / planning for exponential advances in biomedical research and treatment.

    1. Mr. Scalona’s family was one of those that was never able to fully climb back from that first eviction; this winter, his parents are again facing eviction.

      They chose to have 6 children. We do not know their full story, perhaps they were very unlucky, but if you can not afford to look after your place to live, should you be having that many children? I can not afford it, that's why I am not having any children until I can.

    1. I won’t be lining up to get a COVID-19 vaccine

      That is a strange way to finish an otherwise nuanced paragraph. Why will you not get a COVID-19 vaccine? You've just quoted someone saying

      We should mourn the deaths of the elderly Manhattan nursing home residents

      And then you effectively say: oh well, never mind, I could do something to help those nursing home residents but I won't.

      Not all vaccines are the same. What if they do not have the aluminium adjuvant?

    2. Journalist Lawrence Solomon has also written two excellent articles about measles: 1) Lawrence Solomon: The untold story of measles, and 2) Lawrence Solomon: Vaccines can’t prevent measles outbreaks.

      Who has a whole article on Dr Gregory Poland who is strongly pro-vaccination and has recommended the current COVID-19 vaccine.

    3. Measles: The New Red Scare. (If you read it, you will be deeply disillusioned by the media hype—don’t say I didn’t warn you!)

      My friend's child is brain damaged from Measles because there was not sufficient herd immunity to protect them, it's a horrible disease. No mention of that in this "comprehensive article".

      On page 13 though there is a good case made for immune system reduction. As in measles actually destroys your immune system which can lessen various auto-immune conditions. However it can also reverse previously acquired immunity (either from natural infection or vaccination). That is not mentioned at all, and that lack of balance is worrying.

      It also only focuses on deaths and not on quality adjusted years of life: would you prefer to have a 1% chance of death of a 2% chance of being alive but in a vegetative state?

    4. A town newly planned on the most up-to-date principles of space and air, and adopting the “Leicester Method” of Sanitation, could bid defiance not to small-pox only, but to other infectious, if not to nearly all zymotic, diseases.”

      Unfortunately this is likely mis placed hyperbole: https://www.leicestermercury.co.uk/news/leicester-news/sharp-rise-local-daily-covid-4806090 Unless someone can prove building and sanitation standards have fallen over the last 100 years.

    5. vastly outweighed the impact of vaccination (where he saw dramatic vaccine injury and ineffectiveness).

      Could we have eradicate smallpox only through good sanitation? I can't imagine so.

    1. always use http; never use https

      Would be interesting to know why

    1. its central role in the allocation of academic prestige trump the public interest

      an alternative to impact factor is needed.

    1. We agree, and call for the entire concept of statistical significance to be abandoned.

      Knee jerk. 1. What would you replace it with? 2. Is it not better to educate scientists and readers of science in how to correctly use and interpret statistical tools and the phrase "statistically significant".

      In CERN etc. the barrier for statistical significance is raised very high, to 9.9999% (I think)... they do not claim it is true, just provide some measure of the confidence they have in the results and conclusions they have drawn.

      They have not called "for the entire concept of statistical significance to be abandoned".

    1. It wouldn’t be hard.

      Misplaced dangerous hubris

    2. Look at a map of Britain, and you’ll see a pair of arms reaching out of north Wales to hug Ireland. Pwllheli, where Elin Hywel is a town councillor, is on the lower limb, the Llŷn Peninsula. It’s also where her party, Plaid Cymru, was founded.

      ? Seemed to be sane article up until this point

    1. There isn’t one. Why weren’t there such people between apes and human beings? Not just human beings, but other things as well. None of the evolved animals that he referred to had the transitional process.

      This is a classic objection which is easily explained by evolution and a simulation might help people understand it better.

    1. After the farm worker learned ASL he still never fully understood why people went to church and what an illegal alien was. Understanding these things requires complex use of language

      This is fascinating. <del>Is language required for religion? But he's learnt some ASL so no, so what is required for religion? A disconnection from your body? No that sounds wrong.</del> Perhaps he understood religion but not why people go to Church.

    2. language is so intimately tied to consciousness that the two seem inseparable

      I guess it depends how you define consciousness but that definition in this case seems very narrow considering most would view young children as conscious before the child can speak.

    1. Twitter claimed it was a routine effort to stop inauthentic and spam accounts

      If it was then that's reasonable. This article provides no evidence to discredit Twitter's claims supporting that action.

    1. There is very little evidence on asymptomatic transmission. And testing asymptomatic people is likely to be of only marginal benefit
    1. The story of Mermaids’ success is testament to the credulity of adults who should know better, and the vulnerability of the children they ought to protect.

      But they thought they were doing the right thing or at last the public narrative / political correctness / political pressure meant the head wind to fight against was "too strong".

  9. Nov 2020
    1. Samples(n)True positiveFalsepositiveTrue negativeFalse negativeePlex SARS-CoV-2 Test2251012*1241**TheePlex SARS-CoV-2 testdemonstrated the following assay performance:Sensitivity 99.02% (94.66 –99.98%; 95% CI)Specificity 98.41% (94.38 –99.81%; 95% CI)

      Results showing high but not perfect PPA (sensitivity) and NPA (specificity).

    2. TCID50/mL

      This is not an SI unit. We need to stop using this.

    3. The evaluation sample panel totalled 230 specimens, including respiratory clinical specimens negative (n= 120) and positive (n=93) for SARS-CoV-2 as determined by the in-house PHE PCR assay.

      Samples used in characterisation

    1. if reaction inhibition is a significant source of false negative results, a control material capable of detecting the inhibition.

      Requirement for materials to detect inhibition of test

    2. At least once each day patient specimens are assayed or examined perform the following for - (i) Each quantitative procedure, include two control materials of different concentrations; (ii) Each qualitative procedure, include a negative and positive control material;

      Minimum control procedures

    1. No mentions of the limitations of the study:

      Inconclusive results, missing data, variable adherence, patient-reported findings on home tests, no blinding, and no assessment of whether masks could decrease disease transmission from mask wearers to others.

    2. randomised controlled trial – making it the highest quality scientific evidence.

      Wrong. It's not double blinded so it is not the highest quality (as it doesn't say it's paired either so...). The behaviour of participants is likely having a significant and unknown effect. When you're wearing a mask maybe you go out more. Maybe you get closer to others. This study does not control for those potential confounding factors.

    1. This is a disadvantage for laboratories, whichmust make decisions and investments in reagents and in-struments without complete knowledge of test accuracy.

      EUA disadvantage

    2. some degree of variation in the performance of theseassays

      could also read "some degree of variation in assessment of the performance of these assays"

    1. Senator Rand Paul introduced the Verified Innovative Testing in American Laboratories Act of 2020

      VITAL Act of 2020

    2. The clinical laboratory community rapidly provided widely available H1N1 influenza molecular testing, facilitating a swift pandemic response.2Jernigan D.B. Lindstrom S.L. Johnson J.R. Miller J.D. Hoelscher M. Humes R. Shively R. Brammer L. Burke S.A. Villanueva J.M. Balish A. Uyeki T. Mustaquim D. Bishop A. Handsfield J.H. Astles R. Xu X. Klimov A.I. Cox N.J. Shaw M.W. Detecting 2009 pandemic influenza A (H1N1) virus infection: availability of diagnostic testing led to rapid pandemic response.Clin Infect Dis. 2011; 52: S36-S43Crossref PubMed Scopus (65) Google Scholar,  3Crawford J.M. Stallone R. Zhang F. Gerolimatos M. Korologos D.D. Sweetapple C. De Geronimo M. Dlugacz Y. Armellino D.M. Ginocchio C.C. Laboratory surge response to pandemic (H1N1) 2009 outbreak, New York City metropolitan area, USA.Emerg Infect Dis. 2010; 16: 8-13Crossref PubMed Scopus (31) Google Scholar,  4Meltzer M.I. McNeill K.M. Miller J.D. Laboratory surge capacity and pandemic influenza.Emerg Infect Dis. 2010; 16: 147-148Crossref PubMed Scopus (8) Google Scholar,  5van der Vries E. Jonges M. Herfst S. Maaskant J. Van der Linden A. Guldemeester J. Aron G.I. Bestebroer T.M. Koopmans M. Meijer A. Fouchier R.A.M. Osterhaus A.D.M.E. Boucher C.A. Schutten M. Evaluation of a rapid molecular algorithm for detection of pandemic influenza A (H1N1) 2009 virus and screening for a key oseltamivir resistance (H275Y) substitution in neuraminidase.J Clin Virol. 2010; 47: 34-37Crossref PubMed Scopus (67) Google Scholar,  6

      References for H1N1 pandemic response

    3. AMP member peer-to-peer listserv communications have been robust as colleagues rapidly shared concerns, challenges, knowledge, experience, and solutions to support the clinical laboratory community's COVID-19 testing response

      Private peer to peer "expert crowdsourced" intelligence

    1. The EUA template also streamlined submission paperwork. A typical submission seeking full FDA approval for a test is about 1000 pages for laboratories and about 2000 pages for commercial manufacturers that distribute tests. The template reduced commercial manufacturers’ EUA submissions to 100 to 200 pages and laboratory submissions to about 40 pages, of which only about half were generated solely to meet FDA requirements, and most of those consisted of data rather than text.

      Traditional submission process versus EUA templates

    1. Food and Drug Administration ("FDA") will not require premarket review of laboratory developed tests ("LDT") absent notice-and-comment rulemaking, as opposed to through guidance documents, compliance manuals, website statements, or other informal issuances

      This change was summarised in this article.

    1. assure that samples mimic actual patient specimens when possible and that samples are homogeneous

      Call for similarity to real patient specimens

    2. White blood cell differential Target ±3SD based on the percentage of different types of white blood cells in the samples. Erythrocyte count Target ±6%. Hematocrit (Excluding spun hematocrits) Target ±6%. Hemoglobin Target ±7%. Leukocyte count Target ±15%. Platelet count Target ±25%.

      Differences in accuracy that can be expected from lab analysis.

    3. 820
    4. 640
    1. (F) Testing results The Secretary shall establish a system to make the results of the proficiency testing programs subject to the standards established by the Secretary under subparagraph (A) available, on a reasonable basis, upon request of any person. The Secretary shall include with results made available under this subparagraph such explanatory information as may be appropriate to assist in the interpretation of such results.

      PT results are made available

    1. GPS system malfunctions when the battery dies

      GPS uses a tiny amount of energy versus the energy needed to move a vehicle. If the GPS stops working when the battery is flat you have much much bigger problems and could use the last known location to send a rescue team to the dysfunctional vehicle.

    2. This mainly happens because the signals will also be affected by the changes in the weather.

      There are so many problems with this statement.

      Firstly climate is not the same as weather.

      Secondly, what weather patterns interfere with GPS? It seems to work in icy winter, in the middle or storms, during rain, when it's cloudy or sunny, when it's a heatwave. So I don't understand why, when or how the signals will be affected.

      Thirdly, why would the signals stop working forever. Surely they would be useful for most of the time?

    1. essential vitamins such as Vitamin D and A are also broken down into microscopic particles

      Is there a reference for this statement? It sounds like patent nonsense. Vitamin D and A are molecules... they're already far smaller than "microscopic" and I would be very surprised if mechanical action breaks chemical bonds in them.

    1. It is inappropriate to describe a test with these properties as “less accurate”— a description that has allowed some companies to launch suboptimal products,12 possibly encouraged by the magnitude of government contracts, low levels of government scrutiny, and the lack of an effective regulatory process for diagnostic tests.13

      Is this test actually allowed to be sold?

    1. commonsense

      commonsense is not common. I'd suggest putting this explicitly and clearly in guidelines or regulations.

    2. We have made note of this QC issue previously in this journal (9), and we argue that this is yet an additional reason that reliability needs to be established during the initial AST

      Related to original authors post.

    3. the cited variability in agar medium should be detected by QC testing.

      QC testing is claimed to be adequate for this failure mode.

    1. QC ranges are typically much lower than the clinical breakpoint. For example, the meropenem-vaborbactam QC ranges span from 0.008 to 0.5 μg/ml for Enterobacterales QC organisms. The Enterobacterales clinical breakpoints are ≤4 μg/ml (susceptible), 8 μg/ml (intermediate), and ≥16 μg/ml (resistant), several dilutions away from these QC ranges (4).

      Inappropriate QC ranges should be updated.

      Related to agreement in rebuttal

    2. QC testing was within acceptable limits

      In this scenario it sounds like QC might be improved to be more sensitive to this class of error: i.e. its improved because it includes more failure modes.

    3. QC does not evaluate all aspects of testing (i.e., preanalytical, analytical, and postanalytical components)

      Seems like a power example to champion expanding the remit of QC to catch more errors.

    1. The establishment of an independent, third party reviewer to develop and verify quality and accuracy of claims prior to review by FDA and the federal CLIA-regulating agencies would enhance the transparency of the process. This entity would be not-for-profit, non-governmental, non-ac-crediting, non-industry, and entirely neutral. Both public health and patient safety would be best served by imple-menting a centralized third party review system rather than a peer review model.

      call for third party independent reviewer

    1. ãþâ»ÄôçÍÑãÑüÑ°üÑĐÄ÷аĐÄ»ÄÄã÷Äüþñ÷ñļÑķ¼°ÝÝēüç¼ççôÀÑã°üÄefforts and resources from makers towards COVID-19 challenges, such as GetusPPE in the US and the HelpfulEngineers open-source group setup by Project Open Air which has more than 3,000+ members looking for different COVID-19 solutions (www.getusppe.org, 2020),(www.app.jogl.io, 2020),(www.projectopenair.org, 2020)
    1. Abortion should be

      Percentage of all voters:

      • Legal + Trump == 12% (24% * 51%)
      • Illegal + Trump == 32% (75% * 42%)
      • Legal + Biden == 37% (72% * 51%)
      • Illegal + Biden == 10% (23% * 42%)
    2. Do you think climate change, also known as global warming, is a serious problem?

      Percentage of all voters:

      • Yes + Trump == 19% (29% * 66%)
      • No + Trump == 26% (84% * 31%)
      • Yes + Biden == 45% (68% * 66%)
      • No + Biden == 5% (15% * 31%)
    3. What is your level of education?

      Percentage of all voters:

      • College + Trump == 18% (42% * 44%)
      • No college + Trump == 27% (49% * 56%)
      • College + Biden == 24% (55% * 44%)
      • No college + Biden == 27% (49% * 56%)
    4. Are you a white evangelical or white born-again Christian?

      Terms:

      • Christian == White evangelical or white born-again Christian
      • Others == All others

      Percentage of all voters:

      • Christian + Trump == 21% (76% * 27%)
      • Others + Trump == 27% (37% * 73%)
      • Christian + Biden == 6% (23% * 27%)
      • Others + Biden == 44% (60% * 73%)

      (sanity check: 21 + 27 + 6 + 44 == 98%)

    1. CMS’ CLIA program does not address the clinical validity of any test

      See bottom paragraph of next page for fuller explanation of this sentence.

      42 CFR 493.1253(b)(2) requires LDTs be assessed on:

      (i) Accuracy.

      (ii) Precision.

      (iii) Analytical sensitivity.

      (iv) Analytical specificity to include interfering substances.

      (v) Reportable range of test results for the test system.

      (vi) Reference intervals (normal values).

      (vii) Any other performance characteristic required for test performance.

    2. 42 CFR 493.1253(b)(2
    1. The origin of the crack was located practically in the centre of slot No 10 (Figure 17), around 14 cm (5.6 inches) behind the front face of the hub and 1.4 mm (0.055 inches) below the surface of the slot bottom. No material quality (composition, microstructure) or manufacturing related anomaly was found.

      Origin of failure

    1. adeno-associated virus vector-based gene therapyindicated for the treatment of patients with confirmed biallelic RPE65mutation-associated retinal dystrophy

      gene therapy

    1. The negatives will be fresh samples, transported within 48 hours, the positives will be frozen. This follows recent work at PHE Porton Down to support the development of this protocol which found there to be no discernible difference in performance when using frozen samples.

      claim that frozen samples are similar to unfrozen samples. New questions: what temperature, what freezing profile, any additives?

    1. continually consult the open databases of SARS-CoV-2 genome sequences to ensure their tests remain up-to-date and that false negatives do not arise because of genome variation

      continuous monitoring needed to avoid mutation enabled false negatives

    1. we do have a whole lot of applications

      referring to FDA EUA backlog

    1. while the ID Now had an LOD of 20,000 copies/ml (9), well above the limit of detection stated in the Abbott ID Now COVID-19 package insert (125 genome equivalents/ml)

      claimed discrepancy between package insert / EUA and third party evaluation.

    1. Senator Rand Paulintroduced the Verified Innovative Testing in AmericanLaboratories Act of 2020

      VITAL Act of 2020

    1. PAHPRA also enhances the authority of the U.S. Food and Drug Administration to support rapid responses to public health emergencies.

      PAHPRA and FDA

  10. Oct 2020
    1. There were a number of science-based options that politicians could have followed in this outbreak. If they chose the wrong ones, then we need to be clear that this was because of broken politics, not broken scientific advice.

      This article is an oxymoron. It claims "The idea that government advisers can separate science and politics is bogus" and then says "science-based options" and "if they chose the wrong ones [blame] politics"... so then the options can [obviously] be independent of politics.

      When approaching any complex area, unless there is insufficient time or resources, then all the (scientific) strategies can be laid out. And the politicians can make their assessment of the political value / cost of each and view the scientific assessment through this political lens.

    1. To ascertain whether this decrease in confidence was as a result of the Cummings events (a Cummings effect), we carried out analyses using two types of comparisons. First, we compared the responses for people living in England to those of people living in the devolved nations of Scotland and Wales who were asked to rate their confidence in their own devolved governments. There was no evidence of a similar large decrease in confidence in the governments of the devolved nations either descriptively (appendix p 1–3) or statistically

      Trust in government

    1. There is some evidence that in care homes where staff receive sick pay, there are lower levels of infection in residents.

      Will be interesting to see how this hypothesis evolves

    1. offered two nasal swabs

      Was the order random or consistent? If consistent, in which order, Antigen then PCR or vice versa? And does this introduce variability?

  11. Sep 2020
    1. Poorly timed testing, if conducted infrequently, could lead to false positives or false negatives,

      A "false negative" can be made more likely if testing too soon or too late. Though also if there's no virus in the specimen but it is in the human it's arguable if you can even call it a false negative.

      But false positives and the timing of a test makes no sense. False positives are inherently independent of when someone is infected... because they're not infected but the test comes back positive. So it's meaningless to say false positives depend on the time of a test.

    1. at the peak of infection

      No, at the peak of infectivity which may be before the peak of infection as when at the peak of infection, symptoms may be causing the person lethargy and they are staying at home, effectively isolating themselves.

    2. PCR may actually be too sensitive in some settings, picking up on scraps of innocuous coronavirus genetic material in patients who are no longer sick; antigen testing could circumvent this.

      Either you want a sensitive test or you don't. If you don't you can circumvent the "sensitive problem" of PCR because almost all are quantitative so just set the threshold lower for what is a positive result. There will still be antigens floating around too.

    3. advertised accuracy rates will almost certainly drop when used at home,

      Some tests are validated in "at home" settings to avoid this uncertainty

    4. antigen tests aren’t great at sussing out small amounts of the coronavirus, which means they’re far more likely to miss a case that a technique like PCR would catch

      No references to support this.

  12. Jun 2019
    1. The division of the base line of facts is indeed worrying but it is already occurring all over the world, in each country, across different social, economic, cultural, demographic, etc lines, even between people who are very close to each other.