A Trump re-election Super PAC has threatened SLAPP intimidation legal action and FCC license challenges to media airing this ad. Sue ME too.
And sue The Guardian.
Everyone, pay it forward.
________
NOW REPORTING FROM BALTIMORE. An eclectic, iconoclastic, independent, private, non-commercial blog begun in 2010 in support of the federal Meaningful Use REC initiative, and Health IT and Heathcare improvement more broadly. Moving now toward important broader STEM and societal/ethics topics. Formerly known as "The REC Blog." Best viewed with Safari, FireFox, or Chrome. NOTES, the Adobe Flash plugin is no longer supported. Comments are moderated, thanks to trolls.
Yeah, right. I'm sure I'll get responses. Of course.I will be looking into your and your competitors' lab QA performance (e.g., @LABCORP). Do you publish your #coronavirus RT-PCR screening assays false positive/negative rates? https://t.co/H7zcyAWRuh— Bobby Gladd (@BobbyGvegas) March 16, 2020
Note: should you accurately test "negative" for this virus, the result only holds for the date and time the specimen was collected. You could become infected with the pathogen at any time thereafter and subsequently be a "positive."
Prevalence, Incidence, R0 ("R-naught"), Etiology, Sensitivity, Specificity, PPV, NPV, Bayesian Priors, Accuracy, Precision, False Positives, False Negatives, Cross-Reactivity, Coefficient of Variation (CV), Spikes, Blanks, Replicates, Matrices, Blinds, Reference Standards, Reagents, Chain of Custody, Cross-Contamination, Screening Test, Confirmation Test, Aliquot, Qualitative, Quantitative, Hockey Stick Curve, de minimus, LLD, RT-PCR (Real Time Polymerase Chain Reaction), CLIA...That's enough for openers. Again, see my prior remarks.
On New Year’s Eve, Chinese officials notified the World Health Organization that a new type of viral pneumonia was circulating in the city of Wuhan. Less than two weeks later, virologists published the entire genetic sequence of a new type of coronavirus from the same family of viruses that caused the SARS and MERS outbreaks.So, right off the bat you're gonna need new "genetic signature" "reference standards" comprised of known quantities of the novel pathogen. Without these "controls" you have no way to determine the relative precision and accuracy of patient specimen outcomes (and the concomitant false positive and false negative error rates).
That blueprint, or genome, provided an effective means of identifying the infectious agent, now officially called SARS-2-CoV, or the 2019 novel coronavirus. Within two weeks of the release of that critical information, another team, led by researchers in Berlin, published a diagnostic method. The test offered one means by which labs could collect throat or nasal swabs and screen for new cases of COVID-19, as the disease caused by the virus is called, based on isolating and amplifying a genetic signature specific to it.
The race was on as the WHO adopted the German-developed tests and distributed it to dozens of countries. But China, the United States, and several other countries developed their own ways to screen for a modern plague that has since infected over 200,000 people worldwide, including 6,500 people in all 50 states, causing at least 107 U.S. deaths...
Some other considerations: the quality (incl expiration dates) of the "reagent" chemicals used in specimen processing; the training and experience levels of the line lab staff; calibration of the analytical instruments, the specimen workload (sample overload raises a number of exigent risks, including workflow corner-cutting and fatigue errors, and elevated likelihood of cross-contamination).I repeat:
CDC has developed a new laboratory test kit for use in testing patient specimens for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. The test kit is called the “Centers for Disease Control and Prevention (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel.” It is intended for use with the Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS 1.4 software. This test is intended for use with upper and lower respiratory specimens collected from persons who meet CDC criteria for COVID-19 testing. CDC’s test kit is intended for use by laboratories designated by CDC as qualified, and in the United States, certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests.I'd be wanting particulars addressing "robust quality control measures." Not that I'm likely to get much in response.
On Monday, February 3, 2020, CDC submitted an Emergency Use Authorization (EUA) package to the U.S. Food and Drug Administration (FDA) in order to expedite FDA permitted use of the CDC diagnostic panel in the United States. The EUA process enables FDA to consider and authorize the use of unapproved, but potentially life-saving medical or diagnostic products during a public health emergency. The U.S. Secretary of Health and Human Services declared the SARS-CoV-2 virus a U.S. public health emergency on Friday, January 31, 2020. FDA issued the EUA on February 4, 2020. IRR began distribution of the test kits to states, but shortly thereafter performance issues were identified related to a problem in the manufacturing of one of the reagents which led to laboratories not being able to verify the test performance. CDC is remanufacturing the reagents with more robust quality control measures. New tests will be distributed once this issue has been addressed. CDC continues to perform initial and confirmatory testing.
But, to be fair, I am by no means oblivious to plausible pushback, e.g., what if there is a significant sub-stratum of those who never evince clinical symptoms yet are nonetheless truly infected and (even if transiently) contagious: i.e., "vectors," asymptomatic "carriers?" How will we reliably estimate that prevalence?One last observation here for now. There are thousands of other types of routine clinical lab tests in process every day, many of them of pressing importance, and all in need of uniform QC for effective dx accuracy and precision.
This Is How We Can Beat the CoronavirusVery interesting article by two nationally esteemed clinician / scholars. Read all of it. They recommend mass screenings, for mandatory "suppression." My QA/QC concerns remain. I'm open to rebuttal.
Mitigation can buy us time, but only suppression can get us to where we need to be.
While many watched the coronavirus spread across the globe with disinterest for months, in the last week, most of us have finally realized it will disrupt our way of life. A recent analysis from Imperial College is now making some Americans, including many experts, panic. The report projects that 2.2 million people could die in the United States. But the analysis also provides reason for hope—suggesting a path forward to avoid the worst outcomes…
Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test KitsYeah, that direct-to-consumer BS stuff is so predictable.
During my lab QC days in Oak Ridge in the 1980s, one of our commercial competitor facilities finally got busted after a year of "dry labbing"--discarding incoming EPA specimens, simply faking and reporting "results," and sending the invoices.More recently, anyone recall Theranos?
Why Widespread Coronavirus Testing Isn’t Coming Anytime SoonRead all of it. Goes beyond the scope of my concerns here, but, yeah.
By Robert P. Baird
March 24, 2020
…The clinical lab director expressed concern that granting regulatory authority to the states means that “we are now in the Wild West of laboratory regulation. It’s really a let-the-buyer-beware world. Essentially, apart from the F.D.A.’s E.U.A. process, there is very limited regulation of the quality, accuracy, and specificity of diagnostic tests for covid-19, and I think that’s a dangerous situation.” Bartkus, in Minnesota, said, “I will tell you, there is pressure to get these tests out: from the public, from the laboratories, from the politicians. It is a challenge to do that in a scientific and equitable way when you have no expertise in authorizing other labs to do testing.”
How the Pandemic Will EndJust a little snip bearing on my part of the "testing" topic.
The U.S. may end up with the worst COVID-19 outbreak in the industrialized world. This is how it’s going to play out.
…the second pressing need: a massive rollout of COVID-19 tests. Those tests have been slow to arrive because of five separate shortages: of masks to protect people administering the tests; of nasopharyngeal swabs for collecting viral samples; of extraction kits for pulling the virus’s genetic material out of the samples; of chemical reagents that are part of those kits; and of trained people who can give the tests. Many of these shortages are, again, due to strained supply chains. The U.S. relies on three manufacturers for extraction reagents, providing redundancy in case any of them fails—but all of them failed in the face of unprecedented global demand…
...The word “epidemiology” is derived from “epi” and “demos”—“above the people.” It is the science of aggregation, the science of the many. Yet it works most effectively when it moves in step with medicine, the science of the one. On the morning I visited the Shitala shrine in Kolkata, the goddess of bygone population-decimating epidemics was also serving as the personal goddess of a mother who had brought a child with a weeklong fever. To win the Kampf against covid-19, it’s essential to trace the course of the virus as it moves through populations. But it’s equally essential to measure its course within a single patient. The one becomes the many. Count both; both count.Siddhartha ROCKS!
From Bats to Human Lungs, the Evolution of a CoronavirusANOTHER, WAPO:
For thousands of years, a parasite with no name lived happily among horseshoe bats in southern China. The bats had evolved to the point that they did not notice; they went about their nightly flights unbothered. One day, the parasite—an ancestor of the coronavirus, sars-CoV-2—had an opportunity to expand its realm. Perhaps it was a pangolin, the scaly anteater, an endangered species that is a victim of incessant wildlife trafficking and sold, often secretly, in live-animal markets throughout Southeast Asia and China. Or not. The genetic pathway remains unclear. But to survive in a new species, whatever it was, the virus had to mutate dramatically. It might even have taken a segment of a different coronavirus strain that already inhabited its new host, and morphed into a hybrid—a better, stronger version of itself, a pathogenic Everyman capable of thriving in diverse species. More recently, the coronavirus found a new species: ours. Perhaps a weary traveller rubbed his eyes, or scratched his nose, or was anxiously, unconsciously, biting his fingernails. One tiny, invisible blob of virus. One human face. And here we are, battling a global pandemic.
The world’s confirmed cases (those with a positive lab test for covid-19, the disease caused by sars-CoV-2) doubled in seven days, from nearly two hundred and thirteen thousand, on March 19th, to four hundred and sixty-seven thousand, on March 26th. Nearly twenty-one thousand people have died. The United States now has more confirmed cases than any country on earth, with more than eighty thousand on March 26th. These numbers are a fraction of the real, unknown total in this country and around the world, and the numbers will keep going up. Scientists behind a new study, published earlier this month in the journal Science, have found that for every confirmed case there are likely five to ten more people in the community with an undetected infection. This will likely remain the case. “The testing is not near adequate,” one of the study’s authors, Jeffrey Shaman, an environmental-health sciences professor at Columbia University, said…
Three months into the pandemic, here is what we know about the coronavirusCNN BREAKING NEWS
FDA authorizes 15-minute coronavirus test
SUNDAY MARCH 15This is the scene at O’Hare airport. The traveler who took the photo said it’s a 6-hour wait for bags then on to customs for 2-4 more of waiting in shoulder-to-shoulder crowds. Police are handing out water and disinfectant wipes. @fly2ohare #ord #coronavirus #COVID19 pic.twitter.com/UTx9E0nj1s— Brooke Geiger McDonald (@BrookeGMcDonald) March 15, 2020
UPDATESres ipsa loquitur
WASHINGTON (Reuters) - The White House has ordered federal health officials to treat top-level coronavirus meetings as classified, an unusual step that has restricted information and hampered the U.S. government’s response to the contagion, according to four Trump administration officials..._____________#Pandumbic
I am the ASQ 2020 Baltimore Science Fair volunteer lead. It may well have to be canceled or postponed.I was fortunate to get press comps to cover the HIMSS events for a half-dozen years, ending in 2016. Great fun.
Hopkins COVID-19 link |
From January of 1986 through about May of 1991 I served under a series of personal services contracts with a laboratory owned by a major environmental engineering and remediation firm. We performed environmental and health physics support analyses for clients with radiation and mixed waste contamination and exposure problems (mixed waste is that which is composed of conventional chemical toxins and radionuclides). Since much of our work involved litigation support, we were trained to—and continually reminded of the need to—perform to forensic standards (i.e., to a quality level sufficient for our analytical results to stand up as viable evidence in court).Alluded to this work in my 1998 grad thesis. to wit:
It was my job to develop, install, and maintain custom, procedure-specific software for use by the technicians in calculating radionuclide concentrations and dose exposures. I also worked on statistical quality control applications, applied research toward development of analytical correction factors, and helped write and subsequently administer our Software Quality Assurance procedure. While at this complex I worked amid much of the very same analytical technology (e.g., High Performance Liquid Chromatography, Gas Chromatography/Mass Spectrometry) also employed by drug testing labs, as much of our specimen workload consisted of urine samples suspected of contamination. I also learned just how difficult it can be to substantiate analytical results. We underwent frequent adversarial lab audits that would be the envy of a Spanish Inquisitor. I have been audited right down to my rounding algorithms…
While the relative "accuracy" (sensitivity & specificity) levels of many clinical methods that estimate disease probabilities (or any type of experimental assay with anterior empirical underpinnings using Bayesian statistical methods [see below] ) are tolerably well-defined (and uniformly well below 99.9%), those pertaining to a TIA program are wholly speculative at this point, and will not clarify for years (if ever). One daunting limitation will come in the form of pervasively inaccurate and/or incomplete data pouring in from the myriad public and private sources. Another will owe to the relative recency and transience of the phenomenon. As Robert Levy of the Cato Institute observes: "Never mind that Pentagon computer scientists believe that terrorists could easily avoid detection, leaving bureaucrats with about 200 million dossiers on totally innocent Americans — instant access to e-mail, web surfing, and phone records, credit-card and banking transactions, prescription-drug purchases, travel data, and court records." (see www.nationalreview.com/comment/comment-levy112602.asp) I could not agree more. While the innocent will more or less simply go on with their customary daily life transactions, our terrorist enemies will undoubtedly take evasive measures. What shall we do? Outlaw, among other things, all anonymous cash transactions? If we don't (and we cannot) the very utility of a TIA database will be fatally compromised at the outset.For now, suffice it to assert that, if you are asymptomatic for COVID-19, you don't want to risk the severe personal upshot of turning up false positive.
Given that no test is infallible, there are inescapable trade-offs in terms of relative false-positive/false negative levels associated with any assessment. For example, where routine workplace drug tests are concerned, labs seek to limit false positives (and the lawsuits they spawn), while they are far less troubled by false negatives (recreational drug users who slip through the screenings). With respect to terrorism, on the other hand, authorities will necessarily fret principally over false negatives -- actual terrorists who go undetected. Should you wrongly end up on a Homeland Security "No-Fly List" or be uselessly visited by a couple of FBI agents in the wake of a false positive TIA "hit", you will likely be met with bureaucratic indifference at best should you protest. At worst, you could be wrongly arrested, have your assets seized, lose your job, or otherwise have your reputation ruined.
Criteria to Guide Evaluation of PUI (Patient Under Investigation) for COVID-19Couple of quick observations here. First, the CDC guidelines are episodically updated, so they are (inescapably) in flux. Second, (inter-subjective albeit informed) "clinical judgment" will have to contend with mostly uninformed "political judgment" (read alarmist pandering).
"…Clinicians should use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested. Decisions on which patients receive testing should be based on the local epidemiology of COVID-19, as well as the clinical course of illness. Most patients with confirmed COVID-19 have developed fever1 and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). Clinicians are strongly encouraged to test for other causes of respiratory illness, including infections such as influenza.
Epidemiologic factors that may help guide decisions on whether to test include: any persons, including healthcare workers, who have had close contact with a laboratory-confirmed COVID-19 patient within 14 days of symptom onset, or a history of travel from affected geographic areas within 14 days of symptom onset…
Close contact is defined as—
a) being within approximately 6 feet (2 meters) of a COVID-19 case for a prolonged period of time; close contact can occur while caring for, living with, visiting, or sharing a healthcare waiting area or room with a COVID-19 caseIf such contact occurs while not wearing recommended personal protective equipment or PPE (e.g., gowns, gloves, NIOSH-certified disposable N95 respirator, eye protection), criteria for PUI consideration are met…"
– or –
b) having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on)
Specimen Type and PriorityEarlier there was a reference to "serum" (blood samples), but that is not now on the CDC page. I'd be wanting to see stratified data minimally on relative sensitivity and specificity for both upper respiratory specimen types and the lower respiratory (sputum). Probably as yet to soon to get solid numbers there.
For initial diagnostic testing for COVID-19, CDC recommends collecting and testing upper respiratory (nasopharyngeal AND oropharyngeal swabs), and lower respiratory (sputum, if possible) for those patients with productive coughs. Induction of sputum is not recommended. Specimens should be collected as soon as possible once a PUI is identified, regardless of the time of symptom onset…
What of the manufacturing QA documentation of the test kits themselves? 'eh? After all, Trump never met a regulatory standard he didn't want to eliminate.Once we get to the actual test kit production analyses (pdf), all the myriad QC risks (and documentation requirements) that apply to lab work generally most certainly apply here. These are not Playskool chemistry kit litmus paper tests.
Epidemic mortality rates are properly derived as "deaths / confirmed cases." You can disingenuously deflate the apparent rate by summarily changing the denominator to "PUIs tested" in the wake of mandating indiscriminate mass testing without pre-screening judgment criteria. Don't tell Trump.ERRATUM: THE OAF OF OFFICE
_____________Here's Trump rambling at length about how smart he is and how well he understands public health pic.twitter.com/1Co6MaRkzl— Aaron Rupar (@atrupar) March 6, 2020
Trump's appearance will be the first time a sitting president has appeared at the event. His HIMSS20 speech is currently scheduled for Monday, March 9, at 4 p.m. in the Valencia Ballroom of the Orange County Convention Center.HIMSS is getting willingly played. I seriously doubt Donald Trump can even pronounce "interoperability." interoperababble
Indeed. Follow the science.Protect yourself and your community from coronavirus with common sense precautions: wash your hands, stay home when sick and listen to the @CDCgov and local health authorities. Save the masks for health care workers. Let’s stay calm, listen to the experts, and follow the science.— Barack Obama (@BarackObama) March 4, 2020
The dangerously flip ignorant recklessness is breathktaking. |
BREAKING: #HIMSS2020 canceled. Coronavirus halts the conference where Trump was scheduled to speak. https://t.co/LIWwl6SwJS— Erica Teichert (@eteichert) March 5, 2020
_____________Following recent reports from the WHO and the CDC, it is clearly necessary to cancel #HIMSS20. More information and the official HIMSS statement are available here: https://t.co/vv5u6eO1d4.— HIMSS (@HIMSS) March 5, 2020
“There’s been a significant breakdown in Americans’ ability to speak to one another and to hear one another. That’s become much worse in the last three years, where there’s been full license given to the otherization of our neighbor.” -- Laurene Powell Jobs
"I'm Calvin, and I approved this message." |
TRIBALISM
The most straightforward cause of strife on the new pastures is tribalism, the (often unapologetic) favoring of in-group members over out-group members. This is going to be a very short section, because there’s little doubt that humans have tribalistic tendencies that promote conflict. Insofar as there is a debate about our tribalistic tendencies, it’s not about whether we have them, but about why. In my view, the evidence strongly suggests that we have innate tribalistic tendencies. Once again, anthropological reports indicate that in-group favoritism and ethnocentrism are human universals. Young children identify and favor in-group members based on linguistic cues. Reaction-time tests (IATs) reveal widespread negative associations with out-group members in adults, children, and even monkeys. People readily favor in-group members over out-group members, even when the groups are arbitrarily defined and temporary. People readily replace racial classification schemes with alternative coalitional classification schemes, but they don’t do the same for classification by gender, as predicted by evolutionary accounts of human coalitional psychology. And there is a neurotransmitter, oxytocin, that makes people selectively favor in-group members. Finally, all biological accounts of the evolution of cooperation with non-kin involve favoring one’s cooperation partners (most or all of whom belong to one’s group) over others. Indeed, some mathematical models indicate that altruism within groups could not have evolved without hostility between groups.
In short, we appear to be tribalistic by nature, and, in any case, we are certainly tribalistic. This is bound to cause problems— though by no means insurmountable problems— when human groups attempt to live together.Also goes to recent topical interests of mine such as "Deliberation Science."
COOPERATION, ON WHAT TERMS?
Tribalism makes it hard for groups to get along, but group-level selfishness is not the only obstacle. Cross-cultural studies reveal that different human groups have strikingly different ideas about the appropriate terms of cooperation, about what people should and should not expect from one another...
Greene, Joshua (2013-10-31). Moral Tribes: Emotion, Reason, and the Gap Between Us and Them (pp. 78-79). Penguin Group US. Kindle Edition.