Thursday, December 17, 2020

Here come the non-Rx OTC Covid-19 in-home assays

Good idea? I guess we'll see.

Aussie vendor. First home kit to get an FDA EUA permit. What about QA concerns? I am not yet privy to any data. Stay tuned to this Bat Channel.

“Our test is what’s called a fluorescent immunoassay. So we use a quantum dot nanoparticle, which we developed in conjunction with our friends at Thermo Fisher to create an ultra-bright fluorescent reporter to detect proteins of coronavirus. So ours is an antigen test which uses next-generation immunoassay technology to get improved performance on the existing immunoassay products that are in the market.” —Dr. Sean Parsons, Ellume CEO, during a BBC interview.

"ELLUME’S COVID-19 HOME TEST SHOWS 96% ACCURACY IN MULTI-SITE US CLINICAL STUDY"

Like to see some clarification and independent verification on that.

FROM THE FDA EUA

The Authorized Product
Your product is a non-prescription home use test intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens from mid-turbinate nasal swabs that are self-collected by an individual age 16 years or older, or are collected by an adult from an individual 2 years of age and older. This test is intended for use in individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection.

The SARS-CoV-2 nucleocapsid protein antigen is generally detectable in mid-turbinate nasal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but the clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results in an asymptomatic individual are presumptive and may need to be confirmed with a molecular assay. Positive results do not rule out a bacterial infection or co-infection with other viruses

Negative results are presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or management decisions for the individual, including infection control decisions. Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.

Test results from your product will be automatically reported to relevant public health authorities, via your product’s software application (app), in accordance with local, state, and federal requirements, using appropriate LOINC and SNOMED codes, as defined by the “Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests” provided by the Centers for Disease Control and Prevention (CDC).

Your product is a rapid, lateral flow immunoassay that involves the pre-mixing an d binding of fluorophore specific to SARS-CoV-2 with viral nucleocapsid protein present in a patient specimen. First, the Processing Fluid is added into the Dropper to release the fluorophore. After collecting a mid-turbinate nasal specimen, the Nasal Swab is locked into the Dropper to release the viral antigens from the specimen, which are then bound by the fluorophore. An aliquot of the sample containing the fluorophore-labelled antigen complexes is dispensed into the Analyzer Sample Port. The deposited liquid wicks into the test strip by capillary action. The sample flows across a membrane and traverses a series of discrete capture zones, consisting of immobilized complementary antibodies to SARS-CoV-2 viral nucleoprotein. Fluorescence signals at the two test zones are detected using a single-use optoelectronics reader system, housed within the Analyzer. The tests and controls are interpreted according to thresholds set within the microprocessor contained in the Analyzer. The computed result is communicated to the app and displayed on the user’s smartphone and if selected are also emailed to the user. The total time for the test is 20 min, 5 min for test set up and 15 min once the analyser is activated.

Your product requires the following internal control materials, or other authorized control materials (refer to Condition L), that are processed along with the specimens. All internal controls listed below must generate expected results in order for a test result to be considered valid…

III. Waiver of Certain Requirements 
[FDA is] waiving the following requirements for your product for the duration of this EUA:

Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of your product, but excluding Subpart H (Acceptance Activities, 21 CFR 820.80 and 21 CFR 820.86), Subpart I (Nonconforming Product, 21 CFR 820.90), and Subpart O (Statistical Techniques, 21 CFR 820.250)

(IV)(N). You must have lot release procedures and the lot release procedures, including the study design and statistical power, must ensure that the tests released for distribution have the clinical and analytical performance claimed in the authorized labeling.

(P) You must evaluate the analytical limit of detection and assess traceability7 of your product with any FDA-recommended reference material(s). After submission to and concurrence with the data by FDA, you will update your labeling to reflect the additional testing. Such labeling updates will be made in consultation with, and require concurrence of, DMD/OHT7- OIR/OPEQ/CDRH...

Fairly reassuring, though a number of technical questions remain at this point.

A COMPETITOR?

This company started following me on Twitter. Will have to probe further. Click the image above for the link.

_________

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Brave New Health

Commonwell Health Alliance

Another important read (pdf)

I love this kind of stuff. It sustains and humbles me. "As politicians, advertisers, salesmen, and propagandists for various political, economic, moral, religious, psychic, environmental, dietary, and artistic doctrinaire positions know only too well, fallible human minds are easily tricked, by clever verbiage... Common language—or at least, the English language—has an almost universal tendency to disguise epistemological statements by putting them into a grammatical form which suggests to the unwary an ontological statement. A major source of error in current probability theory arises from an unthinking failure to perceive this."

Quotes

"An economist is a person who sees something that works in practice and tries to figure out whether it will work in theory."

- J.D. Kleinke, medical economist
___

"The only person who enjoys change is a baby with a wet diaper."

"Every misspent dollar in our health care system is part of somebody's paycheck.

- Brent James, M.D., M.Stat

“We could do healthcare, at markedly higher quality, for everyone in this country, without rationing or denying anybody the care that they need, without having the government dictate how doctors practice or whether hospitals could expand, at half the cost we do it now.”

- Health Care Futurist Joe Flower

Most of the sciences, unlike parts of medical science, are not concerned with the impossible. There is not complementary and alternative physics, or chemistry, or biochemistry, or engineering. These disciplines compare their ideas against reality, and, if the ideas are found wanting, abandoned."

- Mark A. Crislip, MD

"Q: How much alcohol is too much?
A: More than your doctor drinks."

- a physician I once heard speak during a CME presentation

“Just because science doesn’t know everything, doesn’t mean you get to fill in the gaps with whatever fairy tale most appeals to you.”

- Dara O’Briain

'[I]t is one small step from using the computer for "helping" doctors to monitoring them, judging them, dictating to them what to do, and withdrawing payment for computer non-compliance. The use of computer data is a multi-edged sword. It can be used for the "good," facilitating diagnosis and treatment and making it more accurate and up-to-date, and for “evil,” invading privacy, inviting security breechs, and making decisions based on the opinions of remote authorities rather than those present at the patient-doctor encounter.'

- Richard Reece, MD

“[T]here ARE statistics which are non-political. Just because The Washington Post/Fox News reports the temperature is 75 degrees doesn’t mean it’s really snowing and sunscreen is a liberal/conservative plot. Even if you earn a living being ideological.”

- Michael L. Millenson

"It is a generally a fairly convincing argument that people shouldn’t have to be subsidized to undertake a change which is in their best interest.

The reconciliation seems to be that EHR is not supposed to make a doctor’s practice more efficient and higher quality. It is supposed to make the system of care more efficient and higher quality, which is not the same thing. Those of you who took calc recall that maximizing the total of variables is not achieved by maximizing any one variable and this is a perfect example of that.

Those of you have served in combat certainly noticed that too — if everyone works as a team the unit takes fewer casualties. If you try to save your own hide, you might, but at the expense of more casualties overall."

- Al Lewis

"There are two ideas to keep in mind about Bayesian reasoning and how we tend to mess it up. The first is that base rates matter, even in the presence of evidence about the case at hand. This is often not intuitively obvious. The second is that intuitive impressions of the diagnosticity of evidence are often exaggerated."

- Daniel Kahneman, "Thinking, Fast and Slow"

"Physicians apply advanced scientific knowledge, but they must do so without the favorable conditions that experimental scientists create for themselves. Multitasking is forced on physicians, often in chaotic environments and under severe time and resource constraints."

- Lawrence and Lincoln Weed, "Medicine in Denial"

"It’s time to stop the whining about Obama care and acknowledge we already have universal health care. We just pay for it in the stupidest way possible that ensures problems are that much more disastrous and complicated when they’re finally treated."

- Mark Hoofnagle, MD, PhD

"Every act of conscious learning requires the willingness to suffer an injury to one's self-esteem. That is why young children, before they are aware of their own self-importance, learn so easily."

- Thomas Szasz, MD
___

"Of course, one reason that process metrics* are so popular is that processes are much easier to define and measure than outcomes."

- The Skeptical Scalpel
___

"There is an “illusion of validity” for any random data point, a seductive sense that is colored by what we hope will be true. Mountains of pharmaceutical claims are often made from mere molehills of data."

- Danielle Ofri, MD
___

"Joy empowers people. It is a source of energy that enables people to hope and plan and change their lives for the better. Spend some time around someone who is relentlessly negative and how do you feel–drained, right? More and more research shows that joy is not something that just happens to you, like a bolt of lightening out of the blue. Joy is, instead, a habit to cultivate. Negative thinking and despair are the crabgrass of our souls–weeds that take root and spread, sometimes to all areas of life. Joy, in contrast, is a soul’s rose–hardy when cared for, able to put down roots over time and withstand disease and extremes. Like a rose, however, your joy can become blighted from neglect or harsh conditions. We all need to tend to our joy–to prune away the badness, and to know that, even though it may look like a prickly bare root, if you invest time in a joyous outlook, gorgeous things will bloom, even in the harshest conditions."

- Dr. Jan Gurley
___

"'Solutions' exist only in mathematics."

- Karen Martin
___

"The issue of how to regulate clinical software is, in the long run, indistinguishable from the issue of how to regulate medicine. The only difference is that medicine is practiced in the open, without secrecy, subject to peer review, and under a merit-based state license."

- Adrian Gropper, MD
___

"Economist, rope, tree: some assembly required."

- Source unknown

DISCLAIMER:

I write this blog wholly on my own time and my own dime. The views proffered are expressly my own as a concerned and active citizen/taxpayer (in addition to being the result of my substantive experience in the various IT fields), and in no way reflect any policy views of my former employer, notwithstanding that some of the thinking has indeed obviously been spurred by the implications of the work with which I have been doing for them.

FAIR USE POLICY
I cite a ton of news and web sources spanning the breadth of relevant technical and policy domains, sometimes at substantial length. I believe I remain well within the bounds of "Fair Use," as [1] I am not doing any of this for profit, [2] I always provide attribution and links -- which, [3] far from negatively impacting any copyright holders' commercial interests, might actually increase traffic to and interest in their offerings.

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Thursday, December 17, 2020

Here come the non-Rx OTC Covid-19 in-home assays

"ELLUME’S COVID-19 HOME TEST SHOWS 96% ACCURACY IN MULTI-SITE US CLINICAL STUDY"

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