29 April 2020 Blog Post: COVID-19 Antibody Testing

29 April 2020 Blog Post: COVID-19 Antibody Testing

We have used LabCorp as our commercial laboratory for many years now. They were the first laboratory with whom we were able to integrate our EMR into their clinical reporting systems, which was a critical step in reducing paperwork and receiving labs in a timely manner. We have been utilizing their expertise in the PCR identification of COVID-19 in respiratory samples since early March. They are now offering COVID-19 IgG antibody testing to the general public.

I have known for the past couple few weeks that they had been performing limited COVID-19 antibody testing targeting frontline healthcare workers. Beginning Monday April 27th, they have begun to offer IgG antibody testing more broadly to the general public. However, they are not including IgM and IgA testing at this time. IgG results will be reported not as a numeric measurement but instead as positive, negative or equivocal.

I have been critical of antibody testing efforts to date but in this instance LabCorp seems to have struck a conciliatory balance. They note that their testing modality has not been evaluated by the FDA, nor is it intended to diagnose disease, and has significant limitations in interpretation.

To contextualize the alphabet soup of IgM, IgA and IgG antibodies (and the relative importance of IgG compared to the other two in validating a person’s protection from subsequent infection), I’ll present a brief review of these antibodies. This is represented schematically in the figure below.Β 

The first response to a new infection (and COVID-19 will be new to everybody) is an IgM response; I remember this by equating IgM with the words “iMmediate” and “iMmature”. It is our immune system’s “oh crap, what the hell is that?” response and begins around Day 7 post-infection. It is essentially a spider web of a molecule. IgM itself is constructed of five or six units hastily constructed in an attempt to simply trap a virus – you can see its general structure in the second figure.

IgG production begins around Day 14 post-infection. I think of it as the assassin of the immune system. If IgG were in a movie, Mark Wahlberg would play it (Will Ferrell would be a great IgM – somewhat goofy and lovable but not an action hero). You can see from the third figure that IgG is streamlined and efficient. It contains two identical heavy chains and two identical light chains. Its is the major immunoglobulin in blood and the central player in the immune response, keying the vital mechanisms that cells use to cope with microorganisms. Vaccines mostly mediate protection through the induction of highly specific IgG serum antibodies.

Notice that I have left out a discussion of IgA which is the principal antibody class found in respiratory passages and the gastrointestinal (GI) tract, as well as in saliva and tears. It is also found in the blood. Live oral or nasal vaccines, such as nasal infuenza, and cholera vaccines, induce an IgA response. A recent study of commercially available IgA tests for COVID-19 showed that these were of lower specificity (able to identify a true negative) than IgG assays (Okba et al., Erasmus Medical Center, Rotterdam, the Netherlands). Further, the precise role of IgA in natural infection is also less clear than that of IgG and IgM. While there is agreement that it plays an important role on body surfaces, whether or not it is critical to immunity remains unresolved. While some people who lack IgA suffer from recurrent sinus or GI infections, many exhibit no apparent issues whatsoever. So I would not think that IgA is a critical measurement in COVID-19 antibody testing.

So after all of this, what do I advise? I think IgG testing is a useful diagnostic tool and is now available from a reputable source. For those who have had a positive PCR nasal or throat swab and are now more than several weeks away from that test, it will be a clinically meaningful piece of information. For those that experienced a COVID-like illness and have recovered, it may also provide some clarity. For others without known disease or suspicious illness, its utility is less clear. Positive tests may be the result of past infection with non-COVID-19 coronavirus strains which account for up to 30% of seasonal ‘common’ colds. A negative test does not rule out prior infection.

As with most of COVID-19, we are all learning as we go along but it is a tremendous benefit to see such progress.

𝗦𝗢𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 π—’π˜‚π—Ώ π—‘π—²π˜„π˜€π—Ήπ—²π˜π˜π—²π—Ώ

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27 April 2020 Blog Post: A few highlights of ongoing progress and news regarding COVID-19

27 April 2020 Blog Post: A few highlights of ongoing progress and news regarding COVID-19

1. “Immunity passports”: Over the weekend, The World Health Organization stated that there was no evidence of immunity against a second infection among those previously infected with COVID-19. They then backtracked on their messaging saying that while they did expect an infection to result in some degree of immunity, they were more responding to the idea that “immunity passports” could be given to people who have recovered from COVID-19 and have antibodies. The passport could theoretically allow someone to travel or return to work. In a statement, the WHO said, “People who assume that they are immune to a second infection because they have received a positive test result may ignore public health advice. The use of such certificates may therefore increase the risks of continued transmission.” (Plus there is the ‘crappy’ test issue that we have covered in prior posts.)

2. “New” symptoms: The CDC has added chills, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell to its list of possible COVID-19 symptoms. These join fever, shortness of breath or difficulty breathing, and cough on the list. We have known about these both in clinical practice and in more widespread media reports for several weeks now so I am unclear how these are “new”. Perhaps they are new to the CDC.

3. Presymptomatic transmission in skilled nursing facility: Prior posts have explored the risk of presymptomatic and asymptomatic spread of COVID-19. A New England Journal of Medicine report specifically studied viral transmission in a skilled nursing facility and may have implications for other close living quarters (e.g. assisted living, retirement homes, college dorms, military barracks). Of 89 residents in this Washington State facility, 64% had tested positive for SARS-CoV-2 by March 26 β€” 23 days after the first positive result in a resident Of those who tested positive, 56% were essentially asymptomatic at testing, but most developed symptoms later. The case fatality rate was 26%. Editorialists write: “A new approach that expands Covid-19 testing to include asymptomatic persons residing or working in skilled nursing facilities needs to be implemented now.”

4. Chloroquine/hydroxychloroquine warning: The FDA is warning the public that chloroquine and hydroxychloroquine should not be taken for COVID-19 outside a hospital or clinical trial setting, as the drugs confer potentially life-threatening cardiac risks. In a study from Brazil, roughly 11% of patients taking these medications had a QTC interval above 500 ms, “a known marker of high risk of malignant arrhythmia and sudden cardiac death.” Now, it must be qualified that this study evaluated a Hydroxychloroquine dose 4-times higher than what is administered in an ongoing University of Minnesota randomized prevention trial to comprehensively evaluate its efficacy. The Minnesota study has had 3 interim safety analysis without any identified concerns in over 1000 participants.

5. Kidney-transplant recipients: A New York hospital reported that among 36 adult kidney-transplant recipients who tested positive for COVID-19 only 58% had fever as an initial symptom. Transplant recipients also had faster clinical progression, and at 3 weeks, 28% had died.

6. Kids’ mental health: An estimated 23% of primary school children surveyed in China’s Hubei province while they were under home confinement reported feeling depressive symptoms, and 19% said they had symptoms of anxiety, according to a study in JAMA Pediatrics

𝗦𝗢𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 π—’π˜‚π—Ώ π—‘π—²π˜„π˜€π—Ήπ—²π˜π˜π—²π—Ώ

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26 April 2020 Blog Post: COVID-19 Update On Generalizability

26 April 2020 Blog Post: COVID-19 Update On Generalizability

I had been blissfully unaware of the “news conference” held by Dr. Dan Erickson of Accelerated Health Care in Bakersfield until a colleague texted me a link to a YouTube video. It has now generated more than 6.5 millions views. I had just finished reading Bill Gates’ 13 page blog post entitled “Pandemic I – The First Modern Pandemic” when the text arrived.

Bill Gates’ paper is thoughtful and composed in its messaging, reflecting the intellectual fortitude of a generational genius who has now devoted his life to understanding global public health challenges. Dr. Erickson’s monologue is riddled with sampling bias, factual errors and sweeping generalizations from somebody with no such acumen or experience. The contrast between the two could not be more stark.

Dr. Erickson begins his press conference with the basic facts of his investigation, which are useful to know and laudable insofar as he took such initiative particularly early in the pandemic. HIs company, Accelerated Urgent Care performed 5,213 COVID-19 tests at its five Bakersfield locations, and, of these, 340 were positive (6.5%). This effort is impressive and far outstrips the pound-for-pound efforts of the UC Health System. UC Irvine for instance has only done 1.987 tests to date.

However, it isn’t long before his conference goes completely off the statistical rails. Dr. Erickson claims that if that percentage of positive cases seen in their Urgent Care were assumed to represent the entire population of Kern County, it would mean about 58,000 people in Kern have had the virus, far more than the nearly 700 official total. But it is impossible that the patients seen at 5 Urgent Care sites represent the underlying population. Who goes to Urgent Care? People that feel unwell. Who doesn’t go to Urgent Care? Everybody else. In fact, outpatient visits to healthcare providers have declined nearly 60% since mid-March and have stayed at that level through April (Dr. Erickson references himself references a ‘dramatic decrease’ in visits to his own facilities). This is akin to estimating the average height of an American adult male by surveying NBA players.

The impact of COVID-19 Pandemic on Outpatient Visits: A Rebound Emerges

But wait! There’s more. Dr. Erickson then extrapolates his findings to the entire State of California. He overlooks the fact that Kern County comprises only 2.25% of the State’s population, is significantly younger (average 31.5 years versus 36.3 years for California as a whole) and more widely spread geographically (109 people per square mile – Los Angeles County is 2488 people per square mile) on average.

He then doubles down (literally doubles down) on his estimate of actual infection rates stating that the real prevalence of COVID-19 infections in California is actually 12 percent of the population. From where did he get this number? His own data suggested 6.5%. Who knows – and it doesn’t really matter. His misadventures in mathematics aside, he ceremoniously arrives at a COVID-19 mortality rate of 0.03% or 3 deaths per 10,000 infections.

This mortality rate is ludicrious. Before generalizing any estimate, it must be checked against outside data. In New York City, for instance, over 12,000 people have died from COVID-19 in a population of 8.4 million. This is a mortality rate of 0.14% or 14 deaths per 10,000 population. Notice I said population, not infections. Yes, even if we assume that every single resident of NYC is either actively infected with the virus or has recovered from the virus, COVID-19 would have to be 5 times less lethal in California as compared to NYC.
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All of this aside, my greatest critique is saved for Dr. Erickson’s conclusion – which is that COVID-19 infection is “similar to flu” and “if we don’t shut down the country for flu, should we keep doing it for coronavirus?” As a physician, Dr. Erickson should be reminded that we have both a vaccine and an effective treatment for influenza. And, if he had read Mr. Gates’ essay, Mr. Gates suggests that we need a COVID-19 treatment that approaches “95% effectiveness” or a vaccine or both before we can go back to normal.
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I’m going to stick with Bill Gates on this one.

𝗦𝗢𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 π—’π˜‚π—Ώ π—‘π—²π˜„π˜€π—Ήπ—²π˜π˜π—²π—Ώ

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22 April 2020 Blog Post: Los Angeles County Seroprevalence Survey. Please Make It Stop

22 April 2020 Blog Post: Los Angeles County Seroprevalence Survey. Please Make It Stop

Honestly, I now spend more time battling misinformation and poorly constructed clinical studies than I do actually communicating useful information. Earlier this morning I wrote about flaws in commercially available antibody testing. I deliberately did not write about Stanford’s misleading Santa Clara study as this has been covered nicely elsewhere (see: Feud over Stanford coronavirus study: The author owe us all an apology)

But now in Los Angeles we have our own misleading study to discuss. Yesterday morning, a study out of the University of Southern California on a sampling of residents in Los Angeles reports that hundreds of thousands of adults here may have already been infected. As of Monday, Los Angeles County had recorded fewer than 13,000 cases. From this study in Los Angeles, the estimated infection rate ranged from 2.8% to 5.6%. The Los Angeles Times then immediately reported that this figure is 55 times higher than the reported official case count.

So apparently the new model in COVID-19 science is to release study reports to journalists without publishing the methodology of the study. Or having the study peer reviewed.

So the first methodologic critique is study sampling. According to the press release, USC researchers and Public Health officials conducted drive-through antibody testing April 10th and 11th at six sites. Participants were recruited via a proprietary database that is representative of the county population. The database is maintained by LRW Group, a market research firm. According to their website – LRW is “an analytics-driven marketing services company powered by data, sophisticated analytics, and deep human understanding.” And not a single epidemiologist in senior management. So who precisely was recruited and, of those, how many agreed?

Second, the USC study used a test manufactured by Hangzhou Alltest Biotech which is the same test used in the Stanford study critiqued above. An independent study(Lassauniere et al. from Statens Serum Institut and Copenhagen University Hospital in Denmark) found this to be the least reliable immunoassay of 9 that they evaluated. It is so unreliable that the UK, who had ordered 3.5 million of the tests, will not even use it. The Danish study suggested a a specificity of 87%. Researchers did not test sensitivity further because it performed so poorly. A separate study reported testing sensitivity of 88.7% and specificity of 90.3%. The Alltest Biotech testing kit was shown to cross react with antibodies to Influenza A, Influenza B, adenovirus, and dengue.

So lets work the numbers. The USC/LA County survey included 863 adults in Los Angeles County. They estimate 4.1% of the county’s adult population has antibody to the virus which means that they had 35 positive tests. Using the published sensitivity and specificty numbers of the Alltest Biotech kit, we can then accurately and mathematically critique this study.

Now, the test performs well when it is negative as its negative predictive value is 99.5% (95% confidence interval: 98.6% to 99.8%). This is the probability that subjects with a negative screening test truly don’t have the disease.

This test performs terribly when it is positive as its positive predictive value is 72.1% (95% confidence interval: 62.6% to 79.9%). This is the probability that subjects with a positive screening test truly have the disease.

This potential error in the test can easily dominate the results, especially in such a small sample size.

Statistician John Cherian of D. E. Shaw Research, a computational biochemistry company, made his own calculations given the test’s sensitivity and specificity β€” and conservatively estimated the proportion of truly positive people in the Stanford study to range from 0.2% to 2.4%. I would suspect that Los Angeles County has similar true seroprevalence rates. But faulty underlying data on 863 people in a County of over 10 million hasn’t stopped wide and sweeping conclusions.

Dr. Sooj (USC Professor and lead author) – β€œThe estimates also suggest that we might have to recalibrate disease prediction models and rethink public health strategies.”
(I disagree)
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Dr. Simon (Chief Science Office at LA County) – “Though the results indicate a lower risk of death among those with infection than was previously thought, the number of COVID-related deaths each day continues to mount, highlighting the need for continued vigorous prevention and control efforts.”
(I agree with the second half of his statement but it is frankly dangerous to communicate a lower mortality rate giving people a false sense of security).
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Dr. Ferrer (Director LA County Health Department) – “These results indicate that many persons may have been unknowingly infected and at risk of transmitting the virus to others. These findings underscore the importance of expanded polymerase chain reaction (PCR) testing to diagnose those with infection so they can be isolated and quarantined while also maintaining the broad social distancing interventions.”
(So based on the results from this testing modality you are suggesting we use another testing modality to find out what is really going on?)
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I think we need some sort of cease fire on misleading COVID-19 studies. At a minimum, they need to be submitted to a peer-reviewed journal and critiqued before issuing a press release.

Link:

Hundreds of thousands in L.A. County may have been infected with coronavirus, study finds

𝗦𝗢𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 π—’π˜‚π—Ώ π—‘π—²π˜„π˜€π—Ήπ—²π˜π˜π—²π—Ώ

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22 April 2020 Blog Post: COVID-19 Update Looking for Inspiration

22 April 2020 Blog Post: COVID-19 Update Looking for Inspiration

As I reflected on some of my more recent posts, it occurred to me that many have been (warranted) critiques of testing, response and messaging from local, regional and national leadership to COVID-19. I decided today that I wanted to find some of the inspiring stories in this pandemic.

One such story comes from The Broad Institute of MIT and Harvard (same Broad provided funding as for The Broad Art Museum here in Los Angeles) which has pivoted from its usual research efforts to fill gaps in COVID-19 testing. I have a personal connection to The Broad Institute as I worked there for the better part of two years in 2001/2002 when it was still the Whitehead/MIT Center for Genome Research.

Massachusetts ranks fourth in the nation for coronavirus testing, per capita. About 6% of those tests have been conducted by the Massachusetts State Public Health Laboratory. And just ten (not 10%, ten tests total) were performed by the federal Centers for Disease Control and Prevention. More than 50,000 tests have been run by hospital and academic labs.

In late March 2020, Broad Institute converted their large-scale genomics facility into a center that can processes COVID-19 tests. To date, they have run over 38,000 tests (real time link: https://covid19-testing.broadinstitute.org/)

At the Broad Institute, the transformation from basic biomedical research to coronavirus testing facility began with a phone call from Dr. Deborah Hung, an Infectious Disease physician and Broad member, to Dr. Stacey Gabriel, director of the genomics platform at the Broad. Although they had never done the particular biological test needed to diagnose SARS-CoV-2, they quickly figured it out. Dr. Gabriel says they can now run 4,000 samples a day and may scale up further.

(Dr. Gabriel was similarly exceptional when I was there from 2001/2002. She was responsible for a quarter million samples per day as part of the Human Genome sequencing project, She was nice enough to let me use her Sequenom machine on weekends as long as I didn’t break anything).

Not enough good news? It gets better.
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The Broad Institute has also partnered with the City of Cambridge to test Cambridge residents experiencing homelessness. By making testing available with rapid turn around time, they are able minimize any potential transmission among those who may have passed screenings and did not exhibit symptoms, but were unknowingly carrying the virus.

𝗦𝗢𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 π—’π˜‚π—Ώ π—‘π—²π˜„π˜€π—Ήπ—²π˜π˜π—²π—Ώ

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21 April 2020 Blog Post: On Why I Don’t Offer Antibody Testing… Yet

21 April 2020 Blog Post: On Why I Don't Offer Antibody Testing... Yet

Several days ago I posted the rationale behind my reluctance to begin COVID-19 antibody testing in the office – this after a number of questions asking about its availability. My primary concern at that time was for the lack of validation data. This was lacking because the FDA had not required companies to submit such as part of the approval pathway (this position has since been reversed).
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Over the weekend I read a story about a reporter who drove to Orange County, remained in his car in line for 2 hours and received an antibody test purported to be of 90% accuracy. The reported noted that “90% seemed like a good deal to me.” However, 90% is not a good deal as there are two errors that can be made in testing – a falsely positive test and a falsely negative test. An HIV test for example is 99.9% and 99.5% accurate in these measures.
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The FDA has now issued a letter warning healthcare providers about the limits of serological tests to detect SARS-CoV-2 antibodies. The agency is urging clinicians to “not use serological (antibody) tests as the sole basis to diagnose COVID-19 but instead as information about whether a person may have been exposed.”
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In mid-March, the FDA “provided regulatory flexibility” (I think this is a generous description but I applaud the author for their linguistic creativity) for test developers. This has resulted in scores of antibody tests quickly hitting the market without the agency’s usual review. As of April 18, just four antibody assays had received emergency use authorization from the FDA.
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The agency said it “is not aware of an antibody test that has been validated for diagnosis of SARS-CoV-2 infection.” (Stunning.)
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A New York Times story details the low accuracy seen with many of the tests on the market β€” sometimes as low as 20–30%. One infectious disease expert told the Times: “People don’t understand how dangerous this test is. We sacrificed quality for speed.”
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I am hopeful that within these tests is one that is effective and accurate. Now we just need to take the time to identify which one that is.

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𝗦𝗢𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 π—’π˜‚π—Ώ π—‘π—²π˜„π˜€π—Ήπ—²π˜π˜π—²π—Ώ

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20 April 2020 Blog Post: COVID-19 Update On Being Ahead of The Curve

20 April 2020 Blog Post: COVID-19 Update On Being Ahead of The Curve

Thus far in the #COVID19 pandemic, the United States has been decidedly behind the curve in our response. This has been perplexing given that we had advance warning. Further, other countries affected more proximally (South Korea, Taiwan, Singapore) had a more prompt and effective public health response. Our relatively ineffective effort in terms of daily deaths is presented graphically below (data current through 4/17/2020).

Singapore, in particular, had been praised by the World Health Organization (WHO) for their ability to limit spread without imposing restrictive lock down measures. That was, until the second wave hit. Since March 17, Singapore’s number of confirmed coronavirus cases grew from 266 to over 5,900.Β 

So what happened?
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I remember early in the US epidemic (which was like 8 weeks ago but seems like a lifetime), I was looking for resources on self-quarantine and case isolation. The instructions I posted our Facebook page were from the Public Health Department of Ottawa. I had looked initially to Singapore for their guidance, but upon reviewing their materials I discovered that public health officers came to the homes of those infected with COVID-19. Patients received a box of instructions as well as disinfecting sprays, wipes and masks/gloves needed to effectively clean common areas thus preventing the spread of the virus. So there were no published materials because quarantine instructions were delivered directly(!) to cases.
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Unfortunately, in Singapore, these public health officers appeared to have overlooked clusters of cases among migrant workers living in cramped quarters. From this origin, the virus was secondarily able to spread through a city where lock down measures had not been put in place.
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So what can we learn?
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The key take away here and one which is applicable to the US as we move towards the minefield that is re-opening, is that the resurgence of cases comes from “overlooked” cases who live in close proximity to one another.
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Any thoughts of where similar pockets might be in the US? I can think of some: prison populations, long term care facilities, assisted living, nursing homes, homeless shelters, retirement communities, military barracks, aircraft carriers, submarines, dormitories, and migrant worker housing. No doubt there are many others.
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But the good news is that it is far easier to implement control and preventive measures in a cluster outbreak is than it is for a distributed community spread disease. One way to conceptualize the second wave of COVID-19 might be similar to a nationwide foodborne outbreak. In such, epidemiologists first identify institutional settings (e.g., hospitals and schools), as potential sources of a disease. As an investigation continues, cases from a particular institutional settings may point to a common source. Our response can then be predicated on policy and guidelines developed from this outbreak experience and virtual certainty about the etiology of the problem and its mode of spread.
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It’s never too late to learn.
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[Acknowledging the late Dr. Michael B. Gregg who served as Editor-in-Chief for the classic text “Field Epidemiology” from which this information was gleaned ]

𝗦𝗢𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 π—’π˜‚π—Ώ π—‘π—²π˜„π˜€π—Ήπ—²π˜π˜π—²π—Ώ

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17 April 2020 Blog Post: Silencing Healthcare Workers during COVID-19: The #GetMePPE Movement

17 April 2020 Blog Post: Silencing Healthcare Workers during COVID-19: The #GetMePPE Movement

There is a lot to worry about in the midst of a pandemic. Information changes daily and the accumulation of cases and deaths in the United States seems beyond comprehension at times. With so much to process, concerns about working conditions among healthcare workers seems like just one more thing in this tornado of uncertainty.

There are times in this process where I stop and remind myself that this is actually my second pandemic as a healthcare professional. HIV/AIDS being my first. Since the first cases of acquired immunodeficiency syndrome (AIDS) were reported in 1981, infection with human immunodeficiency virus (HIV) grew to pandemic proportions, resulting in an estimated 75 million infections and 32 million deaths to date. I wonder if we can learn anything from that tragic experience.

In 1986, the deeply religious and brilliant pediatric surgeon C. Everett Koop was finally authorized, as Surgeon General, to write a report on the federal response to HIV/AIDS. Many were fearful given his unabashed evangelical Christian views (I can attest to these personally as I heard him speak as a trustee of my high school). Yet, Dr. Koop wrote in the report’s foreword, “At the beginning of the AIDS epidemic, many Americans had little sympathy for people with AIDS. The feeling was that somehow people from certain groups ‘deserved’ their illness. Let us put those feelings behind us. We are fighting a disease, not people …The country must face this epidemic as a unified society. We must prevent the spread of AIDS while at the same time preserving our humanity and intimacy.”

As if it is any wonder, his confidant and advisor in writing this report was none other than Dr. Anthony Fauci who said of Dr. Koop – “He was deeply driven by principle when it came to public health, not by any ideology.”

We know from survey data both in the US and Italy that 20% of COVID-19 infections are among healthcare workers. To date in the US at least 5,400 healthcare providers have been infected resulting in dozens of deaths. Researchers in Nebraska could find viral DNA in 2/3rds of air samples collected in isolation rooms in hospitals treating severe COVID-19 cases as well as in a quarantine facility for patients with mild infection. Further, a recent study published by Dr. Sutton and colleagues at Columbia Presbyterian Hospital Obstetrics ward showed that 13.7% of routine (non-COVID related) admissions were positive for COVID-19. Of these 88% had no symptoms of such. So, in reality, any healthcare worker involved in the care of any patient is ‘frontline.’

We have seen protests from nurses in our own City of Santa Monica decrying the lack of PPE. The rationale given by the hospital system is that providers caring for non-COVID-19 patients do not need N95 masks or enhanced protective equipment. However, we have emerging evidence that COVID-19 may have a lengthy ‘presymptomatic’ phase and that there may be carriers who are entirely asymptomatic. Assuming all patients have the infection until proven otherwise is the only logical manner in which to proceed.

To rephrase Dr. Koop, the country must face this COVID-19 epidemic as a unified society. We must prevent the spread of coronavirus while at the same time preserving our humanity and intimacy. John Manuel-Androite wrote in The Atlantic, “By his willingness to rise to the moment, to respond from his faith in God and his powerful belief in his calling as a doctor, as his fellow humans called out from their fear and suffering, C. Everett Koop changed the course of history. He also ensured that his honored memory will live on in history.”

We owe it to our frontline medical professionals to do the same. And, now, every single one of them is on the frontline.

Link:

Hospitals Tell Doctors They’ll Be Fired If They Speak Out About Lack of Gear

𝗦𝗢𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 π—’π˜‚π—Ώ π—‘π—²π˜„π˜€π—Ήπ—²π˜π˜π—²π—Ώ

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17 April 2020 Blog Post: COVID-19 Update

17 April 2020 Blog Post: COVID-19 Update

Reported deaths to coronavirus in the US continue to rise exponentially. Reporting them by week:
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5 weeks ago: 41 deaths
4 weeks ago: 195 deaths
3 weeks ago: 1,195 deaths
2 weeks ago: 5.983 deaths
1 week ago: 16,684 deahts
Now: 33,268 deaths
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Here are some of the latest developments on novel coronavirus disease (COVID-19):
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1. Risks associated with smoking and asthma: Not surprisingly, past or current smokers with COVID-19 have double the risk for severe disease outcomes as people who’ve never smoked. About 18% of those with a history of smoking experienced disease progression, compared with 9% of never-smokers. On the other hand, data from NYC has shown that asthma has been underrepresented in patients who were sick enough to get treated in New York. Only 5% of those who died from COVID-19 in the state had asthma. At Santa Monica Primary Care, we have been managing asthma in our patients more aggressively – perhaps because patients are more aware of any chest tightness / congestion or shortness of breath.
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2. Convalescent plasma: The FDA is now encouraging people who have recovered from COVID-19 to donate their plasma to help others who are ill. Each donation could be given to as many as four patients through convalescent plasma or hyperimmune globulin. We have been encouraging such in our practice as well and have already referred a number of recovered patients to the Red Cross (www.redcrossblood.org). As part of our testing efforts, we have performed testing post-recovery seeking a negative result. A confirmed negative result after infection is a gating item question in the plasma donation process, at least with the Red Cross.

𝗦𝗢𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 π—’π˜‚π—Ώ π—‘π—²π˜„π˜€π—Ήπ—²π˜π˜π—²π—Ώ

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15 April 2020 Blog Post: On Antibody Testing and “Crappy” Testing

15 April 2020 Blog Post: On Antibody Testing and "Crappy" Testing

I have had a number of questions recently expressing interest in antibody testing for COVID-19 and wondering when it will be available at Santa Monica Primary Care. This is not yet a modality we are offering in the office not only because of lack of availability but also insufficient validation data. Today, the American Public Health Lab Association provided support for this approach referring to “crappy” (their word!) tests that are flooding the market. Let me explain further and try to quantify “crappy.”

First – what is an antibody test? Unlike a throat or nasal swab which indicates the presence of active infection, an antibody test can distinguish between someone who has been exposed the virus from someone who lacks immunity. Two antibody classes are typically checked: IgM which is the first antibody to appear in the response to initial exposure and IgG which is a secondary immune response that ensures long term immunity.

There are pitfalls to this testing however. For instance, an antibody test can yield a falsely negative result in an infected patient who has not yet developed an adequate response to the virus. Similarly a test may be incorrectly positive if antibody to a coronavirus other than the pandemic novel strain is present (note that there are four human coronaviruses which an estimated 15-30% of seasonal “common” colds).

While antibody tests by themselves are of limited value in immediate diagnosis, using this type of test will undoubtedly help us better understand how the immune response against the SARS-CoV-2 virus develops. We can also begin to estimate how many people in the overall population may have been infected. Lastly, these test results can aid in determining who may donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19.

Currently available antibody testing in the US are limited by the fact that they are qualitative (Yes/No answer) as opposed to quantitative (How much?) testing. Tests on the market now are akin to home pregnancy testing which are “+/-” yet do not give any information about how far along one is in a pregnancy. There is currently significant debate about the degree of immunity conferred by coronavirus exposure and how we might deem one ‘sufficiently’ immune. One massive potential pitfall of Yes/No testing is providing patients with misplaced confidence about their own level of protection – leaving them susceptible to community spread infection.

Throughout my COVID-19 posts I have repeated a theme that the US population should demand better in our pandemic response. Validation series of these new tests, pushed to the market under Emergency Use Authorization guidelines, are lacking and we should demand better. Some tests on the market have only been double checked against 50 or 60 known cases and controls. One commonly marketed test (linked below) reports a sensitivity of 88.7% (identifying a known positive case as positive) and a specificity of 90.6% (identifying a known negative case as negative). These numbers sound impressive – but compare them to the sensitivity of HIV testing which has a sensitivity of about 99.9%. The specificity of these tests is slightly lower, about 99.5%

As we shelter in place for the next month, there will no doubt be rapid improvement in antibody and serologic testing. I do not have an expectation that testing will approach the operating characteristics of HIV testing, but we should continue to demand more accurate testing if such will be employed in the population at large. For the moment, it is best to insist on something better than a ‘crappy’ test which can be sold because the FDA has done away with a requirement to submit validation data.

There is no rush – our advice for the next month will remain the same. Stay at home, avoid contact with our most susceptible populations, wear a mask when performing essential activities and wash your hands. Lets wait for and insist on better.

𝗦𝗢𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 π—’π˜‚π—Ώ π—‘π—²π˜„π˜€π—Ήπ—²π˜π˜π—²π—Ώ

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