The Kroll Medical Group

The Kroll Medical Group Welcome to the Kroll Medical Group. We are an Internal Medicine Practice providing medical care for

We are an Internal Medicine Practice providing medical care for adult patients over the age of 18. We work closely with the region's top specialists and CentraState Medical Center. At the Kroll Medicine Group, our goals are simple: We want to provide you with the highest quality medical care and make every visit to our practice as positive and satisfying as possible. Our physicians believe good health involves more than seeing your doctor when you are sick. We will work with you to develop the best health plan for your needs, to help you prevent disease as well as treat current problems and conditions. We firmly believe that the more information you have, the better decisions you will make for your health. We will work with you to make sure you understand your current health situation and the options available to you.

03/30/2022
03/30/2022

Welcome to the Kroll Medical Group. We are an Internal Medicine Practice providing medical care for

01/01/2022

Fauci's prediction about the future of the Omicron variant likely gave hope to many people. Here's why those hopes could be dashed—and why it is risky to make any predictions about the future of this or any crisis.

Covid-19 Testing:  Rapid vs PCR     Omicron variant Covid-19 is highly contagious but may be less lethal.  With the expl...
12/23/2021

Covid-19 Testing: Rapid vs PCR

Omicron variant Covid-19 is highly contagious but may be less lethal. With the explosion of Omicron variant cases, there has been a growing number of people testing positive for COVID on a rapid antigen test (LFT) but then testing negative on a polymerase chain reaction (PCR) test. People have been led to believe that PCR tests are the “gold standard” and LFTs are crude mass-testing devices – that PCRs should pick up cases that antigen tests miss, not the other way around.
This is not the case. Both tests are important and have strengths. There are important distinctions for why these tests should be done. And they both have weaknesses.

A review of testing theory. All tests have an inherent sensitivity and specificity. These terms relate to the false positive and false negative results of the test. The predictive value of the test utilizes the sensitivity and specificity values of the test as well as the prevalence of the disease in the population being tested.

In the attached figure are the predicted numbers for sequential LFT testing followed by PCR testing.

About 96% (7,000/7,297) of people testing positive on a rapid antigen test will be true positives. This is because LFTs are very “specific” – they don’t give many false positives. For every 10,000 LFTs tests by person who does not have COVID, there will be fewer than three false positives (a specificity of 99.97%).

In a population of 1 million people where 1% have COVID, 297 people will have a LFT that says they have the virus when they don’t (a false positive). And because PCR tests are (almost) 100% specific, when they follow their LFT with one of these, they’ll then get a negative PCR result.

But here is the problem of accuracy: LFTs have gained a bad reputation because of their low “sensitivity” – meaning they have a high rate of false negatives. Around 30% of the time when someone has COVID, an LFT won’t pick this up. PCR tests are much better, with a false negative rate of only 5%.

But the 5% false negative rate of PCR testing can also lead to a positive-then-negative testing sequence. With the current prevalence of COVID, 7,000 of 1 million people will correctly be flagged as having COVID by an LFT. Of these, 5% – 350 people – will then get an incorrect false negative from their “confirmatory” PCR test.

It’s important to remember that because of its high specificity, you can be pretty confident that a positive LFT result is genuine –for every 7,000 that are right, only 297 are wrong. And even if your positive result is followed by a negative PCR test, it’s currently more likely that you have COVID than do not (350 vs 297).

In addition, there are now reports that some of the LFT tests, released under emergency use authorization, are not detecting Omicron variant. These would then be considered a “false negative” and therefore these tests have a lower sensitivity. These tests are being removed from the marketplace – but it is possible that people may still be purchasing them in pharmacies and online.

It seems that Omicron variant can easily infect a vaccinated person, and in so doing, will continue to mutate to more variants. This is the true concern at this point. Even if Omicron is not as “deadly” as previous strains, the infectivity of the virus means that ANY positive, on either a LFT or PCR test, should be taken seriously in order to reduce transmission of the virus to other people.

Testing theory can reliably be used to predict that if the prevalence of viral infection increases (which seems to be happening, as daily Omicron cases have now surpassed Delta variant cases at their peak), there will now be even greater positive LFT followed by negative PCR stories.

LFTs should be used for screening. Families can use the test to see if they should get together for holidays or travel. Antigens detected from nasal swabs should be interpreted that a person is infectious. Sequential antigen testing can be used to track exposure, but single antigen testing should not be used in this way. PCR testing is a good strategy to test for exposure. PCR tests can detect virus before and after a person is contagious. These distinctions are subtle but important.

12/09/2021

Here is what I am seeing in my medical practice and what I am gleaning from scientific publications:

There is very little known about the Omicron variant so far. We are at the beginning stages of understanding the nature of this variant. With other variants, it has taken several months to gain a full understanding of the clinical ramifications of the viral shift. Initially, we do neutralization antibody assays - which take vaccinated people's blood and expose it to Omicron like spike proteins to see if these antibodies are effective. So far with preliminary studies, there seems to be a substantial drop off in the effectiveness of these antibodies to neutralize the Omicron variant Spike protein.
But this may not extend out to real life scenarios. Beta variant, for example, was almost completely resistant to neutralization by vaccine mediated antibodies. Clinically, however, this variant did not seem to be substantially more lethal, nor did it seem to be more easily capable of spreading. But there is a big caveat: Beta variant was quickly replaced by delta variant, which is far more contagious. The Delta variant quickly grew to be the predominant coronavirus infection throughout the world.

So far, we have not modified the vaccines for variants. The tests for the strength of vaccine protection against these variants are compared to the neutralization of the original covid-19 strain. That strain is what was used for the design of the three commercially available vaccinations. Pharmaceutical companies are in the process of making modifications. But new vaccines will need to be tested for safety, even with emergency use authorization.

Clinical data so far shows that Omicron and is spreading quickly but those who are vaccinated do not seem to be getting as sick. Breakthrough infections are being seen at a higher rate with Omicron variant. A concern is that if Omicron is as contagious or more so than Delta, those who are not vaccinated may be especially susceptible.
Early in the pandemic, the thought was that children seemed to be less at risk for Coronavirus infection and hospitalization. This has radically changed. Partially because adults are generally getting vaccinated. Therefore the proportion of children who are getting sick and hospitalized has risen dramatically. This may become worse with an even more infectious variant.

Patients are requesting antibody levels to determine whether they should be vaccinated or receive a booster vaccination. The commercially available laboratory measures for antibodies are highly variable and difficult to interpret. Different experts maintain vastly different interpretations of “protective” levels. The only thing I have observed is that the antibody levels drop off over time, but there is no defined threshold that says that a person has an antibody level to protect them from infection.

There is clear clinical data that vaccination protects people from hospitalization. I frequently see breakthrough infections. But those who are vaccinated almost always have mild symptoms. Importantly, I have not seen people who have received the booster shot having even less symptoms with breakthrough infections.
Next is the question of natural immunity. The data from South Africa, in a very small study, is that natural immunity (from prior Covid19 infection) plus vaccination seems to provide better neutralizing antibodies than vaccination alone. It is likely that natural immunity provides a more robust and adaptive immune response which can respond to variants of the virus. This is by no means a reason to get infected, but may mean that we need polyvalent type vaccines or repeated vaccination, as different variants emerge.

The three questions regarding Omicron variant is 1) Will it be very contagious and surpass delta variant? 2) Is it more pathogenic (deadly) than previous variants? And 3) Are our current vaccinations less effective than they are for prior variants?
There is a lot of speculation as to the individual mutations. What is the effect of each mutation on vaccine resistance and viral lethality? This may be misguided. Mutations in protein coding can have vastly different effects on three-dimensional conformation depending on the other mutations. It is too simplistic to analyze and predict what individual mutations will do. It is the compendium of mutations and their interactions with each other that will determine virality and vaccine resistance.

We are far away from knowing lots of these details. At the beginning of the summer, we saw the first cases of Delta variant. This virus variant came to surpass other variants. And in doing so, we saw a significant spike in non vaccinated cases of infection. We may see the same with Omicron.

As the virus continues to replicate, mutations in the spike protein will continue to occur. This is natural selection. The virus changes to keep spreading. The only way to stop this is by universal vaccination.

09/21/2021

Covid Immunity - By Spencer Kroll MD PhD Part 1

Many people are wondering about their immunity status to the COVID-19 virus after natural infection and recovery. Or alternatively after vaccination. In some cases, people have been infected and then vaccinated. And in some cases, people have had "breakthrough" infections after vaccination.

There is tremendous confusion and false messaging about testing and its implications for evaluation of immunity. This has impacted peoples moves towards vaccination and "booster" shots. It has also impacted people's general behavior regarding quarantine, masking and testing. ​

Here are the latest facts, presented from the latest scientific information and peer reviewed literature, rather than spin from opposing media outlets.

1) The mRNA vaccines are effective in keeping people out of the hospital and dying. This immunity - both in terms of antibody based immunity as well as longer term T cell and memory B cell immunity has shown some fall off over time. It has also shown some limitation in terms of response to Delta variant virus.

2) The mRNA vaccines may not provide the same adaptable immunity as natural infection. This means that vaccines, which are designed based on the Corona virus spike protein, may not be as effective as getting infected, as the virus spike protein changes through emerging variants.
​3) Getting infected, and the natural immunity that should follow, is not a viable option as a therapeutic strategy to control the virus. This strategy has not worked in any country or location where it has been tried. There is HIGHLY variable response in terms of immunity to infection. Some people with mild infection develop early neutralizing antibodies that dissipate over weeks. This is similar to the immunity that develops from other types of corona viruses that cause colds and mild upper respiratory infections. People with more severe cases have little antibody early in the infection and develop a "cytokine storm" and vigorous antibody production as they get significantly sicker. These people usually require hospitalization and sometimes intubation. People should not bet on where they will come out regarding this because a milder infection causes less sustained neutralizing antibodies to fight future encounters with the virus. Neutralizing antibody production after infection lasts for a shorter duration than vaccination.

4) Children may be partially protected from infection because other corona viruses are endemic in pediatric patients. This is very important to testing because antibody testing cross reacts with antibodies to these other corona viruses and may provide a false positive result in both adults and children.

5) Recovery from natural infection followed by 1 dose of mRNA vaccine, may provide the best protection from delta variant - which now makes up 99% of the infections in the United States. This result does not undermine the effectiveness of two doses of the mRNA vaccine: which is a predictable result. The limitations of vaccination in this regard need better understanding.

6) Immunity testing has also been very misunderstood. Before the late summer, commercial laboratories such as Quest and Labcorp were testing a polyclonal mix of antibodies to corona virus and reporting a qualitative result - either positive or negative. There are multiple antibodies that can be measured for Covid19 including multiple spike domains, the receptor binding domain and nucleocapsid domain. These different measures have vastly different results for interpretation of immunity from infection versus immunization. Many clinicians DO NOT understand these distinctions, nor are they clear on the results sheets delivered from the commercial laboratories. In many instances, results that showed immunity may have shown immunity from past infection - NOT from vaccination. Conversely, negative results from commercial laboratories have occurred because the incorrect antibody tests were being ordered.

7) In August, 2021, the commercial laboratories began to differentiate testing of different Covid19 antibodies and reporting quantitative values. First off, these quantitative values, according to most experts, should not be interpreted as the strength of immunity or compared between samples or between laboratories. People are requesting repeated antibody testing with levels. There is no validity to these numbers besides whether they are positive or negative in terms of protection, or to the strength of protection. There MAY be correlation , however, to a projection of the timing of falloff of immunity, if the numbers are dropping.

The CDC is not recommending serology (antibody testing) and has only issued emergency use authorization of these tests. They specify that there is "currently no recognized public health or clinical indication for preferential use of semi-quantitative tests.

9) Longitudinal patient follow-up studies are ongoing to measure antibody levels before and after vaccination or natural infection to identify an association between responses below a certain threshold and vaccine failure or re-infection. These longitudinal patient follow-up studies are expected to elucidate the relationship between antibodies and protection from reinfection. In addition, T-cell-mediated adaptive immunity following natural infection, which is much more difficult to measure, likely contributes to protection from subsequent exposure to the virus.

10) Manufactured antibody infusion therapy (i.e. Regeneron or Eli Lilly), will affect accuracy of antibody detection for months until these external antibodies are cleared by the body. These therapies are for short term therapy and not for long term immunity.

​In Part 2, I will discuss the differences between each of the antibody tests in terms of which ones to utilize, accuracy and reproducibility. In addition, I will discuss new tests for T cell immunity and viral neutralization.

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