Posts Tagged ‘ coronavirusantibodytesting ’

CMO and Caduceus Covid-19 Coronavirus Team August Updates

By editor
August 13, 2020


I’m not looking to fight with you
Frighten you or tighten you
Drag you down
Chain you down
Or bring you down
All I really want to do
Is discuss Covid with you
 
Ok, so we took some liberty with Mr. Dylan’s poetry.  It’s time to look at the path we have traveled the last five months. 
 
We began Covid testing March 11, and enrolled Covid patients in our program immediately. We published our observations a couple months ago, and a lot has changed since then. Let’s revisit what we have learned.
 
We have tested over 7,500 patients for Covid- both the swab for the virus and the blood for the antibodies. We have diagnosed or been referred roughly 750 cases as of this writing.  That corresponds well to the national average of a 10% positive rate with broad scale testing.
 
Our false positives have been under 1%--as advertised by the literature.
 
False negatives? Around 5-9%- again, as expected. 
 
So any speculation by pundits on social and mainstream media stating the tests are inaccurate is hooey. At least in our admittedly limited practice the tests are reliable.
 
What is noteworthy is in May we had just passed the 100 mark of cases. So the other 650 cases have been found in the last three months. This is partially explained by our ability to procure sufficient tests to allow testing five days a week at multiple sites, as well as a corporate program that brings us company employees to test. Admittedly we have been aggressive in encouraging our patients to test, and obtained more innovative tests that allow earlier detection of antibodies. The new moderate complexity antibody tests we offer have been very impressive indeed. 
 
Nonetheless, the number of new cases exploded.  In June our new cases per week doubled. July? Quadrupled! Why?
Yes, we reopened perhaps too soon, and definitely not smart. Beach weekends, protests, church services, BBQ’s, and parties all contributed their part to the deluge in cases. 
 
At one get together in a beach town, ONE unmasked person with not-yet-diagnosed Covid, caused the infections in EIGHT other party goers. Remember, we said the 14 day incubation period combined with being very contagious was a perfect storm? Well, there ya have it.
 
Of the 750 cases, about 100 never showed symptoms.
400 have recovered totally.
250 are under active care.
Only nine needed hospitalization--yes a 1.2% rate. This compares to a 4.6% rate nationally. 
And yes, still no deaths (insert sign of the cross being made).
 
More stats that may be of interest---
85% of those that swab positive formed IgM antibodies--again just as the biologists would predict based on other viral diseases.
 
Even better, after eight weeks, 95% form IgG--the antibody that theoretically confers immunity. This is in line with SARS 1 in 2005, another Coronavirus mutation. 
 
More evidence that the doom-and-gloom of the non-experts is baloney. These numbers are exactly what the immunology textbooks would have predicted.
 
We have seen the virus change though, at first, fatigue, fever, and cough were the three most common symptoms.  Now fatigue is still #1, but headache and diarrhea have replaced cough and fever. That's right, in April 80% of new cases had a fever. Now it’s just over 50%. So much for the temperature-at-the-door test huh?
 
At first, we were treating primarily a respiratory illness. Now we need to look for--and we have seen- blood clots, cardiac and muscle inflammation, strokes, kidney failure, and major depression.
 
Covid appears in some patients to cause a cascading inflammatory response that can affect literally every major organ system. 
 
The lungs still require the most attention. We still give the double Z’s (Zpak and Zinc) but have recently seen a better response to Augmentin and Doxycycline to the Zpak. 
 
We still push aggressive pulmonary hygiene...we obsess over keeping the lungs free of mucus to avoid a life threatening pneumonia...perhaps a factor in our low hospitalization rate. 
 
I'm sure we would get emails if I failed to mention Plaquenil.  We used it successfully until Lancet and New England Journal published articles showing no effect. Within weeks of publishing these two previously respected journals were forced to retract those studies for faulty data. The political backlash regarding using Plaquenil was unlike anything I have seen in over 40 years of practice. I’ll simply leave it at Plaquenil being in our tool box and our decision to use it is between our patients and our doctors, on a case by case basis.
 
We have found a couple of new treatments more effective than Plaquenil.
 
One is Decadron, the steroid. The studies are using it on in-patients to prevent intubation. But we found using it early in patients with obvious inflammation turns the corner quickly. Decadron helps to reduce inflammation and calms down an overactive immune system.
 
The other is Symbicort--a steroid inhaler (Budesonide) with a dilator (formoterol), used with almost any respiratory symptom.  There is no doubt to us that Decadron with or without Symbicort is a game changer. 
 
There IS one "magic bullet" for Covid cases that are very sick...convalescent plasma. Yes, they take the plasma from patients who have shown IgG, and infuse it into the sicker patients. So far, a 100% IMMEDIATE SUCCESS. Well, in fairness, we have had it used in six of the nine hospitalizations, and it worked every time. Yes, more evidence that IgG DOES bind to the Covid antigen and will prevent a second case.
 
Even more evidence: How many cases of a positive swab that converted to an IgG antibody have we seen?  Around 150.  How many of these have contracted Covid for a second time? That’s right...Zip. Zero. 
 
The problem lies in how long the IgG will hang around. We had one patient lose it in a month. In another case it only lasted two months. Using SARS 1, Chinese, and European data, it should last four-six months in most people. So to get herd immunity, we will need an effective vaccine. We cannot count on our natural IgG to protect us for years as it does against measles.
 
 
Other observations:


Smokers, vapers, diabetics, and obese patients are a much higher risk of a severe case and hospitalizations. The patients we encouraged to purchase a pulse oximeter as well as an incentive spirometer had a much easier time managing their Covid.
 
Since June, Covid in our practice is a disease of the YOUNG. Our average age is 36 for a new diagnosis. How many cases are diagnosed in seniors over 65 in our population? Would you believe less than 10%? Good, because it’s lower---UNDER 5%!
 
We respectfully and strongly disagree with the CDC and our own Health Department that the quarantine may end after a week of no fever or symptoms, with no re-swab necessary.  There is simply no evidence that a positive swab with no symptoms is not contagious. I have a challenge for the CDC/Health Department--take off your mask and let one of my Covid cases that swabbed positive but have no symptoms for a week cough in your face. Case closed. 
 
We have seen a change in behavior by the Covid patients as the summer dragged on. Now, only 15% of our cases agree to be re-swabbed.  That may relate to the young age of these patients, the seniors tend to be more compliant. 
 
Only 25% of newly diagnosed agree to quarantine---that’s not a typo.  Many may agree to stay at home for a week, but do not avoid household contacts; many even go to work. I’m not making this up. They travel, go out to eat, go grocery shopping. They use how sick they feel to guide them. But they are very contagious until they swab negative. 
 
If we want to look at why our August numbers are still high, we need to look no further than the poor compliance on re-swabbing and quarantining. 
 
Overall, we have learned a lot about treating Covid since March.  Meds have changed, symptoms have changed, and patient compliance has changed. Early bedrest, use of steroids-oral and inhaled, and aggressive surveillance via telehealth all play a part in keeping our patients out of the hospital and ventilators. And we are encouraged by the immediate improvement of all patients receiving convalescent plasma.
 
Conclusions?
1. Test Test Test. Know if you’re contagious. Know if you’re immune. If you're contagious, QUARANTINE. If you’re not immune, wear your mask, stay at home, social distance and hunker down. It may save your life.
2. If you are positive, QUARANTINE and RE-SWAB! Do not risk infecting others by spreading your Covid particles.
3. If you have IgM or are recovering from Covid, have your antibody checked every 4-6 weeks until your IgG is positive. Then you may want to still check your antibody every 4-6 week to see how long it will last.
4. If you must come into contact with people (job) or elderly (visiting grandparents) we advise a monthly swab. Yours truly has a swab every 10 days, to reassure my patients, and come to think of it, to reassure ME.
5. To help those who need convalescent plasma, contact the local blood bank directly if you are IgG positive. You may save someone's life.
 
To paraphrase Mr. Dylan:
 
I do want to straight face you
Chase you, track you, and trace you
Disgrace you and confine you
All I really want to do
Is have you die of something OTHER than Covid
After many years pass through
 
Sorry Bob.  I guess it’s time for my boot heels to be wanderin'…
 
Gregg DeNicola MD
Chief Medical Officer
Caduceus Medical Group

NOW OFFERING ORANGE COUNTY MODERATE/HIGH COMPLEXITY COVID-19 CORONAVIRUS ANTIBODY TEST-

By editor
July 30, 2020

OK, another game....Let’s pick something "low" complexity, and then counter with the first "high" complexity thing we think of...Ready??

Low complexity........floating in your pool on a rubber raft.
High complexity...taking on Class V rapids in the Grand Canyon.
 
Got it? Easy huh? OK OK let’s do a few more...
 
Low complexity...driving a Kia to the grocery store.
High complexity...driving auto pilot in a Tesla X in Downtown LA.
 
Low Complexity....making a grilled cheese sandwich from the Betty Crocker cookbook.
High Complexity...making a grilled cheese sandwich from James Beard winner Nancy Silverton’s cookbook.
 
Low complexity...binge watching "Breaking Bad" on Netflix.
High complexity…binge watching "Northern Exposure" from old video cassettes.
 
Alright.. so.. how does this tie into Covid? Well, the drive-thru tests for antibody offered throughout Southern California are "point of care,”meaning the test is run right then and there from a finger stick. It does NOT require government approval since it is "CLIA" waived. 

CLIA stands for "Clinical Laboratory Improvement Amendments.” CLIA is federal agency that mandates their approval for a lab to run tests and charge for them. And to get CLIA approved is quite a process...we have gone through the process and it would have been easier to get approval to launch a spaceship a la Elon Musk. 

To allow some tests to be done in old fashioned physician offices, like urinalyses, pregnancy tests, and strep screens, CLIA "waives" the tests they feel are "low complexity.” The current generation of antibody tests are low complexity and thus CLIA waived and able to be done at the "point-of-service" instead of having to be couriered to a clinical lab.
 
Are moderate/high complexity tests more accurate? Kinda…Maybe. Depends on how you define "accurate.”
 
In general, they can pick up cases earlier or with a lower "count.” They are more complex to design and run, hence the term "moderate/high complexity.” And, of course more expensive. (You saw that coming right?)
 
Let’s illustrate with an example I know a lot about...food!

The grilled cheese from Betty Crocker IS a legit grilled cheese. And decent too. No false advertising there.

On the other hand- Nancy Silverton's grilled cheese? OMG. I mean just the ingredients are high complexity....here they are verbatim:
 
•    1/3 Cup Olive Oil, Extra Virgin
•    2 ½ Tbsp. White Wine Vinegar
•    2 Tbsp. Kosher Salt
•    1 Tbsp. Freshly Cracked Black Pepper
•    2 Medium Yellow Onions, Sliced into 1/8-Inch-Thick Slices
•    ¼ Cup Whole Grain Mustard
•    8 oz. Gruyere cheese, sliced into 24-32 1/16 inch-thick slices
•    Whole country sourdough loaf

I could go thru the actual process but it would be easier to explain how to split an atom. Nevertheless at the end of the process, you also have a grilled cheese sandwich. Just unlike any you've ever had. 

The point is; both are grilled cheese. One is just high complexity. (Full disclosure-I do not receive a kickback from Nancy-but if you want to enjoy the best grilled cheese you've ever had I highly recommend her sandwich cookbook, Nancy Silverton's Sandwich Book: The Best Sandwiches Ever--from Thursday Nights at Campanile.) 

Now we can compare that to the office pregnancy test. It is accurate and picks up the pregnancy a day or two after the missed menses. The OTC test from the drugstore may need you to be 3-5 days late. Both are low complexity. But the moderate/high complexity CLIA approved test can pick it up a bit earlier than either of those that are CLIA waived. It isn't technically more accurate; just more sensitive. It picks up the hormones at a lower level.
 
You can see where this is going with Covid antibodies. The usual test available in the past through Caduceus and PDQ Urgent Care and More (and other facilities) is CLIA waived. It gives us two antibodies.. IgM -which tells us if you have had Covid, and also IgG which implies immunity. Despite what I read on both social media and mainstream media, it IS accurate. But it requires a decent antibody load to pick up the antibodies.

What is antibody load? It’s like having a single shot latte to wake up mid-day compared to a triple shot espresso. It’s easier to pick up caffeine if you are analyzing the triple shot compared to the single shot. A moderate/high complexity "caffeine test" can pick up the single shot, the low complexity just the triple shot.
 
We have partnered with KOS labs here in Orange County and Healgen Labs in Houston for a "New Improved" antibody test that is moderate/high complexity and thus requires CLIA approval. 

There are some differences between the new test and the current one being offered.
 
*The current test uses a finger stick, the new one needs a blood draw.
*The current test gives a same day answer, the new one takes overnight. 
*The current test has about a 10% false negative rate, the new one less than 5%.
*The current test picks up the antibodies 4-16 weeks out, the new one weeks earlier. 
*We of course bill insurance, but if you need to pay cash the current one costs $75, the new one is $85. 
 
As CMO I endorse the newer test if you are having the antibody test. 

We have been searching for the most accurate antibody test to offer our patients and this appears to be the gold standard.  It can still be drawn curbside. And of course, the sooner you find out if you are immune the better for all involved.

The better sensitivity and accuracy outweigh the overnight wait and the $10 price bump. We will now be using the "moderate/high complexity" test as the default. If you prefer the finger stick/same day/low complexity test we of course will honor that. We will keep both tests available.

And because I know I’ll get emails inquiring, I am not aware of this test being offered by other Orange County groups, but it may be. If they require a blood draw and an overnight wait, good chance they are offering the moderate/high complexity test. To be legal they would need to be partnering with a CLIA approved lab.
 
And of course the video visits are from the privacy of your home and the testing is from the comfort of your car.
 
Conclusions? 
1. If you want to know if you've had Covid, you need an antibody test looking for IGM.

2. If you want to know if you are immune, you need an antibody tests looking for IgG.

3. If possible have a "moderate/high complexity antibody test" in lieu of the low complexity version. We work hard to not run low on inventory, and I still ask EVERY Caduceus patient to have an antibody test.

4. So far, there has not been a reported new positive Covid test in a patient with a positive IgG--at least that I can find. A positive IgG should reassure that you are immune.

5. KNOW IF YOU'RE CONTAGIOUS (Swab)
    KNOW IF YOU'RE IMMUNE (Antibody via blood)
    Test.Test.Test.
 
Ok; let’s do one more…
 
Low Complexity....Reading this blog eating a bologna sandwich.
High Complexity...Reading this blog eating a Nancy Silverton grilled cheese...no way you'll pay attention to the blog!


Gregg Denicola MD
Chief Medical Officer 
Caduceus Medical Group


 

Antibody Testing.. Fact or Schiznick??

By editor
May 14, 2020


Since there are no sports to entertain us, let’s play a new sport we can do from our homes....we call it “Covid FACT or SCHIZNICK??”  Ok; we COULD call it TRUE or FALSE but what fun is that?

We will make a statement about Covid and you have to figure out if it is FACT..a true-ism, or SCHIZNICK- we are just fooling around. 
OK, ready?  Let’s commence!

The antibody test for Covid will confirm you cannot get re-infected...Got your answer? 
OK… Soooo the answer is-
SCHIZNICK!
Fine; we cheated a little on this one. Yes, if you have IgG antibodies it implies immunity—i.e. you are not going to get re-infected....but three problems;

1. The Covid virus may have mutated, in which case you can still get the mutated form.
2. Covid looks like other corona viruses and the antibody test may have picked up the wrong corona virus.
3. No one knows how long the antibody lasts; experts are guessing 1-3 years. Key word-guessing.
We still advise you get the antibody test--so far it’s been a good marker for immunity.

The antibody test will tell you if you've had Covid19 lately.
And drumroll....
SCHIZNICK!
Unfortunately, data is telling us only 60% of Covid victims will turn IgM positive--and even then it may take four weeks from infecton. But that is the idea of getting the antibody test. If your IgM is positive, you did have Covid lately.

If my Covid antibody is positive, I will still need the vaccine when it is available.
and......
FACT! 
We told you above that it’s unlikely the antibody to Covid will give lifelong immunity ---1-3 years is about it. The vaccine may not give lifelong immunity either, but they are shooting for at least five, maybe 10 years--kind of like a tetanus shot. 

The antibody test may not be "free;” not all insurances are covering it...
Is this a trick question? Doesn't the law require it to be covered?...well.....
FACT!
Here we have the classic case of conflicting facts.  Federal law relieves patient responsibility for "Covid testing" but health plans are allowed to not cover tests that are not FDA approved. Most antibody tests available now are FDA "authorized" as opposed to "approved.” Yes; as Chick Hearn would say, "ticky-tack". So far, our experience is around half of payors are covering it outright and half are "working on it.” For those plans, you may be asked to pay $75 and be reimbursed if and when they do pay, which we predict will happen.  We doubt payors will refuse once the Feds give them a call. 

If someone has had Covid, they will be immune eventually.
Hmmmm and.....
FACT!
Using data from SARS1, MERS, and from Asia and Europe, it appears about 99 % of Covid19 cases will turn IgG positive, implying immunity. But unlike other viruses, it is taking 30-90 days for this to show up. 
So if you tested positive on April 1, it may take until late June to turn the antibody test positive. We say be prepared for a retest if you are checking the antibody too early.

Employers who want to test their staff prior to them returning to work should have them get the antibody test.

Seems obvious right?   Noooooooooooooooooo…
SCHIZNICK!!
This is a double edged sword. To test immunity and know if the staff will not be infected; yes, the antibody test is indicated. But less than 10% of the population is testing positive so far. For the employer to assure customers the staff is not contagious; they should actually get the nasal PCR swab for the actual virus. Ideally they would order BOTH the antibody test for immunity AND the nasal swab for active virus.

How did you do?  Here is the scale-
0-7 correct - You need to keep reading the blogs to increase your Covid knowledge 
8 correct -CONGRATS! You know more than Dr. Fauci and Bill Gates combined!

Gregg DeNicola MD 
Chief Medical Officer 

If you would like to schedule an antibody test or for other any other medical needs including annual exams, urgent care, or medication refills please email us at videovisits@caduceusmedicalgroup.com.

COVID 19 ANTIBODY TESTING- WHAT YOU NEED TO KNOW

By editor
April 29, 2020


Since March 1st, we have evolved—
 
-First there was no test available for Covid 19.
- Then came the nasal PCR swab PCR to show us evidence of the live virus.
-And now, antibody testing has arrived. 
 
Depending on your age, you can hear Roseanne Roseannadanna in the distance.
 I know a lot of you are asking, what is an antibody test? Do I need one? Where do I get this test? Do I have to pay for it or is it free? Do I come to you or do you come to me? Can you do it from my car curbside or do I have to go into the office? Do I see a doctor first? If I have had Covid 19 do I get one? If I haven’t do I get one?   
 
Well dear patients; you sure ask a lot of stupid questions! God bless Gilda Radner looking down with a smile...
 
Of course these are not stupid questions at all.  Let’s answer succinctly.
 
This is a perfect time to bring up the old adage LET THE BUYER BEWARE…
 
The WHO has put out many cautions that the antibody test may not actually predict your immunity. Many experts are also cautioning that the antibody test may not actually predict immunity since COVID-19 is such a new virus; it would be dangerous to rely on a test that has no track record.
 
At Caduceus, we completely agree. On the other hand, it’s “the best we got.” It appears clear that if you need a high degree of assurance of your immunity, you should pass on the antibody test for now.
 
However only by doing antibody tests on a large population of people will we be able to find out if it’s accurate. A true catch 22.
 
Covid 19 is a virus and when it is in your body acts as an antigen. Your body forms antibodies to fight off the virus.  You need a test to find out if you've had Covid 19 and to check for immunity.
 
Some health plans are paying for it; others will not tell us yet. You may be asked to pay $75 if it’s unclear your health plan will reimburse for it. We are also offering a cash price for those uninsured of $99 which includes the video visit screening and curbside antibody test from your car. 
 
Caduceus is only doing testing curbside. The staff will be bundled up well in PPE. We advise against having the test inside a medical office or hospital. At Caduceus, a physician’s order is required, and the doctor will help you interpret the test. It is NOT a simple positive/negative as with the PCR nasal swab.
 
You SHOULD consider having one no matter if you've had Covid 19 or not. 
 
Two cautionary tales…
 1.  In our opinion, antibody tests available prior to April 20th are very suspect. Distributors were frankly “shady” and prices were all over the map, there were high false negative rates, and no FDA emergency blessing. We searched high and low to find one that we are comfortable with recommending for our patients and the community at large.   All antibody tests are NOT the same. Before having one vetted, stay away from sites that charge over $125, do not require a doctor’s order, give you results in two minutes, require you to enter a lobby with other possibly sick patients, or in general appears sketchy. This is one test you may want to avoid the “Motel 6 variety.” Hold out for the “Four Seasons” version. 2.  Studies are showing it may take up to 90 days for the antibody to “show up” on the tests. If you were exposed in early March that means ideally you'd be tested in June. Realizing most patients will not want to wait, be prepared to be re-tested in the summer if you test negative now.

 
Let’s have a little fun....and play doctor....NO not that game!  Instead I’ll give you FOUR short cases and you guess which is the right test; nasal PCR swab or blood antibody?
 
Case 1-
Suzy is 44 and has a fever, cough, and loss of taste for the last week. Two weeks ago she went to the grocery without a mask and the deli worker did sneeze a couple of times near her. What test should she have?  ANSWER- Nasal swab. It will show active Covid 19 virus accurately. The antibody test will be negative for weeks more. 
 
Case 2-
Sam is 55 and went to a New Year’s Eve party where a couple were coughing and saying they were “getting over a flu bug.”  A week later, he spiked a high temperature, started coughing, and had chills and body aches. He went to an urgent care where they diagnosed the flu and gave him Tamiflu. It took two weeks to recover, and Sam now believes he may have actually had Covid 19 since the couple at the party was hosting a Chinese exchange student over holiday break.  What test for Sam?  ANSWER - antibody test.  The virus is most likely out of his body but the antibody test will reveal if he has antibodies against Covid 19, thus confirming that was his proper diagnosis in January. 
 
Case 3-
Tammy is 26 with an active social life and who also cares for her frail 79 year old grandfather. A month ago, a close friend tested positive for Covid 19. A week later, Tammy had a mild sore throat and low grade fever for two days. She did not get tested. She wants to be sure she is not a carrier so she does not spread Covid 19 to her friends or grandfather. Which test to order?  ANSWER- A PCR nasal swab will rule out her being contagious. An antibody test does not test for active virus but would tell Tammy if she indeed had Covid 19 but NOT if she’s a contagious carrier. 
 
Case 4-
Joe is 50 and has been furloughed from his job for a month now. He has been well, with no symptoms or known exposure. His boss has announced his intent to reopen the office and resume operations sometime in May, but he is requiring all staff to show whether they have had Covid 19 and if they are immune.  What test does Joe ask for?  Answer- An antibody test will actually give Joe TWO results on antibodies; IgM will tell us if he has had Covid 19 recently. IgG will confirm immunity. A PCR nasal swab fails on these criteria. 
 
Did you have a perfect score at FOUR for FOUR? If so we may want to deputize you! I mean every Sheriff Taylor needs his Barney right?

Gregg DeNicola MD
Chief Medical Officer
Caduceus Medical Group
 

Please follow these directions to request an antibody test:

  • Email videovisits@caduceusmedicalgroup.com and include your full name, date of birth, cell phone, and if you are not an existing patient any insurance information or if you will be paying cash. 
  • A staff member will email you back same day between the hours of 8-5 M-F.
  • You will be scheduled for a video visit antibody screening (just like a Facetime call) from the comfort of your home on your cell phone or other mobile device.  If you do  not have a cell phone you can also use a laptop or desktop and to guarantee the best connection we do recommend using a mobile device.
  • The medical provider will review with you on the video call the four possible readings and then direct you to one of our two curbside testing sites in Yorba Linda or Laguna Beach.
  • You will receive a call back from a staff member or provider the same day to review your results.  
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