Archive for the ‘Testing’ Category

In vitro and in vivo Evaluation of Cephalosporins for the Treatment of Lyme Disease

In vitro and in vivo evaluation of cephalosporins for the treatment of Lyme disease.

Pothineni VR, et al. Drug Des Devel Ther. 2018. doi: 10.2147/DDDT.S164966. eCollection 2018.


Background: Lyme disease accounts for >90% of all vector-borne disease cases in the United States and affect ~300,000 persons annually in North America. Though traditional tetracycline antibiotic therapy is generally prescribed for Lyme disease, still 10%-20% of patients treated with current antibiotic therapy still show lingering symptoms.

Methods: In order to identify new drugs, we have evaluated four cephalosporins as a therapeutic alternative to commonly used antibiotics for the treatment of Lyme disease by using microdilution techniques like minimum inhibitory concentration (MIC) and the minimum bactericidal concentration (MBC). We have determined the MIC and MBC of four drugs for three Borrelia burgdorferi s.s strains namely CA8, JLB31 and NP40. The binding studies were performed using in silico analysis.

Results: The MIC order of the four drugs tested is cefoxitin (1.25 µM/mL) > cefamandole (2.5 µM/mL), > cefuroxime (5 µM/mL) > cefapirin (10 µM/mL). Among the drugs that are tested in this study using in vivo C3H/HeN mouse model, cefoxitin effectively kills B. burgdorferi. The in silico analysis revealed that all four cephalosporins studied binds effectively to B. burgdorferi proteins, SecA subunit penicillin-binding protein (PBP) and Outer surface protein E (OspE).

Conclusion: Based on the data obtained, cefoxitin has shown high efficacy killing B. burgdorferi at concentration of 1.25 µM/mL. In addition to it, cefoxitin cleared B. burgdorferi infection in C3H/HeN mice model at 20 mg/kg.


For more on Dr. Lewis’ work:


All His Symptoms Pointed Toward the Flu. But the Test Was Negative. RMSF in Connecticut

All His Symptoms Pointed Toward the Flu. But the Test Was Negative.

CreditCreditIllustration by Andreas Samuelsson


“I think I’m losing this battle,” the 58-year-old man told his wife one Saturday night nearly a year ago.

While she was at the theater — they’d bought the tickets months earlier — he had to crawl up the stairs on his hands and knees to get to bed. Terrible bone-shaking chills racked him, despite the thick layer of blankets. The chills were followed by sudden blasts of internal heat and drenching sweats that made him kick off the covers — only to haul them back up as the cycle repeated itself.

“I need to go to the E.R.,” he told his wife. He’d been there three times already. They’d give him intravenous fluids and send him home with the diagnosis of a viral syndrome. He would start to feel better soon, he was told. But he didn’t.

This all began nine days before. That first day he called in sick to his job as a physical therapist. He felt feverish and achy, as if he had the flu. He decided to drink plenty of fluids, take it easy and go back to work the next day. But the next day he felt even worse. That’s when the fever and chills really kicked in. He was alternating between acetaminophen and ibuprofen, but the fever never let up. He’d started sleeping in the guest room because his sweat was soaking the sheets, and his chills shook the bed, waking his wife.

After three days of this, he made his first visit to the Yale New Haven Hospital emergency room. He was already taking antibiotics. Several weekends earlier, he developed a red, swollen elbow and went to an urgent-care center, where he was started on one antibiotic for a presumed infection. He took it for 10 days, but his elbow was still killing him. He went back to urgent care, where he was started on a broader-spectrum drug, which he had nearly finished. Now his elbow was fine. It was the rest of his body that ached as if he had the flu.

But at the hospital, his flu swab was negative. So was his chest X-ray. It was probably just a virus, he was told. He should take it easy until it passed. And come back if he got any worse.

The next day his fever spiked above 105. He went again to the E.R. It was a mob scene — crowded with people who, like him, appeared to have the flu. It would be hours before he could be seen, he was told, because they already knew he didn’t have it. Discouraged, he went home to bed. He went back the next morning after a nurse called to say the E.R. was more manageable.

He might not have the flu, he thought, but he was sure he had something. But the E.R. doctor didn’t know what. He didn’t have chest pain or shortness of breath. No cough, no headache, no rash, no abdominal pain, no urinary symptoms. He felt weak but no longer achy. His heart was beating hard and fast, but otherwise his exam was fine. His white count was low — which was a little strange. White blood cells are expected to increase with an acute infection. Still, a virus can cause white counts to drop. His platelets — the tiny blood fragments that form clots — were also low. That can also be seen in viral infections, but it was less common.

The E.R. staff sent the abnormal blood results to the patient’s primary-care provider and told the patient to follow up with him. He’d been trying get in to see him for days, but the doctor’s schedule was full. When he called again, he was told that the soonest he could be seen was the following week.

The patient asked the doctor to order blood tests to look for an infection in his blood. And could they also test him for tick-borne infections? This was Connecticut, after all. He dragged himself to the lab and then waited for his doctor to call with the results. The call never came. In his mind, he fired his doctor. He’d been sick for over a week, and the doctor’s office couldn’t arrange an appointment, and they couldn’t even call him with the lab results for the test he had to ask for in the first place.

That Sunday morning after the man’s wife had been to the theater, he went once more to the emergency room. It was brought to the attention of the physician assistant on duty that the man had been there several times before and had lab abnormalities. She ordered a bunch of blood tests — looking for everything from H.I.V. to mono. She ordered another chest X-ray and started him on broad-spectrum antibiotics, as well as doxycycline, an antibiotic often used for tick-borne infections. He was given Tylenol for his fever and admitted to the hospital. As he was preparing to leave the emergency department, a new flu test came back positive. He was pretty sure he didn’t have it; he’d never heard of a flu being this bad for this long. But if he could stay in the hospital, where someone could monitor him, he was happy to take Tamiflu.

The lab called again the next day to say that the test had been read incorrectly; he did not have the flu. By then other results started to come in. It wasn’t an infection in his elbow. He didn’t have H.I.V.; he didn’t have mono or Lyme; he didn’t have any of the other respiratory viruses that, along with the worse influenza outbreak in years, had filled up so much of the hospital.

CreditIllustration by Andreas Samuelsson

Yet after a couple of days, the patient began to feel better. His fever came down. The shaking chills disappeared. His white count and platelets edged up. It was clear he was recovering, but from what? More blood tests were ordered, and an infectious-disease specialist consulted.

Gabriel Vilchez, the infectious-disease specialist in training, reviewed the chart and examined the patient. He thought that the patient most likely had a tick-borne infection. The hospital had sent off blood to test for the usual suspects in the Northeast: Lyme, babesiosis, ehrlichiosis and anaplasmosis. Except for the Lyme test, which was negative, none of the results had come back yet. Vilchez considered that given the patient’s symptoms — and his response to the doxycycline — it would turn out that he’d have one of them.

And yet, the results for tick-borne infections were negative. Vilchez thought about other tick-borne diseases that are not on the usual panel. The most likely was Rocky Mountain spotted fever (R.M.S.F.). The name is a misnomer: R.M.S.F. is much more common in the Smoky Mountains than the Rocky Mountains, and the spotted-fever part, the rash, is not seen in all cases. It’s unusual to acquire the infection in Connecticut but not unheard-of. Vilchez sent off blood to be tested for R.M.S.F. The following day, the patient felt well enough to go home. A couple of days later, he got a call. He had Rocky Mountain spotted fever.

Why did the diagnosis take so long? The patient had an unusual infection. But perhaps the bigger issue was that he was one of many patients in the emergency room with flulike symptoms in the midst of a flu epidemic. Under those circumstances, the question for the staff simply becomes: Does he have the flu? When the answer is no, doctors tend to move on to the next very sick patient in line. It’s hard to get back to the question of what the nonflu patient does have.

For the patient, recovery has been tough. Though the antibiotic helped with the acute symptoms, it took months before he had the stamina to resume his usual patient load at work. He feels that the illness brought him as close to dying as he had ever been. Indeed, Rocky Mountain spotted fever is one of the most dangerous of all the tick-borne infections, with a mortality rate as high as 5 percent even with current antibiotics.

One thing he was certain about, however: He needed a new primary-care doctor. And he got one.

Lisa Sanders, M.D., is a contributing writer for the magazine and the author of “Every Patient Tells a Story: Medical Mysteries and the Art of Diagnosis.” If you have a solved case to share with Dr. Sanders, write her at



This is playing out all over the world.  He was one of the lucky ones to finally get an accurate diagnosis.

It is interesting; however, that they are quick to state he doesn’t have the other tick-borne infections when the testing for all of them misses over half of all cases.  Once they gave him doxy, they should have retested him.  This is called a “provocation test” and is used by many LLMD’s (Lyme literate doctors) as they’ve learned this often finally shows an active infection(s) due to the ability of the body to NOW see the pathogens in the blood stream allowing antibodies to be made and picked up by the tests.

RMSF is a nasty beast on it’s own; however, this man should be monitored over time.  If symptoms come back or new ones show up, TBI’s should be suspected.

It’s also a mind boggler how in Connecticut of all places, TBI’s wouldn’t be the FIRST thing medical practitioners think of.  It’s literally ground zero.  

Please know RMSF IS IN WISCONSIN and is on the move:

More on RMSF:

It’s also been found to be spread by the common brown dog tick:  It’s usually spread by the American dog tick and the closely related Rocky Mountain wood tick. But in recent years the bacterial infection has also been spread by the brown dog tick — a completely different species…The researchers were investigating an epidemic of the infection that broke out in the border town of Mexicali starting in 2008. It’s already sickened at least 4,000 people, according to Mexican government estimates. Several hundred have died, and at least four people have died in the U.S. after crossing the border, according to this report and others.

“I was absolutely startled,” Foley said in an interview.

The people who had been sickened in Mexicali had a heavy load of the infectious agent in their blood — something that had not been seen in past outbreaks.
The epidemic is worrisome because the brown dog tick is more likely to bite people and it adapts easily to living in a house, as opposed to living on wild animals, the researchers said.

“The Rocky Mountain spotted fever epidemic in Mexicali has not been contained and may be spreading to other parts of Baja California and into the United States,” the team wrote.

And now it’s possible that for some reason, the infection the brown dog tick transmits is more virulent, Foley said.  “When you go to these pumpkin patches and petting zoos and all those fun fall activities, wear pants, long socks and shoes!”
“Make sure you check for tics! This was me 2 years ago after being bit by a tick and contracting Rocky Mountain spotted fever at a pumpkin patch,” she continued. “I couldn’t walk, my whole body was in pain, my hair fell out, and I almost died.”  “This has been a horribly scary experience for our family. I’m thankful that I did my own research and brought it to my doctors attention. So don’t EVER be afraid to be an advocate for your child or yourself when it comes to things like this!” McNair continued, adding that “doctors are humans and have to figure out the puzzle just like the rest of us do!”

Wiser words were never spoken.

P.s. Regarding the red, swollen elbow…..

My journey was similar with the same issue in both my elbow and knee in the middle of January in Wisconsin.  I was told, and I promise I didn’t make this up, that I had “Washer Woman’s Knee,” and “Barstool elbow.”  

I kid you not.

Now, first, I use a mop and rarely get on my knees.  Second, I assure you, I’m not sitting at the bar and have NO reason to have a red, swollen, excruciatingly painful elbow.

Effective tick borne illness treatment completely ameliorated both conditions once I was finally diagnosed with Lyme/MSIDS.  For that exciting journey, that continues to this day, go here:

For effective Lyme treatment:

Please remember, Lyme is the rock star we all know by name.  There are many, many other players involved and people are often coinfected.  Mainstream medicine has yet to accept and deal with this very real fact.






Study Finds Q Fever & Rickettsia (Typhus) in Australian Ticks and People

Ixodes holocyclus Tick-Transmitted Human Pathogens in North-Eastern New South Wales, Australia.

Graves SR, et al. Trop Med Infect Dis. 2016.


A group of 14 persons who live in an area of Australia endemic for the Australian paralysis tick, Ixodes holocyclus, and who were involved in regularly collecting and handling these ticks, was examined for antibodies to tick-transmitted bacterial pathogens.

Five (36%) had antibodies to Coxiella burnetii, the causative agent of Q fever and three (21%) had antibodies to spotted fever group (SFG) rickettsiae (Rickettsia spp). None had antibodies to Ehrlichia, Anaplasma, Orientia, or Borrelia (Lymedisease) suggesting that they had not been exposed to these bacteria.

A total of 149 I. holocyclus ticks were examined for the citrate synthase (gltA) gene of the SFG rickettsiae and the com1 gene of C. burnetii; 23 (15.4%) ticks were positive for Rickettsia spp. and 8 (5.6%) positive for Coxiella spp. Sequencing of fragments of the gltA gene and the 17 kDa antigen gene from a selection of the ticks showed 99% and 100% homology, respectively, to Rickettsia australis, the bacterium causing Queenslandtick typhus.

Thus, it appears that persons bitten by I. holocyclus in NE NSW, Australia have an approximate one in six risk of being infected with R. australis. Risks of Q fever were also high in this region but this may have been due to exposure by aerosol from the environment rather than by tick bite. A subset of 74 I. holocyclus ticks were further examined for DNA from Borrelia spp., Anaplasma spp. and Ehrlichia spp. but none was positive. Some of these recognised human bacterial pathogens associated with ticks may not be present in this Australian tick species from northeastern New South Wales.



Folks in Australia have been fighting the denial of authorities for decades regarding Lyme Disease:  A SYDNEY woman launches a class action against NSW Health after autopsy results showed her husband was riddled with Lyme in his liver, heart, kidney, and lungs.  He was only 44 years old and was bitten by a tick while filming a TV show in Sydney.

Now how in the world did that happen?

While they still deny Lyme (borrelia) this recent study definitively shows a number of pathogens in Australian ticks and humans including Rickettsia (more commonly known as Tick & arthropod TyphusQueensland typhus or Rickettsia australis), as well as Q Fever.

Tick Typhus is similar to Rocky Mountain spotted fever, but deemed not as severe.  Symptoms include:

  • Fever
  • Headache
  • Malaise
  • Bloodshot eyes
  • Red lump at tick bite site
  • Ulceration at tick bite site
  • Black scab at tick bite site
  • Enlarged local lymph nodes
  • Forearm red rash
  • Red body rash
  • Palm rash
  • Rash on soles of feet

Doxycycline is the front-line drug for typhus and broad-spectrum antibiotics aren’t helpful.

Fact sheet on typhus:  The perps are typically lice, fleas, mites, and ticks.  In this article, they found a tropical form of tick typhus in tropical ticks found in Germany. Typhus is making a comeback, particularly in the southern U.S. Migrating birds are transporting ticks as well as the diseases they carry worldwide 

Fact sheet on Q Fever:

Caused by the bacteria Coxiella burnetii, it can cause pneumonia and hepatitis (liver inflammation) in its early stage, and infection of the heart valves (endocarditis) in its chronic stage.  Perps are the Brown Dog Tick (Rhipicephalus sanguine us), Rocky Mountain Wood Tick (Dermacentor andersoni), and the Lone Star Tick (Amblyomma americium).  This article states it’s usually a mild disease with flu-like symptoms but sometimes it can resurface years later.  This more deadly, chronic form, of Q fever can damage heart, liver, brain and lungs. C. burnetii is highly infectious. Humans that are susceptible to this disease can be infected by a single organism. It is considered a significant threat for bio warfare and is classified as a Category B agent of bioterrorism.

The severity and combination of signs and symptoms vary greatly. About half the people infected with Q fever will get sick. Symptoms include:

  • High fever (up to 105°F)
  • Fatigue
  • Severe headache
  • General malaise
  • Myalgia
  • Chills or sweats
  • Non-productive cough
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Chest pain

Doxycycline is also the front-line drug for this with quinolone antibiotics as an alternative.

Add the Ixodes holocyclus tick to this list as well.

And before you think it can only ever be in Australia, this article in the 2013 issue of the Australian Veterinary Journal shows the likelihood of a population of Ixodes holocyclus breeding outside their common range.

Well there goes the neighborhood.

Here’s a nifty chart: (Please remember this is constantly changing)


If there’s one think I know for sure, it’s that nothing about ticks and the diseases they carry is sure.

They are finding tropical ticks in Germany (where they shouldn’t be) and they are finding Asian ticks in the U.S. (where they shouldn’t be)

When is the CDC going to get the memo and scrap the tick maps?





Transmission of Borrelia Miyamotoi By Tranovarially-Infected Larval Ticks

Transmission of the relapsing fever spirochete, Borrelia miyamotoi, by single transovarially-infected larval Ixodes scapularis ticks.

Breuner NE, et al. Ticks Tick Borne Dis. 2018.


The relapsing fever spirochete, Borrelia miyamotoi, is increasingly recognized as a cause of human illness (hard tick-borne relapsing fever) in the United States. We previously demonstrated that single nymphs of the blacklegged tick, Ixodes scapularis, can transmit B. miyamotoi to experimental hosts. However, two recent epidemiological studies from the Northeastern United States indicate that human cases of hard tick-borne relapsing fever peak during late summer, after the spring peak for nymphal tick activity but coincident with the peak seasonal activity period of larval ticks in the Northeast. These epidemiological findings, together with evidence that B. miyamotoi can be passed from infected I. scapularis females to their offspring, suggest that bites by transovarially-infected larval ticks can be an important source of human infection. To demonstrate experimentally that transovarially-infected larval I. scapularis ticks can transmit B. miyamotoi, outbred Mus musculus CD1 mice were exposed to 1 or 2 potentially infected larvae. Individual fed larvae and mouse blood taken 10 d after larvae attached were tested for presence of B. miyamotoi DNA, and mice also were examined for seroreactivity to B. miyamotoi 8 wk after tick feeding.

We documented B. miyamotoi DNA in blood from 13 (57%) of 23 mice exposed to a single transovarially-infected larva and in 5 (83%) of 6 mice exposed to two infected larvae feeding simultaneously. All 18 positive mice also demonstrated seroreactivity to B. miyamotoi. Of the 11 remaining mice without detectable B. miyamotoi DNA in their blood 10 d after infected larvae attached, 7 (64%) had evidence of spirochete exposure by serology 8 wk later.

Because public health messaging for risk of exposure to Lyme disease spirochetes focuses on nymphal and female I. scapularis ticks, our finding that transovarially-infected larvae effectively transmit B. miyamotoi should lead to refined tick-bite prevention messages.




A mother tick CAN transmit to her own children.  (Just as human mothers can):

This is why it is unwise to focus on months of the year regarding when you can and can not become infected.  First, ticks are marvelous ecoadaptors and can survive the harshest environments:  Second, we can’t just be concerned with one stage of the tick but recognize the potential transmission of ALL stages to infect.

There’s a high probability more than ticks can transmit:

Then, there’s the added complexity of being able to transmit many things simultaneously:

They are finding ticks in places they shouldn’t be making geographical maps virtually useless:  (Please also read my comment at end of article)

Time for researchers to quit sounding so “all knowing,” and write research articles carefully, making sure to remember that what they write will and has been used against patients in every possible way imaginable.
Plus, everything they thought they knew is constantly changing.

Got Mold?

Upcoming Toxic Mold Summit FREE and online.  From Jan. 28-Feb 3, 2019.

Register here:


Dr. Neil Nathan’s New Book:  Toxic:  Heal Your Body from Mold Toxicity, Lyme Disease, Multiple Chemical Sensitivities, and Chronic Environmental Illness.

Toxic book


Podcast:  Life After Mold with Dr. Lauren Tessier

Lauren Tessier, ND is a Naturopathic Physician licensed in the state of Vermont. She received her Bachelors in Premedical Sciences and Health Psychology from Massachusetts College of Pharmacy in Boston and later became a Naturopathic Physician at Bastyr University in Kenmore, Washington.

Her practice, Life After Mold, uses a patient-centered approach to help recover those that are suffering from mold-related illness.  She combines naturopathic, functional, and integrative medicine to address the entire person.  She is a Shoemaker Certified Physician specializing in the treatment of Chronic Inflammatory Response Syndrome (CIRS) which results from exposure to water-damaged buildings.

In 2011, Hurricane Irene created an unimaginable flood in Waterbury, Vermont, and she was unprepared for what she would see next in her practice.  Patients were ill with unexplained rashes, allergies that did not respond to treatment, fatigue, breathing difficulties, neurological complaints, headaches, nausea, and immune system dysfunction.  When her normal approaches no longer worked for these patients, she dove deep into mold-related illness.

Her practice is dedicated to helping those suffering with mold, biotoxin, and mycotoxin associated illness resulting from water-damaged buildings. As time passed, she came to the belief that the environment plays a role in all chronic illness.  Environmental illness includes mold, heavy metals, glyphosate exposure, chronic infections such as Lyme disease, Multiple Chemical Sensitivity, and Mast Cell Activation Syndrome.  Dr. Tessier is an Executive Board Member of the International Society for Environmentally Acquired Illness (ISEAI) which aims to advance medical knowledge surrounding environmentally acquired illness.

Key Takeaways

  • What are some of the environmental factors that may predispose an environment to water-damage and the potential for mold illness?
  • What are some of the illness-creating substances that are found in a water-damaged building?
  • What are common symptoms of CIRS?
  • Are there basic screening tests that can be performed of an environment before investing in an IEP?
  • How important are the HLA haplotypes in CIRS?
  • Is there clinical value in urinary mycotoxin testing?
  • Can molds encountered in a water-damaged building lead to colonization within the body?
  • When considering binders, what is absorption vs. adsorbtion?
  • Why is bile flow important and how might it be supported?
  • What options might help reducing inflammation in those with CIRS?
  • Are there downsides of exogenous glutathione supplementation?
  • How important is eradicating MARCoNS in CIRS?
  • How might VIP and Synapsin be helpful in those with CIRS?
  • What triggers Mast Cell Activation Syndrome (MCAS) and how might it be addressed?
  • When someone feels significantly worse, what rescue items might help to move through a detox or Herxheimer reaction?
  • Is there a role for limbic system retraining in CIRS?


In the same vein, here’s another Podcast titled:

Create Your Healthy Home with May Dooley, MS, MA, CMC

In this episode, you will learn about Bau Biologie, or Building Biology, and how to evaluate and improve the health of the external environment in order to improve overall health.

May Dooley, MS, MA, CMC (Council-certified Microbial Consultant) is a former middle school science teacher who loves to educate and empower people with information to improve their environment – and thus, their lives.  She has been an environmental consultant for more than 24 years helping people make their home environment healthier.

She leads her clients through the basic steps to assess and create a healthy home which includes air quality, water quality, and reduced exposure to other stressors that may impact health such as electromagnetic fields.  Her inspections are interactive, and her clients learn how to measure EMFs, reduce body voltage in their bed, use a laser particle counter to evaluate their vacuum cleaner, and to take samples to explore for mold.  She even brings along her microscope and looks at the samples in your home.  Once she has evaluated an environment using the principles of Bau Biologie, she provides an easy-to-understand series of steps to improve the environment.

Key Takeaways

  • Why might culture plate air sampling be a better option than spore trap testing?
  • What are the pros and cons of the ERMI?
  • What is the CAP ERMI?
  • What role do microbial VOCs play in the health of an environment?
  • How often can mold issues be remediated?
  • How is a microscope helpful in exploring the potential for mold?
  • When moving to a new environment, what testing should be done to validate the environment is safe?
  • What belongings can be brought from a moldy environment to a new environment?
  • What can be used to address small amounts of visible mold?
  • What vacuum cleaners are ideal?
  • What are the 5 different types of EMFs and their sources?
  • What is body voltage and how is it measured?
  • What is grounding and how should it be done?
  • Why should the bed have no metal materials?
  • What light bulbs might be best?



The content of this show is for informational purposes only and is not intended to diagnose, treat, or cure any illness or medical condition. Nothing in today’s discussion is meant to serve as medical advice or as information to facilitate self-treatment. As always, please discuss any potential health-related decisions with your own personal medical authority.


For more:


Direct Test for LD. Carl Tuttle Chews up CDC & Spits Them Out.

Direct Diagnostic Tests for Lyme Disease

Carl Tuttle
Hudson, NH
OCT 13, 2018 —

Latest message to the TBD Working Group:
———- Original Message ———-
From: Carl Tuttle <>
Date: October 12, 2018 at 1:48 PM

Subject: Re: News Release: Dr. Sin Hang Lee Accuses CDC of Resorting to Politically Motivated False Science to Cover Up Its Failure to Promote More Exacting Test for Lyme Disease

To the Tick Borne Disease Working Group,

Please see the viewpoint below recently published in Clinical Infectious Diseases regarding direct detection tests for Lyme disease.

I have purposely highlighted coauthor Martin E Schriefer of the Centers for Disease Control because he was one of the CDC officials working directly with Dr. Sin Lee of Milford Molecular Diagnostics regarding “direct detection” of Lyme disease.

All communication from the CDC stopped with Dr. Lee with absolutely no explanation whatsoever prompting the current lawsuit.
And now we see Schriefer’s name on this publication pushing for DNA tests?

It’s time to fire the CDC and take control of this runaway plague as all the evidence indicates deliberate mishandling of a disease that is destroying lives, ending careers while leaving its victims in financial ruin.

Carl Tuttle
Lyme Endemic Hudson, NH


Direct Diagnostic Tests for Lyme Disease

Steven E Schutzer, Barbara A Body, Jeff Boyle, Bernard M Branson, Raymond J Dattwyler, Erol Fikrig, Noel J Gerald, Maria Gomes-Solecki, Martin Kintrup, Michel Ledizet, Andrew E Levin, Michael Lewinski, Lance A Liotta, Adriana Marques, Paul S Mead, Emmanuel F Mongodin, Segaran Pillai, Prasad Rao, William H Robinson, Kristian M Roth, MARTIN E SCHRIEFER, Thomas Slezak, Jessica L Snyder, Allen C Steere, Jan Witkowski,Susan J Wong, John A Branda

Clinical Infectious Diseases, ciy614,

Published: 11 October 2018

Borrelia burgdorferi was discovered to be the cause of Lyme disease in 1983, leading to seroassays. The 1994 serodiagnostic testing guidelines predated a full understanding of key B. burgdorferi antigens and have a number of shortcomings. These serologic tests cannot distinguish active infection, past infection, or reinfection. Reliable direct-detection methods for active B. burgdorferi infection have been lacking in the past but are needed and appear achievable. New approaches have effectively been applied to other emerging infections and show promise in direct detection of B. burgdorferi infections.



Subject: Re: News Release: Dr. Sin Hang Lee Accuses CDC of Resorting to Politically Motivated False Science to Cover Up Its Failure to Promote More Exacting Test for Lyme Disease

On September 25, 2018 at 11:11 AM Carl Tuttle <> wrote:

To the Tick-Borne Disease Working Group,

Before you read the following press release I would like to point out that Patient #45 from Table 2 of the attached CDC document titled, “Reply to Response to Motion to Dismiss” (page 26) had a bulls-eye rash and a single positive Western blot Band 41 which as you know is the flagellar antigen of Borrelia burgdorferi.

Patient #45 has a case of early Lyme confirmed by the bulls-eye rash but hadn’t yet produced a full set of antibodies to the infection. Dr. Lee’s 16S rRNA gene sequencing was able to accurately detect early infection before antibody production.

The CDC claims the following:

“ with respect to pretreatment patients, he (Dr. Sin Hang Lee) reported B. burgdorferi in a patient whose antibody testing failed to indicate the presence of the disease at all (patient 45). Attachment I at 4287 and 4292. Therefore, Dr. Lee’s tests were not accurate.”

For the record, you will find the following statement from the CDC website:

Diagnosis, Testing, and Treatment

As with serologic tests for other infectious diseases, the accuracy of the test depends upon the stage of disease. During the first few weeks of infection, such as when a patient has an erythema migrans rash, the test is expected to be negative.


The CDC is responsible for the current Lyme disease crisis where patients cannot obtain a timely diagnosis through accurate early detection.

This perpetuated outdated dogma of using a restricted pattern of antibody tests for disease definition is now on record disclosing the hidden agenda of the bureaucrats in charge of the Lyme disease policy.


2044 Bridgeport Avenue
Milford, CT 06460

September 25, 2018

Media Contact:
Kevin Moore


In Unprecedented CDC lawsuit, Dr. Sin Hang Lee Accuses CDC of Resorting to Politically Motivated False Science to Cover Up Its Failure to Promote More Exacting Test for Lyme Disease

Milford, Conn. – Dr. Sin Hang Lee, the Connecticut based pathologist who, in May, filed an unprecedented $57.1 million Lyme disease related lawsuit against theUnited States Centers for Disease Control and Prevention (CDC),charged the CDC in a legal filing* this week of employing false, pseudo-scientific theories in order to justify its own anti-consumer actions aimed at perpetuating Lyme disease testing by a flawed technology previously endorsed by the CDC. It is also believed that certain current and former CDC representatives receive personal financial gains (royalties) as a result of their having worked on the approval and promotion/CDC endorsement of a Lyme disease serology test.

According to Dr. Lee, the truth behind the CDC’s inexplicable retreat from supporting a cutting-edge test capable of diagnosing Lyme disease infections with 100% accuracy, came to the surface in the CDC’s lawsuit-related recent filing in theU. S. Court of Federal Claims. For the purpose of suppressing direct detection tests to diagnose early Lyme disease infections, the CDC’s lawyers wrote,

“with respect to pretreatment patients, he (Dr. Sin Hang Lee) reported B. burgdorferi in a patient whose antibody testing failed to indicate the presence of the disease at all (patient 45). Attachment I at 4287 and 4292. Therefore, Dr. Lee’s tests were not accurate.”

Dr. Lee informed the Court through his legal counsel,

“Using Lyme disease serology test results to overrule 16S ribosomal RNA gene sequencing diagnosis of Lyme borreliosis is to practice Lysenkoism in disguise.” It is serious when the CDC allows its policies to be made on the basis of bogus science, said Dr. Lee.

Dr. Sin Hang Lee, a Connecticut pathologist and the plaintiff in the $57.1 million lawsuit against the CDC, said Lyme disease is actually a chronic tick-borne borrelia infection or its sequelae because this bacterial infection has not been diagnosed correctly at the early stage for timely appropriate treatment.

The world’s scientific literature of medicine all agrees that 16S rRNA DNA sequencing of bacterial genes in patient specimens is a tool to reach irrefutable diagnosis of bacterial infections, including those due to Borrelia, even if antibodies to the bacteria in the patient are not measurable.

When a government authority, like the CDC, insists upon using a negative antibody testing result to overrule the 16S rRNA gene sequencing diagnosis of Borrelia burgdorferi infection in official federal court documents, this is concrete evidence that the CDC has resorted to Lysenkoism to perpetuate Lyme disease in the United States, said Dr. Lee through his lawyer*.

Lysenkoism once prevailed in the Soviet Union under Stalin when bogus science was used to suppress true biological and medical sciences and to punish the scientists and medical doctors who did not follow the Party Line. Since the CDC has now, for the first time, officially narrowed the case definition of Lyme disease in a Federal Court case as an illness to be diagnosed by testing the antibodies against a particular strain of Borrelia burgdorferi to the exclusion of all other direct detection diagnostics, including Sanger sequencing, this Party Line must be challenged by evidence-based science in the public eye as well as in Court, said Dr. Lee.

* See document, called Sur-Reply filed on September 20, 2018 at the U.S. Federal Court of Claims in response to the CDC statements previously submitted to the Court on August 27, 2018.
1. Lee – Reply to Response to Motion to Dismiss
2. Lee – Sur-Reply re Motion to Dismiss 2018-09-20

Carl Tuttle
Lyme Endemic Hudson, NH


For more:

Key quote: “These serologic tests cannot distinguish active infection, past infection, or reinfection.”

In plain English, the CDC’s “FDA approved” two-tiered tests don’t show squat.

Direct detection is nothing new. Dr. Sin Hang Lee sued the CDC over their suppression of HIS direct detection test.
Another great article showing how they’ve worked tirelessly to suppress direct detection tests:  (This article does a great job explaining the tests)

In the comment section I explain how small labs like IGeneX have been poisonously smeared by the CDC.  I actually attended a public meeting at the WI capital where a pediatric doctor quoted right off the CDC website and called the IgeneX Lyme test, “Home-brewed.”
“Often these are laboratory-developed tests (also known as “home brew” tests) that are manufactured and used within a single laboratory and have not been cleared or approved by FDA. 

Patients, the doctors who dare treat them, and these smaller labs specializing in bacteriology and virology have been quaking in their boots for decades due to the antics of the CDC.

The CDC is a bully, plain & simple.

Paving the Way for Better Lyme Diagnostic Tests

As promised, here is the followup from earlier today on the “new” direct testing for Lyme:

LYME SCI: Paving the way for better Lyme diagnostic tests

By Lonnie Marcum

For decades, one of the biggest barriers to good medical care for Lyme disease has been a dearth of effective and accurate Lyme diagnostic tests.

Through the years, the CDC has continued to recommend an inadequate test that was designed in the 1980s.

All along, the CDC, the IDSA, and others in the medical mainstream have insisted that what’s called “two-tier Lyme serology” is the appropriate way to determine who does and does not have the illness.

Now, a group of researchers from Rutgers, Yale, Harvard, FDA, NIH, CDC and other institutions have published an article in Clinical Infectious Diseases acknowledging the failings of the current IDSA diagnostic guidelines recommended at the Dearborn Conference in 1994.

The scientists reached the following conclusion:

“The 1994 serodiagnostic testing guidelines predated a full understanding of key B. burgdorferi antigens and have a number of shortcomings.”

“A number of shortcomings? That’s putting it mildly,” says’s Founder and President Phyllis Mervine. “Since the first Lyme case was identified in 1977, the Lyme community has been crying for an accurate test and better treatment. The powers-that-be kept telling us how benign Lyme is, how great the Lyme diagnostic tests are and how easily the disease can be cured.”

Luckily, better tests are finally becoming available.

New Lyme diagnostic tests detect multiple species

As the CDC has not promoted any improvements in testing since 1994, many private laboratories have taken on the burden of research and development themselves.

One such private lab, IGeneX, has developed two new immunoblot tests capable of detecting multiple species of Borrelia (see below). The “Lyme ImmunoBlot” test is approved for use in all states including New York. The “TBRF ImmunoBlot” is currently undergoing validation review by New York State, Department of Health and thus is available to all US residents outside of New York.

IGeneX ImmunoBlots Detect:

Lyme ImmunoBlot                TBRF ImmunoBlot
B. burgdorferi B31                   B. coriaceae
B. burgdorferi 297                    B. hermsii
B. afzelii                                   B. miyamotoi
B. Californiensis                      B. parkerii
B. garinii                                  B. turcica
B. mayonii                               B. turcatae
B. spielmanii                           B. texasensis
B. valaisiana

What is the CDC-recommended test for Lyme disease?

The currently recommended Lyme diagnostic test was originally designed for surveillance (to track the spread) of a single species of bacteria—later named Borrelia burgdorferi B31—that was first detected in and around Lyme, Connecticut. That test was never intended to diagnose Borreliosis (infection caused by Borrelia) in other parts of the US or on other continents.

Today, we know there are over 300 strains of Borrelia worldwide. They are divided into two broad categories: Borrelia burgdorferi sensu lato (which causes Lyme disease), and Tick-borne Relapsing Fever Borrelia (which causes Lyme-like illness or TBRF). Let’s call these types A and B. The current Lyme test detects only a fraction of type A cases and gives anyone with type B a negative result.

As Dr. Jyotsna Shah, CEO of IGeneX explains,

“With the increase of international travel, people may get infected in various parts of the US or abroad. Thus, it is important to have a test that can detect the infection no matter where it was acquired.”

Sensitivity vs. Specificity

Currently, the CDC recommends a two-step indirect method for Lyme testing, designed to detect the body’s immune response (antibodies) to infection. The first step uses an Indirect Immunofluorescent assay or an automated ELISA. These are fast and relatively inexpensive. Only if the first step is positive will the second step be performed. The second test, a Western Blot, is more inclusive but also more complex and subject to human error.

Ideally, to design an accurate 2-tier Lyme test, the first step (ELISA) would be very sensitive (i.e. no false-negatives, but some false-positives). The second step (Western blot) used for confirmation, would be very specific (i.e. no false-positives).

In a perfect world, all tests would be 100% sensitive and 100% specific, meaning not a single person with infection would go undetected and all uninfected persons would test negative. Think of HIV, where you want to be 100% certain that you do not misdiagnose a single case.

The whole topic of “sensitivity” and “specificity” is one we hear a lot about in relation to testing, but it’s one that many of us do not fully understand. For simplicity sake, I’ll use the example of an airport metal detector to explain the two-tier testing process.

First step should detect anything questionable

Like a metal detector, you want the first step to be highly sensitive, capable of detecting anything that is remotely questionable. Thus, even metal belt buckles and key chains will set off an alarm—even though they aren’t what the security agents are looking for.

If the detector senses anything suspect, the passenger is then subjected to a second, highly specific screening that involves a hand-held wand and closer examination to determine exactly what the object is.

The idea is that it’s better to take a second look at something that may turn out to be harmless—like a watch or a metal pen—then to let somebody board the airplane with a weapon.

Likewise, the ELISA (the first step) would ideally detect all suspected cases of Lyme. Unfortunately, with the standard test for Lyme, almost 30% of the people with Lyme disease and all the people with TBRF will test negative on the first step, and never be given the second confirmatory Western blot that is far more specific.

This is akin to setting airport metal detectors so that they only find big weapons, like machine guns, and anything smaller than that will sail through without notice.

How secure would you be with such a system?

Why Lyme disease is so difficult to diagnose

  1. The majority of people do not realize they were bitten by a tick, and do not see the “bull’s-eye” rash that is typical of Lyme;
  2. It takes 2-8 weeks (or longer) for the immune system to produce the markers (antibodies) necessary for detection on standard blood testing,
  3. The bacteria can form biofilms and prefer to live in deep tissues rather than the blood stream where blood tests are most effective at detecting antibodies;
  4. Borrelia have special mechanisms called “sleeper cells” that allow them to hide from the immune system, thus further suppressing the production of antibodies;
  5. Patients with co-infections often have suppressed immune systems and many never develop antibodies to Borrelia.
  6. Seronegativity could also be due to antibody being bound in immune complexs and therefore not available for binding to antigens on the immunoblot strip.
  7. The patient may be infected with a strain of Borrelia that is not detected by standard tests.

Adding to the difficulty of diagnosis, Lyme disease is known as a “great imitator,” because it can infect every system of the body causing a myriad of symptoms that mimic illness such as Arthritis, ALS, Chronic Fatigue Syndrome (CFS), Fibromyalgia, Lupus, Multiple Sclerosis (MS) or Myalgic Encephalomyelitis (ME).

New and improved immunoblots

The primary difference between the CDC-recommended two-tier test and IGeneX’s new ImmunoBlots is the sensitivity. Where the CDC test was designed to be highly exclusive (only detects one species of Borrelia, B31), the ImmunoBlots are designed to be highly inclusive (sensitive to multiple species of Borrelia).

For many years IGeneX was able to increase the sensitivity of its Western Blot by adding an additional species, Bb 297). Today, the company has further increased the sensitivity of its new ImmunoBlots by sourcing antigens from multiple species of Borrelia from the US and Europe (see chart).

“The Lyme ImmunoBlot is intentionally more inclusive for Borrelia burgdorferi sensu lato than the currently available Western blots because we now know that other species such as B. mayonii, B. californiensis and B. spielmanii all cause disease in the US,” said Dr. Shah.

High Accuracy Across the Disease Spectrum

The accuracy of the Lyme ImmunoBlot and TBRF ImmunoBlot have been established by exhaustive testing. The sensitivity with well-characterized samples have been shown to be greater than 90%, whereas the two-tier testing recommended by CDC has a sensitivity of about 55%.

And this high degree of sensitivity does not come at the cost of specificity. IGeneX has done this by:

  1. Including two bands that are highly specific to the outer surface proteins of Borrelia (see Band 31 OspA and 34 OspB below), and
  2. Eliminating the bands that are non-specific to Borrelia (see Bands 18, 28, 30, 45, 58, 66 below)


Additionally, the ImmunoBlots detect the full spectrum of the disease: early, active and late-stage disease. This high degree of sensitivity does not come at the cost of specificity, with the ImmunoBlots showing 99 and 97% and 95 and 97.5% specificity for Lyme and TBRF IgM and IgG respectively.

Future directions

As FDA, CDC & NIH researchers are finally acknowledging, newer approaches to testing that have been effectively applied to other emerging infectious diseases show promise in the detection of Borrelia infections.

The lead author of the IDSA paper, Steven Schutzer, a physician-scientist at Rutgers New Jersey Medical School states,

”It will not be surprising to see direct tests for Lyme disease join the growing list of FDA-approved direct tests for other bacterial, fungal and viral infections that include Staphylococcus, Streptococcus, Candida, influenza, HIV, herpes and hepatitis, among others.”

The Lyme community has been waiting decades for these improvements and will applaud when these Lyme diagnostic tests become the standard of care for all patients.

LymeSci is written by Lonnie Marcum, a Licensed Physical Therapist and mother of a daughter with Lyme. Follow her on Twitter: @LonnieRhea Email her at: .

New techniques can detect Lyme disease weeks before current tests:

Pilot Study of Immunoblots with Recombinant Borrelia burgdorferi Antigens for Laboratory Diagnosis of Lyme Disease:

NCBI: Taxonomy Browser, Borrelia:



Lyme literate doctors (LLMD’s) trained by the International Lyme and Associated Diseases Society (ILADS) have always preferred labs such as IGeneX due to the very fact they include more bands and are more sensitive.  But, these very doctors have always known Lyme/MSIDS is a clinical diagnosis.

Lazy practitioners, on the other hand, treat this as any other infectious disease and it just can’t be treated that way.  It’s far too complex.

The CDC has undertaken a smear campaign against IgeneX any other lab that has dared to compete with their “FDA approved” tests.  I actually attended a public meeting at the WI capital where a pediatric doctor quoted right off the CDC website and called the IgeneX Lyme test, “Home-brewed.”

“Often these are laboratory-developed tests (also known as “home brew” tests) that are manufactured and used within a single laboratory and have not been cleared or approved by FDA. Recently, CDC has received inquiries regarding a laboratory-developed test that uses a novel culture method to identify Borrelia burgdorferi, the spirochete that causes Lyme disease. Patient specimens reportedly are incubated using a two-step pre-enrichment process, followed by immunostaining with or without polymerase chain reaction (PCR) analysis. Specimens that test positive by immunostaining or PCR are deemed “culture positive” (2). Published methods and results for this laboratory-developed test have been reviewed by CDC. The review raised serious concerns about false-positive results caused by laboratory contamination and the potential for misdiagnosis (3).  CDC recommends that laboratory tests cleared or approved by FDA be used to aid in the routine diagnosis of Lyme disease. A complete searchable list of such tests is available online (4).”

Then they complete the same rant we’ve all heard 1,000 times about the distinction between “FDA approved” and “CLIA certified” and essentially diss CLIA because it doesn’t address the clinical validity of a specific test.  FDA approval, on the other hand, promises that a test has “adequate analytical and clinical validation and is safe and effective.”

Even though their tests completely suck.


I can only guess what it costs a lab to go through the FDA process.  Meanwhile, the CDC and their ilk spread a smear campaign to every single doctor worldwide about how bad these small, specialty labs are leaving only a handful of quaking doctors who are threatened by state medial boards on a daily basis for treating us, using them.  Let’s just say these small specialty labs have had it rough.  They have fought tooth and nail just to keep their doors open.  FDA approval has been the last thing they have been worried about.

Oh, yes, my friends, the CDC plays dirty and has a lot to answer for.

As lab certifications go, CLIA is one of the toughest, most stringent certifications a lab can undertake.  And, these smaller labs specialize in virology and bacteriology where huge monopolies like Lab Corp and Quest specialize in nothing, yet for decades have profited hugely by giving the CDC garbage can Lyme test that tells you little to squat.  If you test positively on that sucker, you’ve won the lotto.

Countless patients have tested negatively on this insensitive test and have been told they are making up symptoms for attention.  They are offered an anti-depressant and are sent home with something that could kill them.

Yeah, I’m a little ticked off.  Pardon the pun.