Limitations of Serological Diagnostic Tests

FEB 17, 2021 — 

I was appointed by Governor Chris Sununu to the NH Lyme Disease Study Commission as a result of HB490

Next Zoom meeting: Mar 26, 2021 09:00 AM Eastern Time

Our charter is to “study the use and limitations of serological diagnostic tests to determine the presence or absence of Lyme and other tick-borne diseases and the development of appropriate methods to educate physicians and the public with respect to the inconclusive nature of prevailing test methods.”



Here is a statement I read at the end of last Friday’s monthly Lyme Disease Study Group via the Zoom meeting.

Since the last meeting I have sent nine emails with topics to discuss in our meetings. The emails have contained many supporting references to my claim that serology is no better than a coin toss, harm caused by false negative Elisa tests reported to the NH Dept of Health ten years ago, comments from 340 NH residents with many reporting delayed diagnosis due to false negative serology and a list of references identifying seronegative disease.  A recent Johns Hopkins study reveals that if you’re not treated within the very narrow widow of 30 days, you run the risk of ending up with chronic Lyme disease [1] and yet humans won’t produce antibodies to the infection for 4-6 weeks after a tick bite. So, by the time serology is positive, if ever, it’s already too late as the spirochete responsible for Lyme disease were just recently identified in the brains of mice one week after infection. [2]

The possibility of missing a timely diagnosis is extremely high in a state with one of the highest rates of Lyme in the country especially in the absence of a bulls-eye rash. This was the case with all Tuttle family members. None of us developed the bulls eye rash, none of us met the strict CDC criteria for positive test results and as I mentioned previously, if we had not met Dr. Sam Donta, none of us would have been treated.

The sobering fact about this travesty is that it has been going on for over three decades and no matter how many complaints are submitted, nothing changes and lives continue to be ruined by an infection misclassified as a simple nuisance disease; “hard to catch and easily treated.” Everyone here is a single tick bite away from experiencing this health disaster as tick-borne disease infection rates in the ticks found in Litchfield for example are as high as 77% as indicated in the 2009 UMass tick study I sent to all of you yesterday. Of course, all these details are well hidden from the public. So I hope that we can make a difference here, get the truth out to the public and save lives that otherwise would have been upended by this life-altering/life threatening infection.

Ben Franklin once said, “Justice won’t be served until those unaffected are as outraged as those who are.”

Carl Tuttle
Hudson, NH
1. Treatment Delays Increase Risk of Persistent Illness in Lyme Disease

2. A murine model of lyme disease demonstrates that Borrelia burgdorferi colonizes the dura mater and induces inflammation in the central nervous system


Summary of emails “Topics for discussion at our next meeting”

———- Original Message ———-
Cc: All members of the Study Commission
Date: 02/08/2021 3:20 PM
Subject: Summary of emails “Topics for discussion at our next meeting”

To members of the Lyme Study Commission,

I have organized the emails I have sent since our last meeting so that these topics won’t be missed in the upcoming meeting(s)

Next Zoom Meeting: Friday Feb 12, 2021 9:00AM

Summary of emails “Topics for discussion at our next meeting”

#1 Dec 30, 2020

Presentation request

 -Amanda Elam, President and CEO of Galaxy Diagnostics has a 20min presentation for the Lyme Study Commission

Galaxy Diagnostics Launches the Most Sensitive Test Available for Direct Detection of Lyme Disease ($295)

“Galaxy validation data (unpublished) shows that the Nanotrap® Urine Test will often confirm active infection in patients with negative TTT (Two-Tiered Testing) results.”
#2 Jan 14, 2021

-2005 Johns Hopkins Study: Serology no better than a coin toss
-2016 Meta-analysis of test accuracy: Serology no better than a coin toss
-2020 Johns Hopkins study: Treatment Delays of 30 Days associated with chronic Lyme disease
-1998 Dennis Parenti’s vaccine presentation: Seronegative Lyme. At 36% is a common presentation

#3 Jan 15, 2021

-1995 Seronegative Chronic Relapsing Neuroborreliosis: The patient never had detectable free antibodies to B. burgdorferi in serum or spinal fluid
-2010 Registered Complaint to the NH Dept of Health: Identifying five NH cases where a FALSE negative Elisa led to patient harm (Willful neglect?)

#4 Jan 17, 2021

-Comments from 344 individuals living in New Hampshire: Individuals in bold lettering have been adversely affected by faulty/misleading Lyme disease testing
#5 Jan 20, 2021

-Not Using Ivermectin, One Year In, Is Unethical And Immoral: Used as an example of mismanagement of an epidemic as we have experienced with Lyme disease

#6 Jan 25, 2021

-Dr. Kenneth Liegner’s communication with public health officials at the CDC regarding patient harm to Jennifer Lilly from the faulty two-tiered serology test for Lyme disease.
-Includes many references to poor performance of serologic testing

#7 Jan 30, 2021

-Letter addressed to Rochelle Walensky, MD Director of the CDC: includes references to seronegative Lyme disease and evidence of persistent infection through culture performed by the Centers for Disease Control at Fort Collins, Colorado

#8 Feb 3, 2021

-PDF file identifying Seronegativity in Lyme borreliosis and Other Spirochetal Infections 16 September 2003: “If false results are to be feared, it is the false negative result which holds the greatest peril for the patient.”

#9 Feb 5, 2021

-Study published this month identifying the spirochete responsible for Lyme disease in the brains of mice one week after infection. Lyme tests won’t be positive for 4-6 weeks after a tick bite (if you actually do produce antibodies) and you’ll miss the narrow window of opportunity for successful short-term treatment. Now you’ve gone past that thirty day mark that Johns Hopkins has recently identified as problematic as these patients end up with chronic Lyme disease. Serology is an inappropriate diagnostic tool for this life-altering/life-threatening infection.

Respectfully submitted,

Carl Tuttle
Hudson, NH


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