Laboratory testing for Lyme disease

Carl Tuttle
Hudson, NH, United States
DEC 15, 2018 —

Direct detection laboratory testing (DNA/PCR Sequencing) is used for many infections (Ebola (1), Zika (2), Bartonella (3) etc.) but not Lyme disease.

  1. Ebola RealStar® Filovirus Screen RT-PCR Kit 1.0
  2. CDC Lauds New DNA Test for Zika in Blood
  3. In May of 2012 the CDC announced the Development of a Novel Genus-specific Real-time PCR Assay for Detection and Differentiation of Bartonella Species and Genotypes

For over two decades (Dearborn conference 1994) The U.S. Centers for Disease Control has avoided and denounced all direct detection methods for Lyme disease while promoting the faulty/misleading two tier antibody algorithm. Serology for Lyme disease cannot be used to gauge treatment failure or success so it is the ideal tool for concealing chronic Lyme disease.
The CDC does use DNA/PCR testing however to verify infection in postmortem patients who died suddenly of Lyme carditis. (1, 2, 3)

  1.  A case report of a 17-year old male with fatal Lyme carditis
  2. Three Sudden Cardiac Deaths Associated with Lyme Carditis:
  3. Cardiac Tropism of Borrelia burgdorferi: An Autopsy Study of Sudden
    Cardiac Death Associated with Lyme Carditis. (March 2016)
So it would appear that you have to die first to obtain irrefutable proof of Lyme disease.

Please see the following letter addressed to the Director of Quest Diagnostics-New England regarding current antibody testing for Lyme disease. These tests are the root cause of unimaginable pain and suffering.

——— Original Message ———-
To:,, Alex.Azar@HHS.GOV,,
Cc: (64 undisclosed recipients)
Date: December 13, 2018 at 12:10 PM
Subject: Lyme disease Western Blot test (2009 communication follow-up)

Dec 13, 2018

Quest Diagnostics-New England
415 Massachusetts Ave.
Cambridge, MA 02139
Attn: Salim E. Kabawat, M.D. Medical Director

Dear Dr. Kabawat,

I would like to call attention to the following publication coauthored by Paul Mead, MD, MPH Acting Branch Chief of the Division of Vector-Borne Diseases at the CDC in Fort Collins, Colorado:

Direct Diagnostic Tests for Lyme Disease
Clinical Infectious Diseases, ciy614,

Published: 11 October 2018 Paul S Mead


“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.”

Has Dr. Paul Mead of the CDC reached out to you to ask that you include this disclaimer in your Western blot serology test results for Lyme disease?

Dr. Neil Spector’s serology was repeatedly negative leaving his Lyme untreated for four years resulting in the need of a heart transplant. [1]

Four negative Lyme test results led to a misdiagnosis of Multiple Sclerosis prompting a lawsuit in Pennsylvania.


Per the email thread below, I had this conversation with you nine years ago. How many patients since then have been misdiagnosed and left untreated because there is no disclaimer on your test results informing the patient (and physician) that a negative result does not necessarily mean that you don’t have Lyme disease?

Don’t you think it is time for change; full disclosure perhaps?

A response to this inquiry is requested.

Carl Tuttle
Lyme Endemic Hudson, NH

Cc: ADM Brett P. Giroir, M.D., Assistant Secretary for Health

1. Neil Spector “Gone in a Heartbeat”

2009 Response from Director Kabawat:
———- Original Message ———-
From: Kabawat, Salim E
Cc: Panarelli, Robert M
Date: June 12, 2009 at 2:17 PM
Subject: Lyme disease Western Blot test

Mr. Carl Tuttle 33 David Dr
Hudson, NH 03051

Greetings Mr. Tutle; Regarding your question on Lyme disease Western Blot Test, Quest Diagnostics follows CDC guidelines regarding Lyme reporting. See MMWR August 11, 1995 / 44(31);590-591 “It was recommended that an IgM immunoblot be considered positive if two of the following three bands are present: 24 kDa (OspC) * , 39 kDa (BmpA), and 41 kDa (Fla) (1). It was further recommended that an that IgG immunoblot be considered positive if five of the following 10 bands are present: 18 kDa, 21 kDa (OspC) *, 28 kDa, 30 kDa, 39 kDa (BmpA), 41 kDa (Fla), 45 kDa, 58 kDa (not GroEL), 66 kDa, and 93 kDa (2).”

Salim E. Kabawat, M.D.

Quest Diagnostics-New England| Medical Director | 415 Massachusetts Ave., Cambridge, MA 02139 | phone617.520.8242 | fax 617.520.7703 ||

2009 follow-up letter to Dr. Kabawat: (No response)

———- Original Message ———-
To: Salim E Kabawat <>
Cc: Robert M Panarelli <>
Date: June 17, 2009 at 1:06 PM

Subject: Re: Lyme disease Western Blot test

June 17, 2009
Quest Diagnostics-New England
415 Massachusetts Ave.
Cambridge , MA 02139
Attn: Salim E. Kabawat, M.D. Medical Director

Dear Dr Kabawat,

Each week for the past month I submitted the following question through your online patient inquiry portal:

“Could you please tell me why Quest Labs’ Western blot Lyme test doesn’t include band 31 and 34? Is it possible that your exclusion of these bands is missing many Lyme cases since band 31 and 34 are highly specific to Borrelia burgdorferi and were originally chosen for vaccine development?”

On June 9, 2009 you responded to my inquiry referring to a thirteen year old CDC guideline for Lyme disease reporting dated August 11, 1995
(MMWR 44(31);590-591). You then cut and pasted the following information from that guideline:

“It was recommended that an IgM immunoblot be considered positive if two of the following three bands are present: 24 kDa (OspC) * , 39 kDa (BmpA), and 41 kDa ( Fla ) (1). It was further recommended that an that IgG immunoblot be considered positive if five of the following 10 bands are present: 18 kDa, 21 kDa (OspC) *, 28 kDa, 30 kDa, 39 kDa (BmpA), 41 kDa (Fla), 45 kDa, 58 kDa (not GroEL), 66 kDa, and 93 kDa (2).”

On February 11, 2005 the Centers for Disease Control and Prevention issued the following caution (MMWR Morb Mortal Wkly Rep 2005; 54:125–6) regarding testing for Lyme disease:

Health-care providers are reminded that a diagnosis of Lyme disease should be made after evaluation of a patient’s clinical presentation and risk for exposure to infected ticks, and, if indicated, after the use of validated laboratory tests.

As I review my wife and daughter’s Western blot lab results which were ordered through Quest laboratory Apr 16, 2009 and May 7, 2009 respectively, I cannot locate the disclaimer reminding the physician that a diagnosis of Lyme disease should be made after evaluation of the patient’s clinical presentation or risk for exposure to infected ticks. In fact, my daughter’s primary care physician called to inform her that she didn’t have Lyme disease based on your lab results alone without considering clinical symptoms whatsoever.

The attached CDC deer tick/Lyme study concludes that we are living in an area with one of the highest rates in the state. Residents in our area have a 77% chance of contracting Lyme through a deer tick bite. Physicians in this “endemic area” as we have experienced are not familiar with the clinical manifestations of Lyme especially when the patient does not present with the typical bulls eye rash or recall experiencing a tick bite as is the case 50% of the time.

UMass Amherst NH deer tick/Lyme study:

Your lab tests are contributing to the problem as all the physician sees is the word NEGATIVE on the results.

Under the Infectious Conditions for Public Health Surveillance page, the Centers for Disease Control updated its Lyme Case Definition in 2008 stating the following:

“This surveillance case definition was developed for national reporting of Lyme disease; it is not intended to be used in clinical diagnosis

This includes the thirteen year old 1995 CDC guideline for reporting purposes that you referred to in your original response.

Lyme literate Infectious Disease Specialists recognize that it is not necessary to have five positive Western blot IgG bands or two IgM bands in order to diagnose Lyme disease. Those guidelines were strictly developed for surveillance purposes only.

Your lab results neglect to mention any of this so Quest Labs along with other commercial labs is misleading the physician. I don’t believe this is intentional but more on the lines of complacency.

I have first hand experience after chasing an unresolved fatigue for twelve years as my Western blot results show only two positive bands. I would like to mention that private Lyme testing labs (i.e. IGeneX Labs) are informing the patient with disclaimers stating that diagnosis should not be based on laboratory tests alone and results should be interpreted in conjunction with clinical symptoms and patient history.

There is a moral responsibility to provide accurate information as I have identified in this letter. I would like to remind you of the following statement found on your Company Info page:

“Quest Diagnostics is People. Dedicated people who understand that behind every specimen and result there is a human life

Our Vision, Mission & Values

As a company and as individuals, we accept full responsibility for our performance and acknowledge our accountability for the ultimate outcome of all that we do. We strive for continuous improvement, believing that competence, reliability, and rigorous adherence to process discipline are the keys to excellence

How many Lyme patients have been misdiagnosed and told they do not have Lyme disease due to your “NEGATIVE” lab results and missing disclaimers? There is a dire need to change your methods and educate the physician to avoid patient suffering by missing the window of opportunity for treatment.

Carl Tuttle
Hudson , NH 03051


More on testing:

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