What is the status of direct diagnostic tests for Lyme disease?

MAY 5, 2020 — 

A fellow supporter of this petition sent a letter to Dr. Ben Beard regarding the status of direct diagnostic tests for Lyme disease after reading the previous update: (Thank you Troy Plum!)

Previous update: TBDWG April 27, 2020 – Written Public Comment


Response from the Centers for Disease Control:

Dear Troy,

Thank you for your letter. Early and accurate diagnosis and treatment of Lyme and other tickborne diseases has been and will remain a top priority in CDC’s Division of Vector-Borne Diseases.

CDC partnered with the Minnesota Department of Health, Mayo Clinic, and Vanderbilt University Medical Center to obtain clinical specimens from patients with suspected tickborne illness, such as Lyme disease, anaplasmosis, or ehrlichiosis. CDC is in the process of evaluating 30,000 samples from tick bite patients with acute illness following a tick bite. Using a method called metagenomics, researchers are attempting to identify specific tickborne bacteria that caused these patients’ illnesses. An update on this project has recently been published (Kingry et al, Surveillance for and discovery of Borrelia species in US patients suspected of tickborne illness. Clin Infect Dis. 2018 Jun 1;66(12):1864-1871. doi: 10.1093/cid/cix1107). The ongoing project has identified several novel tickborne pathogens not previously seen in people. The project has also detected the new Lyme disease agent, Borrelia mayonii, originally discovered in 2013. The metagenomics method is one of several new methods being used to increase our knowledge of the pathogens that are causing tickborne illness, upon which new, direct diagnostic tests can be developed for Lyme and other tickborne diseases.

We know that early and accurate diagnosis and treatment is essential for assuring the best treatment outcomes and remain committed to identifying and disseminating the best diagnosis and treatment options for tickborne diseases, in collaboration with other federal agencies. CDC does not conduct studies on treatment options for tickborne disease patients, but relies on our sister agency, the National Institutes of Health, for this work.

CDC is very concerned for patients who suffer from tick-associated illness, and we remain committed to reducing the impact of Lyme and other tickborne diseases through Public Health action (https://www.cdc.gov/lyme/why-is-cdc-concerned-about-lyme-disease.html


Centers for Disease Control and Prevention

Division of Vector-Borne Diseases
3156 Rampart Road
Fort Collins, CO

Carl Tuttle’s response to the CDC…….. 

Dr. Beard,

The CDC responded to my question regarding direct detection tests for Lyme disease referencing the following publication:

(Kingry et al, Surveillance for and discovery of Borrelia species in US patients suspected of tickborne illness. Clin Infect Dis. 2018 Jun 1;66(12):1864-1871. doi: 10.1093/cid/cix1107)



“…using a Borrelia genus-level TaqMan polymerase chain reaction (PCR). Borrelia species and sequence types (STs) were characterized by multilocus sequence typing (MLST) utilizing next-generation sequencing.”

I shared this CDC response with knowledgeable individuals familiar with direct detection methods……

Here are just a few comments:

-None of the technologies described in this article are better than the conventional nested PCR and Sanger sequencing which of course they are trying very hard to avoid; perpetuating the status quo of a dysfunctional system. 

-They just drew another pie in the sky. The complexity and cost of the test will discourage any potential users. We need a direct test which can be implemented by hospital labs in the Lyme endemic areas.

MLST and next-generation sequencing are useless for diagnosing individual patients, at least with the current state of technology and probably forever. They may have some value for monitoring ticks, epidemiology etc. but NOT for diagnostic testing.


It would appear that the CDC response to the question; What is the status of Direct Diagnostic Tests for Lyme Disease is little more than lip service to project an image that our public health officials have everything under control.

If the CDC is “moving progressively in the direction of direct diagnostic testing” then give us the list of studies currently funded and the name of the institutions/researchers actively involved in bringing an accurate direct detection test to market within an accelerated time-frame to address America’s coexisting pandemic of Lyme disease which has spiraled out of control over the past three decades.

Respectfully submitted,

Carl Tuttle

Lyme Endemic Hudson, NH

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