Borrelia miyamotoi Testing Highlights Limits of FDA-Approved Lyme Tests
Emerging tick-borne infections may require specialized testing.
Borrelia miyamotoi can resemble Lyme disease and relapsing fever.
Concerns remain about restricting access to lab developed tests.
If the FDA were to limit clinicians to only FDA-approved diagnostic testing for tick-borne diseases, access to specialized laboratory testing could become significantly more restricted.
This concern becomes increasingly important as emerging tick-borne pathogens spread into new geographic regions.
Borrelia miyamotoi Can Mimic Lyme Disease
Borrelia miyamotoi is a relapsing fever bacterium capable of causing symptoms similar to Lyme disease.
The organism was first identified in humans in Russia in 2011 and has subsequently been reported in the northeastern United States, California, Europe, and Japan.2-4
At the time of this article, there was no widely available FDA-approved test specifically designed for Borrelia miyamotoi.
This raises an important question: how should clinicians diagnose emerging tick-borne infections when standardized testing remains limited?
Borrelia miyamotoi Often Requires Specialized Testing
Researchers have diagnosed Borrelia miyamotoi using blood smears, polymerase chain reaction (PCR), molecular detection of bacterial DNA, and direct detection of spirochetes in cerebrospinal fluid.2,5-7
Many of these approaches historically fell outside traditional FDA-approved Lyme disease testing pathways.
At the same time, these methods contributed substantially to the recognition and characterization of this emerging infection.
Emerging Tick-Borne Diseases Continue Expanding
Tick populations continue expanding geographically while new vector-borne pathogens are increasingly recognized.
Clinicians evaluating patients with unexplained fevers, neurologic symptoms, relapsing illness, or atypical Lyme disease presentations may require access to evolving diagnostic approaches.
Restricting access to specialized testing too early could potentially slow innovation and limit the ability to identify emerging infections.
“It is premature to require further regulatory oversight of the tests we need for emerging tick-borne illnesses,” says Dr. Daniel Cameron, Internist and Epidemiologist.
Lyme Disease Testing Still Has Limitations
Early Lyme disease testing may not always detect infection during the first stages of illness.
Similarly, emerging infections such as Borrelia miyamotoi may require clinicians to combine clinical judgment, exposure history, evolving symptoms, and specialized laboratory methods when evaluating patients.
For additional discussion, see Lyme test accuracy and Types of Lyme disease tests.
FAQ: Borrelia miyamotoi Testing
What is Borrelia miyamotoi?
Borrelia miyamotoi is a tick-borne relapsing fever bacterium that may cause symptoms overlapping with Lyme disease.
How is Borrelia miyamotoi diagnosed?
Diagnosis may involve PCR testing, blood smears, molecular testing, cerebrospinal fluid analysis, and clinical evaluation.
References:
- FDA to regulate tests for Lyme disease, other illnesses. Boston Globe.
- Krause PJ, Narasimhan S, Wormser GP, et al. Human Borrelia miyamotoi infection in the United States. N Engl J Med. 2013;368(3):291-293.
- Chowdri HR, Gugliotta JL, Berardi VP, et al. Borrelia miyamotoi infection presenting as human granulocytic anaplasmosis. Ann Intern Med. 2013;159(1):21-27.
- Padgett K, Bonilla D, Kjemtrup A, et al. Comparative prevalence of Borrelia miyamotoi and Borrelia burgdorferi in Ixodes pacificus. PLoS One. 2014;9(10):e110853.
- Dworkin MS, Schwan TG, Anderson DE Jr., Borchardt SM. Tick-borne relapsing fever. Infect Dis Clin North Am. 2008;22(3):449-468.
- Gugliotta JL, Goethert HK, Berardi VP, Telford SR 3rd. Meningoencephalitis from Borrelia miyamotoi in an immunocompromised patient. N Engl J Med. 2013;368(3):240-245.
- Hovius JW, de Wever B, Sohne M, et al. A case of meningoencephalitis caused by Borrelia miyamotoi in Europe. Lancet. 2013;382(9892):658.
Dr. Daniel Cameron, MD, MPH
Lyme disease clinician with over 30 years of experience and past president of ILADS.
Symptoms • Testing • Coinfections • Recovery • Pediatric • Prevention
