Borrelia miyamotoi Testing: Is There an FDA-Approved Test?
No FDA-approved test is available specifically for Borrelia miyamotoi
Diagnosis may involve PCR and specialized antibody testing
Standard Lyme disease tests cannot reliably exclude the infection
Is there an FDA-approved test for Borrelia miyamotoi? Currently, there is no FDA-approved diagnostic test specifically for B. miyamotoi infection. Instead, clinicians may rely on laboratory-developed PCR and antibody assays, interpreted alongside the patient’s symptoms and exposure history.
Borrelia miyamotoi is a relapsing fever bacterium transmitted by the same Ixodes ticks that transmit Lyme disease. Human infection was first reported in Russia in 2011, with subsequent cases identified in the United States, Europe, and Asia. [1-4]
The infection can cause fever, chills, headache, fatigue, and muscle or joint pain. Some patients, particularly those who are immunocompromised, may develop neurologic complications.
Because the symptoms may overlap with Lyme disease and other infections, B. miyamotoi is one of several emerging tick-borne coinfections clinicians may need to consider.
Standard Lyme disease antibody tests are designed to detect immune responses to Borrelia burgdorferi and should not be relied upon to rule out Borrelia miyamotoi infection.
Is There an FDA-Approved Test for Borrelia miyamotoi?
No FDA-approved diagnostic test is currently available specifically for Borrelia miyamotoi infection. However, specialized laboratories offer laboratory-developed tests, including PCR and antibody assays, that may assist with diagnosis.
Laboratory-developed tests are performed in clinical laboratories and validated under Clinical Laboratory Improvement Amendments (CLIA) requirements, but they have not been individually cleared or approved by the FDA.
A 2018 study examining serologic testing for B. miyamotoi stated that no FDA-approved diagnostic tests were available for the infection. [5]
How Is Borrelia miyamotoi Diagnosed?
Diagnosis may involve:
- PCR testing: Detects B. miyamotoi DNA, typically in whole blood during the acute phase of illness. PCR may also be performed on cerebrospinal fluid when neurologic infection is suspected.
- Blood smear examination: Spirochetes may occasionally be visible during periods of substantial spirochetemia, although a negative smear does not exclude infection.
- Antibody testing: Specialized assays may look for antibodies to proteins such as GlpQ, which is found in relapsing fever Borrelia but not in B. burgdorferi.
- Cerebrospinal fluid testing: PCR and other testing may be considered when meningitis or meningoencephalitis is suspected.
The usefulness of each method depends partly on when the specimen is collected. PCR is generally most helpful while the organism is circulating in the blood, whereas antibodies may not become detectable until later.
Test results should be interpreted in the context of the patient’s symptoms, timing of illness, immune status, possible tick exposure, and prior antimicrobial treatment.
Can a Standard Lyme Test Detect Borrelia miyamotoi?
Standard two-tier Lyme disease testing is intended to detect antibodies associated with Borrelia burgdorferi. It is not designed to diagnose Borrelia miyamotoi infection.
Cross-reactive results can sometimes occur. For example, some patients with B. miyamotoi infection may react to the C6 peptide used in certain Lyme disease assays. However, this does not make standard Lyme testing a reliable diagnostic test for B. miyamotoi. [5]
A negative Lyme disease test therefore does not exclude Borrelia miyamotoi infection.
For a broader discussion of the limitations of tick-borne disease testing, see our guide to Lyme test accuracy.
Why Laboratory-Developed Tests Remain Important
Laboratory-developed tests can provide diagnostic options for emerging or uncommon infections when no FDA-approved commercial assay is available.
In May 2024, the FDA issued a final rule that would have changed its oversight of laboratory-developed tests. However, a federal district court vacated that rule on March 31, 2025. In September 2025, the FDA formally restored the regulatory language that existed before the 2024 rule.
The regulatory debate does not change the central clinical problem: patients and physicians still need accurate, accessible, and appropriately validated tests for emerging tick-borne infections.
“It is important to encourage the careful development and validation of tests for emerging tick-borne illnesses,” says Dr. Daniel Cameron, an internist and epidemiologist.
For a summary of available testing approaches, visit types of Lyme disease diagnostic tests.
Frequently Asked Questions
Is there an FDA-approved test for Borrelia miyamotoi?
No. There is currently no FDA-approved diagnostic test specifically for Borrelia miyamotoi. Specialized laboratories may offer laboratory-developed PCR and antibody assays validated under CLIA requirements.
How is Borrelia miyamotoi diagnosed?
Diagnosis may involve PCR testing of whole blood, specialized antibody testing, blood smear examination, and cerebrospinal fluid testing in selected neurologic cases.
Can PCR testing identify Borrelia miyamotoi?
Yes. PCR can detect Borrelia miyamotoi DNA in whole blood and, in selected cases, cerebrospinal fluid. Testing is generally most useful during the acute phase while the organism is circulating.
Can a standard Lyme disease test detect Borrelia miyamotoi?
Standard Lyme disease tests are not designed to diagnose Borrelia miyamotoi. Cross-reactive results may occur, but a positive or negative Lyme test cannot reliably confirm or exclude the infection.
What symptoms can Borrelia miyamotoi cause?
Symptoms may include relapsing or persistent fever, chills, headache, fatigue, and muscle or joint pain. Neurologic complications have also been reported, particularly in immunocompromised patients.
Clinical Takeaway
There is no FDA-approved diagnostic test specifically for Borrelia miyamotoi. PCR and specialized antibody assays may help identify the infection, but their usefulness depends on the timing of testing and the clinical circumstances.
A standard Lyme disease test should not be used to rule out Borrelia miyamotoi infection.
Related Articles
Borrelia miyamotoi infection: Symptoms, testing, and treatment
Lyme test accuracy
Why Lyme tests miss disease
Lyme disease coinfections
References
- Platonov AE, Karan LS, Kolyasnikova NM, et al. Humans infected with relapsing fever spirochete Borrelia miyamotoi, Russia. Emerg Infect Dis. 2011;17(10):1816-1823.
- 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: A case report. Ann Intern Med. 2013;159(1):21-27.
- Gugliotta JL, Goethert HK, Berardi VP, Telford SR III. Meningoencephalitis from Borrelia miyamotoi in an immunocompromised patient. N Engl J Med. 2013;368(3):240-245.
- Molloy PJ, Weeks KE, Todd B, Wormser GP. Seroreactivity to the C6 peptide in Borrelia miyamotoi infections occurring in the northeastern United States. Clin Infect Dis. 2018;66(9):1407-1410.
- U.S. Food and Drug Administration. Laboratory Developed Tests. Updated September 19, 2025.
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
