Test Catalog

Test ID: PBORB    
Lyme Disease, Molecular Detection, PCR, Blood

Useful For Suggests clinical disorders or settings where the test may be helpful

Supporting the diagnosis of Lyme disease in conjunction with serologic testing

Testing Algorithm Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Acute Tick-Borne Disease Testing Algorithm in Special Instructions

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Lyme disease is a multisystem and multistage tick-transmitted infection caused by spirochetal bacteria in the Borrelia burgdorferi sensu lato (Bbsl) complex.(1) Nearly all human infections are caused by 3 Bbsl species; B burgdorferi sensu stricto (hereafter referred to as B burgdorferi) is the primary cause of Lyme disease in North America, while B afzelii and B garinii are the primary causes of Lyme disease in Europe. In 2012, B mayonii was identified as a less common cause of Lyme disease in the upper Midwestern United States.(2,3) This organism has only been detected in patients with exposure to ticks in Minnesota and Wisconsin and has not been detected in over 10,000 specimens from patients in other states including regions of the northeast where Lyme disease is endemic.


Lyme disease is the most commonly reported tick-borne infection in Europe and North America, causing an estimated 300,000 cases in the United States each year, and 85,000 cases in Europe.(4,5) The clinical features of Lyme disease are broad and may be confused with various immune and inflammatory disorders. The classic presenting sign of early localized Lyme disease caused by B burgdorferi is erythema migrans (EM), which occurs in approximately 80% of individuals. Other early signs and symptoms include malaise, headache, fever, lymphadenopathy, and myalgia. Arthritis, neurological disease, and cardiac disease may be later stage manifestations. Erythema migrans has also been seen in patients with B mayonii infection, but diffuse rashes are more commonly reported.(2) The chronic skin condition, acrodermatitis chronicum atrophicans, is also associated with B afzelii infection.


The presence of EM in the appropriate clinical setting is considered diagnostic for Lyme disease and no confirmatory laboratory testing is needed. In the absence of a characteristic EM lesion, serologic testing is the diagnostic method of choice for Lyme disease.(6) However, serology may not be positive until 1 to 2 weeks after onset of symptoms, and may show decreased sensitivity for detection of infection with B mayonii. Therefore, detection of Bbsl DNA using PCR may be a useful adjunct to serologic testing for detection of acute disease. PCR has shown utility for detection of Borrelia DNA from skin biopsies of Lyme-associated rashes, and can also be used to detect Borrelia DNA from synovial fluid and synovium biopsies. Less commonly, Borrelia DNA can be detected in cerebrospinal fluid and blood.(7) In general, blood is not the preferred source for detection of Bbsl DNA by PCR, although it may have increased utility for detection of B mayonii, due to the higher levels of observed peripheral spirochetemia with this organism.(2) Lyme PCR should always be performed in conjunction with FDA-approved serologic tests, and results should be correlated with serologic and epidemiologic data and clinical presentation of the patient.(8) The Mayo Clinic Lyme PCR test detects and differentiates the main causes of Lyme disease in North America (B burgdorferi and B mayonii) and Europe (B afzelii and B garinii).(2,7)

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.


Interpretation Provides information to assist in interpretation of the test results

A positive result indicates the presence of DNA from Borrelia burgdorferi, B mayonii, B afzelii, or B garinii, the main agents of Lyme disease.


A negative result indicates the absence of detectable target DNA in the specimen. Due to the diagnostic sensitivity limitations of the PCR assay, a negative result does not preclude the presence of the organism or active Lyme disease.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Serologic tests are recommended for diagnosis of Lyme disease. PCR may play an adjunctive role, but may not detect Borrelia burgdorferi DNA from blood in cases of active or chronic disease. The presence of inhibitory substances may also cause a false-negative result. PCR test results should be used as an aid in diagnosis and not considered diagnostic by themselves. These results should be correlated with serologic and epidemiologic data and clinical presentation of the patient.


Concurrent infections with multiple tick-borne pathogens, including Ehrlichia muris eauclairensis, Anaplasma phagocytophilum, Babesia microti, and B miyamotoi (a relapsing-fever Borrelia) have been reported in the United States, and consideration should be given to testing for other pathogens if clinically indicated.


This assay detects most members of the B burgdorferi sensu lato complex, including B andersonii, B americana, and B bissettii, which have been rarely detected in humans. Detection of DNA from these organisms would be reported as an atypical result and prompt additional laboratory testing to further identify the DNA present. The sensitivity of this assay for detecting these organisms has not been determined.


This assay also detects some members of the B burgdorferi sensu lato (Bbsl) complex that are not considered to be human pathogens, but may be found in ticks and other animals. Therefore, this assay should not be used to test nonhuman specimens.

Supportive Data

The following validation data supports the use of this assay for clinical testing.


Analytical Sensitivity/Limit of Detection (LoD):

The lower LoD is approximately 300 to 1,000 genomic copies/mL in cerebrospinal fluid, tissue, blood, and synovial fluid.


Accuracy/Diagnostic Sensitivity and Specificity:

Spiking studies of whole organism in whole blood (spiked near the approximate limit of detection) showed 100% recovery.


Analytical Specificity:

No PCR signal was obtained from the extracts of 22 bacterial, viral, parasitic, and fungal isolates that can cause symptoms similar to Lyme disease including; Rickettsia rickettsii, R typhi, Ehrlichia canis, Babesia microti, Plasmodium falciparum, P vivax, Bartonella henselae, Bartonella quintana, Herpes simplex virus, and Toxoplasma gondii. Relapsing fever borreliae (including Borrelia miyamotoi) are also not detected with this assay.



Interassay precision was 100% and intra-assay precision was 100%.


Reference Range:

The reference range for this assay is negative. This assay is only to be used for patients with a clinical history and symptoms consistent with Lyme, and must be interpreted in the context of serologic tests, which are the gold standard for diagnosis of Lyme disease. This test should not be used to screen asymptomatic patients.


Reportable Range:

This is a qualitative assay, and the results are reported as negative or positive for targeted Borrelia burgdorferi.

Clinical Reference Recommendations for in-depth reading of a clinical nature

1. Stanek G, Wormser GP, Gray J, Strle F: Lyme borreliosis. Lancet 2012;379(9814):461-473

2. Pritt BS, Mead PS, Johnson, DK, et al: Identification of a novel pathogenic Borrelia species causing Lyme borreliosis with unusually high levels of spirochetemia: a descriptive study. Lancet Infect Dis 2016 May;16(5):556-564

3. Pritt BS, Respicio-Kingry LB, Sloan LM, et al: Borrelia mayonii sp. nov., a member of the Borrelia burgdorferi sensu lato complex, detected in patients and ticks in the upper midwestern United States. Int J Sys Evol Microbiol 2016;66(11):4878-4880

4. Hinckley AF, Connally NP, Meek JI, et al: Lyme disease testing by large commercial laboratories in the United States. Clin Infect Dis 2014;59(5):676-681

5. Lindgren E, Jaenson TGT: Lyme borreliosis in Europe: influences of climate and climate change, epidemiology, ecology and adaptation measures. Copenhagen, Denmark: World Health Organization; 2006

6. Centers for Disease Control and Prevention. Recommendations for test performance and interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease. MMWR Morb Mortal Wkly Rep 1995;44(31):590-591

7. Babady NE, Sloan LM, Vetter EA, et al: Percent positive rate of Lyme real-time polymerase chain reaction in blood, cerebrospinal fluid, synovial fluid, and tissue. Diagn Microbiol Infect Dis 2008;62(4):464-466

8. CDC: Recommendation for test performance and interpretation. From second national conference on serological diagnosis of lyme disease. MMWR Morb Mortal Wkly Rep 1996;45:481-484

Special Instructions Library of PDFs including pertinent information and forms related to the test