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

Reporting Name

Lyme Disease PCR, B

Useful For

Supporting the diagnosis of Lyme disease in conjunction with serologic testing

Clinical Information

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)

Interpretation

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.

Testing Algorithm

See Acute Tick-Borne Disease Testing Algorithm in Special Instructions

Analytic Time

1 day

Day(s) and Time(s) Performed

Monday through Saturday; multiple runs per day (June through November)

Monday through Friday; 8 a.m. (December through May)

Clinical Reference

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

Method Name

Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization

Specimen Type

Whole Blood EDTA


Advisory Information


This assay does not detect Borrelia miyamotoi. If infection with this organism is suspected, order BMIYB / Borrelia miyamotoi Detection PCR, Blood or BMIYC / Borrelia miyamotoi Detection PCR, Spinal Fluid.



Specimen Required


Container/Tube: Lavender top (EDTA)

Specimen Volume: 1 mL


Specimen Minimum Volume

0.3 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Whole Blood EDTA Refrigerated (preferred) 7 days
  Frozen  7 days

Reference Values

Negative

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

87476

87798 x 2

87999 (if appropriate for government payers)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
PBORB Lyme Disease PCR, B 90892-1

 

Result ID Test Result Name Result LOINC Value
56080 B. burgdorferi PCR, B 94247-4
38290 B. mayonii PCR, B 94248-2
38291 B. garinii/B. afzelii PCR, B 94249-0
38340 Lyme Disease PCR Comment 59464-8

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.

Mayo Clinic Laboratories | Neurology Catalog Additional Information:

mml-Behavioral, mml-Demyelinating-Diseases, mml-CNS-Infections, mml-Neuromuscular, mml-Pediatric, mml-Spinal-Cord