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Test ID: PBORR Lyme Disease, Molecular Detection, PCR, Varies

Reporting Name

Lyme Disease PCR

Useful For

Supporting the diagnosis of Lyme disease in conjunction with serologic testing

 

Specific indications including testing skin biopsies when a rash lesion is not characteristic of erythema migrans, and testing synovial fluid or synovium to support the diagnosis of Lyme arthritis

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 has been 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 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 also be used to detect Borrelia DNA from synovial fluid and synovium biopsies. Less commonly, Borrelia DNA can be detected in cerebrospinal fluid.(7) Lyme PCR should always be performed in conjunction with FDA-approved serologic tests, and the 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 clinical sensitivity limitations of the PCR assay, a negative result does not preclude the presence of the organism or active Lyme disease.

Testing Algorithm

The following algorithms are available in Special Instructions:

-Acute Tick-Borne Disease Testing Algorithm

-Meningitis/Encephalitis Panel Algorithm

Analytic Time

1 day

Day(s) and Time(s) Performed

Monday through Saturday (June through November)

Monday through Friday (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

Varies


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.



Necessary Information


Specimen source is required.



Specimen Required


Submit only 1 of the following specimens:

 

Specimen Type: Spinal fluid

Container/Tube: Sterile vial

Specimen Volume: 1 mL

Collection Instructions: Label specimen as spinal fluid.

 

Specimen Type: Synovial fluid

Container/Tube: Sterile vial

Specimen Volume: 1 mL

Collection Instructions: Label specimen as synovial fluid.

 

Specimen Type: Tissue (fresh only)

Sources: Skin or synovial biopsy

Container/Tube: Sterile container with normal saline

Specimen Volume: Approximately 4 mm(3)

Collection Instructions:

1. Submit only fresh tissue.

2. Skin biopsies:

a. Wash biopsy site with an antiseptic soap. Thoroughly rinse area with sterile water. Do not use alcohol or iodine preparations. A local anesthetic may be used.

b. Biopsy specimens are best taken by punch biopsy to include full thickness of dermis.

3. Label specimen with source of tissue.


Specimen Minimum Volume

Spinal Fluid, Synovial Fluid: 0.3 mL
Tissue: NA

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies 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
PBORR Lyme Disease PCR 94253-2

 

Result ID Test Result Name Result LOINC Value
SRC71 Specimen Source 31208-2
23635 B. burgdorferi PCR 94250-8
38288 B. mayonii PCR 94251-6
38289 B. garinii/B. afzelii PCR 94252-4
38323 Lyme CSF 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