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Test ID PBORR Lyme Disease (Borrelia burgdorferi), Molecular Detection, PCR

Useful For

Confirmation of active Lyme disease

 

Supporting the diagnosis of Lyme arthritis

 

Testing of cerebrospinal fluid (CSF) by PCR in patients with suspected Lyme neuroborreliosis should be requested only on patients with positive Borrelia burgdorferi antibody in serum confirmed by Western blot assay LYWB / Lyme Disease Antibody, Immunoblot, Serum and with abnormal CSF findings (elevated protein and WBC >10 cells/high-power field).

Testing Algorithm

See Acute Tick-Borne Disease Testing Algorithm in Special Instructions.

Method Name

Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)

Reporting Name

Lyme Disease PCR

Specimen Type

Varies

Forms: If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

Microbiology Test Request Form (T244) (http://www.mayomedicallaboratories.com/it-mmfiles/microbiology_test_request_form.pdf)

Neurology Test Request Form-General (T732) (http://www.mayomedicallaboratories.com/it-mmfiles/neurology-request-form.pdf)

 

Specimen source is 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 or Synovial Fluid: 0.3 mL; Tissue: NA

Specimen Stability Information

Specimen Type Temperature Time
Varies Refrigerated (preferred) 7 days
  Frozen  7 days

Clinical Information

Lyme disease is a multisystem and multistage infection caused primarily by 3 species of tick-borne spirochetes in the Borrelia burgdorferi sensu lato genogroup. These spirochetes include Borrelia burgdorferi sensu stricto (North America and Western Europe), Borrelia afzelii (Central and Western Europe and Russia), and Borrelia garinii (Europe, Russia, and northern Asia). Endemic areas for Lyme disease in the United States correspond with the distribution of 2 tick species, Ixodes scapularis (Northeastern and Upper Midwestern US) and Ixodes pacificus (West Coast US). In Europe, Ixodes ricinus transmits the spirochete. Lyme disease is the most commonly reported tick-borne infection in Europe and North America (CDC).

 

Lyme disease exhibits a variety of symptoms that may be confused with immune and inflammatory disorders. Inflammation around the tick bite causes skin lesions. Erythema (chronicum) migrans (ECM), a unique expanding skin lesion with central clearing that has a ring-like appearance, is typically the first stage of the disease. Arthritis, neurological disease, and cardiac disease may be later stage manifestations.

 

Serology is currently the diagnostic method of choice for Lyme disease. However, serology may not be positive until 2 to 4 weeks after onset of ECM, and direct detection of Borrelia species. Target DNA using PCR may be a useful adjunct to existing diagnostic tests for acute disease. PCR has shown utility for detection of Borrelia DNA from skin biopsies of ECM lesions, as well as DNA from synovial and cerebrospinal fluid in late-stage disease.(1) Borrelia DNA can also, rarely, be detected from blood, but is not the test of choice from this source.

 

Lyme PCR may be useful for adjunctive testing to support a serologic diagnosis of Lyme disease, and should be performed in conjunction with FDA-approved serologic tests.

PCR results should be correlated with serologic and epidemiologic data and clinical presentation of the patient.

Reference Values

Negative

Cautions

A negative result does not rule-out Lyme disease, since inhibitory substances may be present in the specimen and the assay has limited clinical sensitivity when testing certain specimen types (eg, cerebrospinal fluid: CSF). If clinical features of illness are highly indicative of Lyme neuroborreliosis, serologic testing on CSF is warranted. Patients with active infection due to Borrelia afzelii or Borrelia garinii may have positive results from this PCR test, which will be reported as atypical gene sequence and prompt additional testing. 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 chaffeensis/Anaplasma phagocytophilum and Babesia microti have been reported in United States, and consideration should be given to testing for other pathogens if clinically indicated.

Day(s) Performed

Monday through Saturday (June through November)

Monday through Friday (December through May)

Report Available

1 day

Performing Laboratory

Mayo Medical Laboratories in Rochester

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

NY State Approved

Yes