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Test Code LYMPV Lyme Disease, Molecular Detection, PCR, Varies


Ordering Guidance


This assay does not detect Borrelia miyamotoi. If infection with this organism is suspected, order BMIPB / 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.


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

 

This test should not be used to screen asymptomatic patients.

Testing Algorithm

The following algorithms are available:

-Acute Tick-Borne Disease Testing Algorithm

-Meningitis/Encephalitis Panel Algorithm

Method Name

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

Reporting Name

Lyme Disease, PCR, Varies

Specimen Type

Varies

Specimen Minimum Volume

Spinal Fluid: 0.3 mL; Synovial Fluid: 0.5 mL; Tissue: See Specimen Required

Specimen Stability Information

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

Reference Values

Negative

Reference values apply to all ages.

Interpretation

A positive result indicates the presence of DNA from Borrelia burgdorferi, Borrelia mayonii, Borrelia afzelii, or Borrelia 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 polymerase chain reaction assay, a negative result does not preclude the presence of the organism or active Lyme disease.

Clinical Reference

1. Stanek G, Wormser GP, Gray J, Strle F: Lyme borreliosis. Lancet. 2012 Feb;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 Nov;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 Sep;59(5):676-681

5. Lindgren E, Jaenson TGT: Lyme borreliosis in Europe: influences of climate and climate change, epidemiology, ecology and adaptation measures. 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 Aug;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 Dec;62(4):464-466

8. Centers for Disease Control and Prevention (CDC). Lyme disease--United States, 1995. MMWR Morb Mortal Wkly Rep. 1996 Jun;45(23):481-484

Day(s) Performed

June through November: Monday through Saturday

December through May: Monday through Friday

Report Available

Same day/ 1 to 4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US 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
LYMPV Lyme Disease, PCR, Varies 94253-2

 

Result ID Test Result Name Result LOINC Value
LYMS Specimen Source 31208-2
618333 B. burgdorferi PCR 94250-8
618334 B. mayonii PCR 94251-6
618335 B. garinii/B. afzelii PCR 94252-4
618336 Lyme CSF Comment 59464-8

Forms

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