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Test Name:
Lyme Disease (Borrelia species) DNA Detection, by PCR

• SBMF No:
  44014
• Performance Lab Name:
  ARUP Laboratories
• Test Mnemonic:
  LYMEPCR
• ABN:
  Required – Not FDA-Approved
• CPT Code:
  87476
• LOINC Code:
  19146-0; 4991-6
• Ref Lab Test No:
  0055570
• Also Known As:
  Lyme Disease, by PCR
  Tick borne disease
• Spec Type:
  Serum or Plasma
• Spec Container:
  Red top (serum) or lavender top (EDTA) tube
• Alt Spec Type:
  Cerebrospinal, synovial fluid, or skin punch biopsy
• Alt Spec Container:
  Sterile plastic tube with screw-top cap
• Pref Vol:
  1.0 mL
• Min Vol:
  0.5 mL
• Fasting:
  No
• Spec Collect:
  Blood: Routine venipuncture
  Cerebrospinal fluid, synovial fluid, skin biopsy: Collected by physician
• Spec Process:
  

  Serum or plasma:
  – Serum sample tubes, clot 30 minutes
  – All tubes, promptly centrifuge 15 minutes
  – Immediately transfer serum or plasma to separate plastic tube and freeze

  Cerebrospinal or synovial fluid – Freeze and transport frozen

  Skin punch biopsy – Freeze skin tissue immediately

• Spec Store Transport:
  Frozen
  Submit specimen according to Biological Substance, Category B, shipping guidelines
• Spec Stability:
  8 hours room temperature (20-30°C) – excludes tissue
  3 days refrigerated (2-8°C) – excludes tissue
  1 year frozen (-20°C) – Do not use frost-free units that undergo repeated freeze/thaw cycles
• Spec Reject:
  Heparinized or severely lipemic sample
  Frozen or clotted whole blood sample
  Non-sterile or leaking containers
• Methodology:
  Qualitative Polymerase Chain Reaction (PCR)
• Clinical Significance:
  Refer to:
  
• Reference Range:
  

  Negative – Borrelia species DNA not detected by PCR
  Positive – Borrelia species DNA detected by PCR

  Interpretive Data:
  A negative result does not rule out the presence of PCR inhibitors in the patient specimen or Borrelia species DNA concentrations below the level of detection of the assay.

• Additional Test Info:
  This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
• Day Run:
  Mon, Wed, Fri
• Time Reported:
  2-5 days
• Test Type:
  INFECTIOUS ORGANISM