The Lyme Multiplex PCR-based diagnostic test for Borrelia burgdorferi, performed directly on a clinical specimen. The combination of the following three steps imparts very high specificity and sensitivity:

  • Hybridization/Selection
  • Amplification of the specific DNA (genomic and plasmid)
  • Detection of B. burgdorferi-specific amplified DNA fragments by dot-blot assay using B. burgdorferi specific probes.

Result Interpretation

Reference Range

Negative- Genomic: B. burgdorferi DNA not detected

Negative- Plasmid: B. burgdorferi DNA not detected

Clinical Significance

The Lyme Multiplex PCR test is a 3 step amplified nucleic acid assay that detects B. burgdorferi specific DNA sequences. The gene fragments are first selected with specific probes. Then, DNA is amplified in two independent PCR assays using different primers from the Osp A gene and flagellin gene. Lastly, the amplified products are detected by hybridizations to specific probes in a Southern Dot-Blot Assay. This test detects DNA from:B. burgdorferi, B. afzelii, B. andersonii, B. garinii and  B. mayoni (based on sequence information). The sample is considered positive if either the genomic or plasmid result is positive.

Limitations

  1. This test should only be performed in conjunction with Southern Dot-Blot.
  2. Results should be interpreted in conjunction with other laboratory and clinical findings.
  3. Test results can only help the physician in confirming clinical diagnosis.

Ordering Information

Test Number

Sample Type

Minimum Volume

Container

456

EDTA Whole Blood

2ml

EDTA lavender top tube

453

Serum

2ml

SST or Leak-proof tube

450

Urine

3ml

Plastic container with screw cap lid

465

Pooled Urine

3ml x 3

Plastic containers with screw cap lid

459

Cerebral Spinal Fluid

2ml

Sterile leak-proof tube

462

Miscellaneous

1-5 g tissue, 2ml fluids

Sterile leak-proof tube

Collection and Shipping Instructions

Tests 456, 453: See Serum and Whole Blood Samples-Collection & Shipping Instructions

Tests 450, 465: See Urine Samples- Collection & Shipping Instructions

Tests 459, 462: See Miscellaneous Specimen Collection & Shipping Instructions

Test Offered

Test# 453 Lyme Multiplex PCR – Serum CPT Code 87800, 87801
Test# 456 Lyme Multiplex PCR – Whole Blood CPT Code 87800, 87801
Test# 450 Lyme Multiplex PCR – Urine CPT Code 87800, 87801
Test# 465 Lyme Multiplex PCR – Urine (pooled from 3 samples) CPT Code 87800, 87801
Test# 459 Lyme Multiplex PCR – Cerebral Spinal Fluid (CSF) CPT Code 87800, 87801
Test# 462 Lyme Multiplex PCR – Miscellaneous** CPT Code 87800, 87801
Lyme Multiplex PCR Serum and Whole Blood are part of the following Test Panels:
Test Panel# 477 Newborn Panel (cord blood)
Test Panel# 5010 Initial Lyme Panel
Test Panel# 6050 Complete Lyme Panel**
Test Panel# 8055 NN Special Borrelia Panel**
Test Panel# 6060 Basic Borreliosis Panel**
Test Panel# 6070 Complete Borreliosis Panel**
Test Panel# 8045 Complete Relapsing Fever Panel with Urine**
Test Panel# 875 Urine Lyme Panel**
Test Panel# 8075 NN Urine Panel**
Test Panel# 8085 CSF Panel**
Test Panel# 6090 Super Borreliosis panel**

**Test/Panels are not yet available for New York Residents