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Test Code LAB5509 Lyme Disease, Molecular Detection, PCR, Blood

Important Note

Mayo's test code: PBORB

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Reporting Name

Lyme Disease PCR, B

Specimen Type

Whole Blood EDTA


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.



Specimen Required


Container/Tube: Lavender top (EDTA)

Specimen Volume: 1 mL

Collection Instructions: Send whole blood specimen in original tube. Do not aliquot.


Reject Due To

Gross hemolysis OK

Specimen Stability Information

Specimen Type Temperature Time Special Container
Whole Blood EDTA Refrigerated (preferred) 7 days
  Frozen  7 days

Specimen Minimum Volume

0.3 mL

Day(s) Performed

June through November: Monday through Saturday

December through May: Monday through Friday

Specimen Retention Time

1 week

Report Available

1 to 4 days

Reference Values

Negative

Reference values apply to all ages.

Useful For

Supporting the diagnosis of Lyme disease in conjunction with serologic testing

 

This test should not be used to screen asymptomatic patients.

Testing Algorithm

For more information see Acute Tick-Borne Disease Testing Algorithm.

CPT Code Information

87476

87798 x 2

87999 (if appropriate for government payers)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
PBORB Lyme Disease PCR, B 90892-1

 

Result ID Test Result Name Result LOINC Value
56080 B. burgdorferi PCR, B 94247-4
38290 B. mayonii PCR, B 94248-2
38291 B. garinii/B. afzelii PCR, B 94249-0
38340 Lyme Disease PCR Comment 59464-8

Supportive Data

The following validation data supports the use of this assay for clinical testing.

 

Analytical Sensitivity/Limit of Detection:

The lower limit of detection is approximately 300 to 1000 genomic copies/mL in cerebrospinal fluid, tissue, blood, and synovial fluid.

 

Accuracy/Diagnostic Sensitivity and Specificity:

Spiking studies of whole organism in whole blood (spiked near the approximate limit of detection) showed 100% recovery.

 

Analytical Specificity:

No polymerase chain reaction signal was obtained from the extracts of 22 bacterial, viral, parasitic, and fungal isolates that can cause symptoms similar to Lyme disease, including Rickettsia rickettsii, Rickettsia typhi, Ehrlichia canis, Babesia microti, Plasmodium falciparum, Plasmodium vivax, Bartonella henselae, Bartonella quintana, herpes simplex virus, and Toxoplasma gondii. Relapsing fever borreliae (including Borrelia miyamotoi) are also not detected with this assay.

 

Precision:

Interassay precision was 100% and intra-assay precision was 100%.

 

Reference Range:

The reference range for this assay is negative. This assay is only to be used for patients with a clinical history and symptoms consistent with Lyme disease and must be interpreted in the context of serologic tests, which are the gold standard for diagnosis of Lyme disease.

 

Reportable Range:

This is a qualitative assay, and the results are reported as negative or positive for targeted Borrelia burgdorferi.

Forms

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