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Test Code BMIYC Borrelia miyamotoi Detection PCR, Spinal Fluid

Useful For

Aids in the diagnosis of Borrelia miyamotoi infection in conjunction with clinical findings

 

This test is not useful for detecting the Borrelia species that cause Lyme disease.

Reporting Name

Borrelia miyamotoi Detection PCR, C

Specimen Type

CSF


Specimen Required


Container/Tube: Sterile vial

Specimen Volume: 1 mL

Collection Instructions: Submit aliquot from collection vial 2.


Specimen Minimum Volume

0.3 mL

Specimen Stability Information

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

Reject Due To

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Reference Values

Negative

Supportive Data

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

 

Accuracy/Diagnostic Sensitivity and Specificity:

Clinical Samples:

-Sixty-two clinical EDTA blood specimens received in the clinical laboratory for Ehrlichia/Anaplasma polymerase chain reaction (PCR) analysis were tested using the Borrelia miyamotoi PCR assay. Results were compared to the MDH 16S ribosomal RNA TaqMan assay.

-In addition, 2 retrospectively identified B miyamotoi positive specimens were confirmed by the B miyamotoi PCR assay and the MDH TaqMan assay.

 

Spiking studies:

-To supplement the clinical specimens, negative whole blood and spinal fluid (CSF) specimens were spiked with genomic or plasmid DNA of B miyamotoi near the limit of detection and tested in a blinded fashion. The sensitivity of the PCR assay was 100% and the specificity with spiked specimens was 100%.

 

Analytical Sensitivity/Limit of Detection:

-The limit of detection is 2800 target copies/mL (5.6 target copies/mcL) of whole blood or CSF.

 

Analytical Specificity:

-No PCR signal was obtained from the extracts of 31 bacterial, viral, parasitic, and fungal isolates from similar organisms or from organisms commonly found in the specimens tested.

 

Precision:

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

 

Reference Range:

-The reference range of this assay is negative. This assay is designed to detect only species of clinical significance and is to be used for patients with a clinical history and symptoms consistent with tick-borne relapsing fever. It should not be used to screen healthy patients.

 

Reportable Range:

-This is a qualitative assay, and the results are reported as negative or positive for B miyamotoi DNA.

Day(s) Performed

Monday through Saturday

Report Available

Same day/1 to 4 days

Specimen Retention Time

1 week

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87478

LOINC Code Information

Test ID Test Order Name Order LOINC Value
BMIYC Borrelia miyamotoi Detection PCR, C 82476-3

 

Result ID Test Result Name Result LOINC Value
64969 B. miyamotoi PCR, C 82476-3

Forms

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

Testing Algorithm

For more information see Acute Tick-Borne Disease Testing Algorithm