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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.

Method Name

Real-Time Polymerase Chain Reaction (PCR)

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.

Clinical Information

Borrelia miyamotoi is a spirochetal bacterium. It is closely related to the Borrelia species that cause tick-borne relapsing fever (TBRF) and is more distantly related to the Borrelia species that cause Lyme disease. This organism causes a febrile illness like TBRF, with body and join pain, fatigue, and, rarely, rash, and has been detected in Ixodes scapularis and Ixodes pacificus ticks. These ticks are also the vectors for Lyme disease, anaplasmosis, and babesiosis.

 

The preferred method for detecting B miyamotoi is real-time polymerase chain reaction. Less sensitive and specific methods for detecting B miyamotoi and agents of TBRF include identification of spirochetes in peripheral blood films, cerebrospinal fluid preparations, and serologic testing. This assay does not detect the Borrelia species that cause Lyme disease.

Reference Values

Negative

Interpretation

A positive result indicates the presence of Borrelia miyamotoi DNA and is consistent with active or recent infection. While positive results are highly specific indicators of disease, they should be correlated with symptoms and clinical findings of tick-borne relapsing fever.

Cautions

Inadequate specimen collection or improper storage may invalidate test results.

 

Borrelia miyamotoi DNA may be detectable for an unknown period of time after adequate treatment.

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.

Method Description

The assay is performed on the Roche LightCycler (LC) 2.0 instrument, following DNA extraction on the Roche MagNA Pure. The LC 2.0 instrument amplifies and monitors the development of target nucleic acid (amplicon) after each polymerase chain reaction (PCR) cycle.

 

The DNA target for this PCR assay is a gene encoding the glycerophosphodiester phosphodiesterase (glpQ) gene specific to Borrelia species in the relapsing fever group. This gene is not found in Borrelia species that cause Lyme disease.

 

The specific base pair DNA target sequence is amplified by PCR. The detection of amplicon is based on fluorescence resonance energy transfer (FRET), which utilizes 1 hybridization probe with a donor fluorophore, fluorescein, at the 3' end, and a second hybridization probe with an acceptor fluorophore, LC-Red 640, at the 5' end. When the target amplicon is present, the LC-Red 640 emits a measurable and quantifiable light signal at a specific wavelength. Presence of the specific organism nucleic acid is confirmed by performing a melting temperature analysis of the amplicon; the presence or absence of a melting peak in the appropriate temperature range is used to determine if a specimen is positive or negative.(Unpublished Mayo method)

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

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

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