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Test Code BMIPB Borrelia miyamotoi Detection, PCR, Blood


Ordering Guidance


This assay does not detect the Borrelia species that cause Lyme disease. If Lyme disease is suspected, order SLYME / Lyme Antibody Modified 2-Tier with Reflex, Serum.



Specimen Required


Container/Tube:

Preferred: Lavender top (EDTA)

Acceptable: Royal blue top (EDTA), pink top (EDTA), or sterile vial containing EDTA-derived aliquot

Specimen Volume: 1 mL

Collection Instructions: Send whole blood specimen in original tube (preferred).


Useful For

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

 

Preferred method for detection of B miyamotoi using blood specimens

Testing Algorithm

For information see Acute Tickborne Disease Testing Algorithm.

Reporting Name

Borrelia miyamotoi Detection, PCR, B

Specimen Type

Whole Blood EDTA

Specimen Minimum Volume

0.3 mL

Specimen Stability Information

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

Reject Due To

Gross hemolysis OK
Gross lipemia Reject

Reference Values

Negative

Reference values apply to all ages.

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) were tested using the Borrelia miyamotoi PCR assay. Results were compared to the Minnesota Department of Health 16S rRNA 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%. The samples were extracted and tested in a blinded fashion.

 

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 and intra-assay precision were 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 tickborne 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 Sunday

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
BMIPB Borrelia miyamotoi Detection, PCR, B 82475-5

 

Result ID Test Result Name Result LOINC Value
618298 B. miyamotoi PCR, B 82475-5

Forms

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