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Test Code BMIYB Borrelia miyamotoi Detection PCR, Blood

Secondary ID

64970

Useful For

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

 

Preferred method for detection of B miyamotoi using blood specimens

Special Instructions

Method Name

Real-Time Polymerase Chain Reaction (PCR)

Reporting Name

Borrelia miyamotoi Detection PCR, B

Specimen Type

Whole Blood EDTA

Specimen Required


Specimen Required


Container/Tube: Lavender top (EDTA)

Specimen Volume: 1 mL


Specimen Minimum Volume

0.3 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Whole Blood EDTA Refrigerated 7 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject

Clinical Information

Borrelia miyamotoi is a spirochetal bacterium that is closely related to the Borrelia species that cause tick-borne relapsing fever (TBRF), and it 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 I pacificus ticks. These ticks are also the vectors for Lyme disease, anaplasmosis, and babesiosis.

 

The preferred method for detecting B miyamotoi is real-time PCR. Less sensitive and specific methods for detecting B miyamotoi and agents of TBRF include identification of spirochetes in peripheral blood films, spinal 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:

-62 clinical EDTA blood specimens received in the clinical laboratory for Ehrlichia/Anaplasma PCR were tested using the Borrelia miyamotoi PCR assay. Results were compared to the MDH 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 (LoD):

-The LoD is 2,800 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.

Clinical Reference

1. Gugliotta JL, Goethert HK, Berardi VP, Telford SR III: Meningoencephalitis from Borrelia miyamotoi in an Immunocompromised Patient. N Engl J Med 2013;368:240-245

2. Fomenko NV, Borgoyakov VY, Panov VV: Genetic Features of DNA of Borrelia miyamotoi Transmitted by Ixodes persulcatus. Mol Gen Microbiol Virol 2011;26:60-65

3. Platonov AE, Karan LS, Kolyasnikova NM, et al: Humans Infected with Relapsing Fever Spirochete Borrelia miyamotoi, Russia. Emerg Infect Dis 2011;17:1816-1823

Method Description

The assay is performed on the Roche LightCycler (LC) 480 instrument, following DNA extraction on the Roche MagNA Pure. The LC 480 instrument amplifies and monitors the development of target nucleic acid (amplicon) after each cycle of PCR.

 

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.(Cockerill FR, Uhl FR: Applications and challenges of real-time PCR for the clinical microbiology laboratory. In Rapid Cycle Real-Time PCR. Edited by U Reischl, C Wittwer, F Cockerill. Springer, NY, 2002)

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. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

87798

LOINC Code Information

Test ID Test Order Name Order LOINC Value
BMIYB Borrelia miyamotoi Detection PCR, B 82475-5

 

Result ID Test Result Name Result LOINC Value
64970 B. miyamotoi PCR, B 82475-5

NY State Approved

Yes

Forms

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

Testing Algorithm

See Acute Tick-Borne Disease Testing Algorithm in Special Instructions.