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Test Catalog

Test ID: BMIYB    
Borrelia miyamotoi Detection PCR, Blood

Useful For Suggests clinical disorders or settings where the test may be helpful

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

 

Preferred method for detection of B miyamotoi using blood specimens

Testing Algorithm Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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 Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Interpretation Provides information to assist in interpretation of the test results

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 Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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 Recommendations for in-depth reading of a clinical nature

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

Special Instructions Library of PDFs including pertinent information and forms related to the test