Test Catalog

Test Id : BMIYC

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Borrelia miyamotoi Detection PCR, Spinal Fluid

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Overview

Test Catalog

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

Highlights

This assay is intended as an aid in the diagnosis of Borrelia miyamotoi infection in conjunction with clinical findings.

 

The preferred method for detecting B miyamotoi is PCR.

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.

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

Method Name
A short description of the method used to perform the test

Real-Time Polymerase Chain Reaction (PCR)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Borrelia miyamotoi Detection PCR, C

Aliases
Lists additional common names for a test, as an aid in searching

Tick-Borne Relapsing Fever

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.

Specimen Type
Describes the specimen type validated for testing

CSF

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube: Sterile vial

Specimen Volume: 1 mL

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

Forms

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.3 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

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

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

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

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, cerebrospinal fluid (CSF) 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%.

 

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

Method Description
Describes how the test is performed and provides a method-specific reference

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 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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

1 week

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87478

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
BMIYC Borrelia miyamotoi Detection PCR, C 82476-3
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
64969 B. miyamotoi PCR, C 82476-3

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
Test Status - Test Delay 2022-08-05