Test Catalog

Test Id : PBORB

Lyme Disease, Molecular Detection, PCR, Blood

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

Supporting the diagnosis of Lyme disease in conjunction with serologic testing

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)/DNA Probe Hybridization

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

Lyme Disease PCR, B

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

Borrelia burgdorferi by PCR

Lyme Disease (PCR)

PCR

Tick-Borne Diseases

Spirochetes

Borrelia burgdorferi

Lyme Disease

Sensu lato genogroup

Borrelia garinii

Borrelia afzelii

Borrelia mayonii

Borrelia burgdorferi sensu lato genogroup

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

Whole Blood EDTA

Ordering Guidance

This assay does not detect Borrelia miyamotoi. If infection with this organism is suspected, order BMIYB / Borrelia miyamotoi Detection PCR, Blood or BMIYC / Borrelia miyamotoi Detection PCR, Spinal Fluid.

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

Container/Tube: Lavender top (EDTA)

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 a 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

Gross hemolysis OK

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
Whole Blood EDTA Refrigerated (preferred) 7 days
Frozen 7 days

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

Supporting the diagnosis of Lyme disease in conjunction with serologic testing

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

Lyme disease is a multisystem and multistage tick-transmitted infection caused by spirochetal bacteria in the Borrelia burgdorferi sensu lato (Bbsl) complex.(1) Nearly all human infections are caused by 3 Bbsl species; B burgdorferi sensu stricto (hereafter referred to as B burgdorferi) is the primary cause of Lyme disease in North America, while B afzelii and B garinii are the primary causes of Lyme disease in Europe. In 2012, B mayonii was identified as a less common cause of Lyme disease in the upper Midwestern United States.(2,3) This organism has only been detected in patients with exposure to ticks in Minnesota and Wisconsin and has not been detected in over 10,000 specimens from patients in other states including regions of the northeast where Lyme disease is endemic.

 

Lyme disease is the most commonly reported tick-borne infection in Europe and North America, causing an estimated 300,000 cases in the United States each year, and 85,000 cases in Europe.(4,5) The clinical features of Lyme disease are broad and may be confused with various immune and inflammatory disorders. The classic presenting sign of early localized Lyme disease caused by B burgdorferi is erythema migrans (EM), which occurs in approximately 80% of individuals. Other early signs and symptoms include malaise, headache, fever, lymphadenopathy, and myalgia. Arthritis, neurological disease, and cardiac disease may be later stage manifestations. Erythema migrans has also been seen in patients with B mayonii infection, but diffuse rashes are more commonly reported.(2) The chronic skin condition, acrodermatitis chronicum atrophicans, is also associated with B afzelii infection.

 

The presence of EM in the appropriate clinical setting is considered diagnostic for Lyme disease and no confirmatory laboratory testing is needed. In the absence of a characteristic EM lesion, serologic testing is the diagnostic method of choice for Lyme disease.(6) However, serology may not be positive until 1 to 2 weeks after onset of symptoms, and may show decreased sensitivity for detection of infection with B mayonii. Therefore, detection of Bbsl DNA using PCR may be a useful adjunct to serologic testing for detection of acute disease. PCR has shown utility for detection of Borrelia DNA from skin biopsies of Lyme-associated rashes, and can also be used to detect Borrelia DNA from synovial fluid and synovium biopsies. Less commonly, Borrelia DNA can be detected in cerebrospinal fluid and blood.(7) In general, blood is not the preferred source for detection of Bbsl DNA by PCR, although it may have increased utility for detection of B mayonii, due to the higher levels of observed peripheral spirochetemia with this organism.(2) Lyme PCR should always be performed in conjunction with FDA-approved serologic tests, and results should be correlated with serologic and epidemiologic data and clinical presentation of the patient.(8) The Mayo Clinic Lyme PCR test detects and differentiates the main causes of Lyme disease in North America (B burgdorferi and B mayonii) and Europe (B afzelii and B garinii).(2,7)

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 DNA from Borrelia burgdorferi, B mayonii, B afzelii, or B garinii, the main agents of Lyme disease.

 

A negative result indicates the absence of detectable target DNA in the specimen. Due to the diagnostic sensitivity limitations of the PCR assay, a negative result does not preclude the presence of the organism or active Lyme disease.

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

Serologic tests are recommended for diagnosis of Lyme disease. PCR may play an adjunctive role, but may not detect Borrelia burgdorferi DNA from blood in cases of active or chronic disease. The presence of inhibitory substances may also cause a false-negative result. PCR test results should be used as an aid in diagnosis and not considered diagnostic by themselves. These results should be correlated with serologic and epidemiologic data and clinical presentation of the patient.

 

Concurrent infections with multiple tick-borne pathogens, including Ehrlichia muris eauclairensis, Anaplasma phagocytophilum, Babesia microti, and B miyamotoi (a relapsing-fever Borrelia) have been reported in the United States, and consideration should be given to testing for other pathogens if clinically indicated.

 

This assay detects most members of the B burgdorferi sensu lato complex, including B andersonii, B americana, and B bissettii, which have been rarely detected in humans. Detection of DNA from these organisms would be reported as an atypical result and prompt additional laboratory testing to further identify the DNA present. The sensitivity of this assay for detecting these organisms has not been determined.

 

This assay also detects some members of the B burgdorferi sensu lato (Bbsl) complex that are not considered to be human pathogens, but may be found in ticks and other animals. Therefore, this assay should not be used to test nonhuman specimens.

Supportive Data

The following validation data supports the use of this assay for clinical testing.

 

Analytical Sensitivity/Limit of Detection (LoD):

The lower LoD is approximately 300 to 1,000 genomic copies/mL in cerebrospinal fluid, tissue, blood, and synovial fluid.

 

Accuracy/Diagnostic Sensitivity and Specificity:

Spiking studies of whole organism in whole blood (spiked near the approximate limit of detection) showed 100% recovery.

 

Analytical Specificity:

No PCR signal was obtained from the extracts of 22 bacterial, viral, parasitic, and fungal isolates that can cause symptoms similar to Lyme disease including; Rickettsia rickettsii, R typhi, Ehrlichia canis, Babesia microti, Plasmodium falciparum, P vivax, Bartonella henselae, Bartonella quintana, Herpes simplex virus, and Toxoplasma gondii. Relapsing fever borreliae (including Borrelia miyamotoi) are also not detected with this assay.

 

Precision:

Interassay precision was 100% and intra-assay precision was 100%.

 

Reference Range:

The reference range for this assay is negative. This assay is only to be used for patients with a clinical history and symptoms consistent with Lyme, and must be interpreted in the context of serologic tests, which are the gold standard for diagnosis of Lyme disease. This test should not be used to screen asymptomatic patients.

 

Reportable Range:

This is a qualitative assay, and the results are reported as negative or positive for targeted Borrelia burgdorferi.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Stanek G, Wormser GP, Gray J, Strle F: Lyme borreliosis. Lancet 2012;379(9814):461-473

2. Pritt BS, Mead PS, Johnson, DK, et al: Identification of a novel pathogenic Borrelia species causing Lyme borreliosis with unusually high levels of spirochetemia: a descriptive study. Lancet Infect Dis 2016 May;16(5):556-564

3. Pritt BS, Respicio-Kingry LB, Sloan LM, et al: Borrelia mayonii sp. nov., a member of the Borrelia burgdorferi sensu lato complex, detected in patients and ticks in the upper midwestern United States. Int J Sys Evol Microbiol 2016;66(11):4878-4880

4. Hinckley AF, Connally NP, Meek JI, et al: Lyme disease testing by large commercial laboratories in the United States. Clin Infect Dis 2014;59(5):676-681

5. Lindgren E, Jaenson TGT: Lyme borreliosis in Europe: influences of climate and climate change, epidemiology, ecology and adaptation measures. Copenhagen, Denmark: World Health Organization; 2006

6. Centers for Disease Control and Prevention. Recommendations for test performance and interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease. MMWR Morb Mortal Wkly Rep 1995;44(31):590-591

7. Babady NE, Sloan LM, Vetter EA, et al: Percent positive rate of Lyme real-time polymerase chain reaction in blood, cerebrospinal fluid, synovial fluid, and tissue. Diagn Microbiol Infect Dis 2008;62(4):464-466

8. CDC: Recommendation for test performance and interpretation. From second national conference on serological diagnosis of lyme disease. MMWR Morb Mortal Wkly Rep 1996;45:481-484

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

Nucleic acid is extracted from clinical specimens using the automated MagNA Pure LC instrument system. The extract is then transferred wells of a 96-well plate for amplification. The LightCycler is an automated instrument that amplifies and monitors the development of target nucleic acid (amplicon) after each cycle of PCR. The DNA target for PCR assay is the 283-bp plasminogen-binding protein gene (OppA2), which is present at a frequency of 1 copy per organism in all 4 confirmed pathogenic species of the Borrelia burgdorferi sensu lato genogroup (B burgdorferi sensu stricto, B afzelii, B garinii, and B mayonii). A 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 610, at the 5' end. When the target amplicon is present, the LC-Red 610 emits a measurable and quantifiable light signal at a specific wavelength. Presence of the specific organism nucleic acid may be confirmed by performing a melting curve analysis of the amplicon. Using features of the melting curve analysis, the assay primers and specific hybridization probes are able to detect and differentiate B burgdorferi sensu stricto from B mayonii, B afzelii, and B garinii, although the melting curve analysis cannot differentiate between B afzelii and B garinii. Each assay run can be completed within 60 minutes.(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.

June through November: Monday through Saturday

December through May: Monday through Friday

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.

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 Regional Manager. 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.

87476

87798 x 2

87999 (if appropriate for government payers)

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
PBORB Lyme Disease PCR, B 90892-1
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.
56080 B. burgdorferi PCR, B 94247-4
38290 B. mayonii PCR, B 94248-2
38291 B. garinii/B. afzelii PCR, B 94249-0
38340 Lyme Disease PCR Comment 59464-8

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