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LYMESO Lyme Disease Serology (LYME)

Lyme Disease Serology (LYME)
Test Code: LYMESO
Synonyms/Keywords

​Lyme C6 Peptide Assay
Borrelia burgdorferi
B. burgdorferi
Tick-borne
Tick
VlsE1/pepC10 Assay
Lymes

Useful For

Diagnosis of Lyme disease

This test should not be used as a screening procedure for the general population.

This test should not be used for treatment monitoring as IgG can remain for years postresolution of infection. Instead, monitoring resolution of symptoms in response to treatment is recommended.

Specimen Requirements
Fasting RequiredSpecimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
​Serum​Serum gel (SST)​Red Top Tube (RTT)​0.5 mL​0.4 mL
Collection Processing Instructions

​Centrifuge and aliquot serum into plastic vial.

Specimen Stability Information
Specimen TypeTemperatureTime
​Serum​Refrigerated (preferred)​10 days
​Frozen​30 days
Rejection Criteria
Gross hemolysisReject ​ ​
​Gross Lipemia
​Heat inactivated
Interference

​Patients infected with other members of the B burgdorferi sensu lato complex, including Borrelia garinii, Borrelia afzelii, and Borrelia mayonii will be detected by this assay; however, they cannot be differentiated.

This test should not be performed as a screening procedure for the general population. The predictive value of a positive or negative result depends on the prevalence of analyte (antibodies present to VlsE1 and pepC10 antigens) in a given population. Testing should only be performed when clinical evidence suggests the diagnosis of Borrelia infection or related etiological conditions observed by the physician.

This test will not distinguish results that are both IgG and IgM positive from results that are either IgG or IgM positive.

A negative result does not exclude the possibility of infection with Borrelia burgdorferi. Patients in the early stages of Lyme disease and those who have been treated with antibiotics may not exhibit detectable antibody titers. Patients with clinical history, signs, or symptoms suggestive of Lyme disease should be retested in 2 to 4 weeks in the event that the initial test result is negative.

A positive result is not definitive evidence of infection with B burgdorferi. It is possible that other disease conditions may produce artifactual reactivity in the assay (eg, infectious mononucleosis, syphilis). All equivocal or positive results should be supplemented immunoblot testing for IgM- and IgG-class antibodies in accordance with Centers for Disease Control and Prevention and the Association of State and Territorial Public Health Laboratory. Directors (CDC/ASTPHLD) recommendations.​

This test will not distinguish results that are both IgG and IgM positive from results that are either IgG or IgM positive.

Performing Laboratory Information
Performing LocationDay(s) Test PerformedAnalytical TimeMethodology/Instrumentation
​Mayo Clinic Laboratories​Monday -  Friday​1 day​Enzyme-Linked Immunosorbent Assay (ELISA)
Reference Lab
Test Information

​If Lyme disease serology is positive, then Lyme disease antibody confirmation (by Western blot) will be performed at an additional charge.

Lyme disease (LD) is caused by infection with a member of the Borrelia burgdorferi sensu lato complex, which includes B burgdorferi sensu stricto (herein referred to as B burgdorferi), Borrelia afzelii, and Borrelia garinii. Among these species, B burgdorferi is the most frequent cause of LD in North America. These tick-borne spirochetes are transmitted to humans through the bite of Ixodes species ticks. Endemic areas for Lyme disease in the United States correspond with the distribution of 2 tick species, Ixodes scapularis (Northeastern and upper Midwestern US) and Ixodes pacificus (West Coast US).

Transmission of LD-associated Borrelia requires at least 36 hours of tick attachment. Approximately 80% of infected individuals will develop a unique expanding skin lesion with a central zone of clearing, referred to as erythema migrans (EM; stage 1). In the absence of treatment, patients may progress to early disseminated disease (stage 2), which is characterized by neurologic manifestations (eg, meningitis, cranial neuropathy, radiculoneuropathy) and is often associated with B garinii infection. Patients with late LD often present with intermittent or persistent arthralgia, most often associated with B burgdorferi infection, or with acrodermatitis chronica atrophicans (ACA), typically due to infection with B afzelii.

Diagnosis of LD is currently based on a 2-tiered serologic testing algorithm, as recommended by the Centers for Disease Control and Prevention (CDC), and involves an initial screening assay for detection of antibodies to LD-causing Borrelia species. Samples that are screen positive or equivocal are subsequently reflexed for supplemental assessment using a B burgdorferi immunoblot for detection of IgM- and IgG-class antibodies to specific B burgdorferi antigens.  

Importantly, while serologic assessment for LD may be negative in the early weeks following infection, over 90% of patients with later stages of infection are seropositive by serology, which remains the diagnostic method of choice for this disease.

Reference Range Information
Reference Range

​Negative

Reference values apply to all ages.

No evidence of antibodies to Borrelia burgdorferi detected. False-negative results may occur in recently infected patients (< or =2 weeks) due to low or undetectable antibody levels to B burgdorferi. If recent exposure is suspected, a second specimen should be collected and tested in 2 to 4 weeks.

Equivocal:

Not diagnostic. Supplemental testing by immunoblot has been ordered by reflex.

Positive:

Not diagnostic. Supplemental testing by immunoblot has been ordered by reflex.

Interpretation

​Negative:

No evidence of antibodies to Borrelia burgdorferi detected. False-negative results may occur in recently infected patients (< or =2 weeks) due to low or undetectable antibody levels to B burgdorferi. If recent exposure is suspected, a second specimen should be collected and tested in 2 to 4 weeks.

Equivocal:

Not diagnostic. Supplemental testing by immunoblot has been ordered by reflex.

Positive:

Not diagnostic. Supplemental testing by immunoblot has been ordered by reflex.

Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
​86618​1
​86617​2(​for reflex test LYWB)​As needed
Synonyms/Keywords

​Lyme C6 Peptide Assay
Borrelia burgdorferi
B. burgdorferi
Tick-borne
Tick
VlsE1/pepC10 Assay
Lymes

Ordering Applications
Ordering ApplicationDescription
COM​​Lyme Disease Serology, Serum
​Portal​​Lyme Disease Serology, Serum
​Cerner​​Lyme Disease Serology, Serum SO 
​Centricity​​Lyme Disease Serology, Serum
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Fasting RequiredSpecimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
​Serum​Serum gel (SST)​Red Top Tube (RTT)​0.5 mL​0.4 mL
Collection Processing

​Centrifuge and aliquot serum into plastic vial.

Specimen Stability Information
Specimen TypeTemperatureTime
​Serum​Refrigerated (preferred)​10 days
​Frozen​30 days
Rejection Criteria
Gross hemolysisReject ​ ​
​Gross Lipemia
​Heat inactivated
Interference

​Patients infected with other members of the B burgdorferi sensu lato complex, including Borrelia garinii, Borrelia afzelii, and Borrelia mayonii will be detected by this assay; however, they cannot be differentiated.

This test should not be performed as a screening procedure for the general population. The predictive value of a positive or negative result depends on the prevalence of analyte (antibodies present to VlsE1 and pepC10 antigens) in a given population. Testing should only be performed when clinical evidence suggests the diagnosis of Borrelia infection or related etiological conditions observed by the physician.

This test will not distinguish results that are both IgG and IgM positive from results that are either IgG or IgM positive.

A negative result does not exclude the possibility of infection with Borrelia burgdorferi. Patients in the early stages of Lyme disease and those who have been treated with antibiotics may not exhibit detectable antibody titers. Patients with clinical history, signs, or symptoms suggestive of Lyme disease should be retested in 2 to 4 weeks in the event that the initial test result is negative.

A positive result is not definitive evidence of infection with B burgdorferi. It is possible that other disease conditions may produce artifactual reactivity in the assay (eg, infectious mononucleosis, syphilis). All equivocal or positive results should be supplemented immunoblot testing for IgM- and IgG-class antibodies in accordance with Centers for Disease Control and Prevention and the Association of State and Territorial Public Health Laboratory. Directors (CDC/ASTPHLD) recommendations.​

This test will not distinguish results that are both IgG and IgM positive from results that are either IgG or IgM positive.

Useful For

Diagnosis of Lyme disease

This test should not be used as a screening procedure for the general population.

This test should not be used for treatment monitoring as IgG can remain for years postresolution of infection. Instead, monitoring resolution of symptoms in response to treatment is recommended.

Reference Range Information
Reference Range

​Negative

Reference values apply to all ages.

No evidence of antibodies to Borrelia burgdorferi detected. False-negative results may occur in recently infected patients (< or =2 weeks) due to low or undetectable antibody levels to B burgdorferi. If recent exposure is suspected, a second specimen should be collected and tested in 2 to 4 weeks.

Equivocal:

Not diagnostic. Supplemental testing by immunoblot has been ordered by reflex.

Positive:

Not diagnostic. Supplemental testing by immunoblot has been ordered by reflex.

Interpretation

​Negative:

No evidence of antibodies to Borrelia burgdorferi detected. False-negative results may occur in recently infected patients (< or =2 weeks) due to low or undetectable antibody levels to B burgdorferi. If recent exposure is suspected, a second specimen should be collected and tested in 2 to 4 weeks.

Equivocal:

Not diagnostic. Supplemental testing by immunoblot has been ordered by reflex.

Positive:

Not diagnostic. Supplemental testing by immunoblot has been ordered by reflex.

For more information visit:
Performing Laboratory Information
Performing LocationDay(s) Test PerformedAnalytical TimeMethodology/Instrumentation
​Mayo Clinic Laboratories​Monday -  Friday​1 day​Enzyme-Linked Immunosorbent Assay (ELISA)
Reference Lab
For billing questions, see Contacts
Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
​86618​1
​86617​2(​for reflex test LYWB)​As needed
For most current information refer to the Marshfield Laboratory online reference manual.