Test Catalog

Test ID: LYME    
Lyme Disease Serology, Serum

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

Diagnosis of Lyme disease

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

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

 

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 (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), B afzelii, and B 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 I 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 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

Reference values apply to all ages.

Interpretation Provides information to assist in interpretation of the test results

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 sample 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.

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

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.

 

Patients infected with other members of the B burgdorferi sensu lato complex, including B garinii, B afzelii, and B 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.

 

Lyme serology 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.

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

1. Theel ES: The Past, Present and (Possible) Future of Serologic Testing for Lyme Disease. J Clin Microbiol 2016;54(5):1191-1196

2. Dattwyler RJ: Lyme borreliosis: an overview of clinical manifestations. Lab Med 1990;21:290-292

3. Schwan TG, Burgdorfer W, Rosa PA: Borrelia. In Manual of Clinical Microbiology. Seventh edition. Edited by PR Murray. Washington, DC, ASM Press, 1999, pp 746-758

4. 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