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