Cautions

A negative result does not exclude the possibility of infection with Lyme disease causing Borrelia species. 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 if the initial test result is negative.

A positive result is not definitive evidence of infection with Borrelia burgdorferi. It is possible that other disease conditions may produce artifactual reactivity in the assay (eg, infectious mononucleosis, syphilis). All samples with equivocal or positive results should be tested using a second-tier method, including either immunoblot testing or enzyme immunoassay (EIA) methods 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 specific population. Testing should only be performed when clinical evidence suggests the diagnosis of Borrelia infection or related etiological conditions observed by the healthcare professional.

Lyme serology should not be used for treatment monitoring as IgG can remain for years post-resolution of infection. Instead, monitoring resolution of symptoms in response to treatment is recommended.

Specimens with abnormal IgG and rheumatoid factor (RF) antibody concentrations may interfere with this assay.

Interpret test results of specimens from immunosuppressed patients with caution.

Performance characteristics of the device have not been established for matrices other than serum or with specimens containing heterophile antibodies (known to cause false positive immunoassay results).

False-positive results may occur in patients with syphilis infection (current or past) or infectious mononucleosis.

False-negative results may occur in patients tested too soon following infection, in immunosuppressed patients or in patients treated for Lyme disease immediately following exposure/infection.

Specimens known to contain potentially cross-reactive antibodies to B burgdorferi due to infections with tick-borne relapsing fever, rickettsial diseases, ehrlichiosis, babesiosis and leptospirosis have not been tested. The performance of this device is unknown if there are any cross-reactive antibodies present.

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

The MTTT study was conducted using the Anti-Borrelia VlsE1/pepC10 IgG/IgM as the first-tier assay and the Anti-B burgdorferi IgG/IgM Test System; the Anti-B burgdorferi IgM Test System; or the Anti-B burgdorferi IgG Test System as the second-tier assay with testing performed in that order. The performance characteristics of the device have not been established for the alternate order of testing or for the use of other enzyme immunoassay (EIA) assays in the MTTT (2-EIA) procedure.

Hemolytic, icteric, or lipemic samples and specimens with abnormal IgG and RF antibody concentrations may interfere with the outcome of this assay. Avoid the use of these types of specimens.