Any antigen-specific antibody in the sample will bind to the immobilized antigen. Diluted test sera are incubated in antigen coated microwells. The Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system is designed to detect IgG- and IgM-class antibodies (not differentiated by the assay in the final result) in human sera to VlsE1 and pepC10 antigens. The first-tier Lyme disease screening enzyme-linked immunosorbent assay (ELISA) is the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system. Instead, monitoring resolution of symptoms in response to treatment is recommended. Lyme serology should not be used for treatment monitoring as IgG can remain for years post-resolution of infection. This test will not distinguish results that are both IgG and IgM positive from results that are either IgG or IgM positive. Testing should only be performed when clinical evidence suggests the diagnosis of Borrelia infection or related etiological conditions observed by the physician.
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. This test should not be performed as a screening procedure for the general population. 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. 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, the Association of State and Territorial Public Health Laboratory and directors (CDC/ASTPHLD) recommendations. It is possible that other disease conditions may produce artifactual reactivity in the assay (eg, infectious mononucleosis, syphilis). 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.Ī positive result is not definitive evidence of infection with B burgdorferi. Patients in the early stages of Lyme disease and those who have been treated with antibiotics may not exhibit detectable antibody titers. 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.Ī negative result does not exclude the possibility of infection with Borrelia burgdorferi. 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. Patients with late LD often present with intermittent or persistent arthralgia, most often associated with B burgdorferi infection, or with acrodermatitis chronica atrophicans, typically due to infection with B afzelii.ĭiagnosis of LD is currently based on a 2-tiered serologic testing algorithm, as recommended by the Centers for Disease Control and Prevention, and involves an initial screening assay for detection of antibodies to LD-causing Borrelia species. 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.
#SEROLOGICAL TESTING CHART 4 WESTERN BLOT RESULTS SKIN#
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). Transmission of LD-associated Borrelia requires at least 36 hours of tick attachment. 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). These tick-borne spirochetes are transmitted to humans through the bite of Ixodes species ticks. Among these species, B burgdorferi is the most frequent cause of LD in North America. 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.
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