For in vitro diagnostic use Catalog #:
DK-E601-096 (manual kit, 96 wells, CE marked)
DK-E601-096A (automated kit, 96 wells, CE marked)
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Overview Lyme disease can be difficult to diagnose. In the absence of a defining erythema migrans (EM) rash, the clinical symptoms for Borrelia infection are ill defined and ambiguous. In addition, the human antibody response to Borrelia infection develops slowly; this makes early detection challenging for antibody screening tests. Efficiency and reliability in a single Lyme screening test The C6 Lyme ELISA test is designed for both high sensitivity and high specificity:
These advantages make the use of the C6 Lyme ELISA test an efficient and reliable choice in Lyme disease screening. A reliable first step in Lyme disease screening
Traditional Lyme ELISA tests have been developed to be used in conjunction with a confirmatory test. Therefore, they seek to deliver higher sensitivity, at the expense of lower specificity. Many are based on Whole Cell Sonicates (WCS) and contain multiple antigens, leading to cross-reactivity and a higher number of false positives. These inaccurate or ambiguous results generate many unnecessary confirmatory tests, which are both costly and time-consuming.
In many areas, the standard protocol for Lyme disease testing calls for the use of the antiquated two-tier testing method, which has inherent limitations. It calls for an ELISA screen followed by a confirmatory western blot for all positive and indeterminate results. Seeking a more efficient process, leading Lyme disease scientists conducted a major study to determine whether the C6 Lyme ELISA test could replace the two-tier protocol. Their results showed that the C6 Lyme ELISA test delivered higher sensitivity than the two-tier system (75% vs. 51.5%), and the specificity was only marginally lower (98.9% vs. 99.5%).1 The advantage of the C6 peptide The unique aspect of the C6 Lyme ELISA Kit is its use of the C6 peptide, a 26-amino acid sequence within the Borrelia membrane protein VlsE. The use of the C6 peptide was pioneered by Immunetics® and was the first truly specific and sensitive marker for infection with the Borrelia burgdorferi spirochete. This peptide has been shown to represent the immunodominant portion of VlsE, containing substantially all of the antigenic reactivity of the whole protein. The C6 peptide sequence is highly antigenic, generating an immune response in nearly all human cases soon after infection, and is specific to Borrelia strains causing Lyme disease.2 This means that the C6 Lyme ELISA test can detect all of the major infectious European Borrelia species: B. afzelii, B. garinii, and B. burgdorferi.2 In addition, the C6 peptide sequence is not found in other infectious organisms, eliminating cross-reactivity at the source.1 The C6 Lyme ELISA test uses a synthetic version of the C6 peptide antigen. This precisely defined antigen makes possible a highly sensitive, specific and reproducible ELISA for infection with the Borrelia burgdorferi spirochete, and is one of the main reasons why the test has been used in dozens of peer-reviewed clinical studies around the world. Test usage The C6 Lyme ELISA test is intended for use in the presumptive detection of IgG and IgM antibodies to B. burgdorferi in patients with clinical history, and signs or symptoms consistent with B. burgdorferi infection. In many regions, positive or equivocal results should be supplemented by testing with a standardized western blot method. The diagnosis of Lyme disease must be made based on history, signs, symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative test results should not be used to exclude Lyme disease. Product Information Along with superior performance, the C6 Lyme ELISA test offers an easy-to-use protocol, with a rapid turnaround time of approximately one hour.
Immunetics is a trademark of Immunetics, Inc. a wholly-owned subsidiary of Oxford Immunotec USA Inc., which is a wholly-owned subsidiary of Oxford Immunotec Ltd. The C6 Lyme ELISA is a trademark of Oxford Immunotec Ltd.