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Infectious Disease Borrelia burgdorferi IgG, IgM Fully automated chemiluminescence assays for quantitative determination of Borrelia antibodies in serum and CSF FOR OUTSIDE THE US AND CANADA ONLY Infectious Disease Borrelia burgdorferi IgG, IgM Searching for diagnostic clarity: LIAISON® Borrelia serology line Unique selection of raw materials The diagnosis of Lyme borreliosis is based on clinical manifestations and history of exposure to ticks in an endemic area. Clinical manifestation of Lyme borreliosis may be similar to that of other diseases, and serological detection of Borrelia antibodies represents a fundamental aid to diagnosis (Fig.1). Tests with high diagnostic accuracy are particularly important for differential diagnosis since additional factors complicate serological findings: The LIAISON® Borrelia assays are based on recombinant proteins that allow reduction of cross-reactivity problems providing higher specificity in comparison with whole-cell lysate assays. The use of immunodominant Borrelia antigens, VIsE for IgG assay, OspC and VlsE for IgM assay, have improved the diagnostic sensitivity in all stages of Lyme infection. • early stage of infection may not show a measurable immune response • LIAISON® Borrelia IgG features the antigen VlsE, an outer surface lipoprotein playing a major role in the immune response to Lyme disease and leading to decisive increase of sensitivity in neuroborreliosis (NB). The VlsE antigen is poorly represented in whole-cell lysate obtained from in vitro cultured B. burgdorferi. • IgM antibodies may persist for months • cross-reaction with other spirochaete proteins, or other infectious diseases or autoimmune disorders may cause false positive antibody response A substantial progress in solving diagnostic ambiguities, has been achieved with the LIAISON® Borrelia line. • LIAISON® Borrelia IgM Quant uses two recombinant antigens: OspC, an outer surface protein highly specific for IgM detection in the early phase of infection and VlsE protein. This antigen combination guarantees an higher diagnostic sensitivity, making this assay the most suitable diagnostic tool for laboratory diagnosis during the early stages of Lyme disease and especially in neuroborreliosis. IgG and/or IgM antibody prevalence in serum or CSF Fig. 1 100 90 70-90% Responders (%) 80 80-100% CSF 90-100% 70 60 50 40 20-50% 30 20 Stage I Stage II Stage III Days/weeks Weeks/months Months/years 10 0 Time after tick-bite Table 1 Clinical condition Number of samples IgG % positive IgM % positive IgG and/or IgM % positive Erythema migrans 45 80.0 55.6 88.9 Neuroborreliosis 57 93.0 57.9 96.5 Arthritis 39 97.4 30.8 97.4 LIAISON® Borrelia IgM Quant and Borrelia IgG: serum and CSF quantitative detection Assay format ensures reliable results Neuroborreliosis is a serious inflammatory disease of the peripheral and central nervous system. The diagnosis of neuroborreliosis is a clinical decision which should be supported by laboratory data. The first step would be testing for specific antibodies in serum and investigation of the CSF. The detection of B. burgdorferi specific antibodies in CSF is suggestive of intrathecally- synthesized antibodies when evaluated in association with other laboratory findings. LIAISON® Borrelia IgM Quant and LIAISON® Borrelia IgG are the first fully automated assays for quantitative measurement of specific IgM and IgG antibodies in serum and in CSF. LIAISON® Borrelia assays permit the test of serum and CSF in the same assay run, with the same reagent cartridge using two different specimen dilutions performed by the instrument. The diagnostic sensitivity was determined in a clinical study performed at the German National Reference Center for Borreliae by testing 141 serum specimens from patients with clinically characterized Lyme borreliosis (Table1). The diagnostic specificity was determined by testing serum specimens from subjects living in an endemic area and without history of tick contact or Lyme disease: LIAISON® Borrelia IgM Quant (88 samples) Diagnostic specificity 96.6% (95% CI: 90.4-99.3%) LIAISON® Borrelia IgG (100 samples) Diagnostic specificity 98.0% (95% CI: 93.0-100%) Flexibility enables quick results Number of tests 100 Borrelia IgG: 0-240 AU/mL Assays format: quantitative assays Borrelia IgM Quant: 0-190 AU/mL Borrelia IgG Serum CSF 5 μL 50 μL Borrelia IgM Quant Serum CSF 10 μL 50 μL Borrelia IgG Serum CSF 1:50 1:5 Borrelia IgM Quant Serum CSF 1:147 1:2.6 Tiny sample volume Specimen dilutions Infectious Disease LIAISON® Borrelia serology line Ordering information LIAISON® Borrelia IgG cod. 310880 LIAISON® Borrelia IgM Quant cod. 310020 LIAISON® Control Borrelia IgG cod. 310881 LIAISON® Control Borrelia IgM Quant/Borellia IgM II cod. 310011 LIAISON® Control Borrelia IgG Liquor cod. 310882 LIAISON® Control Borrelia IgM Liquor cod. 310012 AVAILABLE ON SYSTEMS M0870004177/C 12224 0612 Product availability subject to required regulatory approval. Diasorin S.p.A. Via Crescentino 13040 Saluggia (VC) - Italy Tel. +39 0161.487526 Fax: +39 0161.487670 www.diasorin.com E-mail: [email protected] Infectious Disease Borrelia burgdorferi IgG, IgM Fully automated chemiluminescence assays for an accurate detection of IgG and IgM antibodies to Borrelia Burgdorferi FOR OUTSIDE THE US AND CANADA ONLY Infectious Disease Borrelia burgdorferi IgG, IgM Searching for diagnostic clarity: LIAISON® Borrelia serology line Unique selection of raw materials The diagnosis of Lyme borreliosis is based on clinical manifestations and history of exposure to ticks in an endemic area. Clinical manifestation of Lyme borreliosis may be similar to that of other diseases, and serological detection of Borrelia antibodies represents a fundamental aid to diagnosis (Fig.1). The LIAISON® Borrelia assays are based on recombinant proteins that allow reduction of cross-reactivity problems providing higher specificity in comparison with whole-cell lysate assays. The use of immunodominant Borrelia antigens, VIsE for IgG assay, OspC and VlsE for IgM assay, has improved the diagnostic sensitivity in all stages of Lyme infection. Tests with high diagnostic accuracy are particularly important for differential diagnosis since additional factors complicate serological findings: • early stage of infection may not show a measurable immune response • LIAISON® Borrelia IgG features the antigen VlsE, an outer surface lipoprotein playing a major role in the immune response to Lyme disease and leading to decisive increase of sensitivity in neuroborreliosis (NB). The VlsE antigen is poorly represented in whole-cell lysate obtained from in vitro cultured B. burgdorferi. • IgM antibodies may persist for months • cross-reaction with other spirochaete proteins, or other infectious diseases or autoimmune disorders may cause false positive antibody response A substantial progress in solving diagnostic ambiguities, has been achieved with the LIAISON® Borrelia line. • LIAISON® Borrelia IgM II uses two recombinant antigens: OspC, an outer surface protein highly specific for IgM detection in the early phase of infection, and the VlsE protein. This antigen combination guarantees an higher diagnostic sensitivity, making this assay a suitable diagnostic tool for laboratory diagnosis during the early stages of Lyme disease. IgG and/or IgM antibody prevalence in serum Fig. 1 100 90-100% 90 70-90% 80 Responders (%) 70 60 50 20-50% 40 30 20 Stage I Stage II Stage III Days/weeks Weeks/months Months/years 10 0 0 Time after tick-bite Table 1 Clinical condition Number of samples IgG % positive IgM % positive IgG and/or IgM % positive Erythema migrans 45 80.0 46.7 88.9 Neuroborreliosis 57 93.0 43.9 96.5 Arthritis 39 97.4 25.6 97.4 Assay format ensures reliable results All guidelines for microbiological diagnosis of Lyme borreliosis reccomend a two-test approach using a sensitive assay, differentiating IgM and IgG, followed by a confirmatory assay. LIAISON® Borrelia IgG and LIAISON® Borrelia IgM II are the first fully automated assays for measurement of specific IgM and IgG antibodies. The combined result, obtained with LIAISON® Borrelia IgM II and LIAISON® Borrelia IgG, reppresents an highly sensitive and specific screening tool for Lyme disease. The diagnostic specificity was determined by testing serum specimens from subjects living in an endemic area and without history of tick contact or Lyme disease: LIAISON® Borrelia IgM II (88 samples) Diagnostic specificity 100% (95% CI: 95.9-100%) LIAISON® Borrelia IgG (100 samples) Diagnostic specificity 98.0% (95% CI: 93.0-100%) The diagnostic sensitivity was determined in a clinical study performed at the German National Reference Center for Borreliae by testing 141 serum specimens from patients with clinically characterized Lyme borreliosis (Table1). Flexibility enables quick results Number of tests 100 Borrelia IgG: quantitative assay 0-240 AU/mL Assays format Borrelia IgM II: qualitative assay 0-6 Index Borrelia IgG Serum CSF 5 μL 50 μL Borrelia IgM II Serum 10 μL Borrelia IgG Serum CSF 1:50 1:5 Borrelia IgM II Serum 1:147 Tiny sample volume Specimen dilutions Infectious Disease LIAISON® Borrelia serology line Ordering information LIAISON® Borrelia IgG cod. 310880 LIAISON® Borrelia IgM II cod. 310010 LIAISON® Control Borrelia IgG cod. 310881 LIAISON® Control Borrelia IgM Quant/Borellia IgM II cod. 310011 LIAISON® Control Borrelia IgG Liquor cod. 310882 AVAILABLE ON SYSTEMS M0870004179/B 12226 0612 Product availability subject to required regulatory approval. Diasorin S.p.A. Via Crescentino 13040 Saluggia (VC) - Italy Tel. +39 0161.487526 Fax: +39 0161.487670 www.diasorin.com E-mail: [email protected]