Borrelia Burgdorferi Igg, Igm Fully Automated Chemiluminescence Assays for an Accurate Detection of Igg and Igm Antibodies to Borrelia Burgdorferi

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: Unique selection of raw materials LIAISON® Borrelia serology line

The diagnosis of Lyme borreliosis is based on clinical The LIAISON® Borrelia assays are based on recombinant proteins manifestations and history of exposure to ticks in an endemic that allow reduction of cross-reactivity problems providing area. Clinical manifestation of Lyme borreliosis may be similar higher specificity in comparison with whole-cell lysate assays. to that of other diseases, and serological detection of Borrelia The use of immunodominant Borrelia antigens, VIsE for IgG antibodies represents a fundamental aid to diagnosis (Fig.1). 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 • LIAISON® Borrelia IgG features the antigen VlsE, an serological findings: outer surface lipoprotein playing a major role in the immune response to Lyme disease and leading to decisive • early stage of infection may not show a measurable immune increase of sensitivity in neuroborreliosis (NB). The response VlsE antigen is poorly represented in whole-cell lysate obtained from in vitro cultured B. burgdorferi. • IgM antibodies may persist for months • LIAISON® Borrelia IgM II uses two recombinant antigens: • cross-reaction with other spirochaete proteins, or other OspC, an outer surface protein highly specific for infectious diseases or autoimmune disorders may cause IgM detection in the early phase of infection, and the false positive antibody response VlsE protein. This antigen combination guarantees an higher diagnostic sensitivity, making this assay a A substantial progress in solving diagnostic ambiguities, has suitable diagnostic tool for laboratory diagnosis during been achieved with the LIAISON® Borrelia line. the early stages of Lyme disease.

IgG and/or IgM antibody prevalence in serum Fig. 1

100 90-100% 90 70-90% 80

50 20-50% 40 Responders (% ) 30

20 Stage I Stage II Stage III

0 0 Days/weeks Weeks/months Months/years Time after tick-bite Table 1 Number IgG IgM IgG and/or IgM Clinical condition of samples % positive % positive % 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 The diagnostic specificity was determined by testing serum reccomend a two-test approach using a sensitive assay, specimens from subjects living in an endemic area and without differentiating IgM and IgG, followed by a confirmatory assay. history of tick contact or Lyme disease: LIAISON® Borrelia IgG and LIAISON® Borrelia IgM II are the first fully automated assays for measurement of specific IgM and LIAISON® Borrelia IgM II (88 samples) IgG antibodies. The combined result, obtained with LIAISON® Diagnostic specificity 100% (95% CI: 95.9-100%) Borrelia IgM II and LIAISON® Borrelia IgG, reppresents an highly sensitive and specific screening tool for Lyme disease. 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

Serum 5 μL Borrelia IgG CSF 50 μL Tiny sample volume Borrelia IgM II Serum 30 μL

Serum 1:50 Borrelia IgG CSF 1:5 Specimen dilutions Borrelia IgM II Serum 1:147 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

Product availability subject to required regulatory approval. M0870004179/C 04/20

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 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: Unique selection of raw materials LIAISON® Borrelia serology line

The diagnosis of Lyme borreliosis is based on clinical The LIAISON® Borrelia assays are based on recombinant manifestations and history of exposure to ticks in an endemic proteins that allow reduction of cross-reactivity problems area. providing higher specificity in comparison with whole-cell Clinical manifestation of Lyme borreliosis may be similar to lysate assays. The use of immunodominant Borrelia antigens, that of other diseases, and serological detection of Borrelia VIsE for IgG assay, OspC and VlsE for IgM assay, have improved antibodies represents a fundamental aid to diagnosis (Fig.1). the diagnostic sensitivity in all stages of Lyme infection. Tests with high diagnostic accuracy are particularly important for differential diagnosis since additional factors complicate • LIAISON® Borrelia IgG features the antigen VlsE, an outer serological findings: surface lipoprotein playing a major role in the immune response to Lyme disease and leading to decisive increase of • early stage of infection may not show a measurable immune sensitivity in neuroborreliosis (NB). response The VlsE antigen is poorly represented in whole-cell lysate obtained from in vitro cultured B. burgdorferi. • IgM antibodies may persist for months • LIAISON® Borrelia IgM Quant uses two recombinant • cross-reaction with other spirochaete proteins, or other antigens: OspC, an outer surface protein highly specific for infectious diseases or autoimmune disorders may cause IgM detection in the early phase of infection and false positive antibody response VlsE protein. This antigen combination guarantees an higher diagnostic sensitivity, making this assay the most A substantial progress in solving diagnostic ambiguities, has suitable diagnostic tool for laboratory diagnosis during the been achieved with the LIAISON® Borrelia line. early stages of Lyme disease and especially in neuroborreliosis.

IgG and/or IgM antibody prevalence in serum or CSF Fig. 1

100 80-100% 90-100% 90 CSF 70-90% 80

Responders (%) 20-50% 40

30 Stage I Stage II Stage III 20

0 Days/weeks Weeks/months Months/years Time after tick-bite Table 1 Number IgG IgM IgG and/or IgM Clinical condition of samples % positive % positive % 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 Assay format ensures reliable results IgG: serum and CSF quantitative detection

Neuroborreliosis is a serious inflammatory disease of the The diagnostic sensitivity was determined in a clinical study peripheral and central nervous system. performed at the German National Reference Center for The diagnosis of neuroborreliosis is a clinical decision which Borreliae by testing 141 serum specimens from patients with should be supported by laboratory data. The first step would clinically characterized Lyme borreliosis (Table1). be testing for specific antibodies in serum and investigation of the CSF. The detection of B. burgdorferi specific antibodies in The diagnostic specificity was determined by testing CSF is suggestive of intrathecally- synthesized antibodies when serum specimens from subjects living in an endemic area evaluated in association with other laboratory findings. LIAISON® and without history of tick contact or Lyme disease: Borrelia IgM Quant and LIAISON® Borrelia IgG are the first fully automated assays for quantitative measurement of specific IgM LIAISON® Borrelia IgM Quant (88 samples) and IgG antibodies in serum and in CSF. LIAISON® Borrelia assays Diagnostic specificity 96.6% (95% CI: 90.4-99.3%) permit the test of serum and CSF in the same assay run, with the same reagent cartridge using two different specimen dilutions LIAISON® Borrelia IgG (100 samples) performed by the instrument. 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

Serum 5 μL Borrelia IgG CSF 50 μL Tiny sample volume Serum 30 μL Borrelia IgM Quant CSF 50 μL Serum 1:50 Borrelia IgG CSF 1:5 Specimen dilutions Serum 1:147 Borrelia IgM Quant CSF 1:2.6 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

Product availability subject to required regulatory approval. M0870004177/D 04/20

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]