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Borrelia burgdorferi IgG, IgM - diasorin.com Disease Borrelia burgdorferi IgG, IgM The diagnosis of Lyme borreliosis is based on clinical manifestations and history of exposure to

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Text of Borrelia burgdorferi IgG, IgM - diasorin.com Disease Borrelia burgdorferi IgG, IgM The diagnosis of...

  • Infectious Disease

    Borrelia burgdorferi IgG, IgMFully automated chemiluminescence assaysfor quantitative determination of Borrelia antibodiesin serum and CSF

    FOR OUTSIDE THE US AND CANADA ONLY

  • Infectious Disease

    Borrelia burgdorferi IgG, IgM

    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:

    earlystageofinfectionmaynotshowameasurableimmune response

    IgMantibodiesmaypersistformonths

    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.

    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, VIsEforIgGassay,OspCandVlsEforIgMassay,haveimproved the diagnostic sensitivity in all stages of Lyme infection.

    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.

    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.

    Searching for diagnostic clarity:LIAISON Borrelia serology line

    Unique selection of raw materials

    70-90%

    80-100%

    0

    10

    20

    30

    40

    50

    60

    70

    80

    90

    100

    Days/weeks

    Stage I Stage II

    CSF

    20-50%

    Months/years

    90-100%

    Weeks/months

    Stage III

    Resp

    onde

    rs (%

    )

    Time after tick-bite

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

  • Clinical condition Numberof 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

    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 BorreliaIgMQuantandLIAISON Borrelia IgG are the first fully automatedassaysforquantitativemeasurementofspecificIgMand 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 testingserum specimens from subjects living in an endemic areaand 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%)

    LIAISON Borrelia IgM Quant and BorreliaIgG: serum and CSF quantitative detection

    Assay format ensures reliable results

    Table 1

    Flexibility enables quick results

    Number of tests 100

    Assays format: quantitative assays

    Borrelia IgG: 0-240 AU/mL

    Borrelia IgM Quant: 0-190 AU/mL

    Tiny sample volume

    Borrelia IgGSerumCSF

    5 L50 L

    Borrelia IgM QuantSerumCSF

    10 L50 L

    Specimen dilutions

    Borrelia IgGSerumCSF

    1:501:5

    Borrelia IgM QuantSerumCSF

    1:1471:2.6

  • Infectious Disease

    Diasorin S.p.A.Via Crescentino

    13040 Saluggia (VC) - ItalyTel. +39 0161.487526Fax: +39 0161.487670

    www.diasorin.comE-mail: [email protected]

    M08

    7000

    4177

    /C 1

    2224

    061

    2

    AVAILABLE ON SYSTEMS

    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.

  • Infectious Disease

    Borrelia burgdorferi IgG, IgMFully automated chemiluminescence assaysfor an accurate detection of IgG and IgM antibodiesto Borrelia Burgdorferi

    FOR OUTSIDE THE US AND CANADA ONLY

  • Infectious Disease

    Borrelia burgdorferi IgG, IgM

    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 importantfor differential diagnosis since additional factors complicate serological findings:

    earlystageofinfectionmaynotshowameasurableimmune response

    IgMantibodiesmaypersistformonths

    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.

    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,OspCandVlsEforIgMassay,hasimprovedthediagnosticsensitivity in all stages of Lyme infection.

    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.

    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.

    Searching for diagnostic clarity:LIAISON Borrelia serology line

    Unique selection of raw materials

    00

    10

    20

    30

    60

    80

    90

    100

    40

    50

    70

    Days/weeks

    Time after tick-bite

    Weeks/months Months/years

    Res

    po

    nd

    ers

    (%)

    Stage I

    70-90%

    Stage II

    90-100%

    Stage III

    20-50%

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

  • All guidelines for microbiological diagnosis of Lyme borreliosis reccomend a two-test approach using a sensitive assay, differentiatingIgMandIgG,followedbyaconfirmatoryassay.LIAISON Borrelia IgG and LIAISONBorreliaIgMIIarethefirstfully automated assays for measurement of specific IgM andIgG antibodies. The combined result, obtained with LIAISON BorreliaIgMIIandLIAISON Borrelia IgG, reppresents an highly sensitive and specific screening tool for Lyme disease.

    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 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%)

    Assay format ensures reliable results

    Flexibility enables quick results

    Number of tests 100

    Assays format

    Borrelia IgG: quantitative assay 0-240 AU/mL

    Borrelia IgM II: qualitative assay 0-6 Index

    Tiny sample volume

    Borrelia IgGSerumCSF

    5 L50 L

    Borrelia IgM II Serum 10 L

    Specimen dilutions

    Borrelia IgGSerumCSF

    1:501:5

    Borrelia IgM II Serum 1:147

    Table 1

    Clinical condition Numberof 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

  • Diasorin S.p.A.Via Crescentino

    13040 Saluggia (VC) - ItalyTel. +39 0161.487526Fax: +39 0161.487670

    www.diasorin.comE-mail: [email protected]

    M08

    7000

    4179

    /B 1

    2226

    061

    2

    AVAILABLE ON SYSTEMS

    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.