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:

• early stage of infection may not show a measurable immune response

• 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.

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.

• 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, 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 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 μL50 μL

Borrelia IgM II Serum 30 μL

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: info@diasorin.it

M08

7000

4179

/C 0

4/20

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.

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:

• early stage of infection may not show a measurable immune response

• 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.

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.

• 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® 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 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 μL50 μL

Borrelia IgM QuantSerumCSF

30 μL50 μL

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: info@diasorin.it

M08

7000

4177

/D 0

4/20

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.