Download Borrelia burgdorferi IgG, IgM

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]