Download EUROLINE Myositis-Profil 3 (IgG).

EUROLINE Myositis Profile 3 (IgG)
EUROIMMUN
Immunoblots
Autoantibody determination:
OJ
Control
SRP
PL-12
PM-Scl75
EUROASSAY:
flexible profiles of up to 7 antigens from:
ENA and related antigens: nRNP/Sm, Sm,
SS-A, Ro-52, SS-B, Scl-70, Jo-1, dsDNA,
histones, nucleosomes, CENP B,
PM-Scl, ribosomal P-proteins, AMA M2
liver antigens: LKM-1, LC-1, SLA/LP,
AMA M2, M4, M9
ANCA antigens: MPO, PR3
thyroid antigens: TG, TPO
Ku
MYO
Ro-52
EJ
PL-7
Jo-1
PM-Scl100
Mi-2
Indication: Test system for the in vitro determination of antibodies against myositis-associated
antigens in human serum or plasma for the diagnosis of the following diseases: dermato- and
polymyositis, idiophatic myositis, anti-synthetase syndrome, overlap syndrome.
Clinical significance: Myositis is an inflammatory disease of the skeletal musculature. Myositides may be hereditary or caused by infections, malfunctions of the immune system or by
toxins.
Polymyositis is a systemic inflammatory disease of the skeletal muscles of unknown aetiology
with perivascular lymphocytic infiltration. In cases of skin involvement the disease is known as
dermatomyositis. There are five different forms of polymyositis: a) primary idiopathic polymyositis (33% of cases), b) primary idiopathic dermatomyositis (33%), c) paraneoplastic dermatomyositis of the lungs, ovaries, mamma, gastrointestinal tract and in myeloproliferative diseases
(8%), d) infantile dermatomyositis and accompanying vasculitis (5% to 10%) and e) myositis
overlap syndrome in collagenoses (20%). Dermato-/polymyositis is often of paraneoplastic origin, particularly in elderly patients. Dermatomyositis symptoms can occur before the presence
of the tumour is even diagnostically detectable.
Clinical symptoms of polymyositis are muscle weakness, unspecific signs of inflammation,
arthralgia, possibly Reynaud’s syndrome, trouble with swallowing and involvement of inner
organs. In dermatomyositis skin symptoms appear as purple-coloured exanthema on the eye
lids, nose bridge and cheeks, periorbital oedema, local erythema and scaly eczema dermatitis.
Laboratory results show an increased level of muscle enzymes. The detection of myositis-associated autoantibodies with specific tests is essential in the diagnosis of dermato-/polymyositis,
in controlling the course of the disease and in therapy management. Although the mortality
rate is increased by a factor of 4 – with heart and lung diseases being the primary cause of
death – half of patients recover fully, although a slight weakness of the muscles may remain.
In 30% of cases the disease can be stopped. Around 20% of patients experience deterioration
despite therapeutic measures.
EUROLINE:
ANA Profile 1: nRNP/Sm, Sm, SS-A, Ro-52,
SS-B, Scl-70, Jo-1, CENP B, dsDNA,
nucleosomes, histones, ribosomal P-proteins
ANA Profile 3: nRNP/Sm, Sm, SS-A, Ro-52,
SS-B, Scl-70, PM-Scl, Jo-1, CENP B,
PCNA, dsDNA, nucleosomes, histones,
ribosomal P-proteins, AMA M2
ANA Profile 5: nRNP/Sm, Sm, RNP70, RNPA, RNPC,
SS-A, Ro-52, SS-B, Scl-70, PM-Scl, Jo-1, CENP B,
PCNA, dsDNS, nucleosomes, histones, ribosomal
P-proteins, AMA M2
Anti-ENA Profile 1: nRNP/Sm, Sm, SS-A, Ro-52,
SS-B, Scl-70, Jo-1
Systemic Sclerosis Profile: Scl-70, CENP A, CENP B,
RP11, RP155, Fibrillarin, NOR90, Th/To, PM-Scl100,
PM-Scl75, Ku, PDGFR, Ro-52
Myositis Profile 3: Mi-2, Ku, PM-Scl100, PM-Scl75,
SRP, Jo-1, PL-7, PL-12, OJ, EJ, Ro-52
Liver Profiles: AMA M2, 3E (BPO), Sp100, PML,
gp210, LKM-1, LC-1, SLA/LP, Ro-52
Neuronal Antigens Profile 2: amphiphysin, CV2.1**
PNMA2 (Ma-2/Ta), Ri, Yo, Hu
Anti-Ganglioside Profile 1: GM1, GD1b, GQ1b
Anti-Ganglioside Profile 2: GM1, GM2, GM3,
GD1a, GD1b, GT1b, GQ1b
ANCA Profiles: MPO, PR3, GBM
EUROLINE-WB:
neuronal antigens (+ recomb. Hu, Yo, Ri)
HEp-2 cell antigens (+ SS-A and Ro-52, CENP B)
Infectious serology:
EUROLINE:
Bordetella pertussis (IgA, IgG)
Borrelia-RN-AT (p18, p19, p20, p21, p58, OspC,
p39, p83, LBb, LBa, VlsE Bg, VlsE Bb, VlsE Ba)
EBV Profile (IgG, IgM, VCA gp125, VCA p19
and EBNA-1, p22, EA-D)
Hanta virus (IgG, IgM)
TORCH Profile* (T. gond., rubella, CMV, HSV-1, -2)
Westernblot:
Borrelia burgdorferi (IgG, IgM)
Borrelia afzelii (IgG, IgM)
Borrelia garinii (IgG, IgM)
Epstein-Barr virus (IgG, IgM)
Rubella virus (IgG)
Treponema pallidum (IgG, IgM)
Yersinia enterocol. virulence fact. (IgA, IgG)
EUROLINE-WB:
Anti-Borrelia (B. afzelii + rec. VlsE)
Anti-HSV (HSV-1 + HSV-2 gG2)
Helicobacter pylori (VacA, Cag A; IgA, IgG)
Treponema pallidum + cardiolipin
Allergology:
Antibodies against Mi-2 are highly specific for dermatomyositis. They can be found in 15% to
30% of dermatomyositis patients and in 8% to 12% of idiopathic myositis cases. Antibodies
against Ku have a prevalence of up to 10% in systemic lupus erythematosus (SLE). Anti-Ku antibodies are also detected in 5% to 25% of cases of polmyositis/scleroderma overlap syndrome.
Anti-Ku-antibody-positive patients have myositis, symptoms of scleroderma or SLE in around
40% of cases for each, and frequently also exhibit vascular manifestations. The antigens PMScl100 and PM-Scl75 also enable the identification of overlap syndrome. This disease manifests itself by a combination of polymyositis, dermatomyositis and systemic sclerosis symptoms. PM-Scl75 is the main antigen of the anti-PM-Scl immune response in diffuse systemic
sclerosis, although in overlap syndrome the majority of anti-PM/Scl antibodies are directed
against PM-Scl100. Since antibodies against PM-Scl75 and PM-Scl100 occur independently of
each other, both antibodies should be determined routinely. In this way maximal sensitivity
is attained: 19.8% for diffuse systemic sclerosis and 23.7% for overlap syndrome. Antibodies
against the signal recognition particle (SRP), which participates in protein biosynthesis, have
a prevalence of 4% to 5% in myositis patients. Antibodies directed against aminoacyl-tRNA
synthetases occur with differing prevalences (anti-Jo-1: 25% to 55 %, anti-PL-7: 3 % to 6 %,
anti-PL-12: up to 3 %, anti-EJ: 1 % , anti-OJ: 1 %) in myositis patients and are often associated
with other, simultaneously occurring autoimmune diseases (e.g. SLE, SSc or interstitial lung
fibrosis). Antibodies against Ro-52 are not associated with a specific disease, but are found in
autoimmune and infectious diseases with a prevalence of 5% to 81%.
EUROASSAY:
Food Profile (IgE)
Inhalation Profile (IgE)
Pediatric/Atopy Profile (IgE)
Insect Venom Profile (IgE)
EUROLINE:
Atopy Profile (IgE; also region-specific profiles)
Food Profile (IgE; also region-specific profiles)
Inhalation Profile (IgE; also region-specific profiles)
Paediatric Profile (IgE)
Pollen–Food Cross Reaction Profile (IgE)
Insect Venom Profile (IgE)
Software/Automation:
EUROLineScan
camera system EUROBlotCamera
scanner system EUROBlotScanner
incubation processor EUROBlotMaster
EUROIMMUN
Radioimmunoassays
Autoantibody determination:
thyroid peroxidase (TPO; IgG)
thyroglobulin (TG; IgG)
TSH receptor (IgG)
acetylcholine receptor (ACHR; IgG)
glutamic acid decarboxylase (GAD; IgG)
insulin (IAA; IgG)
P/Q calcium channel* (VGCC; IgG)
tyrosine phosphatase (IA2; IgG)
dsDNA (IgA/IgG/IgM)
Antigen determination:
Application of the EUROLINE Myositis Profile 3 (IgG): The isolated presence of autoantibodies
against individual myositis-specific antigens is characteristic for autoimmune myositides. Comprehensive studies in various centres in Europe have shown that the simultaneous investigation
of large profiles of various myositis-specific antibodies increases the serological hit rate to up
to 37%. For the first time, the EUROLINE Myositis Profile 3 (IgG) enables automated analysis of
11 different myositis-specific antibodies on one test strip.
thyroglobulin (TG)
Hormone determination:
free triiodothyronine (FT3)
free thyroxine (FT4)
thyrotropin (TSH)
calcitonin
* Currently not available as IVD in the EU.
** CV2 partial protein, which only contains the
N-terminally localised epitopes of the antigen.
Made in Germany
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
Test Characteristics
EUROLINE Myositis Profile 3 (IgG)
EUROIMMUN
Microplate ELISA
Autoantibody determination:
AMA M2-3E (IgG)
ANCA Profile (IgG)
ANA Screen (IgG)
ANA Screen 9 or 11 (IgG)
BP180-NC16A-4X (IgG)
BP230-CF (IgG)
C1q (IgG)
cardiolipin (IgA, IgG, IgM, IgAGM)
circulating immune complexes (CIC)
cyclic citrullinated peptide (CCP; IgG)
centromere protein B (IgG)
desmoglein 1 (IgG)
desmoglein 3 (IgG)
double-stranded DNA (dsDNA, nDNA; IgG)
dsDNA-NcX (IgG)
ENA Pool (IgG)
ENA PoolPlus (IgG)
ENA ProfilePlus 1 or 2 (IgG)
ENA SLE Profile 1 or 2 (IgG)
GAD
GAD/IA-2 Pool
glomerular basement membrane (GBM; IgG)
ß2-glycoprotein 1 (IgA, IgG, IgM, IgAGM)
histones (IgG)
IA-2
intrinsic factor (IgG)
Jo-1 (IgG)
liver cytosolic antigen type 1 (LC-1; IgG)
liver-kidney microsomes (LKM-1; IgG)
myeloperoxidase (MPO; IgG)
nRNP/Sm (IgG)
nucleosomes (IgG)
ovary (IgAGM, Ig typing)
parietal cells (PCA; IgG)
PM-Scl (PM-1; IgG)
phosphatidylserine (IgA, IgG, IgM, IgAGM)
PR3 hn-hr (IgG)
PR3 capture (IgG)
rheumatoid factor (IgA, IgG, IgM)
ribosomal P-proteins (IgG)
Sa (IgG)
Scl-70 (IgG)
single-stranded DNA (ssDNA; IgG)
SLA/LP (IgG)
Sm (IgG)
spermatozoa (IgAGM, Ig typing)
SS-A (Ro; IgG)
SS-B (La; IgG)
thyroglobulin (TG; IgG)
thyroid peroxidase (TPO; IgG)
tiss. transglutaminase (endomy.; IgA, IgG, IgAG)
TSH receptor (TBII; IgG)
TRAk Fast (IgG)
zona pellucida (IgAGM, Ig typing)
Latex agglutination tests:
spermatozoa
ovary
zona pellucida
Test principle: The EUROLINE is a qualitative in vitro immunoassay, in which membrane strips
printed with lines of purified, biochemically characterised antigens are used as solid phase.
Each antigen is coated onto a separate membrane fragment, enabling the production process
and thereby the efficiency of antibody detection to be optimised for each protein. Since antigen bands are located at defined positions, results can be evaluated visually without the need
for additional equipment. Correct performance of all test steps is confirmed by staining of the
control band.
Computer-based evaluation: The EUROLineScan programme from EUROIMMUN provides
automated evaluation of EUROLINE analyses
and detailed documentation of results. The incubated membrane strips are either scanned
onto a protocol sheet using a flatbed scanner
(EUROBlotScanner) or photographed directly
in the incubation tray using a camera system
(EUROBlotCamera). EUROLineScan recognises the position of the strips, even if they have
been laid inexactly. It then identifies the bands
and measures their intensity. The EUROLineScan programme facilitates data management
and eliminates the need to archive potentially
infectious material. A separate results sheet can be produced for each patient. Online connection to other programmes is possible, e.g. laboratory management systems (LIMS).
Prevalence and specificity:
153 Sera from myositis patients,
77 control sera
(University of Uppsala, Sweden)
Further autoimmune diagnostics:
gliadin (GAF-3X; IgA, IgG)
Saccharomyces cerevisiae (IgA, IgG)
Infectious serology:
Adenovirus (IgA, IgG, IgM)
Bordetella pertussis (IgA, IgG, IgM)
Bordetella FHA (IgA, IgG)
Borrelia (IgG, IgM)
Borrelia VlsE (IgG)
Brucella abortus (IgA, IgG, IgM)
Campylobacter jejuni (IgA, IgG)
Chlamydia pneumoniae (IgA, IgG, IgM)
Chlamydia trachomatis (IgA, IgG, IgM)
Cytomegalovirus (IgG, IgM)
Dengue virus (IgG, IgM)
Diphtheria toxoid (IgG)
Echinococcus granulosus (IgG)
Epstein-Barr virus capsid ag (IgA, IgG, IgM)
Epstein-Barr virus early ag (IgA, IgG, IgM)
Epstein-Barr virus nuclear ag, EBNA-1 (IgG)
Hanta virus "Eurasia" + "America" (IgG, IgM)
Helicobacter pylori (IgA, IgG)
Helicobacter pylori CagA (IgA, IgG)
HSV-1 (glycoprotein C1; IgA, IgG, IgM)
HSV-2 (glycoprotein G2; IgA, IgG, IgM)
HSV-1/2 Pool (IgA, IgG, IgM)
Influenza virus type A (IgA, IgG, IgM)
Influenza virus type B (IgA, IgG, IgM)
Influenza Pool (IgA, IgG, IgM)
Legionella pneumophila (IgA, IgG, IgM)
Measles virus (IgG, IgM)
Mumps virus (IgG, IgM)
Mycoplasma pneumoniae (IgA, IgG, IgM)
Parainfluenza virus Pool (IgA, IgG, IgM)
Parvovirus B19 (IgG, IgM)
RSV (IgA, IgG, IgM)
Rubella virus (IgG, IgM)
SARS-CoV (IgG)
TBE virus (IgG, IgM)
Tetanus toxoid (IgG)
Toxoplasma gondii (IgG, IgM)
Treponema pallidum (IgG, IgM)
Varicella zoster virus (IgG, IgM)
West Nile virus (IgG, IgM)
Yersinia enterocol. virulence fact. (IgA, IgG)
Allergology:
total IgE
Allercoat™ 6-ELISA (650 different
allergens and allergen mixtures)
Software EUROIMMUN Allercoat™
Software/Automation:
EUROLabOffice
EUROIMMUN Analyzer I + I2P
194 Sera from SLE patients, 131
sera from sclerodermia patients,
179 sera from polymyositis/dermatomyositis patients, 50 sera
from patients with rheumatoid
arthritis (EUROIMMUN Luebeck)
Antigen
Mi-2
Ku
PMScl100
Jo-1
PL-7
PL-12
SRP
Mi-2
Ku
PMScl100
Jo-1
PL-7 or
PL-12
SRP
EJ
OJ
PMScl75
Prevalence
3%
3%
7%
12 %
3%
0%
5%
4%
5%
4%
21 %
4%
4%
1%
1%
6%
Specificity
100 %
97 %
100 %
99 %
100 %
100 %
97 %
98 %
95 %
100 %
100 %
100 %
99 %
100 %
100 %
98 %
Technical data:
Antigens
Recombinant: Mi-2: Mi-2 protein; Ku: Ku protein; PM-Scl100: PM-Sclprotein (100 kDa); PM-Scl75: PM-Scl protein (75 kDa); SRP: SRP protein (54 kDa, signal recognition particle); PL-7: PL-7 protein (threonyl-tRNA synthetase); PL-12: PL-12 protein (alanyl-tRNA synthetase);
EJ: EJ protein (glycyl-tRNA synthetase); OJ: OJ protein (isoleucyl-tRNA
synthetase); Ro-52: Ro-52 protein (52 kDa).
Native: Jo-1: Jo-1 antigen (histidyl-tRNA synthetase) purified using affinity chromatography.
Sample dilution
Serum or plasma; 1:101 in sample buffer.
Test procedure
30 min / 30 min / 10 min. Room temperature.
Test kit format
16 membrane strips.
Serum proteins and tumour markers:
anti-p53
Saliva diagnostics:
alpha-amylase
cortisol
DHEA
sIgA
testosterone
208 Sera from myositis patients,
214 control sera
(University of Padua, Italy)
Kit includes all necessary reagents.
Automation
Compatible with all commercial blot processing systems, e.g. with the
EUROBlotMaster from EUROIMMUN.
Order number
DL 1530-1601-3 G
* Currently not available as IVD in the EU.
Made in Germany
Version: 10/10
DL_1530_D_UK_A03
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]