EUROIMMUN
Medizinische
Labordiagnostika
AG
Test systems for the diagnosis of
emerging infectious diseases
Chikungunya
virus
Dengue virus
TBE virus
Yellow fever
virus
Hantavirus
Japanese
encephalitis virus
Crimean Congo
fever virus
Leishmania
MERS-CoV
Plasmodium
falciparum
Rift Valley fever
virus
Sandf y fever
virus
SARS-CoV
Schistosoma
mansoni
Sindbis virus
West Nile virus
Trypanosoma cruzi
Usutu virus
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Tel +49 451 58550 · Fax 5855591 · E-mail [email protected]
HI_0000_R_UK_F04, 10/2014
EUROIMMUN
Medizinische
Labordiagnostika
AG
Reliable diagnosis of dengue virus
infections in all disease stages
Detection of the viral protein NS1
Early marker for acute infections –
positive laboratory results already at the f rst symptoms!
Dengue Virus NS1 Antigen ELISA (Types 1-4)
“Without prior performance of an NS1 antigen test it is not possible to make a statement about an acute or very recent
infection.” INSTAND e.V., from the association’s comment on quality assessment scheme Dengue Virus No. 350, March 2014.
Serology
Identif cation of acute and past infections
Screening and investigation of cross reactions
Anti-Dengue Virus ELISA (IgA, IgG, IgM)
Anti-Dengue Virus IIFT (serotypes 1-4; IgG, IgM)
Anti-Flavivirus IIFT Mosaic (IgG, IgM)
Anti-DENV1 positive
1
3
Anti-TBE2 virus positive
Anti-YFV3 positive
Anti-WNV4 positive
Anti-JEV5 positive
DENV: dengue virus (mosaic of four BIOCHIPs: cells infected with serotypes 1, 2, 3 and 4); 2TBE virus: tick-borne encephalitis virus;
YFV: yellow fever virus, 4WNV: West Nile virus, 5JEV: Japanese encephalitis virus
EUROIMMUN AG · D-23560 Luebeck (Germany) · Seekamp 31 · Tel +49 451 58550 · Fax 5855591 · E-mail [email protected]
HI_266a_R_UK_A02, 09/2014
EUROIMMUN
Medizinische
Labordiagnostika
AG
Dengue Virus NS1 ELISA
EUROIMMUN
Microplate ELISA
Indications: Test system for in vitro determination of dengue virus NS1 in human serum or
plasma in the diagnosis of the following diseases: tick-borne encephalitis, meningoencephalitis,
meningitis, encephalitis, yellow fever, dengue fever (DF), dengue haemorrhagic fever DHF),
dengue shock syndrome (DSS).
Clinical signif cance: Dengue viruses belong to the family of flaviviruses. Further known examples are yellow fever, West Nile and TBE viruses. DF is the most common and fastest spreading
vector-transmitted virus infection in humans. There are four different dengue serotypes (DENV1
to DENV4). The vectors for these viruses are mosquitoes of the genus Aedes (A. aegypti,
A. albopictus). Reservoir hosts are monkeys and above all people. The main distribution areas
are Latin America, Central Africa, India, South East Asia and parts of the Pacific Islands. The
virus is also regularly brought into Europe. Around 4000 German people are infected each year.
Thus, DF is one of the most frequent viral infections in German holidaymakers.
Dengue virus infections can cause a wide spectrum of diseases. Classic DF is a self-limiting disease
of short duration, which proceeds with high fever of over 40 °C, severe head, muscle and joint
aches, exanthema and lymph node swelling. The symptoms usually last for 2 to 7 days. No specific
treatment in the form of antiviral drugs is so far available. Treatment focuses on the symptoms.
There is also no vaccine on the market.
First infections are usually mild. Following an infection, life-long immunity exists against the
respective serotype. Cross immunity against other serotypes is only partly present and is
transient. On second infection with another virus serotype the risk of a severe disease course
increases. DHF and/or DSS may develop. DHF manifests in varying intensities of haemorrhagic
symptomologies such as petachiae, melena, nose bleeds and skin bleeding. Possible complications are circulatory disorders up to shock. The lethality of DHF is on average 12 %.
Role of serological diagnostics: Since the symptoms of DF are often unspecific, it must be differentially diagnosed from other tropical diseases such as malaria, yellow fever, West Nile virus
infection and chikungunya fever. Detection of viral RNA or the virus itself is only possible during the viraemic phase in the initial 2 to 7 days of illness by means of RT-PCR or in vitro virus
cultivation. NS1 (nonstructural protein 1) is an important marker for the detection of an acute
dengue infection. NS1 is a highly conserved glycoprotein and can be detected in the serum of
infected patients at the onset of clinical symptoms in both primary and secondary infections.
The Dengue Virus NS1 ELISA is ideally suited for early detection of a dengue virus infection
even before the appearance of IgM and IgG antibodies. In contrast to RT-PCR, ELISA is technically simple to perform and comparatively inexpensive. The NS1 antigen can be detected in the
blood in the early stage of infection, and it can still be detected at a time point when RT-PCR
analysis of viral RNA is already negative. The occurence of a diagnostic gap is thus minimised.
Cross reactions with other flaviviruses must be taken into account.
Primary infection
Secondary infection
Symptoms
Symptoms
Virus
IgG
Titer
Virus
NS1
NS1
IgM
Beta-amyloid (1-40)
Beta-amyloid (1-42)
Total tau
CXCL13
Dengue virus NS1
IgM
0
10
20
30
40
50
0
10
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)
Cardiolipin (IgA, IgG, IgM, IgAGM)
Centromere protein B (IgG)
Circulating immune complexes (CIC)
Collagen type VII (IgG)
Cyclic citrullinated peptide (CCP; 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 Profile2 (IgG)
Envoplakin (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)
Parietal cells (PCA; IgG)
PM-Scl (PM-1; IgG)
Phosphatidylserine (IgA, IgG, IgM, IgAGM)
PLA2R (IgG)
PR3 hn-hr (IgG)
Rheumatoid factor (IgA, IgG, IgM)
Ribosomal P-proteins (IgG)
Scl-70 (IgG)
Single-stranded DNA (ssDNA; IgG)
SLA/LP (IgG)
Sm (IgG)
Spermatozoa (IgAGM)
SS-A (Ro; IgG)
SS-B (La; IgG)
Thyroglobulin (TG; IgG)
Thyroid peroxidase (TPO; IgG)
Tiss. transglutaminase (endomy.; IgA, IgG)
TSH receptor (TBII; IgG)
TRAk Fast (IgG)
Zona pellucida (IgAGM)
Further autoimmune diagnostics:
Gliadin (GAF-3X; IgA, IgG)
Saccharomyces cerevisiae (IgA, IgG)
Infectious serology:
Adenovirus (IgA, IgG, IgM)
Bordetella pertussis (IgM)
Bordetella pertussis toxin (IgA, IgG)
Bordetella FHA (IgA, IgG)
Bordetella pertactin (IgG)
Borrelia (IgG, IgM)
Borrelia VlsE (IgG)
Brucella abortus (IgA, IgG, IgM)
Campylobacter jejuni (IgA, IgG)
Chikungunya virus (IgG)
Chlamydia pneumoniae (IgA, IgG, IgM)
Chlamydia trachomatis (IgA, IgG, IgM)
Cytomegalovirus (IgG, IgM)
Dengue virus (IgA, IgG, IgM)
Diphtheria toxoid (IgG)
Enterovirus (IgA, IgG, IgM)
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)
Hepatitis E virus (IgG, IgM)
HSV-1 (glycoprotein C1; IgG, IgM)
HSV-2 (glycoprotein G2; 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)
Japanese encephalitis virus (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)
TBE virus (IgG, IgM)
Tetanus toxoid (IgG)
Toxoplasma gondii (IgG, IgM)
Treponema pallidum (IgG, IgM)
Usutu virus (IgG)
Varicella zoster virus (IgA, IgG, IgM)
West Nile virus (IgG, IgM)
Yersinia enterocolitica (IgA, IgG)
Allergology:
Total IgE
Allercoat™ 6-ELISA (700 different
allergens and allergen mixtures)
Software EUROIMMUN Allercoat™
Antigen detection:
20
30
40
50
Time [days]
Bone metabolism marker:
25-OH-Vitamin-D
Intact parathyroid hormone
Calcitonin
Saliva diagnostics:
Alpha amylase
Cortisol
sIgA
Testosterone
Software/Automation:
EUROLabOffice
EUROIMMUN Analyzer I + I-2P
EUROLabLiquidHandler
IF Sprinter
Sprinter XL
* Currently not available as IVD in the EU.
Made in Germany
EUROIMMUN AG · 23560 Luebeck · Seekamp 31 · Phone +49 45 1 58 550 · Fax 58 55591 · E-Mail [email protected] · www.euroimmun.de
EUROIMMUN
Medizinische
Labordiagnostika
AG
Test Characteristics
Dengue Virus NS1 ELISA
EUROIMMUN
Immunoblots
Autoantibody determination:
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
EUROLINE:
flexible profiles of up to 18 antigens from:
ENA and related antigens: nRNP/Sm, Sm,
RNP70, RNPA, RNPC, SS-A, Ro-52, SS-B, Scl-70,
PM-Scl, Jo-1, CENP B, PCNA, dsDNA, nucleosomes,
histones, ribosomal P-proteins, AMA M2, Mi-2, Ku
Systemic Sclerosis Profile: Scl-70, CENP A, CENP B,
RP11, RP155, fibrillarin, NOR90, Th/To, PM-Scl100,
PM-Scl75, Ku, PDGFR, Ro-52
Myositis Profiles: 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 Antigen Profiles: amphiphysin, CV2,
PNMA2 (Ma-2/Ta), Ri, Yo, Hu, recoverin, SOX1,
titin
Ganglioside Profiles: GM1, GM2, GM3,
GD1a, GD1b, GT1b, GQ1b
ANCA Profiles: MPO, PR3, GBM
EUROLINE-WB:
HEp-2 cell antigens (+ SS-A and Ro-52, CENP B)
Reproducibility: The reproducibility of the ELISA was investigated by determining the intra- and inter-assay coefficients
of variation using 3 sera. The intra-assay CVs are based on
20 measurements for each serum and the inter-assay CVs
on 3 measurements performed in 10 different test runs.
Reference range: The concentrations of dengue NS1 protein
were determined in a mixed panel1 from 511 persons using
the EUROIMMUN ELISA. At a cut-off of 10 RU/ml none of
the samples was positive for dengue virus NS1.
Correlation with Panbio ELISA: 413 precharacterised patient
samples were investigated with the EUROIMMUN Dengue
Virus NS1 ELISA. The specificity amounted to 98 % at a
sensitivity of 99 % (borderline sera excluded).
Westernblot:
Borrelia burgdorferi (IgG, IgM)
Borrelia afzelii (IgG, IgM)
Borrelia garinii (IgG, IgM)
Cytomegalovirus (IgG, IgM)*
Echinococcus granulosus (IgG)
Epstein-Barr virus (IgG, IgM)
Rubella virus (IgG)
Treponema pallidum (IgG, IgM)
Yersinia enterocolitica (IgA, IgG)
EUROLINE-WB:
Borrelia (IgG, IgM)
Chlamydia-trachomatis (IgA, IgG)
HSV-1/2 (IgG, IgM)
Helicobacter pylori (IgA, IgG)
Treponema pallidum + cardiolipin (IgG, IgM)
Allergology:
Quality assessment results: 19 clinically characterised samples2 were investigated with the EUROIMMUN Dengue Virus
NS1 ELISA. There was a 100% agreement between the results obtained and the target results.
Cross reactivity: The quality of the antibodies used ensures
high ELISA specificity. Sera from patients3 with acute or
past infections with various pathogens were investigated using the Dengue Virus NS1 ELISA. No cross reactions (CR)
were observed.
1
University of Luebeck; EUROIMMUN, Luebeck, Germany; 2 INSTAND e. V.: Society for
Promotion of Quality Assurance in the Medical Laboratories, Duesseldorf, Germany;
3
RKI, Berlin, Germany; Scantibodies Laboratory Inc, USA; EUROIMMUN, Luebeck, Germany.
Inter-assay
variation, n = 3 x 10
Mean
(RU/ml)
CV
(%)
1
9.5
3.1
12.3
9.6
2
28.8
3.2
34.2
10.6
3
36.7
2.8
42.8
7.9
Serum
Panel
Mean
(RU/ml)
CV
(%)
n
Prevalence
Blood donors
150
0 (0 %)
Children aged 0-10
88
0 (0 %)
Pregnant women
100
0 (0 %)
Other
173
0 (0 %)
Panbio
Dengue Virus NS1
ELISA
n = 413
pos. borderl. neg.
pos.
Infectious serology:
EUROLINE:
Bordetella pertussis (IgA, IgG)
Borrelia-RN-AT (IgG, IgM)
Borrelia-RN-AT-adv (IgM)
EBV Profile (IgG, IgM)
Hantavirus profiles (IgG, IgM)
Parvovirus B19 (IgG, IgM)
TORCH Profile* (IgG, IgM)
Intra-assay
variation, n = 20
EUROIMMUN
Dengue Virus boderl.
NS1 ELISA
neg.
76
2
0
0
8
1
1
0
325
Target result of
QA institute
n = 19
pos. borderl. neg.
EUROIMMUN
Dengue
Virus NS1
ELISA
pos.
8
0
borderl.
0
0
0
0
neg.
0
0
11
Parameter
n
CR
TBE
Yellow fever virus
Japanese encephalitis virus
West Nile virus (acute inf.)
Heterophile antibody pos.
HAMA positive
10
10
4
4
16
4
0%
0%
0%
0%
0%
0%
EUROASSAY:
Inhalation Profile (IgE)
Food Profile (IgE)
Pediatric/Atopy Profile (IgE)
Insect Venom Profile (IgE)
Technical Data:
EUROLINE:
Antibodies
Inhalation Profile (IgE; also region-specific profiles)
Food Profile (IgE; also region-specific profiles)
Atopy Profile (IgE; also region-specific profiles)
Paediatric Profile (IgE)
Pollen–Food Cross Reaction Profile (IgE)
Insect Venom Profile (IgE)
Molecular allergology (SPAC)
The microplate wells are coated with monoclonal mouse anti-dengue
virus NS1 antibodies. The antibodies are specific for dengue virus NS1
of serotypes 1, 2, 3 and 4.
Calibration
Quantitative, in relative units per milliliter (RU/ml).
Interpretation
EUROIMMUN recommends interpreting results as follows:
< 8 RU/ml:
negative
> 8 to < 11RU/ml:
borderline
> 11RU/ml:
positive
Sample dilution
Serum or plasma; 1 : 2 in sample buffer.
Reagents
Ready for use, with the exception of the wash buffer (10x). Colour-coded
solutions, in most cases exchangeable with those in other EUROIMMUN
ELISA.
Test procedure
60 min (37°C) / 60 min (37°C) / 15 min (room temperature). Fully automatable.
Measurement
450 nm. Reference wavelength between 620 nm and 650 nm.
Kit format
96 break-off wells. Kit includes all necessary reagents.
Order no.
EQ 266a-9601-1
Software/Automation:
EUROLineScan
EUROBlotCamera
EUROBlotScanner
EUROBlotOne
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:
thyroglobulin (TG)
Hormone determination:
free triiodothyronine (FT3)
free thyroxine (FT4)
thyrotropin (TSH)
calcitonin
* Currently not available as IVD in the EU.
Made in Germany
Version: 04/14
EQ
Q_266a
66a_D_U
UK_A01
0
EUROIMMUN AG · 23560 Luebeck · Seekamp 31 · Phone +49 45 1 58 550 · Fax 58 55591 · E-Mail [email protected] · www.euroimmun.de
Medizinische
Labordiagnostika
AG
EUROIMMUN
DEN
DEN
DEN
DEN
DEN
DEN
DEN
DEN
Anti-Dengue Virus ELISA (IgG)
Indications: Test system for in vitro determination of antibodies against dengue virus in human serum or plasma for the diagnosis of the following diseases: classic dengue fever, dengue
haemorrhagic fever, dengue shock syndrome.
Clinical signif cance: Dengue viruses (types 1, 2, 3 and 4) are enveloped ssRNA viruses of
the family Flaviviridiae. They are transmitted from human to human via the mosquito Aedes
aegypti. This mosquito bites in the daytime, is adapted to human habitats and has a strong
preference for human blood. It breeds in relatively clean water stored for drinking or washing
purposes, and in rainwater that collects in manmade containers.
The population explosion in the last 60 years and subsequent migration from rural to urban
areas, often with poor living conditions, has resulted in the spread of A. aegypti to almost all
tropical countries. Of the 2.5 billion inhabitants of these areas, it is estimated that about 50-100
million individuals become infected with dengue viruses each year. Since the early 1950s, a
syndrome first recognized in South East Asia – dengue haemorrhagic fever/dengue shock syndrome (DHF/DSS) – has spread globally, resulting in hundreds of thousands of hospitalizations
and thousands of death each year. Travellers to most tropical areas are at risk of infection with
dengue virus. In 2001, Hawaii experienced a 6-month epidemic of dengue type 1 transmitted
by Aedes albopticus.
Most primary dengue virus infections in children and many in adults are silent. Dengue infection presents clinically as three overlapping syndromes: undifferentiated fever, dengue fever
syndrome and DHF/DSS. The symptoms of overt dengue infections are common to many acute
viral, bacterial and parasitic infections. The pathophysiologic presentation of classic DSS (history of recent high fever, thrombocytopenia, elevated hematocrit and hypotension or narrow
pulse pressure) is unique in infectious diseases. Presumptive diagnosis of dengue fever or DHF
requires a careful travel history to establish possible exposure to dengue virus infection.
Antibodies against dengue viruses can be detected early after onset of symptoms. Antibodies
of class IgM are detectable from the fifth day of illness and for 2-3 months following initial infection. IgM antibodies are often not detectable after a second infection with another serotype.
Antibodies of class IgG arise several days later than IgM and reach their maximum concentration 2-3 weeks after infection. They probably persist for life. After a second infection with
another serotype an increase in IgG concentration of over 10-fold is often found.
Relevance of serological diagnostics: Dengue fever should always be differentially diagnosed
from other tropical diseases such as malaria, yellow fever, typhus abdominalis and other
bacteraemia due to its mainly unspecific symptoms. The infectious agent can only be detected
within the first few days of the disease during a viraemic phase using RT-PCR or performing
an in vitro cultivation of the virus. Antibodies can be detected after approximately the fifth day
of illness. Since the virus itself can only be detected for approximately ten days and the symptoms occur with a delay, resulting in a delayed medical examination, the serological detection
of antibodies against Dengue virus plays a significant role in the diagnosis of the disease.
Cross reactions with other Flaviviruses must be taken into account.
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
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™
Serum proteins and tumour markers:
anti-p53
Bone metabolism marker:
25-OH-Vitamin-D
Saliva diagnostics:
alpha-amylase
cortisol
sIgA
Software/Automation:
EUROLabOffice
EUROIMMUN Analyzer I + I-2P
* Currently not available as IVD in the EU.
Made in Germany
EUROIMMUN AG · 23560 Luebeck · Seekamp 31 · Phone +49 45 1 58 550 · Fax 58 55591 · E-Mail [email protected] · www.euroimmun.de
EUROIMMUN
Medizinische
Labordiagnostika
AG
Test Characteristics
Anti-Dengue Virus ELISA (IgG)
EUROIMMUN
Immunoblots
Autoantibody determination:
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
Linearity: The linearity of the ELISA was determined by assaying serial dilutions of several
sera with high titers. The Anti-Dengue Virus ELISA (IgG) is linear in the measurement range
2 - 200 RU/ml.
Reproducibility: Coefficients of variation (CVs) were determined using 3 sera in different areas of the standard curve.
The intra-assay CVs are based on 20 measurements for each
serum and the inter-assay CVs on four measurements repeated on six different days.
Reference range: The titer of antibodies against dengue virus
(IgG) was determined in a panel of 500 apparently healthy
blood donors using the EUROIMMUN ELISA. 0.8% of the
blood donors were anti-dengue virus positive (IgG) at a cutoff of 20 RU/ml. This can also be due to cross reactivitiy (e.g.
antibodies against TBE from immunisation).
Sensitivity and specif city: 70 clinically characterised patient
samples (Bernhard-Nocht Institute, Hamburg, Germany; University of Luebeck, Germany) were investigated with the EUROIMMUN Anti-Dengue Virus ELISA (IgG). The test demonstrated
a sensitivity and specificity each of 100%.
Correlation with Panbio ELISA: Antibody concentrations were
determined in 82 sera from patients with suspected dengue
virus infection using Anti-Dengue Virus ELISA from EUROIMMUN and Panbio. The qualitative results of the two ELISA
were 99% in agreement.
Antigen determination:
thyroglobulin (TG)
4.7
93
5.5
113
4.5
115
4.3
3
114
4.4
120
5.6
400
500 Blood donors
300
200
100
10
100
Result from
BNI, Hamburg;
University of Luebeck
n = 70
positive
EUROIMMUN
Anti-Dengue
Virus ELISA
(IgG)
23
0
negative
0
47
Panbio
Anti-Dengue Virus
ELISA (IgG)
n = 82
positive
EUROIMMUN
Anti-Dengue
Virus ELISA
(IgG)
negative
positive
negative
positive
27
0
negative
1
54
Technical Data:
Antigen
The antigen source is dengue virus type 2 cultivated in vero cells.
Microplate wells are coated with high-purified virus particles. Due to
the high structural similarity between dengue virus types 1 to 4, the
use of one virus type is sufficient to detect antibodies against all four
virus types.
Calibration
Quantitative, in relative units per milliliter (RU/ml).
Calibration serum 1:
Calibration serum 2:
Calibration serum 3:
200 RU/ml
20 RU/ml; cut-off
2 RU/ml
Sample dilution
Serum or plasma; 1 : 101 in sample buffer.
Reagents
Ready for use, with the exception of the wash buffer (10x). Colour-coded
solutions, in most cases exchangeable with those in other EUROIMMUN ELISA.
Test procedure
30 min / 30 min / 15 min. Room temperature. Fully automatable.
Measurement
450 nm. Reference wavelength between 620 nm and 650 nm.
Kit format
96 break-off wells. Kit includes all necessary reagents.
Order no.
EA 266b-9601-G
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)
90
2
RU/ml
Software/Automation:
EUROIMMUN
Radioimmunoassays
Inter-assay
variation, n = 4 x 6
Mean
CV
(RU/ml)
(%)
1
1
EUROASSAY:
Food Profile (IgE)
Inhalation Profile (IgE)
Pediatric/Atopy Profile (IgE)
Insect Venom Profile (IgE)
EUROLineScan
camera system EUROBlotCamera
scanner system EUROBlotScanner
incubation processor EUROBlotMaster
Intra-assay
variation, n = 20
Mean
CV
(RU/ml)
(%)
0
Allergology:
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)
Serum
Frequency n
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
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
Version: 02/09
EI_266b_D_UK_A02
EUROIMMUN AG · 23560 Luebeck · Seekamp 31 · Phone +49 45 1 58 550 · Fax 58 55591 · E-Mail [email protected] · www.euroimmun.de
EUROIMMUN
Medizinische
Labordiagnostika
AG
Anti-Hanta Virus Pool 1 “Eurasia” ELISA (IgG)
Indication: Test system for the in vitro determination of antibodies against hantavirus (strains
Hantaan, Dobrava and Puumala) in human serum or plasma for the diagnosis of the following
diseases: haemorrhagic fever with renal syndrome (HFRS), kidney failure, acute respiratory syndrome, hantavirus pulmonary syndrome (HPS), hantavirus cardiopulmonary syndrome (HCPS).
Clinical signif cance:
Hantavirus
serotype
Occurrence
Main vector
Puumala
Central, northern and western Europe, Asia
(1,000 cases/year in Finland)
Bank vole
Dobrava
Balkan countries
Yellow-necked mouse
Seoul
Russia, South East Europe, China, Japan, Korea (several
100,000 cases/year in China and Korea alone)
Norway rat
Hantaan
Korea and South East Asian regions, eastern Russia,
southern Europe
Striped field mouse
Saaremaa
Central Europe, Nordic and Baltic countries
Striped field mouse
High fever, 3-5 days
influenza-like symptoms
Symptoms / Disease
Sin Nombre American continent
Deer mouse
Andes
Deer mouse, cotton rat, rice
rat, white-footed mouse
American continent
Lethality
HFRS (nephro< 1%
pathia epidemica)
HFRS
< 1%
HFRS
Up to 5 %
HFRS
~10 %
HFRS
Unknown
HPS/HCPS
~40 %
HPS/HCPS
up to 36 %
Hantaviruses belong to the Bunyaviridiae family (other members are Sandfly fever virus, Crimean Congo fever virus) and they are transmitted by rat and mouse species. They cause persisting infections in their hosts and are excreted
via saliva, faeces and urine. Transmission to
Initial symptoms
humans occurs through the respiratory tract
by inhalation of dust and aerosols containIgG
ing virus-contaminated excrements of inapparently infected rodents. Hantaviruses are
IgA
Virus
IgM
found worldwide. The hanta species Hantaan,
Seoul, Puumala and Dobrava are the causative
4 Months
agents of the haemorrhagic, nephropatic synTime
drome (HFRS), whose degree of manifestation
Infection
depends on the virus type involved. HFRS can
be treated with chemotherapy.
Day 0
Incubation time
(5-35 days)
Fever period
(3-4 days)
The incubation period is 5 to 35 days. The disease generally starts with abrupt high fever,
which lasts for 3 to 4 days, and unspecific flu-like symptoms, e.g. headache, myalgia, shivering
and conjunctivitis. This phase continues for 4 to 10 days. In approximately 30% of cases this is
followed by haemorrhagic symptoms, which manifest themselves as petechiae of the eye and
the mucous membranes and which are often accompanied by thrombocytopenia, haematuria
and proteinuria. Kidney function may be impaired to the extent that dialysis is required. The
lethality rate of nephropathia epidemica is approximately 1%. In approx. 16% of cases, acute
kidney failure is associated with an involvement of the lungs showing peribronchial infiltrates
and pleural effusion. The first week of infection is characterised by a decrease in blood pressure which leads to a state of shock in 1 to 15% of patients and is fatal in one in three cases. In
reconvalescent patients the remission of symptoms and the return to normal electrolyte levels
take up to 3 months.
Anti-Hanta Virus Pool 1 “Eurasia” ELISA (IgG): Diagnosis of hantavirus infections is generally
based on the clinical picture and serological test results. Cultivation of the virus is difficult and
hardly ever succeeds. Detection of viral RNA in the blood using PCR can only be carried out
during the first few weeks after infection since the viraemic phase is very brief and ends shortly
after the occurrence of the first symptoms. IgM antibodies against Hantavirus can be found at
an early stage and often occur with the onset of first symptoms. IgG antibodies can be detected
shortly after. Whereas IgM antibodies generally disappear within 2 to 3 months (in individual
cases weak IgM results can still be found 1 to 3 years after infection), IgG antibodies persist for
many years, sometimes even lifelong. The Anti-Hanta Virus Pool 1 “Eurasia” ELISA contains a
mixture of recombinant nucleocapsid antigens from the hantavirus strains Hantaan, Dobrava
and Puumala, which are found in Asia and Europe. With this mixture, it provides a sensitive and
specific test system for the detection of hantavirus infections in these regions.
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)
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)
Envoplakin (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)
parietal cells (PCA; IgG)
PM-Scl (PM-1; IgG)
phosphatidylserine (IgA, IgG, IgM, IgAGM)
PR3 hn-hr (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)
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)
Further autoimmune diagnostics:
gliadin (GAF-3X; IgA, IgG)
Saccharomyces cerevisiae (IgA, IgG)
Infectious serology:
Adenovirus (IgA, IgG, IgM)
Bordetella pertussis (IgM)
Bordetella pertussis toxin (IgA, IgG)
Bordetella FHA (IgA, IgG)
Borrelia (IgG, IgM)
Borrelia VlsE (IgG)
Brucella abortus (IgA, IgG, IgM)
Campylobacter jejuni (IgA, IgG)
Chikungunya virus (IgG)
Chlamydia pneumoniae (IgA, IgG, IgM)
Chlamydia trachomatis (IgA, IgG, IgM)
Cytomegalovirus (IgG, IgM)
Dengue virus (IgA, 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; IgG, IgM)
HSV-2 (glycoprotein G2; 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)
TBE virus (IgG, IgM)
Tetanus toxoid (IgG)
Toxoplasma gondii (IgG, IgM)
Treponema pallidum (IgG, IgM)
Usutu virus (IgG)
Varicella zoster virus (IgG, IgM)
West Nile virus (IgG, IgM)
Yersinia enterocolitica (IgA, IgG)
Allergology:
total IgE
Allercoat™ 6-ELISA (650 different
allergens and allergen mixtures)
Software EUROIMMUN Allercoat™
Bone metabolism marker:
25-OH-Vitamin-D
Saliva diagnostics:
alpha-amylase
cortisol
sIgA
Software/Automation:
EUROLabOffice
EUROIMMUN Analyzer I + I-2P
* Currently not available as IVD in the EU.
Made in Germany
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
EUROIMMUN
Autoantibody determination:
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
EUROLINE:
flexible profiles of up to 18 antigens from:
ENA and related antigens: nRNP/Sm, Sm,
RNP70, RNPA, RNPC, SS-A, Ro-52, SS-B, Scl-70,
PM-Scl, Jo-1, CENP B, PCNA, dsDNA, nucleosomes,
histones, ribosomal P-proteins, AMA M2, Mi-2, Ku
Systemic Sclerosis Profile: Scl-70, CENP A, CENP B,
RP11, RP155, fibrillarin, NOR90, Th/To, PM-Scl100,
PM-Scl75, Ku, PDGFR, Ro-52
Myositis Profiles: 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 Antigen Profiles: amphiphysin, CV2,
PNMA2 (Ma-2/Ta), Ri, Yo, Hu, recoverin, SOX1,
titin
Ganglioside Profiles: 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 (IgG, IgM)
Borrelia-RN-AT-adv (IgM)
EBV Profile (IgG, IgM)
Hantavirus profiles (IgG, IgM)
Parvovirus B19 (IgG, IgM)
TORCH Profile* (IgG, IgM)
Westernblot:
Borrelia burgdorferi (IgG, IgM)
Borrelia afzelii (IgG, IgM)
Borrelia garinii (IgG, IgM)
Cytomegalovirus (IgG, IgM)*
Echinococcus granulosus (IgG)
Epstein-Barr virus (IgG, IgM)
Rubella virus (IgG)
Treponema pallidum (IgG, IgM)
Yersinia enterocolitica (IgA, IgG)
EUROLINE-WB:
Borrelia (IgG, IgM)
HSV-1/2 (IgG, IgM)
Helicobacter pylori (IgA, IgG)
Treponema pallidum + cardiolipin (IgG, IgM)
Allergology:
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)
Test Characteristics
Anti-Hanta Virus Pool 1 “Eurasia” ELISA (IgG)
Linearity: The linearity of the Anti-Hanta Virus Pool 1 “Eurasia” ELISA (IgG) was determined
by performing 4 serial dilutions of 6 serum samples. The linear regression R2 was > 0.95 for
all samples. The Anti-Hanta Virus Pool 1 “Eurasia” ELISA (IgG) is linear in at least the tested
concentration range of 14 RU/ml to 142 RU/ml.
Reproducibility: The reproducibility of the test was investigated by determining the intra- and inter-assay coefficients of
variation using 3 sera. The intra-assay CVs are based on 20
determinations and the inter-assay CVs on 4 determinations
performed in 6 different test runs.
Reference range: The levels of anti-hantavirus antibodies (IgG)
were analysed with the EUROIMMUN Anti-Hanta Virus Pool 1
“Eurasia” ELISA (IgG) in a panel of 500 healthy blood donors.
With a cut-off value of 20 RU/ml, 4.4% of blood donors were
anti-hantavirus positive (IgG), in agreement with the known
infection level in adults.
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:
44
5.5
46
11.8
2
90
3.9
93
7.9
3
134
4.0
143
5.3
60
500 Blood donors
50
40
30
20
10
1
10
100
1000
RU/ml
Correlation with the PROGEN ELISA: A panel of 40 patient
samples was investigated using the EUROIMMUN Anti-HantaVirus Pool 1 “Eurasia” ELISA (IgG) and the PROGEN Hantavirus
ELISA (IgG). The agreement between the qualitative results of
the two ELISAs was 86% (excluding borderline sera). Four of
the five discrepant samples achieved a negative result in the
EUROIMMUN Anti-Hantavirus IIFT (IgG).
Sensitivity and specif city (IgG): 12 clinically characterised
patient samples (INSTAND quality assessment, Germany)
were tested using the EUROIMMUN Anti-Hanta Virus Pool 1
“Eurasia” ELISA (IgG). Both the sensitivity and specificity
were 100%.
Cross reactions: 228 sera from patients with different infectious diseases (positive IgG results) who have not previously
been infected with hantaviruses were investigated with the
EUROIMMUN Anti-Hanta Virus Pool 1 “Eurasia” ELISA (IgG).
No cross reactions (CR) were found.
PROGEN
Hantavirus ELISA (IgG)
n = 40
EUROIMMUN
pos.
Anti-Hanta
Virus Pool 1
borderl.
“Eurasia“ ELISA
neg.
(IgG)
pos.
borderl.
neg.
18
1
0
0
1
2
5*
0
13
* 5 discrepant samples: 4 negative and 1 positive in the
EUROIMMUN Anti-Hantavirus IIFT (IgG)
Target values
INSTAND
n = 12
EUROIMMUN
pos.
Anti-Hanta
Virus Pool 1
borderl.
“Eurasia“ ELISA
neg.
(IgG)
pos.
borderl.
neg.
9
0
0
1
0
0
0
0
2
Parameter
n
CR Parameter
n
CR
Adenovirus
12
0 % Mumps virus
12
0%
B. pertussis
12
0 % Mycopl. pneum. 12
0%
C. pneumoniae 12
0 % Parainf. P. virus
0%
CMV
12
0 % Parvovirus B19 12
0%
EBV-CA
12
0 % RSV
12
0%
H. pylori
12
0 % Rubella virus
12
0%
HSV-1
12
0 % Toxop. gondii
12
0%
12
Influenza A v.
12
0 % VZV
12
0%
Influenza B v.
12
0 % Y. enterocolitica 12
0%
Measles virus
12
0%
Technical data:
Antigen
A mixture of recombinant antigens from the Hantavirus strains Hantaan, Dobrava and Puumala.
Calibration
Quantitative, in relative units per milliliter (RU/ml).
Calibration serum 1:
200 RU/ml
Calibration serum 2:
20 RU/ml; cut-off
Calibration serum 3:
2 RU/ml
Sample dilution
Serum or plasma; 1 : 101 in sample buffer.
Reagents
Ready for use, with the exception of the wash buffer (10x). Colourcoded solutions, in most cases exchangeable with those in other EUROIMMUN ELISA kits.
Test procedure
60 min (37 °C) / 30 min / 15 min (room temperature). Fully automatable.
Measurement
450 nm. Reference wavelength between 620 nm and 650 nm.
Test kit format
96 break-off wells. Kit includes all necessary reagents.
Order number
EI 278h-9601-1 G
Hormone determination:
* Currently not available as IVD in the EU.
** CV2 partial protein, which only contains the
N-terminally localised epitopes of the antigen.
1
0.1
thyroglobulin (TG)
free triiodothyronine (FT3)
free thyroxine (FT4)
thyrotropin (TSH)
calcitonin
Inter-assay
variation, n = 4 x 6
Mean value
CV
(RU / ml)
(%)
0
Software/Automation:
EUROLineScan
camera system EUROBlotCamera
scanner system EUROBlotScanner
incubation processor EUROBlotMaster
Intra-assay
variation, n = 20
Mean value
CV
(RU / ml)
(%)
Serum
Frequency n
EUROIMMUN
Immunoblots
Medizinische
Labordiagnostika
AG
Made in Germany
Version: 01/12
EI_278h_D_UK_A03
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
EUROIMMUN
Medizinische
Labordiagnostika
AG
Anti-Hanta Virus Pool 1 “Eurasia” ELISA (IgM)
Indication: Test system for the in vitro determination of antibodies against Hantavirus (strains
Hantaan, Dobrava and Puumala) in human serum or plasma for the diagnosis of the following
diseases: haemorrhagic fever with renal syndrome (HFRS), kidney failure, acute respiratory syndrome, hantavirus pulmonary syndrome (HPS), hantavirus cardiopulmonary syndrome (HCPS).
Clinical signif cance:
Hantavirus
serotype
Occurrence
Puumala
Central, northern and western Europe, Asia
(1,000 cases/year in Finland)
Bank vole
Dobrava
Balkan countries
Yellow-necked mouse
Seoul
Russia, South East Europe, China, Japan, Korea (several
100,000 cases/year in China and Korea alone)
Norway rat
Hantaan
Korea and South East Asian regions, eastern Russia,
southern Europe
Striped field mouse
Saaremaa
Central Europe, Nordic and Baltic countries
Striped field mouse
Symptoms / Disease
High fever, 3-5 days
influenza-like symptoms
Main vector
Sin Nombre American continent
Deer mouse
Andes
Deer mouse, cotton rat, rice
rat, white-footed mouse
American continent
Lethality
HFRS (nephro< 1%
pathia epidemica)
HFRS
< 1%
HFRS
Up to 5 %
HFRS
~10 %
HFRS
Unknown
HPS/HCPS
~40 %
HPS/HCPS
up to 36 %
Hantaviruses belong to the Bunyaviridiae family (other members are Sandfly fever virus, Crimean Congo fever virus) and they are transmitted by rat and mouse species. They cause persisting infections in their hosts and are excreted
via saliva, faeces and urine. Transmission to
Initial symptoms
humans occurs through the respiratory tract
by inhalation of dust and aerosols containIgG
ing virus-contaminated excrements of inapparently infected rodents. Hantaviruses are
IgA
Virus
IgM
found worldwide. The hanta species Hantaan,
Seoul, Puumala and Dobrava are the causative
4 Months
agents of the haemorrhagic, nephropatic synTime
drome (HFRS), whose degree of manifestation
Infection
depends on the virus type involved. HFRS can
be treated with chemotherapy.
Day 0
Incubation time
(5-35 days)
Fever period
(3-4 days)
The incubation period is 5 to 35 days. The disease generally starts with abrupt high fever,
which lasts for 3 to 4 days, and unspecific flu-like symptoms, e.g. headache, myalgia, shivering
and conjunctivitis. This phase continues for 4 to 10 days. In approximately 30% of cases this is
followed by haemorrhagic symptoms, which manifest themselves as petechiae of the eye and
the mucous membranes and which are often accompanied by thrombocytopenia, haematuria
and proteinuria. Kidney function may be impaired to the extent that dialysis is required. The
lethality rate of nephropathia epidemica is approximately 1%. In approx. 16% of cases, acute
kidney failure is associated with an involvement of the lungs showing peribronchial infiltrates
and pleural effusion. The first week of infection is characterised by a decrease in blood pressure which leads to a state of shock in 1 to 15% of patients and is fatal in one in three cases. In
reconvalescent patients the remission of symptoms and the return to normal electrolyte levels
take up to 3 months.
Anti-Hanta Virus Pool 1 “Eurasia” ELISA (IgM): Diagnosis of hantavirus infections is generally
based on the clinical picture and serological test results. Cultivation of the virus is difficult and
hardly ever succeeds. Detection of viral RNA in the blood using PCR can only be carried out
during the first few weeks after infection since the viraemic phase is very brief and ends shortly
after the occurrence of the first symptoms. IgM antibodies against hantavirus can be found at
an early stage and often occur with the onset of first symptoms. IgG antibodies can be detected
shortly after. Whereas IgM antibodies generally disappear within 2 to 3 months (in individual
cases weak IgM results can still be found 1 to 3 years after infection), IgG antibodies persist for
many years, sometimes even lifelong. The Anti-Hanta Virus Pool 1 “Eurasia” ELISA contains a
mixture of recombinant nucleocapsid antigens from the Hantavirus strains Hantaan, Dobrava
and Puumala, which are found in Asia and Europe. With this mixture, it provides a sensitive and
specific test system for the detection of hantavirus infections in these regions.
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
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™
Serum proteins and tumour markers:
anti-p53
Bone metabolism marker:
25-OH-Vitamin-D
Saliva diagnostics:
alpha-amylase
cortisol
sIgA
Software/Automation:
EUROLabOffice
EUROIMMUN Analyzer I + I-2P
* Currently not available as IVD in the EU.
Made in Germany
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
EUROIMMUN
Autoantibody determination:
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
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:
Test Characteristics
Anti-Hanta Virus Pool 1 “Eurasia” ELISA (IgM)
Reproducibility: The reproducibility of the test was investigated by determining the intra- and inter-assay coefficients of
variation using 3 sera. The intra-assay CVs are based on 20
determinations and the inter-assay CVs on 4 determinations
performed in 6 different test runs.
Reference range: The levels of anti-hantavirus antibodies
(IgM) were analysed with the EUROIMMUN Anti-Hanta Virus
Pool 1 “Eurasia” ELISA (IgM) in a panel of 500 healthy blood
donors. With a cut-off of ratio 1.0 RU/ml, 1% of the blood donors were anti-hantavirus positive (IgM).
Intra-assay
variation, n = 20
Mean value
CV
(Ratio)
(%)
Serum
Inter-assay
variation, n = 4 x 6
Mean value
CV
(Ratio)
(%)
1
1
2.5
4
2
2
3.5
4
9.0
6.2
3
4
7.5
2
10.4
80
500 Blood donors
Frequency n
EUROIMMUN
Immunoblots
Medizinische
Labordiagnostika
AG
60
40
20
0
0.01
0.1
1
100
10
Ratio
Correlation with the PROGEN ELISA: A panel of 40 patient
samples was investigated using the EUROIMMUN Anti-HantaVirus Pool 1 “Eurasia” ELISA (IgM) and the PROGEN Hantavirus ELISA (IgM). The agreement between the qualitative results of the two ELISAs was 78% (excluding borderline sera).
Six of the seven discrepant samples achieved a negative result in the EUROIMMUN Anti-Hantavirus IIFT (IgM).
Sensitivity and specif city (IgM): 12 clinically characterised
patient samples (INSTAND quality assessment, Germany)
were tested using the EUROIMMUN Anti-Hanta Virus Pool 1
“Eurasia” ELISA (IgM). Both the specificity and sensitivity
were 100%.
Cross reactions: 77 sera from patients with different infectious
diseases (positive IgM results) were investigated with the EUROIMMUN Anti-Hanta Virus Pool 1 “Eurasia” ELISA (IgM). No
cross reactions (CR) were found.
Anti-Borrelia (B. afzelii + rec. VlsE)
Anti-HSV (HSV-1 + HSV-2 gG2)
Helicobacter pylori (VacA, Cag A; IgA, IgG)
Treponema pallidum + cardiolipin
PROGEN
Hantavirus ELISA (IgM)
n = 40
EUROIMMUN
pos.
Anti-Hanta
Virus Pool 1
borderl.
“Eurasia” ELISA
neg.
(IgM)
pos.
borderl.
neg.
10
0
0
3
0
0
7*
5
15
* 7 discrepant samples: 6 negative and 1 positive in the
EUROIMMUN Anti-Hantavirus IIFT (IgM)
Target values
INSTAND
n=8
EUROIMMUN
pos.
Anti-Hanta
Virus Pool 1
borderl.
“Eurasia” ELISA
neg.
(IgM)
pos.
borderl.
neg.
6
0
0
0
0
0
0
0
6
Parameter
n
CR
Parameter
n
B. burgdorferi
9
0 % Parvovirus B19
8
CR
0%
CMV
9
0 % Rubella virus
10
0%
EBV-CA
9
0 % HSV-1 + HSV-2
2
0%
Measles virus
8
0 % VZV
4
0%
Mumps virus
9
0 % Toxopl. gondii
9
0%
Allergology:
Technical data:
EUROASSAY:
Food Profile (IgE)
Inhalation Profile (IgE)
Pediatric/Atopy Profile (IgE)
Insect Venom Profile (IgE)
Antigen
A mixture of recombinant antigens from the hantavirus strains Hantaan, Dobrava and Puumala.
Calibration
Semiquantitative, calculation of a ratio from the extinction of the sample and the extinction of the calibrator.
Result interpretation
Ratio < 0.8:
Ratio > 0.8 to < 1.1:
Ratio > 1.1:
Sample dilution
Serum or plasma; 1 : 101 in sample buffer.
Reagents
Ready for use, with the exception of the wash buffer (10x). Colourcoded solutions, in most cases exchangeable with those in other EUROIMMUN ELISA kits.
Test procedure
60 min (37 °C) / 30 min / 15 min (room temperature). Fully automatable.
Measurement
450 nm. Reference wavelength between 620 nm and 650 nm.
Test kit format
96 break-off wells. Kit includes all necessary reagents.
Order number
EI 278h-9601-1 M
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:
negative
borderline
positive
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
Version: 11/2011
EI_278h_D_UK_B02
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
EUROIMMUN
Medizinische
Labordiagnostika
AG
Anti-Hanta Virus Pool 2 “America“ ELISA (IgG)
Indication: Test system for the in vitro determination of antibodies of immunoglobulin class G (IgG)
against hantavirus serotypes (Andes/AND and Sin Nombre/SN) in human serum or plasma for
the diagnosis of the following diseases: hantavirus pulmonary syndrome (HPS), hantavirus
cardiopulmonary syndrome (HCPS).
Clinical Signif cance: Worldwide distributed hantaviruses are enveloped viruses of the Bunyaviridae family, which have a threefold-segmented single- and negative-stranded RNA genome.
The regionally differing hantavirus serotypes are transmitted by different mouse and rat species. The viruses, which cause persistent inapparent infections in these rodents, are secreted in
their saliva, faeces and urine. They are then transmitted to humans via contaminated dust or
aerosols, mostly via the respiratory tract but occasionally orally or through contaminated food.
The most important or most frequent of the currently known 22 serotypes are listed in the table
below together with their distribution regions, vectors and diseases.
Hantavirus serotype
Distribution
Vector
Disease
PUUV
Central, northern and western Europe, Asia
Bank vole
HFRS/NE
DOBV
Balkan countries
Yellow-necked mouse
HFRS
HTNV
Korea and other south eastern Asian regions, eastern
Russia, southern Europe
Striped field mouse
HFRS
SEOV
Worldwide
Norway rat
HFRS
SNV
American continent
Deer mouse
HPS
ANDV
American continent
Deer mouse, white-footed
mouse, cotton rat, rice rat
HPS/HCPS
HFRS: haemorrhagic fever with renal syndrome; NE: nephropathia epidemica
The serotypes that are prevalent in Europe and
Initial symptoms
Asia are not transmitted from person to person.
Up until now the only indication of possible
person to person transmission is for the highly
IgG
virulent subtype Andes in South America. The
IgA
Virus
incubation period for hantavirus infection is 2-4
IgM
weeks, in exceptional cases 5-60 days. Pathogenetic similarities are to a greater or lesser extent
4 Months
endothelial dysfunction with increased vessel
Time
Infection
permeability and a drop in blood pressure. The
symptom complex HPS/HCPS is a life-threatening disease, which is caused by the hantavirus serotype AND or SN. These pathogens cause acute
kidney failure and diseases of the respiratory tract with severe lung inflammation, peribronchial
infiltrates, pleural effusion, and in some cases also a drop in blood pressure up to cardiogenic
shock with a fatal course in 40-60% of patients.
Day 0
Incubation time
(2-4 weeks)
Fever period
(3-4 days)
Anti-Hanta Virus Pool 2 “America” ELISA (IgG): Diagnosis of hantavirus infections is generally
based on the clinical picture and serological test results. Culture of the virus is difficult and
rarely succeeds. Detection of viral RNA in the blood using PCR can only be carried out during
the first few days after infection since viraemia ends shortly after the occurrence of the first
symptoms. IgM antibodies against hantaviruses can be found at an early stage and often with
the onset of symptoms; IgG antibodies occur several days later. IgM antibodies are generally
no longer present after 2-3 months. Weak positive IgM antibody reactions may be observed
in isolated cases 1 to 3 years after the infection. IgG antibodies are presumed to persist over
several years, decades or even life-long. There are considerable serological differences between
individual hantavirus types, and in many regions an increasingly diverse mix of different types
has been recorded. A combination of different antigens is therefore required to reliably differentiate hantavirus serotypes, to identify particular serotypes under consideration of endemic
aspects, and to simultaneously detect infections with several different serotypes. In Germany,
the direct or indirect detection of hantaviruses is notifiable.
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)
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)
Envoplakin (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)
parietal cells (PCA; IgG)
PM-Scl (PM-1; IgG)
phosphatidylserine (IgA, IgG, IgM, IgAGM)
PR3 hn-hr (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)
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)
Further autoimmune diagnostics:
gliadin (GAF-3X; IgA, IgG)
Saccharomyces cerevisiae (IgA, IgG)
Infectious serology:
Adenovirus (IgA, IgG, IgM)
Bordetella pertussis (IgM)
Bordetella pertussis toxin (IgA, IgG)
Bordetella FHA (IgA, IgG)
Borrelia (IgG, IgM)
Borrelia VlsE (IgG)
Brucella abortus (IgA, IgG, IgM)
Campylobacter jejuni (IgA, IgG)
Chikungunya virus (IgG)
Chlamydia pneumoniae (IgA, IgG, IgM)
Chlamydia trachomatis (IgA, IgG, IgM)
Cytomegalovirus (IgG, IgM)
Dengue virus (IgA, 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; IgG, IgM)
HSV-2 (glycoprotein G2; 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)
TBE virus (IgG, IgM)
Tetanus toxoid (IgG)
Toxoplasma gondii (IgG, IgM)
Treponema pallidum (IgG, IgM)
Usutu virus (IgG)
Varicella zoster virus (IgG, IgM)
West Nile virus (IgG, IgM)
Yersinia enterocolitica (IgA, IgG)
Allergology:
total IgE
Allercoat™ 6-ELISA (650 different
allergens and allergen mixtures)
Software EUROIMMUN Allercoat™
Bone metabolism marker:
25-OH-Vitamin-D
Saliva diagnostics:
alpha-amylase
cortisol
sIgA
Software/Automation:
EUROLabOffice
EUROIMMUN Analyzer I + I-2P
* Currently not available as IVD in the EU.
Made in Germany
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
EUROIMMUN
Test Characteristics
Anti-Hanta Virus Pool 2 “America“ ELISA (IgG)
Autoantibody determination:
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 (IgG, IgM)
Borrelia-RN-AT-adv (IgM)
EBV Profile (IgG, IgM)
Hantavirus profiles (IgG, IgM)
Parvovirus B19 (IgG, IgM)
TORCH Profile* (IgG, IgM)
Westernblot:
Borrelia burgdorferi (IgG, IgM)
Borrelia afzelii (IgG, IgM)
Borrelia garinii (IgG, IgM)
Cytomegalovirus (IgG, IgM)*
Echinococcus granulosus (IgG)
Epstein-Barr virus (IgG, IgM)
Rubella virus (IgG)
Treponema pallidum (IgG, IgM)
Yersinia enterocolitica (IgA, IgG)
EUROLINE-WB:
Borrelia (IgG, IgM)
HSV-1/2 (IgG, IgM)
Helicobacter pylori (IgA, IgG)
Treponema pallidum + cardiolipin (IgG, IgM)
Allergology:
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
Reference range: The levels of anti-hantavirus IgG antibodies were determined in 500 healthy blood donors1 using
the EUROIMMUN Anti-Hanta Virus Pool 2 “America“ ELISA
(IgG). With a cut-off value of 20 RU/ml, 2.4 % of the blood
donors were anti-hantavirus positive.
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
Version: 02/12
EI_278h_D_UK_C02
Serum
Mean
(RU/ml)
CV
(%)
Mean
(RU/ml)
CV
(%)
1
2
3
137
61
66
2.8
3.4
3.4
138
61
66
2.8
3.4
4.1
80
500 Blood donors
60
40
20
0.1
1
10 20
100
1000
RU/ml
Agreement with quality assessment results: 18 serologically
characterised patient samples2, 3 were investigated using the
EUROIMMUN Anti-Hanta Virus Pool 2 “America“ ELISA (IgG).
There was 100% agreement between the results of the ELISA
and the target values from the quality assurance institute.
n = 18
Target values from
QA institutes
pos. borderl. neg.
EUROIMMUN pos.
Anti-Hanta
borderl.
Virus Pool 2
“America“
neg.
ELISA (IgG)
1
University Clinic of Schleswig-Holstein, Campus Luebeck, Germany; 2 INSTAND e. V.:
Society for Promotion of Quality Assurance in the Medical Laboratories, Duesseldorf,
Germany; 3 Labquality, Helsinki, Finland.
8*
0
0
0
0
0
0
0
10
*
Comparison of the EUROIMMUN Anti-Hanta Virus Pool 2
“America“ ELISA (IgG) with the EUROIMMUN Anti-Hantavirus Prof le Global EUROLINE (IgG): Antibodies against
hantavirus were analysed in 56 serologically and/or clincially characterised patient samples using the EUROIMMUN
Anti-Hanta Virus Pool 2 “America“ ELISA (IgG) and the AntiHantavirus Profile Global EUROLINE (IgG) as reference test.
There was 98% agreement between the qualitative results
for the two test systems (borderline sera excluded).
Anti-PUUV positive sera. These sera can also
be detected due to potential cross reactions
with ANDV and SNV antigens.
n = 56
EUROIMMUN
Anti-Hantavirus
Prof le Global (IgG)
pos. borderl. neg.
EUROIMMUN pos.
Anti-Hanta
Virus Pool 2
borderl.
“America“
neg.
ELISA (IgG)
4
1
0
0
0
0
1
4
46
Cross reactions: 228 sera from patients with different infectious diseases (positive IgG results) who have not previously been infected with hantaviruses
were investigated with the Anti-Hanta Virus Pool 2 “America“ ELISA (IgG). No cross reactions
(CR) were found.
Antibodies against
Adenovirus
Bordetella pertussis
Chlamydia pneumoniae
CMV
EBV-CA
Helicobacter pylori
HSV-1
n
12
12
12
12
12
12
12
CR
0%
0%
0%
0%
0%
0%
0%
Antibodies against
Inf uenza A virus
Inf uenza B virus
Measles virus
Mumps virus
Mycoplasma pneumoniae
Parainf uenza virus Pool
n
12
12
12
12
12
12
CR
0%
0%
0%
0%
0%
0%
Antibodies against
Parvovirus 19
RSV
Rubella virus
Toxoplasma gondii
VZV
Yersinia enterocolitica
n
12
12
12
12
12
12
CR
0%
0%
0%
0%
0%
0%
Technical data:
Antigen
A mixture of purified recombinant antigens (nucleocapsid proteins)
from the hantavirus strains Andes (AND) and Sin Nombre (SN).
Calibration
Quantitative, in relative units per milliliter (RU/ml).
Calibration serum 1:
200 RU/ml
Calibration serum 2:
20 RU/ml; cut-off
Calibration serum 3:
2 RU/ml
Semiquantitative evaluation using a ratio is also possible.
Sample dilution
Serum or plasma; 1 : 101 in sample buffer.
Reagents
Ready for use; exception: wash buffer (10x). Colour-coded solutions, in
most cases exchangeable with those in other EUROIMMUN ELISA kits.
Test procedure
60 min (37 °C) / 30 min / 15 min (room temperature). Fully automatable.
Measurement
450 nm. Reference wavelength between 620 nm and 650 nm.
Test kit format
96 break-off wells. Kit includes all necessary reagents.
Order number
EI 278h-9601-2 G
Antigen determination:
thyroglobulin (TG)
Inter-assay
variation, n = 4 x 6
0
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)
Intra-assay
variation, n = 20
Frequency n
EUROLINE:
flexible profiles of up to 18 antigens from:
ENA and related antigens: nRNP/Sm, Sm,
RNP70, RNPA, RNPC, SS-A, Ro-52, SS-B, Scl-70,
PM-Scl, Jo-1, CENP B, PCNA, dsDNA, nucleosomes,
histones, ribosomal P-proteins, AMA M2, Mi-2, Ku
Systemic Sclerosis Profile: Scl-70, CENP A, CENP B,
RP11, RP155, fibrillarin, NOR90, Th/To, PM-Scl100,
PM-Scl75, Ku, PDGFR, Ro-52
Myositis Profiles: 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 Antigen Profiles: amphiphysin, CV2,
PNMA2 (Ma-2/Ta), Ri, Yo, Hu, recoverin, SOX1,
titin
Ganglioside Profiles: GM1, GM2, GM3,
GD1a, GD1b, GT1b, GQ1b
ANCA Profiles: MPO, PR3, GBM
Reproducibility: The reproducibility of the test was investigated by determining the intra- and inter-assay coefficients of variation using 3 sera. The intra-assay CVs are
based on 20 determinations and the inter-assay CVs on 4
determinations performed in 6 different test runs.
Cut-Off
EUROIMMUN
Immunoblots
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
Medizinische
Labordiagnostika
AG
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
EUROIMMUN
Medizinische
Labordiagnostika
AG
Anti-Hanta Virus Pool 2 “America“ ELISA (IgM)
Indication: Test system for the in vitro determination of antibodies of immunoglobulin class M (IgM)
against hantavirus serotypes (Andes/AND and Sin Nombre/SN) in human serum or plasma for
the diagnosis of the following diseases: hantavirus pulmonary syndrome (HPS), hantavirus
cardiopulmonary syndrome (HCPS).
Clinical Significance: Worldwide distributed hantaviruses are enveloped viruses of the Bunyaviridae family, which have a threefold-segmented single- and negative-stranded RNA genome.
The regionally differing hantavirus serotypes are transmitted by different mouse and rat species. The viruses, which cause persistent inapparent infections in these rodents, are secreted in
their saliva, faeces and urine. They are then transmitted to humans via contaminated dust or
aerosols, mostly via the respiratory tract but occasionally orally or through contaminated food.
The most important or most frequent of the currently known 22 serotypes are listed in the table
below together with their distribution regions, vectors and diseases.
Hantavirus serotype
Distribution
Vector
Disease
PUUV
Central, northern and western Europe, Asia
Bank vole
HFRS/NE
DOBV
Balkan countries
Yellow-necked mouse
HFRS
HTNV
Korea and other south eastern Asian regions, eastern Russia, southern Europe
Striped field mouse
HFRS
SEOV
Worldwide
Norway rat
HFRS
SNV
American continent
Deer mouse
HPS
ANDV
American continent
Deer mouse, white-footed
mouse, cotton rat, rice rat
HPS/HCPS
HFRS: haemorrhagic fever with renal syndrome; NE: nephropathia epidemica
The serotypes that are prevalent in Europe and
Initial symptoms
Asia are not transmitted from person to person.
Up until now the only indication of possible
person to person transmission is for the highly
IgG
virulent subtype Andes in South America. The
IgA
Virus
incubation period for hantavirus infection is 2-4
IgM
weeks, in exceptional cases 5-60 days. Pathogenetic similarities are to a greater or lesser extent
4 Months
endothelial dysfunction with increased vessel
Time
Infection
permeability and a drop in blood pressure. The
symptom complex HPS/HCPS is a life-threatening disease, which is caused by the hantavirus serotype AND or SN. These pathogens cause
acute kidney failure and diseases of the respiratory tract with severe lung inflammation, peribronchial infiltrates, pleural effusion, and in some cases also a drop in blood pressure up to
cardiogenic shock with a fatal course in 40-60% of patients.
Day 0
Incubation time
(2-4 weeks)
Fever period
(3-4 days)
Anti-Hanta Virus Pool 2 “America” ELISA (IgM): Diagnosis of hantavirus infections is generally
based on the clinical picture and serological test results. Culture of the virus is difficult and
rarely succeeds. Detection of viral RNA in the blood using PCR can only be carried out during
the first few days after infection since viraemia ends shortly after the occurrence of the first
symptoms. IgM antibodies against hantaviruses can be found at an early stage and often with
the onset of symptoms; IgG antibodies occur several days later. IgM antibodies are generally
no longer present after 2-3 months. Weak positive IgM antibody reactions may be observed
in isolated cases 1 to 3 years after the infection. IgG antibodies are presumed to persist over
several years, decades or even life-long. There are considerable serological differences between
individual hantavirus types, and in many regions an increasingly diverse mix of different types
has been recorded. A combination of different antigens is therefore required to reliably differentiate hantavirus serotypes, to identify particular serotypes under consideration of endemic
aspects, and to simultaneously detect infections with several different serotypes. In Germany,
the direct or indirect detection of hantaviruses is notifiable.
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)
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)
Envoplakin (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)
parietal cells (PCA; IgG)
PM-Scl (PM-1; IgG)
phosphatidylserine (IgA, IgG, IgM, IgAGM)
PR3 hn-hr (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)
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)
Further autoimmune diagnostics:
gliadin (GAF-3X; IgA, IgG)
Saccharomyces cerevisiae (IgA, IgG)
Infectious serology:
Adenovirus (IgA, IgG, IgM)
Bordetella pertussis (IgM)
Bordetella pertussis toxin (IgA, IgG)
Bordetella FHA (IgA, IgG)
Borrelia (IgG, IgM)
Borrelia VlsE (IgG)
Brucella abortus (IgA, IgG, IgM)
Campylobacter jejuni (IgA, IgG)
Chikungunya virus (IgG)
Chlamydia pneumoniae (IgA, IgG, IgM)
Chlamydia trachomatis (IgA, IgG, IgM)
Cytomegalovirus (IgG, IgM)
Dengue virus (IgA, 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; IgG, IgM)
HSV-2 (glycoprotein G2; 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)
TBE virus (IgG, IgM)
Tetanus toxoid (IgG)
Toxoplasma gondii (IgG, IgM)
Treponema pallidum (IgG, IgM)
Usutu virus (IgG)
Varicella zoster virus (IgG, IgM)
West Nile virus (IgG, IgM)
Yersinia enterocolitica (IgA, IgG)
Allergology:
total IgE
Allercoat™ 6-ELISA (650 different
allergens and allergen mixtures)
Software EUROIMMUN Allercoat™
Bone metabolism marker:
25-OH-Vitamin-D
Saliva diagnostics:
alpha-amylase
cortisol
sIgA
Software/Automation:
EUROLabOffice
EUROIMMUN Analyzer I + I-2P
* Currently not available as IVD in the EU.
Made in Germany
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
EUROIMMUN
Test Characteristics
Anti-Hanta Virus Pool 2 “America“ ELISA (IgM)
Autoantibody determination:
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 (IgG, IgM)
Borrelia-RN-AT-adv (IgM)
EBV Profile (IgG, IgM)
Hantavirus profiles (IgG, IgM)
Parvovirus B19 (IgG, IgM)
TORCH Profile* (IgG, IgM)
Westernblot:
Borrelia burgdorferi (IgG, IgM)
Borrelia afzelii (IgG, IgM)
Borrelia garinii (IgG, IgM)
Cytomegalovirus (IgG, IgM)*
Echinococcus granulosus (IgG)
Epstein-Barr virus (IgG, IgM)
Rubella virus (IgG)
Treponema pallidum (IgG, IgM)
Yersinia enterocolitica (IgA, IgG)
EUROLINE-WB:
Borrelia (IgG, IgM)
HSV-1/2 (IgG, IgM)
Helicobacter pylori (IgA, IgG)
Treponema pallidum + cardiolipin (IgG, IgM)
Allergology:
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)
Reference range: The levels of anti-hantavirus IgM antibodies were determined in 500 healthy blood donors1 using
the EUROIMMUN Anti-Hanta Virus Pool 2 “America“ ELISA
(IgM). With a cut-off ratio of 1.0, 0.2% of the blood donors
were anti-hantavirus positive.
EUROIMMUN
Radioimmunoassays
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.
CV
(%)
Mean
(Ratio)
1
2
8.1
2.2
9.0
9.3
1.5
2.3
1.9
10.8
3
4.9
2.4
1.6
11.4
VC
(%)
500 Blood donors
80
60
40
20
0.01
1
University Clinic of Schleswig-Holstein, Campus Luebeck, Germany; INSTAND e. V.:
Society for Promotion of Quality Assurance in the Medical Laboratories, Duesseldorf,
Germany; 3 Labquality, Helsinki, Finland.
0.1
n = 18
Ratio
1
10
Target values from
QA institutes
pos. borderl. neg.
EUROIMMUN pos.
Anti-Hanta
Virus Pool 2
borderl.
“America“
neg.
ELISA (IgM)
2
5*
0
0
0
0
1
0
0
12
*
Anti-PUUV positive sera. These sera can also
be detected due to potential cross reactions
with ANDV and SNV antigens.
Cross reactions: 84 sera from patients with different infectious diseases (positive IgM results)
were investigated with the Anti-Hanta Virus Pool 2 “America“ ELISA (IgM). Only one patient
with an acute CMV infection showed antibodies against hantavirus. This reaction was probably
the result of polyclonal B-cell stimulation, which can also occur, for example, in EBV infections.
Polyclonal B-cell stimulation is described extensively in the literature.
Antibodies against
n
CR
Antibodies against
n
CR
Borrelia burgdorferi
10
0%
Mumps virus
9
0%
CMV
10
10 %
Parvovirus 19
9
0%
EBV-CA
10
0%
Rubella virus
9
0%
HSV-1/2
2
0%
VZV
5
0%
Measles virus
10
0%
Toxoplasma gondii
10
0%
Technical data:
Antigen
A mixture of purified recombinant antigens (nucleocapsid proteins)
from the hantavirus strains Andes (AND) and Sin Nombre (SN).
Calibration
Semiquantitative, calculation of a ratio from the extinction of the sample
and the extinction of the calibrator.
Result interpretation
Ratio < 0.8:
Ratio > 0.8 to < 1.1:
Ratio > 1.1:
Sample dilution
Serum or plasma; 1 : 101 in sample buffer.
Reagents
Ready for use, with the exception of the wash buffer (10x). Colour-coded
solutions, in most cases exchangeable with those in other EUROIMMUN
ELISA kits.
Test procedure
60 min (37 °C) / 30 min / 15 min (room temperature). Fully automatable.
Measurement
450 nm. Reference wavelength between 620 nm and 650 nm.
Test kit format
96 break-off wells. Kit includes all necessary reagents.
Order number
EI 278h-9601-2 G
Antigen determination:
thyroglobulin (TG)
Mean
(Ratio)
100
Agreement with quality assessment results: 18 serologically
characterised patient samples2, 3 were investigated using the
EUROIMMUN Anti-Hanta Virus Pool 2 “America“ ELISA (IgM).
There was 100% agreement between the results of the ELISA
and the target values from the quality assurance institute
(borderline sera excluded).
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)
Serum
Inter-assay
variation, n = 4 x 6
0
Software/Automation:
EUROLineScan
camera system EUROBlotCamera
scanner system EUROBlotScanner
incubation processor EUROBlotMaster
Intra-assay
variation, n = 20
Frequency n
EUROLINE:
flexible profiles of up to 18 antigens from:
ENA and related antigens: nRNP/Sm, Sm,
RNP70, RNPA, RNPC, SS-A, Ro-52, SS-B, Scl-70,
PM-Scl, Jo-1, CENP B, PCNA, dsDNA, nucleosomes,
histones, ribosomal P-proteins, AMA M2, Mi-2, Ku
Systemic Sclerosis Profile: Scl-70, CENP A, CENP B,
RP11, RP155, fibrillarin, NOR90, Th/To, PM-Scl100,
PM-Scl75, Ku, PDGFR, Ro-52
Myositis Profiles: 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 Antigen Profiles: amphiphysin, CV2,
PNMA2 (Ma-2/Ta), Ri, Yo, Hu, recoverin, SOX1,
titin
Ganglioside Profiles: GM1, GM2, GM3,
GD1a, GD1b, GT1b, GQ1b
ANCA Profiles: MPO, PR3, GBM
Reproducubility: The reproducibility of the test was investigated by determining the intra- and inter-assay coefficients of variation using 3 sera. The intra-assay CVs are
based on 20 determinations and the inter-assay CVs on 4
determinations performed in 6 different test runs.
Cut-off
EUROIMMUN
Immunoblots
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
Medizinische
Labordiagnostika
AG
negative
borderline
positive
Made in Germany
Version: 09/11
EI_278h_D_UK_D01
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
EUROIMMUN
Medizinische
Labordiagnostika
AG
Anti-Chikungunya Virus ELISA (IgG)
Indications: Test system for the in vitro determination of antibodies of immunoglobulin class G
(IgG) against Chikungunya virus (CHIKV) in human serum or plasma for the diagnosis of the
following diseases: Chikungunya fever, Chikungunya fever associated arthritis and haemorrhagic fever.
Clinical signif cance: Chikungunya virus (enveloped ssRNA virus) is the pathogenic agent of
Chikungunya fever, an infectious tropical disease characterised by fever and joint pain. It is
transmitted by mosquitoes of the genus Aedes aegypti (Yellow fever mosquito) and Aedes albopictus (Asian tiger mosquito) that are active day and night. It is sensitive to heat (over 58°C),
dehydration, soap and disinfectants.
Chikungunya fever was first reported in 1952-53 during an epidemic in the Makonde plateau,
which is the border region between Tanzania and Mozambique, East Africa. In the Makonde
language the term Chikungunya stands for “crookedly walking patient“ due to its main symptom of severe joint and muscle pains accompanied by a high sensitivity to touch in the whole
body (70% to 99% of cases). In addition to the generally rapidly rising high fever (38.5 to 40°C),
Chikungunya virus infections are characterised by lymph node swelling, maculo-papulous rash
with little or moderate itching (approx. 50%), rarely occurring punctual bleeding of the skin (petechia), milder forms of mucosa bleeding, e.g. of the nose or gums (approx. 25%), headache,
fatigue and ophthalmitis. Placental or congenital transmission has also been described. The incubation period is 2 to 3 days (1 to 12 days are also possible). Chikungunya fever subsides after
around 10 days, generally without any lasting damage. Approx. 10% of patients experience joint
pains which persist for more than 3 weeks or even months and years. In some cases, fulminant
hepatitis or neurological complications such as encephalopathy or meningoencephalopathy
have been observed. Chikungunya virus infections lead to life-long immunity. Asymptomatic
infections have also been described.
Potential transmission cycles (human to human = urban cycle, or animal to human = sylvatic cycle)
and clinical symptoms partially resemble those of dengue fever and yellow fever. The Chikungunya virus is closely related to the O’nyong-nyong virus, the causative agent of O’nyong-nyong
fever. So far, reservoir hosts have been monkeys and rodents. According to its varying geographic distribution, the virus is divided into five subspecies which can be clearly genetically
differentiated: west African, central African, east and south African, Asian and Indian Ocean
subtypes. Meanwhile, the Chikungunya fever has spread dramatically worldwide.
Application of the Anti-Chikungunya Virus ELISA (IgG): Direct detection of Chikungunya virus
or Chikungunya virus particles by viral culture or RT-PCR is only possible during the viraemic
phase of disease and is negative once antibody titers are detectable. Specific anti-Chikungunya
virus antibodies can already be detected early after the onset of clinical symptoms using serological procedures (e.g. ELISA, IIFT). Antibody detection should be performed using serum
samples taken during the acute and convalescence phases, with a time interval between samples of at least 14 days. A four-fold titer increase in anti-Chikungunya virus IgG antibodies is
significant for a fresh infection.
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)
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)
Envoplakin (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)
parietal cells (PCA; IgG)
PM-Scl (PM-1; IgG)
phosphatidylserine (IgA, IgG, IgM, IgAGM)
PR3 hn-hr (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)
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)
Further autoimmune diagnostics:
gliadin (GAF-3X; IgA, IgG)
Saccharomyces cerevisiae (IgA, IgG)
Infectious serology:
Adenovirus (IgA, IgG, IgM)
Bordetella pertussis (IgM)
Bordetella pertussis toxin (IgA, IgG)
Bordetella FHA (IgA, IgG)
Borrelia (IgG, IgM)
Borrelia VlsE (IgG)
Brucella abortus (IgA, IgG, IgM)
Campylobacter jejuni (IgA, IgG)
Chikungunya virus (IgG)
Chlamydia pneumoniae (IgA, IgG, IgM)
Chlamydia trachomatis (IgA, IgG, IgM)
Cytomegalovirus (IgG, IgM)
Dengue virus (IgA, 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; IgG, IgM)
HSV-2 (glycoprotein G2; 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)
TBE virus (IgG, IgM)
Tetanus toxoid (IgG)
Toxoplasma gondii (IgG, IgM)
Treponema pallidum (IgG, IgM)
Usutu virus (IgG)
Varicella zoster virus (IgG, IgM)
West Nile virus (IgG, IgM)
Yersinia enterocolitica (IgA, IgG)
Allergology:
total IgE
Allercoat™ 6-ELISA (650 different
allergens and allergen mixtures)
Software EUROIMMUN Allercoat™
Bone metabolism marker:
25-OH-Vitamin-D
Saliva diagnostics:
alpha-amylase
cortisol
sIgA
Software/Automation:
EUROLabOffice
EUROIMMUN Analyzer I + I-2P
* Currently not available as IVD in the EU.
Made in Germany
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
EUROIMMUN
Test characteristics
Anti-Chikungunya Virus ELISA (IgG)
EUROIMMUN
Immunoblots
Autoantibody determination:
EUROLINE:
flexible profiles of up to 18 antigens from:
ENA and related antigens: nRNP/Sm, Sm,
RNP70, RNPA, RNPC, SS-A, Ro-52, SS-B, Scl-70,
PM-Scl, Jo-1, CENP B, PCNA, dsDNA, nucleosomes,
histones, ribosomal P-proteins, AMA M2, Mi-2, Ku
Systemic Sclerosis Profile: Scl-70, CENP A, CENP B,
RP11, RP155, fibrillarin, NOR90, Th/To, PM-Scl100,
PM-Scl75, Ku, PDGFR, Ro-52
Myositis Profiles: 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 Antigen Profiles: amphiphysin, CV2,
PNMA2 (Ma-2/Ta), Ri, Yo, Hu, recoverin, SOX1,
titin
Ganglioside Profiles: 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)
Linearity: The linearity of the Anti-Chikungunya Virus ELISA (IgG) was determined by assaying 4 serial dilutions of 6 serum samples. The linear regression R2 amounted to > 0.95 for all
samples. The EUROIMMUN Anti-Chikungunya Virus ELISA (IgG) is linear in the tested concentration range of 2-200 RU/ml.
Reproducibility: The reproducibility of the test was investigated by determining the intra- and inter-assay coefficients of variation using 3 sera. The intra-assay CVs are
based on 20 determinations and the inter-assay CVs on 4
determinations performed in 6 different test runs.
Reference range: Levels of anti-Chikungunya virus IgG antibodies were analysed in 498 healthy blood donors1 using the EUROIMMUN Anti-Chikungunya Virus ELISA (IgG).
With a cut-off of 20 RU/ml, 2 % of the blood donors were
anti-Chikungunya virus positive.
Intra-assay
variation, n = 20
Mean
(RU/ml)
CV
(%)
1
22
2
37
3
95
Westernblot:
Borrelia burgdorferi (IgG, IgM)
Borrelia afzelii (IgG, IgM)
Borrelia garinii (IgG, IgM)
Cytomegalovirus (IgG, IgM)*
Echinococcus granulosus (IgG)
Epstein-Barr virus (IgG, IgM)
Rubella virus (IgG)
Treponema pallidum (IgG, IgM)
Yersinia enterocolitica (IgA, IgG)
EUROLINE-WB:
Borrelia (IgG, IgM)
HSV-1/2 (IgG, IgM)
Helicobacter pylori (IgA, IgG)
Treponema pallidum + cardiolipin (IgG, IgM)
Allergology:
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)
Mean
(RU/ml)
CV
(%)
9.7
24
9.1
7.1
36
7.1
8.4
101
6.0
120
498 Blood donors
100
80
60
40
20
Infectious serology:
EUROLINE:
Bordetella pertussis (IgA, IgG)
Borrelia-RN-AT (IgG, IgM)
Borrelia-RN-AT-adv (IgM)
EBV Profile (IgG, IgM)
Hantavirus profiles (IgG, IgM)
Parvovirus B19 (IgG, IgM)
TORCH Profile* (IgG, IgM)
Inter-assay
variation, n = 4 x 6
Serum
Frequency n
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
Medizinische
Labordiagnostika
AG
0
0.1
1
10
20
100
RU/ml
Correlation of the EUROIMMUN Anti-Chikungunya Virus
ELISA (IgG) with the EUROIMMUN Anti-Chikungunya Virus
IIFT (IgG): Antibodies against Chikungunya virus were analysed in 22 quality control sera 2 using the EUROIMMUN AntiChikungunya Virus
Vir ELISA (IgG) and the EUROIMMUN AntiChikungunya Virus IIFT as reference test. There was 100%
agreement between the results of the two test systems.
EUROIMMUN
Anti-Chikungunya
Virus IIFT (IgG)
n = 22
pos. borderl. neg.
EUROIMMUN pos.
Anti-Chikunborderl.
gunya Virus
neg.
ELISA (IgG)
16
0
0
0
0
0
0
0
6
1
University Clinic of Schleswig-Holstein, Campus Luebeck, Germany; 2 Origin of sera:
France and Germany.
Cross reactivity: 240 sera from patients with different infectious dis- eases (positive IgG results)
who have not previously been infected with Chikungunya virus were investigated with the AntiChikungunya Virus ELISA (IgG). No cross reactions (CR) were found.
Antibodies against
n
CR
Antibodies against
n
CR
Antibodies against
n
CR
Antibodies against
n
CR
Adenovirus
12
0%
EBV-CA
12
0%
Measles virus
12
0%
RSV
12
0%
Bordetella FHA
12
0%
Helicobacter pylori
12
0%
Mumps virus
12
0%
Rubella virus
12
0%
Bordetella pertussis
12
0%
HSV-1
12
0%
Mycoplasma pneum.
12
0%
Toxoplasma gondii
12
0%
Chlamydia pneum.
12
0%
Inf uenza A virus
12
0%
Parainf uenza virus pool
12
0%
VZV
12
0%
CMV
12
0%
Inf uenza B virus
12
0%
Parvovirus B19
12
0%
Yersinia enterocolitica
12
0%
Software/Automation:
EUROLineScan
camera system EUROBlotCamera
scanner system EUROBlotScanner
incubation processor EUROBlotMaster
EUROIMMUN
Radioimmunoassays
Technical data:
Antigen
Recombinant, eukaryotically expressed viral structural protein.
Calibration
Quantitative, in relative units per milliliter (RU/ml).
Calibration serum 1:
200 RU/ml
Calibration serum 2:
20 RU/ml
Calibration serum 3:
2 RU/ml
Result interpretation
EUROIMMUN recommends intepreting results as follows:
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)
< 16 RU/ml:
negative
> 16 to < 22 RU/ml:
borderline
> 22 RU/ml:
positive
Semiquantitative evaluation using a ratio is also possible.
Antigen determination:
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
Version: 02/12
EI_293a_D_UK_A02
Sample dilution
Serum or plasma; 1 : 101 in sample buffer.
Reagents
Ready to use, exception: wash buffer (10x). Colour-coded solutions, in
most cases exchangeable with those in other EUROIMMUN ELISA kits.
Test procedure
360 min (37 °C) / 30 min / 15 min (room temerpature). Fully automatable.
Measurement
450 nm. Reference wavelength between 620 nm and 650 nm.
Test kit format
96 break-off wells. Kit includes all necessary reagents.
Order number
EI 293a-9601 G
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
EUROIMMUN
Medizinische
Labordiagnostika
AG
EUROLINE Hantavirus Prof les 1 and Global (IgG, IgM)
Antigen combination
Examples of incubated strips
PUUV Puumala
PUUV Puumala
PUUV
DOBV Dobrava
DOBV Dobrava
DOBV
HTNV Hantaan
HTNV Hantaan
HTNV
SEOV Seoul
SEOV
SNV Sin Nombre
SNV
ANDV Andes
ANDV
IgG
IgM
IgG
IgM
Control
Control
DN 278h-1601-1 G, M
IgG
IgM
Control
DN 278h-1601-2 G, M
Technical data
Application
Determination of human antibodies of immunoglobulin classes IgG and IgM against three (Profile 1) or six (Profile Global) Hantavirus serotypes Puumala (PUUV), Dobrava (DOBV), Hantaan
(HTNV), Seoul (SEOV), Sin Nombre (SNV) and Andes (ANDV) for the serological diagnosis of
Hantavirus infections.
Antigen substrates
Membrane chips printed with individual lines of purified, biochemically characterised antigens
(nucleocapsid antigens of different Hantavirus serotypes). Each group of antigens is coated onto
a separate membrane chip, providing optimal efficiency of antibody detection for each antigen.
Sample dilution
Serum or plasma; 1:101.
Test procedure
30 min / 30 min / 10 min, room temperature.
Automation
Compatible with all commercial blot processing systems.
Computer-based evaluation and archiving of results with EUROLineScan programme.
Kit format
16 membrane strips. Kits include all necessary reagents.
EUROIMMUN AG · D-23560 Luebeck (Germany) · Seekamp 31 · Tel +49 451 58550 · Fax 5855591 · E-mail [email protected] · www.euroimmun.de
DN_278h_I_UK_A02, 03/2011
EUROIMMUN
Medizinische
Labordiagnostika
AG
Serological Diagnosis of Tropical Diseases
and Special Infections using BIOCHIP Mosaics
Togavirus
Dengue Virus Mosaic
Anti-West Nile virus
Anti-Chikungunya virus
Flavivirus
Coronavirus
Anti-Jap. encephalitis virus
Anti-yellow fever virus
Anti-SARS coronavirus
Single substrates in combination with non-infected cells
Syndrome-oriented combinations of single substrates
Geographically oriented combinations of single substrates
IgG absorption for the detection of specific IgM antibodies
Sandfly Fever Virus Mosaic
Crimean-Congo Fever Virus
Mosaic
Bunyavirus
Hantavirus Mosaic
Anti-Rift Valley fever virus
Plasmodium, EUROPLUS
Protozoa
Anti-Leishmania donovani
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
EUROIMMUN
Medizinische
Labordiagnostika
AG
FLAVIVIRUSES
Dengue virus type 1
(DENV 1)
Dengue virus type 4
(DENV 4)
Dengue virus type 2
(DENV 2)
Dengue virus type 3
(DENV 3)
Anti-DENV pos.
The sensitivity and specificity of the Dengue Virus Mosaic were determined using serologically precharacterised positive sera from
dengue fever patients 1-3 and sera from healthy blood donors 4 as negative controls.
n
Anti-DENV 1-4 positive
n
Anti-DENV 1-4 positive
Patients with dengue fever
59
57
Patients with dengue fever
65
64
Blood donors
200
9
Blood donors
150
IgG
IgM
7
Sensitivity
97 %
Sensitivity
99 %
Specificity
96 %
Specificity
96 %
1
Centre for Biological Safety, Robert Koch Institute, Berlin, Germany (IgG: n = 17, IgM: n = 10); 2 Reference Centre for Imported Virus Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany (IgG: n = 14, IgM: n = 11); 3 King Abdulaziz University Hospital,
Jeddah, Saudi Arabia (IgG: n = 28, IgM: n = 44); 4 University Medical Center Schleswig-Holstein, Campus Luebeck, Germany.
Anti-TBE Virus IIFT, order no. FI/FK 2661- #### G or M
TBE virus (TBEV)
Non-infected cells
Anti-TBE virus pos.
The sensitivity and specificity of the Anti-TBE Virus IIFT were determined using serologically precharacterised positive sera from TBE
virus infected patients 1 and sera from healthy blood donors 2 as negative controls.
n
Anti-TBE virus positive
TBE virus infected patients
112
106
Blood donors
100
5
IgG
n
Anti-TBE virus positive
TBE virus infected patients
83
82
Blood donors
100
IgM
0
Sensitivity
95 %
Sensitivity
99 %
Specificity
95 %
Specificity
100 %
TBE: tick-borne encephalitis; 1 Centre for Biological Safety, Robert Koch Institute, Berlin, Germany (IgG: n = 112, IgM: n = 83), 2 University
Medical Center Schleswig-Holstein, Campus Luebeck, Germany; Literature: Sonnenberg K, Niedrig M, Steinhagen K, Rohwäder E, Meyer
W, Schlumberger W, Müller-Kunert E, Stöcker W. State-of-the-art serological techniques for detection of antibodies against tick-borne
encephalitis virus. Int J Med Microbiol 293, Suppl. 37: 148-151 (2004).
Anti-Yellow Fever Virus IIFT, order no. FI/FK 2665- #### G or M
Yellow fever virus
(YFV)
Non-infected cells
Anti-YFV pos.
For information regarding test kit formats and ordering see last page.
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
2
EUROIMMUN
Medizinische
Labordiagnostika
AG
The sensitivity and specificity of the Anti-Yellow Fever Virus IIFT were determined using serologically precharacterised sera from individuals vaccinated with the 17D-YFV vaccine 1 and sera from healthy blood donors 2 as negative controls.
IgG
n
Anti-yellow fever virus positive
17D-YFV vaccinated persons
150
142
Blood donors
150
8
IgM
n
Anti-yellow fever virus positive
17D-YFV vaccinated persons
144
136
Blood donors
150
5
Sensitivity
95 %
Sensitivity
94 %
Specificity
95 %
Specificity
97 %
1
Berna Biotech Ltd., Switzerland; 2 University Medical Center Schleswig-Holstein, Campus Luebeck, Germany; Literature: Niedrig M,
Kürsteiner O, Herzog C, Sonnenberg K. Evaluation of an indirect immuofluorescence assay for detection of IgM and IgG antibodies
against yellow fever virus. Clin Vaccine Immunol 15(2): 177-81 (2008).
Anti-Japanese Encephalitis Virus IIFT, order no. FI/FK 2663-#### G or M
Japanese encephalitis
virus (JEV)
Non-infected cells
Anti-JEV pos.
The sensitivity and specificity of the Anti-Japanese Encephalitis Virus IIFT were determined using serologically precharacterised positive
and negative sera from individuals vaccinated against JEV 1 and sera from healthy blood donors 2 as negative controls.
n
Anti-Japanesce encephalitis virus positive
n
Anti-Japanesce encephalitis virus positive
Persons vaccinated against JEV
IgG
98
91
Persons vaccinated against JEV
IgM
50
44
JEV-negative persons
102
0
Blood donor
80
0
Sensitivity
93 %
Sensitivity
88 %
Specificity
100 %
Specificity
100 %
1
Centre for Biological Safety, Robert Koch Institute, Berlin, Germany (IgG: n = 98 persons precharacterised as positive, n = 102 persons
precharacterised as negative; IgM: n = 50 samples precharacterised as positive); 2 University Medical Center Schleswig-Holstein, Campus
Luebeck, Germany; Literature: Litzba N, Klade CS, Lederer S, Niedrig M. Evaluation of serological diagnostic test systems assessing the
immune response to Japanese encephalitis vaccination. PLoS Neglected Tropical Diseases (2010), accepted.
Anti-West Nile Virus IIFT, order no. FI/FK 2662-#### G or M
West Nile virus
(WNV)
Non-infected cells
Anti-WNV pos.
The sensitivity and specificity of the Anti-West Nile Virus IIFT were determined using serologically precharacterised positive sera from
patients with West Nile fever 1, 2 and sera from healthy blood donors 3 as negative controls.
n
Anti-West Nile virus positive
n
Anti-West Nile virus positive
West Nile fever patients
IgG
57
57
West Nile fever patients
IgM
17
16
Blood donors
200
5
Blood donors
150
Sensitivity
100 %
Sensitivity
Specificity
98 %
Specificity
1
0
94 %
100 %
2
Saskatchewan Disease Control Laboratory, Regina, Saskatchewan, Canada (IgG: n = 40); SeraCare Life Science Inc., California, USA
(IgG: n =17; IgM: n = 17); 3 University Medical Center Schleswig-Holstein, Campus Luebeck, Germany; Literature: Niedrig M, Sonnenberg
K, Steinhagen K, Paweska JT. Comparison of ELISA and immunoassays for measurement of IgG and IgM antibody to West Nile virus
in human sera against virus neutralisation. J Virol Methods 139: 103-105 (2007).
For information regarding test kit formats and ordering see last page.
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
3
Medizinische
Labordiagnostika
AG
EUROIMMUN
Anti-West Nile Virus IIFT (IgG, avidity determination), order no. FI 2662-#### X
IgG avidity was determined with the Anti-West Nile Virus IIFT using serologically precharacterised sera1 from patients with acute West
Nile fever (2 - 43 days after the onset of symtoms) and from patients with long past infections .
Anti-West-Nile virus IgG positive
Low-avidity
IgG
IgG
n
High avidity
Low avidity
Acute phase
80
1
78
Late phase
61
61
0
+ Urea
Destroyed
bond
Virus antigen
High-avidity
IgG
+ Urea
98 %
Agreement with expected value for high avidity
100 %
Saskatchewan Disease Control Laboratory, Regina, Saskatchewan, Canada; Literature: Levett
PN, Sonnenberg K, Sidaway G, Shead S, Niedrig M, Steinhagen K, Horsman GB, Debrot MA.
Use of immunoglobulin G avidity assays for differentiation of primary from previous infections
with West Nile virus. J Clin Microbiol 43: 5873-5875 (2005).
1
Stable
bond
Virus antigen
Agreement with expected value for low avidity
BIOCHIP Mosaics and profiles for the diagnosis of flavivirus infections
Flavivirus mosaics and profiles from EUROIMMUN are designed for parallel determination of different specific antibodies. They are
used to identify cross reactions between different flavivirus types and allow reliable differential diagnosis in infections with similar or
unclear symptoms.
Flavivirus Mosaic 1, order no. FI/FK 2661-####-1 G or M
AntiTBEV pos.
TBE virus
(TBEV)
Yellow fever virus
(YFV)
West Nile virus
(WNV)
Japanese encephalitis
virus (JEV)
AntiWNV pos.
Flavivirus Profile 2, order no. FI/FK 2661-####-2 G or M
Upper row
TBE virus
(TBEV)
Yellow fever virus
(YFV)
West Nile virus
(WNV)
AntiJEV pos.
AntiDENV pos.
Japanese encephalitis
virus (JEV)
Lower row
Dengue virus type 1
(DENV 1)
Dengue virus type 4
(DENV 4)
Dengue virus type 2
(DENV 2)
Dengue virus type 3
(DENV 3)
Flavivirus Mosaic 3, order no. FI/FK 2661-####-3 G or M
DENV 1
DENV 2
TBEV
DENV 3
DENV 4
WNV
AntiYFV pos.
AntiDENV pos.
Non-infected cells
JEV
YVF
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
4
EUROIMMUN
Medizinische
Labordiagnostika
AG
TOGAVIRUSES
Anti-Sindbis Virus IIFT, order no. FI/FK 291a-#### G or M*
Non-infected cells
Sindbis virus (SINV)
Anti-Sindbis virus pos.
Anti-Chikungunya Virus IIFT, order no. FI/FK 293a-#### G or M
Chikungunya virus
(CHIKV)
Non-infected cells
Anti-CHIKV pos.
The sensitivity and specificity of the Anti-Chikungunya Virus IIFT were determined using serologically precharacterised positve sera
from patients with Chikungunya fever 1, 2 and sera from healthy blood donors as negative controls 3.
n
Anti-Chikungunya virus positive
n
Anti-Chikungunya virus positive
CHIK fever patients
IgG
103
99
CHIK fever patients
IgM
131
126
Blood donors
100
0
Blood donors
100
2
Sensitivity
96 %
Sensitivity
96 %
Specificity
100 %
Specificity
98 %
1
National Reference Centre for Arboviruses, Pasteur Institute, Lyon, France (IgG: n = 56, IgM: n = 81); 2 Reference Centre for Imported
Virus Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany (IgG: n = 47, IgM: n = 50); 3 University Medical Center
Schleswig-Holstein, Campus Luebeck, Germany; Literature: Litzba N, Schuffenecker I, Zeller H, Drosten C, Emmerich P, Charrel R, Kreher
P, Niedrig N. Evaluation of the first commercial chikungunya virus immunofluorescence test. J Virol Meth 149: 175-179 (2008).
BUNYAVIRUSES
Anti-Rift Valley Fever Virus IFT, order no. FI/FK 280a-#### G or M
Rift Valley fever virus
(RVFV)
Non-infected cells
Anti-RVFV pos.
Sandfly Fever Virus Mosaic 1, order no. FI/FK 277a-####-1 G or M
Serotype Sicilian
(SFSV)
Serotype Cyprus
(CYPV)
Serotype Naples
(SFNV)
Serotype Toscana
(TOSV)
Anti-sandfly fever
virus pos.
For information regarding test kit formats and ordering see last page. *Currently not available as IVD in the EU.
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
5
EUROIMMUN
Medizinische
Labordiagnostika
AG
Crimean-Congo Fever Virus Mosaic 2, order no. FI/FK 279a-####-2 G or M
CCHFV nucleocapsid
protein (CCHFV-N)
p
CCHFV glycoprotein
precursor (CCHFV-GPC)
p
Control-transfected cells
Anti-CCHFV- Anti-CCHFVN pos.
GPC pos.
The sensitivity and specificity of the Crimean-Congo Fever Virus Mosaic 2 were determined using serologically precharacterised positive sera
from patients with clinically manifest CCHFV infections 1 or patients with excluded CCHFV infection 1 and sera from healthy blood donors 2.
n
Anti-CCHFV positive
CCHFV infected patients
IgG
191
171
Control persons
88
0
n
Anti-CCHFV positive
CCHFV infected patients
IgM
178
173
Control persons
203
5
Sensitivity
90 %
Sensitivity
97 %
Specificity
100 %
Specificity
98 %
CCHFV: Crimean-Congo haemorrhagic fever virus; 1 Refik Saydam National Centre of Hygiene, Ankara, Turkey (IgG: n = 191 and IgM:
n = 178 samples precharacterised as positive; IgG: n = 43 and IgM: n = 160 samples precharacterised as negative); 2 University Medical
Center Schleswig-Holstein, Campus Luebeck, Germany (IgG: n = 45, IgM: n = 43).
Hantavirus Mosaic 1, order no. FI/FK 278h-####-1 G or M
Hantaan virus (HTNV)
Sin Nombre virus (SNV)
Puumala virus (PUUV)
Dobrava virus (DOBV)
Seoul virus (SEOV)
Saaremaa virus (SAAV)
Anti-hantavirus pos.
Hantavirus Mosaic 3: America, order no. FI/FK 278m-####-3 G or M
Sin Nombre virus (SNV)
Andes virus (ANDV)
Anti-hantavirus pos.
The sensitivity and specificity of the Hantavirus Mosaics were determined using serologically precharacterised positive sera from patients with PUUV, SEOV, SNV, DOBV and ANDV infections 1-5 and sera from healthy blood donors 4, 6 as negative controls.
IgG
PUUV patients
1
n
Anti-hantavirus positive
IgM
1
n
Anti-hantavirus positive
52
52
PUUV patients
52
51
SEOV patients2
5
5
SEOV patients2
5
5
DOBV patients3
8
8
DOBV patients3
3
3
SNV patients4
20
19
SNV patients4
17
16
ANDV patients5
52
52
ANDV patients5
56
51
Blood donors4, 6
89
2
Blood donors4, 6
89
0
Sensitivity
99 %
Sensitivity
96 %
Specificity
98 %
Specificity
100 %
1
Department of Virology, Haartman Institute, University of Helsinki, Finland; 2 Department of Microbiology, Faculty of Medicine, Chinese University of Hongkong, PR China; 3 Arbovirus Reference Centre, Laboratory for Vector-Transmitted Infections, Cantacuzino Institute, Bucharest,
Romania; 4 National Microbiology Laboratory, Health Canada, Winnipeg, Canada (IgG and IgM: n = 25 sera from healthy blood donors); 5 National Reference Centre for Tropical Infectious Diseases / Virological Diagnostics, Bernhard Nocht Institute for Tropical Medicine, Hamburg,
Germany; 6 University Medical Center Schleswig-Holstein, Campus Luebeck, Germany (IgG and IgM: n = 64 sera from healthy blood donors).
Literature: Lederer S, Lattwein E, Hanke M, Sonnenberg K, Stoecker W, Lundkvist A, Vaheri A, et al. Indirect immunofluorescence assay
for the simultaneous detection of antibodies against clinically important old and new world hantaviruses. PLoS Negl Trop Dis. 7 (4) 2013.
For information regarding test kit formats and ordering see last page.
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
6
EUROIMMUN
Medizinische
Labordiagnostika
AG
CORONAVIRUSES
Anti-SARS Coronavirus IIFT, order no. FI/FK 2601-#### A, G or M
SARS coronavirus
(SARS CoV)
Non-infected cells
Anti-SARS CoV pos.
The sensitivity and specificity of the Anti-SARS Coronavirus IIFT were determined using sera from SARS patients (at least 10 days after
disease onset) 1 and sera from healthy blood donors 2 as negative controls.
IgG
1
n
Anti-SARS CoV positive
n
Anti-SARS CoV positive
SARS patients
22
21
SARS patients
IgM
22
17
Blood donors
200
0
Blood donors
151
0
Sensitivity
95 %
Sensitivity
77 %
Specificity
100 %
Specificity
100 %
You‘an Hospital, Beijing, PR China; 2 University Medical Center Schleswig-Holstein, Campus Luebeck, Germany
Anti-MERS Coronavirus IIFT, order no. FI/FK 2604-#### G or M*
MERS coronavirus
(MERS-CoV)
Non-infected cells
Anti-MERS CoV pos.
PROTOZOA
EUROPLUS, Plasmodium falciparum, order no. FI/FK 2264-####-50 G
HRP-2
MSP-2
EUROPLUS
Plasmodium falciparum
Recombinant antigens:
HRP: histidine rich protein
MSP: merozoite surface protein
The sensitivity and specificity of the Plasmodium falciparum EUROPLUS were calculated using serologically precharacterised sera from
patients with malaria tropica or malaria tertiana 1, 2 and sera from healthy blood donors 3.
IgG
n
Anti-Plasmodium falciparum positive
Patients with malaria tropica (Plasmodium falciparum infection)
101
91
Patients with malaria tertiana (Plasmodium vivax infection)
20
---
Blood donors
50
0
Sensitivity
90 %
Specificity
100 %
1
Hospital in Accra, Ghana; 2 Clinic of the LMU Munich, Department for Infectious and Tropical Medicine, Munich, Germany; 3 University
Medical Center Schleswig-Holstein, Campus Luebeck, Germany.
For information regarding test kit formats and ordering see last page. *Currently not available as IVD in the EU.
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
7
EUROIMMUN
Medizinische
Labordiagnostika
AG
Anti-Leishmania donovani IIFT, order no. FI/FK 2231-####
# A, G or M
BIOCHIPs with smears of Leishmania donovani
are available as single substrates for IIFT. They
can also be combined with further substrates in
special mosaics to cover the distribution areas of
the vector (sandfly or psychodidae).
Anti-L. donovani pos.
The specificity and sensitivity of the Anti-Leishmania donovani IIFT were determined using sera that were precharacterised clinically
and by laboratory diagnostics 1, 2 and sera from healthy blood donors3, 4 as negative controls.
n
Anti-L. donovani positive
Patients with visceral leishmaniasis
IgG
10
10
Blood donors
328
2
Sensitivity
100 %
Specificity
99 %
1
National Reference Centre for Tropical Infectious Diseases / Virological Diagnostics, Bernhard Nocht Institute for Tropical Medicine,
Hamburg, Germany (n = 5); 2 All India Institute of Medical Science, New Delhi, India (n = 5); 3 University Medical Center Schleswig-Holstein,
Campus Luebeck, Germany (n = 200); 4 Zimbabwe (n = 128).
TREMATODES
Anti-Schistosoma mansoni IIFT, order no.: FI/FK 2300-####
#G
Anti-Sch. mansoni pos.
The slide contains BIOCHIPs with frozen tissue sections of adult Schistosoma mansoni worms. If antibodies against Schistosoma
mansoni are present in the sample, the substrate shows a specific fluorescence of the outer membrane and/or the intestine. The entire
tissue can be broadly stained.
Order information
For special diagnostic applications further BIOCHIP combinations can be produced from the entire EUROIMMUN
range.
Test kit formats
FI
FK
A
G
M
X
Test kit with reagents
Single slide with cover glasses
Immunoglobulin class A
Immunoglobulin class G
Immunoglobulin class M
Low-avidity antibodies of immunoglobulin class G
####
1003
1005
1010
2005
2010
Format (slide x fields)
10 slides with 3 fields each
10 slides with 5 fields
10 slides with 10 fields each
20 slides with 5 fields each
20 slides with 10 fields each
EUROIMMUN slides are optimally incubated using the TITERPLANE Technology. For this you will need special
reagent trays (order no. ZZ 9999-0110), which must be ordered separately. If you are new to this technology, our
local EUROIMMUN experts will be happy to give you an introduction (for an overview of EUROIMMUN subsidiaries
and distributors see our website www.euroimmun.com).
EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail [email protected]
FI_2600_I_UK_B12, 05/2014
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