Latest Changes: December 13th, 2012
EUROIMMUN Innovations at a Glance
Identify hepatitis E Virus (HEV) infections reliably with ELISA tests from EUROIMMUN
Infections with hepatitis E virus (HEV) are the most frequent cause of non-A, non-B hepatitis worldwide. Since hepatitis E resembles not only hepatitis A, but in its early stages other hepatides as well, differential diagnostic tests as part of the clinical and laboratory investigation are essential, especially in view of the potentially life-threatening nature of the infection.
Alongside PCR analysis of viral RNA in blood or stool (recommended method in the early stages of infection), the detection of HEV-specific IgM and IgG antibodies plays a decisive role in acute diagnostics.
EUROIMMUN now offers two new ELISAs for the detection of HEV-specific antibodies of class IgG and IgM:
Test | Ig class | Oder no. |
Anti-Hepatitis E Virus (HEV) ELISA | IgG, IgM | EI 2525 G or M |
Test advantages at a glance:
- Highest sensitivity and specificity for antibody detection through use of carefully selected recombinant target antigens of HEV genotypes 1 and 3 as the antigenic substrate
- Quantification in international units (IU/ml) – the only commercial anti-HEV ELISA (IgG) to offer this
- First-rate linearity with respect to the WHO standard
- Ideal for differential diagnostics, blood donor screening (in combination with PCR detection of HEV RNA) and epidemiology
- Fully automatable
Anti-Borrelia EUROLINE-RN-AT-adv: highest specificity for borreliosis diagnostics through OspC advanced
- Probst et al., ICLB 2010
IgM antibodies against OspC are the most important serological marker for the diagnosis of acute infections with Borrelia. Scientific studies have shown that native OspC (dimeric form) is an outstanding antigenic substrate. However, the standardised production of native OspC is complicated, and for this reason recombinant OspC is often used in commercial tests. In order to achieve high expression rates, recombinant OspC protein is generally expressed in a shortened form, which prevents to a large extent the formation of covalently bound dimers. In serological tests monomeric OspC reacts with a lower sensitivity than dimeric OspC (Probst et al., 2012) and must therefore be employed in high concentrations. Although this leads to an acceptable detection rate, a large number of unspecific reactions occur.
Scientists at EUROIMMUN have successfully produced recombinant, covalently bound dimeric OspC using genetic techniques (European patent EP 2 199 303 A1). This OspC advanced antigen is over 30% more specific than conventional recombinant OspC, with the same sensitivity as native OspC. OspC advanced is the most important antigenic component in the new Anti-Borrelia EUROLINE-RN-AT-adv (DN 2132-2 M). Thus, with this lineblot the risk of false positive IgM results in borreliosis serology is minimised. Moreover, antibodies against all relevant human pathogenic Borrelia genospecies are reliably detected, since the test contains OspC advanced from B. afzelii, B. burgdorferi, B. garinii and B. spielmanii.
The Anti-Borrelia EUROLINE-RN-AT-adv is part of a complete package for Borrelia diagnostics from EUROIMMUN, which is designed to fulfil all your needs. It is based on international guidelines for two-stage borreliosis diagnostics (DGHM, Germany; RKI, Germany; CDC, USA) and for cerebrospinal fluid (CSF) diagnostics. All reagents are CE certified, and comprehensive automation solutions are available for all test systems. Extensive evaluation data are provided on request.
| Test | Order no. |
Screening test | Anti-Borrelia-plus-VlsE ELISA (IgG) | EI 2132-2 G |
Anti-Borrelia ELISA (IgM) | EI 2132 M | |
Anti-Borrelia Select ELISA (IgG, IgM) | EI 2132-5 G/M | |
Anti-Borrelia IIFT EUROPLUS | FI 2136-1 G/M | |
Confirmatory test | Anti-Borrelia EUROLINE-WB | DY 2131-1 G/M |
Anti-Borrelia Westernblots (all three genospecies) | DY 2131/2/4 G/M | |
Anti-Borrelia EUROLINE-RN-AT | DN 2131 G/M | |
Anti-Borrelia EUROLINE-RN-AT-adv | DN 2131-2 M | |
CSF diagnostics | Anti-Borrelia-plus-VlsE ELISA (IgG) for CSF* | EI 2132-L G |
Anti-Borrelia ELISA (IgM) for CSF* | EI 2132-L M |
* Including ready-to-use, colour-coded controls for verification of the incubation/evaluation
New products for Chlamydia diagnostics
- Anti-C.-trachomatis-EUROLINE-WB
EUROIMMUN Anti-Chlamydia ELISAs (IgA, IgG, IgM) are now available as new screening tests. The ELISAs employ antigens from both C. trachomatis and C. pneumoniae, for example genus-specific LPS (lipopolysaccharide), OMPs (outer membrane proteins) and MOMP (major outer membrane protein), ensuring that antibodies against both species are reliably detected.
EUROIMMUN also offers immunoblots for antibody detection. In the Anti-Chlamydia trachomatis EUROLINE-WB (IgA, IgG) three different antigen categories are used:
1) An electrophoretically separated antigen extract from C. trachomatis
2) Chlamydia-cross-reacting LPS (contained in the antigen extract)
3) Highly specific recombinantly produced MOMP antigens
This combination ensures high sensitivity and specificity.
Advantages of the Anti-C. trachomatis EUROLINE-WB at a glance:
- Unique combination of 3 antigen categories: cross-reacting LPS, specific WB bands and species-specific MOMP
- Very good agreement with results from precharacterised sera (INSTAND e. V.)
- Good correlation with competitor tests
- Very high sensitivity and specificity
- Identical incubation times for all EUROIMMUN infection blots, for easy parallel processing
- Automated incubation and software-based evaluation
(
EUROBlotMaster, EUROBlotOne, EUROLineScan)
EUROIMMUN Anti-Chlamydia tests | Ig class | Oder no. |
Anti-Chlamydia MIF | IgA, IgG, IgM | FI 2190-3 A, G or M |
Anti-Chlamydia ELISA | IgA, IgG, IgM | EI 2190 A, G or M |
Anti-C. trachomatis ELISA | IgA, IgG, IgM | EI 2191 A, G or M |
Anti-C. pneumoniae ELISA | IgA, IgG, IgM | EI 2192 A, G or M |
Anti-C. trachomatis EUROLINE-WB | IgA, IgG | DY 2191-1 A or G |
New Anti-Enterovirus ELISAs: a useful supplement to direct pathogen detection
Our product portfolio for infectious serology has been expanded by the introduction of EUROIMMUN Anti-Enterovirus ELISAs for IgA, IgG and IgM. These tests supplement the Anti-Enterovirus Mosaic 1 (IIFT) and are based on cross-reacting, recombinant VP1 antigens from echovirus and coxsackievirus. This antigen substrate guarantees a consistent antigen composition, in contrast to lysate-based tests.
The ELISAs are highly suited for specific antibody detection and are a useful supplement to direct pathogen detection for the diagnosis of enterovirus infections. A positive IgM and/or IgA result together with a significant increase in the IgG titer in a follow-up sample is considered a clear indication of an acute or recent enterovirus infection.
Test | Ig class | Order no |
IFT: Anti-Enterovius Mosaic 1 | IgA, IgG, IgM | FI 2730-5 A, G or M |
Anti-Enterovirus ELISA | IgA, IgG, IgM | EI 2730 A, G or M |
MEDICA 2012: 25 years of EUROIMMUN – 25 years of MEDICA participation
For a quarter of a century EUROIMMUN has provided you with reliable products for laboratory diagnostics – we thank you for your trust in us and your unwavering loyalty! It is thanks to you that EUROIMMUN has achieved 5th place in the new report "Top 100 ranking small and medium-sized companies" in Germany by the Munich Strategy Group (MSG). EUROIMMUN now belongs to the "spearhead of small and medium-sized companies", which excel by "constant first-rate performance, entrepreneurial vision and continuity". We are extremely pleased with our listing!
At MEDICA 2012, EUROIMMUN once again presented a host of interesting new developments
– in the following areas:
- Nephrology: Test systems for determination of autoantibodies against phospholipase A2 receptors (Anti-PLA2R) (associated with primary membranous glomerulonephritis).
- Neurology: New parameters for the diagnosis of autoimmune encephalitis – target antigens: VGKC (LGI1 + CASPR2), NMDA receptors, AMPA receptors, GABAB receptors and others.
- Infectious serology: For example an innovative ELISA for the detection of anti-hepatitis E virus antibodies (IgG, IgM) – quantifiable in international units (IgG) – outstanding agreement with the WHO standard.
- Allergology: The new product line SPAC (Single Purified Allergen Components) for molecular allergy diagnostics (SPAC Pollen: timothy grass, birch; SPAC insect venoms: wasp, bee).
- Gene diagnostics: Further EUROArrays for the parameters factor V/factor II (thrombophilia), HFE gene (haemochromatosis) and HLA DQ2/DQ8 (coeliac disease).
- Automation: The modularly constructed instruments EUROLabLiquidHandler and EUROTide (sample preparation and incubation), the immunoblot device EUROBlotOne (fully automated incubation and evaluation of blot strips), the Sprinter XL (high-throughput device for IIFT automation) and the system EUROPattern (automatic LED microscope and pattern-recognition software for evaluation of your ANA slides).
EUROPattern: Computer-Aided Immunofluorescence Microscopy (CAIFM)
- EUROPattern microscope
- EUROPattern is a high-performance automation solution designed by EUROIMMUN for the evaluation of immunofluorescence slides in autoimmune diagnostics.
- IIFT patterns and corresponding titers are automatically identified and given for each patient individually (including mixed patterns).
- Validation and export to LIS are carried out at a mouse click using EUROLabOffice (ELO).
- Automated identification of slides via matrix codes.
- Automated processing of up to 500 analysis positions in succession.
- 3D hand control for manual operation.
- Controlled LED (> 50,000 hrs of constant light flux).
- No dark room required.
Sprinter XL: Fast IFT automation for medium and high throughput - also available for ELISA
- Sprinter XL.
Coming soon!
- Consolidation: fully automated processing of immunofluorescence tests and ELISA on one system / in one run.
- Quick results: 4 washable needles and 2 arms allow efficient and optimised time management of worklists.
- Flexibility: various system configurations available to suit different laboratory needs.
- Quality and security: modern washing technology for brilliant fluorescence, clot detection, liquid level detection and precise pipetting.
- User-friendly software and system operation: only four steps to start a worklist.
- 160 (or 240) primary tubes (10 - 16 mm tube diameter).
- 64 (49) controls / calibrators, 20 (12) secondary reagents, 6 samples buffers and 4 wash buffers.
- Up to 30 slides / 6 microplates.
- 162 screening dilutions / 192 titer dilutions.
EUROBlotOne: Unique Automation Solution for the Immunoblot Work Station: From Sample Identification to Final Results
- EUROBlotOne
Coming soon!
- Fully automated system: Processing of immunoblot tests – from sample identification to the final result.
- Security: Integreted barcode identification ensures that the correct samples are pipetted.
- Flexibility: Autoimmune diagnostics, infectious serology and allergology on one system; many innovative multiparameter tests available.
- High walk-away capacity: Up to 44 samples can be analysed in one run.
- Simplified routine diagnostics: User-friendly software and hardware; minimal maintenance requirements.
- Reliability: Automated evaluation using the worldwide established and customer-friendly EUROLineScan software; bidirectional connection to LIS available (via EUROLineScan).
- All-in-one: One supplier providing complete service and support for reagents, automated processor and software.
Autoantibodies against phospholipase A2 receptors in the diagnosis of primary membranous glomerulonephritis
Primary membranous glomerulonephritis (MGN) is associated with autoantibodies against phospholipase A2 receptors (Anti-PLA2R) (Beck et al., N Engl J Med 361: 11, 2009). We have exploited this important new knowledge to rapidly develop new diagnostic tools. The detection of these antibodies can help you obtain a diagnosis (e.g. differentiation from secondary MGN) – and also provides information about the activity of the disease and the response to therapy.
EUROIMMUN exclusively offers two analysis options for this application: an indirect immunofluorescence test (IIFT; order no.: FA 1254-50) and an ELISA (order no.: EA 1254). The IIFT substrate comprises BIOCHIPs with human cells expressing recombinant PLA2R, while the ELISA utilises purified recombinant PLA2R. These test systems were used to generate results in several publications (abstracts attached).
In IIFT we recommend the use of BIOCHIP Mosaics, which allow the detection of multiple autoantibodies that are relevant for nephrology. The profile encompasses additionally e.g. ANA (lupus nephritis), ANCA (Wegener's disease) and antibodies against the glomerular basement membrane (Goodpasture's syndrome). The ELISA demonstrates >98% correlation with the IIFT and is particularly suitable for the quantification of antibody levels in therapy monitoring.
Panel | Anti-PLA2R positive |
Bioptically diagnosed primary MGN | 52% (n = 100) |
Secondary MGN | 0% (n = 17) |
Non-membranous glomerulonephritis | 0% (n = 90) |
Healthy blood donors | 0% (n = 153) |
Sensitivity | 52% (n = 100) |
Specificity | 100% (n = 260) |
Reliable identification of malevolent infections with parvovirus B19
In the coming spring, small parvovirus B19 epidemics will break out in many nurseries and schools. The infection manifests as a febrile disease with a characteristic exanthema (fifth disease, erythema infectiosum). Complications such as arthritis, encephalitis, vasculitis, myocarditis and persisting thrombo- and neutropenia arise occasionally. Transmission occurs predominantly by droplet infection via the respiratory tract. The virus can also be transmitted by blood or blood products as well as diaplacentally. It attacks erythrocyte precursor cells, which leads to a drastic reduction in the number of reticulocytes and the concentration of haemoglobulin. The seroprevalence is 60-70%.
Compared to children, adults show more intensive symptoms. 77% of affected persons suffer, often for months, from peripheral polyarthritis with symmetrical effects particularly in the small joints. Many patients go to a rheumatologist because of joint pain. The clinical picture can resemble that of rheumatoid arthritis. Antibodies of class IgM or low-avidity antibodies of class IgG against parvovirus B19 are a diagnostic pointer, as is a titer increase in IgG.
Parvovirus B19 is of great significance in pregnancy. The pathogen is the most frequent infectious (non-immunohaematological) cause of foetal anaemia and hydrops fetalis. Several hundred children are affected annually in Germany. Therefore it is advisable to identify seronegative pregnant women as part of prenatal care and to implement exposure prophylaxis. Until childbirth these women should avoid community facilities, not bring other children to nursery or school or collect them, and above all not work as nursery carers or school teachers (this also applies to pregnant women with negative measles, mumps, rubella, cytomegalo and varicella virus serology). If an acute parvovirus B19 infection is diagnosed during pregnancy, the condition of the foetus must be monitored in order to identify anaemia early and administer intrauterine transfusions if necessary.
EUROIMMUN offers a highly efficient Anti-Parvovirus B19 ELISA, which is valued by users particularly for its simple test procedure and its detection of IgG and IgM antibodies. It is based on the important VP2 antigen (recombinant, produced in yeast cells). The test supplements the existing wide range of reliable EUROIMMUN ELISAs and can be conveniently processed using the EUROIMMUN Analyzer I.
EUROIMMUN also provides an Anti-Parvovirus EUROLINE that is based on the antigens NS1, VP1, VP2 and VLP and thus contributes substantially to continuative parvovirus diagnostics.
more information
Bordetella pertussis serodiagnostics: state-of-the-art products from EUROIMMUN
To diagnose an acute Bordetella pertussis infection serologically, it is, according to up-to-date knowledge, sufficient in many cases to perform a single determination of IgG antibodies against pertussis toxin (PT). The second blood withdrawal is omitted, and results are interpreted according to the following scheme:
Concentration | Interpretation |
< 40 IU/ml | No indication of an acute infection; further tests only necessary when corresponding symptoms are present. |
40 to <100 IU/ml | Unclear serological constellation; investigate a second sample several days later. |
>= 100 IU/ml | Indication of an acute infection or recent vaccination. |
If a more in depth investigation is necessary, antibodies against pertussis toxin (IgA) and against filamentous haemagglutinin (FHA; IgG or IgA) are measured separately. Generally, test systems that use a mixture of PT and FHA as the antigen are not recommended – they do not allow any meaningful quantification. Age-dependent reference ranges can be obtained from the internet.
EUROIMMUN products ensure consistent, reproducible and state-of-the-art Bordetella pertussis serological diagnostics. The ELISAs are CE-labelled and allow the separate detection of specific antibodies against PT and FHA. Results are evaluated in international units (IU/ml). The ELISAs are complemented by immunoblots for simultaneous investigation of antibodies against adenylate cyclase toxin (ACT), PT and FHA.
Test system | Ig class | Order number |
Anti-Bordetella pertussis Toxin ELISA | IgA, IgG | EI 2050 A or G |
Anti-Bordetella FHA ELISA | IgA, IgG | EI 2050-3 A or G |
EUROLINE Bordetella pertussis (ACT, PT, FHA) | IgA, IgG | DN 2050 A or G |
EUROArray HLA-B27 – an innovative, reliable, rapid and cost-effective microarray test for the diagnosis of Bechterew's disease
The determination of the HLA-B27 allele, which is present in over 90% of patients with Bechterew's disease, but is only found in 6% – 9% of the normal population, plays a key role in the diagnosis of spondylarthritides. Test systems for the determination of this genetic marker should detect all HLA-B27 subtypes, but also indicate the presence of non-disease relevant HLA-B27 subtypes.
The EUROArray HLA-B27 offers this combination. Moreover, this assay enables quick, simple and reliable determination of HLA-B27 at low costs and stands out through the following characteristics:
- An objective, fully automated evaluation and archiving system using the EUROArrayScanner – no time-consuming cell counting or subjective interpretation of gel electrophoresis and blot incubation results
- Ready-to-use PCR reagents – save additional pipetting steps
- Integrated B27 positive control – additional positive controls are not required
- Clear results for each sample – no difficult-to-interpret results caused by borderline bands such as in electrophoresis and blot methods
- No live leukocytes necessary – the samples can be collected, stored for long periods and analysed together (contrary to cytotoxicity tests, Terasaki methods or FACS analyses)
- CE-labelled for in vitro diagnostic use
- Devices available on request
Inform yourself personally about the simple handling and excellent performance of this test system, which has already exceeded the expectations of many rheumatology laboratories! 
more information
Highly efficient allergy diagnostics: Investigate a broad range of relevant antigens in one step using the EUROIMMUN EUROLINE
Do not leave reliable results in allergy diagnostics to chance! With two EUROIMMUN blot tests performed in parallel you can investigate at least 40 parameters at the same reagent costs as with ten single allergens.
Special features of allergen profile blot strips from EUROIMMUN:
– large allergen spectrum available: profiles Inhalation, Food, Atopy, Paediatrics and Insect venoms
– small sample volumes required: 200 µl serum for 40 allergens
– automation (incubation, evaluation) is the same as in other EUROIMMUN blot systems
– antibodies against CCD (cross-reactive carbohydrate determinants): an innovative extra on our allergen profile blot strips is the determination of CCD reactivity, which is a frequent cause of positive in vitro reactions with missing clinical correlate.
For the new products' archive: please click here.
