The EUROIMMUN Innovations at a Glance (Archive)
You'll find the current headlines here.
EUROIMMUN at MEDICA in Düsseldorf, 18th - 21st November 2009: Innovations for the serology laboratory
At MEDICA 2009 EUROIMMUN will once again be presenting a wealth of new developments in the areas of autoimmune diagnostics, infectious serology and allergology. You will be able to find us in Hall 1 (Stand A 8). Get a picture of the innovative diagnostic solutions we have developed for serology:
New test systems (selected examples)
– Reagents for detection of autoantibodies in bullous dermatoses (anti-BP180, anti-BP230, anti-desmoglein 1, anti-desmoglein 3 and others)
– Determination of autoantibodies against glutamate receptors using IIFT, e.g. anti-NMDA receptors
– Platform for microarray diagnostics (EUROArray), e.g. investigation of HLA-B27 alleles for the detection of ankylosing spondylarthritis (BioChancePLUS Project of the Germany Federal Ministry of Education and Research).
– Available soon: Test systems for CSF diagnostics designed for greatest customer convenience (e.g. CSF-serum control pairs included in each test kit, in accordance with Germany quality assurance guidelines (RiliBÄK) for CSF diagnostics, saving of calibration curve possible – for convenient, cost-effective operation).
Automation solutions
– The laboratory software “EUROLabOffice“ for perfect running of your antibody laboratory (e.g. entry of immunofluorescence results directly at the microscope, signing results online from anywhere in the world).
– The automatic LED microscope “EUROScope“ (computer-controlled cross table with autofocus function and slide magazine for fully automated recording of images) and the IIFT pattern-recognition software EUROPattern for evaluation of your ANA slides.
– The automated ELISA systems EUROIMMUN Analyzer I and EUROIMMUN Analyzer I-2P.
– The cost-effective EUROBlotMaster for incubation of your immunoblots, as well as the EUROLineScan system for automated evaluation and archiving – using either a camera system (EUROBlotCamera) or a flatbed scanner (EUROBlotScanner).
In cooperation with Carl Zeiss we will once again be holding a seminar on ”Autoantibody diagnostics using IIFT, enzyme immunotests and RIA“ (MEDICA congress no. 338), which this year takes place on MEDICA Friday (20.11.2009). The seminar starts at 13.30 (!) and ends at 18.00. Location: CCD South, 2nd floor, Room 28. The seminar has been certified with 4 CME points by the Nordrheinischen Akademie für ärztliche Fort- und Weiterbildung. If you are interested you can register online. (www.medica.de).
Up-to-date product examples at a glance
Diagnosis of autoimmune hepatitis using cell line VSM47: A new way to reliably determine anti-F-actin antibodies
Autoimmune hepatitis (AIH) is an immune-mediated chronic inflammation of the liver. In order to secure diagnosis and to rule out combined liver disease (overlap syndrome) it is essential to differentiate AIH from alcohol- or drug-induced cirrhosis and other chronic liver diseases.
The determination of antibodies against F-actin is of particular importance in the diagnosis of autoimmune hepatitis. In contrast to other ASMA, antibodies against F-actin represent a highly specific marker for AIH type I. They cannot be determined using ELISA or Westernblot since they are directed against conformational epitopes that are only preserved in frozen sections. As there are no monospecific tests available, a clear result in IIFT is very important.
For this reason, EUROIMMUN has developed cell line VSM47 (vascular smooth muscle), which allows the quick and reliable differentiation between micro-filamentous (MF) fluorescence patterns and non-MF patterns. The use of cell line VSM47 facilitates and confirms diagnosis, thus representing a new standard in AIH diagnostics.
See also: 
Villalta et al., Autoimmunity 2008
Evaluated by international experts: EUROIMMUN test systems for the serological diagnosis of rheumatic diseases
Our hard working research groups are constantly engaged in developing the most state-of-the-art test systems. Diagnosis of rheumatic diseases is among the fields which are most important to us. In the following, we would like to present some of the test systems EUROIMMUN offers for the serological diagnosis of rheumatic diseases:
As a pioneer in the worldwide introduction of anti-CCP diagnostics EUROIMMUN is among the small number of companies which are able to offer an Anti-CCP ELISA in accordance with the patent of Walter van Venrooij et al. With respect to disease specificity the EUROIMMUN test system is unsurpassed by any other commercial test (N. Bizzaro et al., 2006, 5th International Congress on Autoimmunity, Sorrent, Italy): Some manufacturers use suboptimal antigens to avoid the patent. The Anti-CCP ELISA, however, ranks first in serological diagnostics of rheumatoid arthritis.
The Anti-dsDNA-NcX ELISA is a new milestone in the diagnosis of systemic lupus erythematosus (SLE). Today, DNA is coupled to the surface by means of highly purified, wafer-thinly applied nucleosomes as linker substrate and not, as in the past, by polylysine or protamine sulphate, which sometimes cause unspecific reactions. Due to this new coating technique the new Anti-dsDNA-NcX ELISA is much more sensitive than conventional anti-dsDNA tests: In the investigation of a large SLE panel (R. Biesen et al., 2008, Lupus 17(5): 506-507) the test achieved a sensitivity of 60.8% at a specificity of 98% (Anti-dsDNA RIA by Farr: 53.1%, conventional Anti-dsDNA ELISA: 35.4%, C. luciliae IIFT: 27.4%).
The product "EUROLINE" by EUROIMMUN encompasses a variety of line blot systems which are particularly useful for the determination of antibody profiles in autoimmune diagnostics, infectious serology and allergology. EUROIMMUN researchers examined the disease specificity of antibodies against Ro-52 using these EUROLINE profiles: In cooperation with the Charité, Berlin, Germany, and the You-An Hospital, Beijing, China, it was confirmed that antibodies against Ro-52 are not associated with a specific disease but occur in a large number of different autoimmune and even infectious diseases (Meyer et al., 2008, Annals of the Rheumatic Diseases 67 (Suppl. II): 146). Therefore, we recommend not to use any test systems based on a mixture of SS-A (60 kDa) and Ro-52 for the determination of antibodies against SS-A in the diagnosis of Sjögren's syndrome and SLE since these lead to unspecific reactions!
Highest security in medical care during pregnancy: Determination of IgM antibodies against varicella zoster virus with highly purified virus proteins instead of cell lysates
The varicella zoster virus (VZV) is highly contagious. In primary VZV infections during pregnancy, the congenital varicella syndrome and the neonatal varicella infection are considered to be rare, but severe complications. A reliable serological diagnosis for pregnant women who have had varicella contact is therefore indispensible. Conventional ELISA systems for the detection of antibodies against varicella zoster virus use lyste from VZV infected cellls as target structure. However, it is inevitable that these reagents also target non-viral antigens, which leads to unspecific or ambiguous, and therefore unreliable results.
EUROIMMUN specialsts have developed a new ELISA test system for the detection of IgM antibodies against VZV using the viral main target antigens in the form of highly purified glycoproteins as test substrate. This minimises false-positives, while maintaining sensitivity. In a clinical study the new Anti-VZV Glycoprotein ELISA (order no. EI 2650-9601-2 M) proved its unrivalled specificity, particularly in the panel of pregnant women.
The new Anti-VZV ELISA takes only 75 minutes to perform, which corresponds to the short incubation times known from EUROIMMUN ELISA for infectious serology. If you need to process a large number of samples, we recommend using the automated ELISA system "EUROIMMUN Analyzer I", which allows easy processing of the entire EUROIMMUN product range in infectious serology, autoimmune diagnostics and allergology.
EUROIMMUN at MEDICA in Düsseldorf, 19th to 22nd November 2008
This year at MEDICA EUROIMMUN will again be presenting a wealth of interesting new products for autoimmune diagnostics, infectious serology and allergology. You will be able to find us in Hall 1 (Stand A 8).
The topic "Laboratory automation" is moving ever more into the spotlight. In the area of "Serology" we have developed outstanding solutions:
- The laboratory software "EUROLabOffice" is designed to perfect your antibody laboratory. Immunofluorescence results are, for example, entered on the computer directly at the microscope. To reduce the risk of mixups the exact position of the reaction field being evaluated is registered, and the program assigns the entered results to the correct patient. Completed results can be signed off online from any place in the world (e.g. the Bahamas). In unclear cases a mouseclick conjures up the IIFT pattern onto the screen. We are happy to help you install EUROLabOffice into your IT system.
- With the microscope EUROStar II and the IIFT pattern recognition software EUROPattern your ANA slides are evaluated automatically. And for your ANCA diagnostics we have developed a great BIOCHIP containing HEp-2 cells coated with granulocytes to distinguish pANCA-positive from ANA-positive reactions.
- The established ELISA Instrument EUROIMMUN Analyzer I has now got a little brother, the EUROIMMUN Analyzer I-2P, which is designed especially for small and middle-sized laboratories. All innovative software solutions for the large instrument are also available for the small version.
- For incubation of your immunoblots, we offer the robust and well-priced instrument EUROBlotMaster. Blot strips are evaluated and archived automatically with the system EUROLineScan – using either a camera system (EUROBlotCamera) or a flatbed scanner (EUROBlotScanner).
Anti-CCP Tests: Separating the Wheat from the Chaff
Due to its high specificity for rheumatoid arthritis (RA) and prognostic significance, the anti-CCP test has superseded the rheumatoid factors in diagnostics (specificity: anti-CCP 97%, rheumatoid factors 62%, A. Vasishta, Am. Clin. Lab. 21:34, 2002). As its leading promotor, EUROIMMUN has already been informing the expert public worldwide about this parameter for 5 years now. Not all of the commercially available anti-citrullin ELISA achieve a competitive specificity. Comparison studies have shown that tests which use other citrullinised peptides instead of optimised CCP antigens of the 2nd generation often perform poorly (W. van Venrooij et al. (2002) Neth. J. Med. 60:383). The EUROIMMUN Anti-CCP ELISA however ranks first among anti-citrullin tests, being unsurpassed regarding its high specificity (N. Bizzaro et al. (2006) 5th International Congress on Autoimmunity, Sorrent, Italy) not even by so-called "3rd generation tests" which show a higher sensitivity at the expense of a partly significantly reduced specificity.
M2-3E: A Highly Suited Designer Antigen for the Determination of Antibodies against M2 in the Diagnosis of PBC
To detect primary biliary liver cirrhosis (PBC) doctors determine antibodies against the mitochondrial antigen M2 (AMA M2). This is a complex of several enzymes – of which the following units are important as autoantigens: pyruvate dehydrogenase, branched-chain 2-oxoacid dehydrogenase and oxoglutarate dehydrogenase. Up to 90% of M2-specific autoantibodies are directed against pyruvate dehydrogenase. Therefore, many commercial ELISA are based on this main target antigen – the previous EUROIMMUN ELISA included. A small remainder of patients, who exhibit only antibodies against epitopes of the two other enzymes, could not until now be identified. The new test system from EUROIMMUN, in contrast, utilizes a designer fusion protein, which contains all three relevant enzyme complexes (3E) of the M2 antigen in a defined relationship (according to Moteki et al., Hepatology 24:97, 1996). In a study with 170 sera from clinically characterised patients the EUROIMMUN Anti-M2-3E ELISA showed a previously unattained sensitivity of 93% (conventional anti M2-ELISA with same patient panel: 79%). The specificity of the new test system was 98% – determined using a control panel of 989 sera.
BIOCHIP Mosaics™ for Serological Diagnostics of Tropical Diseases and Special Infections
Increased tourism to exotic destinations is providing a challenge for doctors: for example, in Germany four million people travel to tropical or subtropical countries every year, and almost one in five of them returns with diarrhoea or fever. A typical tropical infection can be detected in around 15% of these. Imported infections with viruses such as Dengue also represent a growing problem. The Robert Koch Institute estimates several hundred cases per year in Germany with a high number of unidentified cases. Since the main symptoms of many tropical febrile diseases are similar and their endemic areas overlap, the specific detection of pathogens and antibodies often helps to clarify ambiguous results and to exclude dangerous infectious diseases. EUROIMMUN has developed an extensive range of indirect immunofluorescence products to enable laboratories to perform reliable, standardised serological diagnostics.
Test systems fo the following pathogens are already available (singe tests or BIOCHIP Mosaics™ in user-defined combinations): SARS corona virus, Dengue virus (types 1-4), West Nile virus, Yellow fever virus, Japanese encephalitis virus, sandfly fever virus (types Sicilian, Naples, Toscana and Cyprus), Hantavirus (types Hantaan, Puumala, Seoul, Dobrava, Saaremaa, Sin Nombre and Andes) and Chikungunya virus. EUROIMMUN also offers ELISA for the determination of antibodies against SARS corona virus, Dengue virus type 2 and West Nile virus. Products are certified according to the IVD guideline 98/79/EC (CE registration). Test systems are evaluated by scientific studies performed in collaboration with renowned institutes. More information
EUROIMMUN at the Analytica in Munich, 1-4 April 2008
What has been new in autoimmune diagnostics, infectious serology and allergology in the past six months? Visit EUROIMMUN in hall A3 at booth 501 and we will present you our latest achievements!
We would be particularly happy to introduce you to our automated solutions. These are sophisticated inter-compatible concepts for the entire spectrum of antibody diagnostics which help you to optimise your daily laboratory routine:
| System/Software | Details |
IIFT | EUROStar II Plus | LED-IIFA microscope with transmitted-light, polarisation/phase contrast |
ELISA | EUROIMMUN Analyzer I | |
| EUROIMMUN Analyzer I-2P | Fully automated ELISA processor (up to 3 plates) |
Blot | EUROBlotMaster | Automatic immunoblot processor (incubation) |
| EUROLineScan | System for the evaluation of incubated blot strips and archiving of results |
LIMS | EUROLabOffice | Software for system connection, result evaluation/administration |
Inform yourself personally about the excellent performance of our customised designer antigens, which have been proven in multi-centre studies to set new quality standards in the serological diagnostics of coeliac disease, systemic lupus erythematosus and Wegener's granulomatosis.
Serological Diagnosis of Bullous Pemphigoid: The New EUROIMMUN Anti-BP180-4X ELISA
Bullous pemphigoid is one of the most frequent autoimmune dermatoses. The incidence rate is between 0.7 and 1.8 new cases per 100,000 inhabitants, depending on the age, and shows a significant increase from the age of 60. In addition to the clinical symptoms, the detection of specific autoantibodies in the skin (direct immunofluorescence) and in the serum (indirect immunofluorescence, ELISA) is decisive for diagnosis. The autoantibodies are mainly directed against the non-collagenous domain NC16A of the BP180/collagen XVII protein ("bullous pemphigoid antigen", 180 kDa), which is responsible for the adhesion of the epidermis to the connective tissue. The prevalence of autoantibodies in bullous pemphigoid is 90% (indirect immunofluorescence on salt-split skin).
For the detection of antibodies against BP180, ELISA test systems are available which have the same sensitivity as indirect immunofluorescence tests. However, these ELISA tests may produce false positives, e.g. in rheumatoid arthritis, SLE or progressive systemic sclerosis. By modifying the antigen used in the ELISA for solid phase coating, it could be achieved to fully present the epitope spectrum to the antibodies present in the serum in an optimised way. For the first time, a multimer structure of the NC16A domain is used for the detection of autoantibodies. Each epitope is present in the molecule several times; if one epitope is blocked by binding to the solid phase, the other epitopes are still available for reaction with the autoantibodies. The significantly optimised immunoreactivity allows to raise the specificity of the test system such that only those sera react, which really contain autoantibodies against BP180.
The EUROIMMUN Anti-BP180-4X ELISA represents a competent alternative for indirect immunofluorescence. The test allows the clear characterisation of the autoantibodies present in bullous pemphigoid and the differentiation of other bullous autoimmune dermatoses such as pemphigus vulgaris, epidermiolysis bullosa acquisita and Duhring's dermatitis herpetiformis. The new test system stands out with its easy handling and short performance time (75 min), compared to other test systems. The Anti-BP180-4X ELISA has a sensitivity of 89.9% and is unrivalled with its impressive high specificity (97.9%)! The serum level of anti-BP180 autoantibodies correlates with the diasease activity. Therefore, this parameter does not only play a major role in primary diagnostics but also in the evaluation of the disease course and the determination of therapeutic measures.
