Innovative products

EUROIMMUN Calprotectin ELISA

For several years, calprotectin has been considered an interesting marker for the diagnosis of gastrointestinal diseases. It is a calcium- and zinc-binding protein that is produced by neutrophil granulocytes and monocytes and is assumed to be bactericidal and fungicidal. In the case of an inflammatory disease of the intestine, granulocytes pass into the intestinal lumen and release calprotectin which is then excreted with the stool. The concentration of calprotectin in stool is therefore an indicator for the severity of an inflammatory process in the intestine.

The EUROIMMUN Calprotectin ELISA is a non-invasive stool test for the following:

  • Differentiation of irritable bowel syndrome (colon irritabile - low calprotectin level) from acute and chronic inflammations of the intestine (e.g. viral or bacterial infections, Crohn’s disease, ulcerative colitis - increased calprotectin level)
  • Monitoring of the disease course and therapy success in patients with chronic inflammatory bowel diseases: With successful treatment, the formerly increased level of calprotectin decreases significantly and increases again in case of a relapse. This behaviour correlates very well with the histological and endoscopic findings. Therefore, investigation of the calprotectin level can help to avoid biopsies or other complicated examinations.
  • Suspected cases of neoplastic changes in the intestine (e.g. intestinal polyps)

The common markers for inflammatory processes, such as C-reactive protein or the erythrocyte sedimentation rate, are determined in serum. Calprotectin, however, is measured in stool and has therefore a higher informational value in gastrointestinal inflammations.

ProductOrder number
Calprotectin-ELISAEQ 6831 W

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Anti-MERS-CoV ELISA and IIFT: First commercial tests worldwide for the determination of antibodies against MERS coronavirus in humans and camels.

Fig. Anti-MERS-CoV IIFT, positive reaction

The Middle East respiratory syndrome (MERS) was first reported in humans in 2012 and is caused by a novel coronavirus (MERS-CoV). So far, all MERS-CoV infections have originated in the Middle East, particularly in Saudi Arabia. To date, more than 1000 cases worldwide of human infection with MERS-CoV have been confirmed, of which more than 370 have proved fatal.

Little is known yet about the way MERS-CoV is transmitted. In most cases, secondary infections were contracted in hospitals. Moreover, a zoonotic transmission to humans is discussed: in the Arab region and some African countries, the seroprevalence in camels is very high, so that infected camels are suspected as reservoir for the pathogen and potential source of sporadic infections in people.

EUROIMMUN offers test systems for the detection of antibodies against MERS-CoV in human and veterinary diagnostics. These are excellently suited as screening tests for acute diagnostics and for epidemiological studies.

The Anti-MERS-CoV IIFT (IgG, IgM) is based on MERS-CoV-infected eukaryotic cells and the Anti-MERS-CoV ELISA (IgG) on purified S1 antigens of MERS-CoV.Owing to this, a high sensitivity and specificity is achieved.

 

ProduktBestellnummer
Anti-MERS-CoV-IIFT (IgG, IgM) FI 2604-1005 G / M
FI 2604-1010 G / M
Anti-MERS-CoV-ELISA (IgG)EI 2604-9601 G
Anti-MERS-CoV-IIFT Camel (IgG)FI 2604-1010 GK
Anti-MERS-CoV-ELISA Camel (IgG)EI 2604-9601 GK

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EUROArray HPV: More certainty in the early diagnosis of cervical cancer

Cervical cancer (cervical carcinoma) is the fourth most frequent cancer disease in women worldwide. The most important risk factor for cervical carcinoma is an infection with human papilloma viruses (HPV) which are distributed worldwide and mainly transmitted by sexual intercourse.

There are approximately 200 different HPV subtypes – 30 (high- and low-risk HPV types) of them can cause infections in the genital area. While low-risk HPV types may only lead to genital warts or minor cellular changes, high-risk HPV have a potential to alter cells suchs that they turn into cancer cells.

An HPV infection does not always cause cancer, as the virus is usually quickly eliminated by the immune system. However, if an infection persists for a longer period of time (persisting infection), this may lead to pre-cancerous changes and cervical cancer. Particularly multiple infections with different HPV subtypes are here considered a risk factor. Therefore, it is important to identify the HPV subtype to evaluate the risk of developing malignant tissue changes and to distinguish between a new infection and a persisting one.

Clinical studies have shown that HPV-based screening offers a 60 to 70% higher protection from invasive cervical cancer, in comparison to the classic cytological screening for altered cervical cells (Pap smear).

To do this, EUROIMMUN offers the EUROArray HPV, with the following characteristics:

  • Simultaneous detection and typing of all 30 relevant anogenital HPV subtypes in one reaction
  • Differentiation between high- and low-risk HPV subtypes, based on detection of the viral oncogenes E6/E7.
  • Significant results already at an early stage of HPV infection
  • Reliable identification of multiple infections
  • Fully automated evaluation with the EUROArrayScan system

more information:

 

 

 

 

TestOrder no
human papillomavirus (HPV)MN 2540

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Reliable diagnosis of dengue virus infections in all disease stages

Dengue fever is an infectious tropical disease and belongs to the haemorrhagic fevers. It is caused by an infection with the dengue virus (DENV). The clinical diagnosis of dengue is particularly difficult as there are a large number of pathologic agents which cause infectious diseases with similar symptoms in the early stage of the illness. In the acute stage of the disease, the laboratory diagnosis of dengue is established using a direct detection method like PCR or NS1 antigen test, whilst indirect methods like tests for the detection of antibodies are used in later stages of the illness.

The highly specific NS1 antigen from DENV is detectable in the serum of infected patients from onset of the clinical symptoms. This is the case in primary as well as in reinfections. The detection of NS1 using ELISA is therefore an important tool for the diagnosis of acute dengue infections and is increasingly used in dengue diagnosis, in parallel to the detection of specific antibodies.

In the detection of antibodies, the exclusion of possible cross reactions with other anti-flavivirus antibodies and the differential diagnosis from other arbovirus infections constitute a challenge. The Flavovirus IIFT Mosaic and the Arbovirus Fever Mosaic 1 from EUROIMMUN are especially suitable for this application.

EUROIMMUN offers the following tests for the diagnosis of dengue virus infections:
 

ProductOrder number
Dengue Virus NS1 ELISAEQ 266a-9601-1
Anti-Dengue Virus ELISA (IgA/IgG/IgM)EI 266b-9601 A/G/M
Mosaic Dengue Virus Types 1-4  (IgG/IgM)FI 266a-1 G/M
Flavivirus Profile 2 (FSME, WNV, JEV, YFV,DENV) (IgG/IgM)FI 2661-2 G/M
Arboviris Fever Mosaic 1 (CHIKV, JEV, DENV) (IgG/IgM)FI 293a-1 G/M

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Reliable identification of hepatitis E virus (HEV) infections with EUROIMMUN ELISA

Infections with hepatitis E virus (HEV) are after hepatitis A and B the most frequent cause of hepatitis worldwide. Since the clinical symptoms of hepatitis E resemble those of other hepatitides, laboratory diagnostics play an essential role in diagnosis. Alongside PCR detection of viral RNA in blood or stool, the serological determination of antibodies of classes IgA/IgG/IgM against HEV is the most important aid for diagnosis of an HEV infection. Pathogen-specific antibodies are usually detectable when the first clinical symptoms appear or shortly afterwards. A positive IgA and/or IgM test and a significant increase in IgG in a serum pair (taken at a time interval of 8-14 days) indicate an acute infection. IgA and IgM anti-HEV titers usually drop rapidly after infection, while the IgG HEV titer persists for over 10 years.

EUROIMMUN offers the following ELISAs for the detection of HEV-specific antibodies:

ProductIg classOrder number
Anti-Hepatitis E Virus (HEV) ELISAIgG, IgMEI 2525 G / M
Anti-Hepatitis E Virus (HEV) ELISA IgAEI 2525 A
Anti-Hepatitis E Virus (HEV) ELISA IgAGMEI 2525 P


Test advantages at a glance:

  • Complete range of CE-labelled ELISAs for separate or parallel determination of IgA, IgG and IgM antibodies against HEV
  • 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 feature
  • 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

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Anti-Borrelia EUROLINE-RN-AT-adv: highest specificity for borreliosis diagnostics through OspC advanced

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 2131-2 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. 

ProductOrder number
Screening testAnti-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 EUROPLUSFI 2136-1 G/M
Confirmatory testAnti-Borrelia EUROLINE-WBDY 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-advDN 2131-2 M
CSF diagnosticsAnti-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


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New products for Chlamydia diagnostics

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)
  • Good correlation with competitor tests
  • Very high sensitivity and specificity
  • Identical incubation times for all EUROIMMUN infection blots, for easy parallel processing
Product Ig class  Order number 
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. pneumonia ELISA IgA, IgG, IgM EI 2192  A, G or M
Anti-C. trachomatis EUROLINE-WB IgA, IgG
DY 2191-1  A or G

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Anti-NMDA receptor encephalitis: Recombinant immunofluorescence test for determination of antibodies against glutamate receptors

Anti-NMDA receptor encephalitis is a severe encephalopathic autoimmune disease, which affects mainly young women with ovarian teratoma, but also women without tumours, men and children. First described in 2007, it is a currently still widely underdiagnosed disease entity (J. Dalmau et al., 2008, Lancet Neurol 7(12): 1091-1098).

Diagnosis of anti-NMDA receptor encephalitis is based on the detection of highly specific autoantibodies directed against glutamate receptors of type NMDA in serum or cerebrospinal fluid. These autoantibodies are detected with high sensitivity and specificity in indirect immunofluorescence using a human recombinant cell line expressing the major target antigen (receptor subunit NR1). The determination of antibodies against glutamate receptors (type NMDA) is of high significance in patients with encephalitis where no pathogen has been detected, as well as in suspected cases of limbic encephalitis. The new cell substrate can be combined with various tissue substrates that are relevant for differential diagnostics (e.g. hippocampus and cerebellum) as BIOCHIP Mosaics, allowing the detection of further autoantibodies associated with limbic encephalitis (e.g. anti-VGKC antibodies, anti-AMPA receptor antibodies). http://www.euroimmun.com/fileadmin/template/images/pdf/NMDAR.pdf

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EUROIMMUN 25-OH Vitamin D ELISA: a reliable, convenient test

Vitamin D is not only essential for strong bones, it is also of vital importance for immune system function, for cancer prevention and for reducing the risk of cardiovascular disease, as demonstrated by numerous studies. Early diagnosis of vitamin D deficiency is therefore indispensible.

The newly developed 25-OH Vitamin D ELISA from EUROIMMUN for the determination of vitamin D levels is now available. The test was designed so that it has a high correlation with established commercial test systems.

The 25-OH Vitamin D ELISA is characterised by:

  • 100% reliability in the determination of vitamins D2 und D3 due to the use of a new monoclonal antibody
  • Quick and simple test performance in less than 3 hours
  • Improved analyte release in only one step without the use of toxic substances
  • Optimised test procedure with only 6 calibrators
  • Predominantly ready-to-use reagents
  • Fully automatable processing
  •  Very attractive price

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