Arboviruses, or arthropod-borne viruses, are on the marchglobally. Increased urbanisationand international travel facilitatethe spread of mosquito vectors and hencethe viral diseases they carry. Zika virus(ZIKV) is currently spreading uncontrollably in the Americas, while dengue virus (DENV) and chikungunya virus (CHIKV) have alreadybecome firmly established in most tropicaland also many non-tropical regions. ZIKV, DENV and CHIKV infections are difficult to tell apart, as they manifest with similar clinical symptoms of fever, exanthema and arthralgia and are epidemic in much the same geographic regions. Therefore, laboratory analyses play an important role in differential diagnostics. Serological tests provide a longer diagnostic window than other methods such as direct detection, and are suitable for diagnosing acute infections as well as for disease surveillance. ELISA and indirect immunofluorescence test(IIFT) systems based on optimised antigens enable sensitive and specific detection of anti-ZIKV, DENV and CHIKV antibodies in patient serum or plasma samples.
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Molecular allergology is a cutting edge technology that enables the triggers of allergies to be characterized to a new level of detail. Two new component-resolved immunoblot test systems provide in-depth profiling of allergic reactions against birch and grass pollens and against bee and wasp venoms. The molecular tests supplement the established Euroline allergy range, which comprises a comprehensive spectrum of applicationoriented profiles designed for use in any diagnostic laboratory.
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Autoantibodies against phospholipase A2 receptors (PLA2R) are a new, highly specific diagnostic marker for primary membranous nephropathy (MN). Detection of anti-PLA2R using easy-to-perform and inexpensive serological assays can indicate primary MN in patients suffering from nephrotic syndrome and secure a differential diagnosis from secondary MN. Anti-PLA2R analysis is also useful for determining the disease activity, assessing the extent of treatment required and monitoring responses to therapy. Anti-PLA2R antibodies can be determined using innovative indirect immunofluorescence and ELISA test systems.
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An innovative technology based on the classic indirect immunofluorescence test (llFT) is driving the rapid introduction of newly identified autoantibody parameters into routine laboratory diagnostics. In the new assay method, transfected cells are used for the first time as antigen substrates in llFT to provide monospecific detection of antibodies. Cell-based llFT systems represent an effective alternative to ELISA and immunoblot, especially for applications where these methods cannot, for various reasons, be deployed. The novel technology has already enriched various diagnostic areas, in particular autoimmune disease diagnostics.
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The analysis of circulating autoantibodies has in recent years become a central tenet of the dermatology workup.
The molecular identification of various target antigens in autoimmune bullous dermatoses has paved the way for the development of novel autoantibody tests. Analysis of autoantibodies against bullous pemphigoid (BP) antigens (BP180 and BP230), desmoglein 1 (Dsg1) and 3 (Dsg3), envoplakin and other antigens now contributes greatly to the diagnosis and differentiation of autoimmune skin-blistering diseases. In particular, new technologies for the indirect immunofluorescence assay (IFA) and ELISA have enhanced and refined the laboratory analysis.
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The spectrum of autoimmune neurological syndromes has expanded substantially in the last fifteen years because of the discovery of novel anti-neuronal autoantibodies. Today's autoantibody test portfolio includes over 32 different specificities associated with neurological diseases.
Alongside classic anti-neuronal autoantibodies against intracellular targets such as Hu, Yo, Ri, etc are newly identified autoantibodies directed against cell surface antigens, for example glutamate receptors of type NMDA or AMPA, GABAB receptors, the voltage-gated potassium channel-associated proteins LGI l and CASPR2, or DPPX. Since many of the autoantibodies occur only rarely, multiplex screening is favoured over selective or sequential testing to avoid diagnostic gaps.
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Dengue virus is of increasing concern to health authorities the world over. Aided by the upsurge in human mobility and the rapid spread of the mosquito vector, the virus has snowballed in recent decades, resulting in millions of new infections and thousands of deaths. More than 2.5 billion individuals worldwide, almost half of the world’s population, are now at risk of infection.
Since the febrile infection is difficult to diagnose clinically, laboratory tests play an essential role in identifying dengue infections. In particular, analysis of the viral antigen NS1 allows cost-effective, early diagnosis already at symptom onset, while antibody analysis provides confirmation of acute and past infections.
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The spectrum of disease-associated antibodies for laboratory testing is constantly growing thanks to the continual identification of novel target antigens. This poses the question of how many, and which antibodies to investigate, in a particular disease suspicion. In many of these instances immunoblots are a useful analysis method, as they can include large panels of antigens. Up to 54 antibodies can easily be investigated in parallel. Line blots composed of individual membrane chips offer the additional benefit of allowing antigens with widely differing properties to be combined on one test strip.
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Molecular genetic analysis is gaining new momentum in diagnostics as the genetic components behind many diseases become better characterised.
Human leukocyte antigen (HLA) alleles, for example, exhibit extreme genetic polymorphism. Specific alleles are associated with particular autoimmune and inflammatory diseases, for example coeliac disease, psoriasis and ankylosing spondylitis, and HLA determination is now an important tool for both diagnosis and prediction of disease risk. Other wellcharacterised mutations, such as those in the blood coagulation factors V and II, are analysed in the management of conditions such as thrombophilia. The following examples illustrate how genetic parameters are now an integral part of routine diagnostics.
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Alzheimer’s disease is a major global challenge of our time, with its prevalence predicted to rise dramatically as population’s age. No cure is available, and early diagnosis is crucial for managing the disease. Since clinical diagnosis is difficult, especially in the initial stages, analysis of biomarkers in patients’ cerebrospinal fluid (CSF) is increasingly used as a diagnostic support tool. Analysis of the beta-amyloid (Aß) peptides 1-42 and 1-40 together with total tau and phosphorylated tau (P-tau) can significantly aid early diagnosis of Alzheimer’s disease. These neurochemical markers can be measured precisely, reproducibly and independently of matrix effects using a new generation of ELISAs based on well-characterised capture antibodies.
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Specialized diagnostic DNA microarrays provide fast and reliable determination of factor V and factor II gene mutations associated with thrombosis or HFE gene defects linked to hereditary hemochromatosis.
The simple microarray procedure includes fully automated data analysis and can be performed on whole blood samples, circumventing the need for preanalytical DNA isolation. Patient genotyping aids diagnosis in symptomatic individuals and risk assessment in healthy individuals, thus facilitating decision making in therapy and prevention.
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"Designer antigens" are at the vanguard of modern serological diagnostics. As immune targets become better characterised,
antigenic substrates used in immunoassays such as ELISA can be adapted to maximise diagnostic performance. Using cuttingedge biomolecular techniques, irrelevant or disease-unspecific epitopes can be removed and disease-relevant epitopes optimised with regard to number, accessibility and reactivity.
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Human papillomaviruses (HPV) are a major contributory
factor to the development of cervical carcinoma. Over recent years it has become evident that effective screening for HPV can significantly reduce the number of cervical cancer cases and deaths, since diagnosis can be made at a very early stage, enabling intervention before the cancer develops.
Direct pathogen detection identifies HPV infections even before morphological cell changes have taken place. New developments in multiplex microarray technology have paved the way for highly sensitive HPV tests that allow complete subtyping of all high- and low-risk anogenital HPV. A microarray system with fully automated data analysis is particularly well suited to high-throughput screening.
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The emerging disease Middle East respiratory syndrome (MERS) continues to
pose a significant health threat in the Middle East and beyond. The severe respiratory illness,
which is caused by a novel coronavirus (MERS-CoV), has so far infected over 1000 people
and claimed nearly 400 lives since its emergence in 2012...
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In recent years, advances in laboratory diagnostic tests for coeliac disease (CD) have transformed the way the disease is diagnosed and monitored, enabling the number of small bowel biopsies performed to be significantly reduced.
Key laboratory investigations comprise the determination of autoantibodies against tissue transglutaminase (anti-tTG) or endomysium (EmA), antibodies against deamidated gliadin peptides and the CD-associated human leukocyte antigens (HLA) DQ2 and DQ8...
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The spectrum of autoantibodies associated with neurological diseases
has expanded rapidly in recent years. Alongside classic anti-neuronal
antibodies such as anti-Hu, anti-Yo, and anti-Ri, antibodies against
neuronal cell surface antigens, for example glutamate receptors of
type NMDA, now play a central role in diagnostics. Early clarification
of diseases such as paraneoplastic neurological syndromes, limbic
encephalitis and neuromyelitis optica enables timely intervention, which
is crucial for a favourable outcome. ...
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Autoantibodies against phospholipase A2 receptors (PLA2R) are a
new and highly specific diagnostic marker for primary membranous
glomerulonephritis (MGN). They were identified only recently as
frequently occurring autoantibody parameters in patients with this
debilitating kidney disease. The rapid development of simple serological
tests to detect anti-PLA2R antibodies has enriched the diagnosis and
monitoring of primary MGN and advanced understanding into the
mechanisms of its pathogenesis. ...
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Efficient laboratory management software is the mainstay of
a smoothly run diagnostic laboratory. One such software,
EUROLabOffice, is designed to streamline daily laboratory routine
in autoimmune diagnostics, infectious serology, allergology and
molecular genetics. It incorporates different diagnostic techniques,
as used by EUROIMMUN test systems, including the indirect
immunofluorescence test (IIFT), ELISA, immunoblot and microarray. ...
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