Various autoantibodies against skin structures can be detected by serological methods such as indirect immunofluorescence (IIF) and ELISA. Optimised designer target antigens and multiplex test formats enhance the analyses, enabling highly efficient serological diagnostics.

Structure of the Skin

The human skin consists of three layers: epidermis, dermis and subcutis (Figure 1). The basal lamina links the epidermis with the dermis. The stability of the cell connections in the epidermis is essential for the protective function of the skin. Desmosomes (Figure 1 A) are responsible for the contact between epidermal cells (keratinocytes). They consist of the transmembrane proteins desmoglein (Dsg) 1 and 3 and desmocollin and intracellular plaque proteins (plakins e.g. envoplakin, periplakin). Hemidesmosomes (Figure 1 B) anchor the cells of the epidermal basal layer to the underlying basal lamina. Major proteins involved in these connections include the cytoplasmic proteins BP230 and plectin, the transmembrane proteins BP180 and integrin α6β4, as well as laminin 332, laminin γ1 (p200) and collagen type VII.

Autoimmune Bullous Dermatoses

In AIBD, the immune system produces autoantibodies against the structural components of the desmosomes or hemidesmosomes, which disrupt intracellular connections and adhesion of the skin layers, leading to separation. Intra- or subepidermal blisters form when tissue fluid enters the splits. The blistering can affect the outer skin and/or the mucous membranes. AIBD are classified into four main groups according to the localisation of the blisters and the target antigens. These are pemphigus diseases, pemphigoid diseases, acquired epidermolysis bullosa and Duhring’s disease. The diagnosis of AIBD is based on the clinical symptoms, histopathology, direct immunofluorescence to detect antibody and/or complement deposits, and serological determination of circulating autoantibodies. The serological techniques encompass IIF, immunoblot and ELISA. The main class of autoantibodies in AIBD is IgG, although in some cases IgA is relevant.

Pemphigus Diseases

Pemphigus diseases are a group of blister-forming diseases affecting the skin and mucous membranes. Untreated, they can be life threatening. Different forms are pemphigus vulgaris (PV), pemphigus foliaceus (PF), paraneoplastic pemphigus (PNP) and IgA pemphigus.

Pemphigus diseases are characterised by intraepithelial disruption of the intercellular connections in the prickle-cell layer of the epidermis (acantholysis). This is caused by autoantibodies that target the desmosomes and thus damage the keratinocytes. In both direct and indirect immunofluorescence the localisation of the immune complexes results in an intercellular, honeycomb-like fluorescence pattern on skin tissue samples and oesophagus sections. Target antigens in the desmosomes are especially Dsg1 and 3, as well as plakins and desmocollin. Dsg1 is expressed particularly on the surface of the epidermis, whereas Dsg3 is mainly localised in the deep layers of the epidermis and in the mucous membranes. The localisation of Dsg1 and 3 explains the different manifestations of various forms of pemphigus.

PV is the most frequent intraepidermal autoimmune blister-forming dermatosis, comprising 80% of all pemphigus cases. It has an incidence of 1 to 16 cases per million inhabitants per year and occurs predominantly in middle-aged and elderly persons. The disease always affects the mucous membranes. The majority of patients only develop lesions in the oral mucosa and exhibit only autoantibodies against Dsg3. If the disease subsequently spreads to other mucous membranes and the skin, it is characterised by autoantibodies against Dsg1 and Dsg3. PF is characterised by blister formation in the upper epidermal layers of the outer skin, while the mucosa is never affected. This form is only associated with antibodies against Dsg1. Thus, the reactivities against Dsg1 and Dsg3 can aid differentiation of PV and PF.

PNP is the least common but most serious form of pemphigus and is always associated with tumours, often haematological neoplasia. Circulating autoantibodies are predominantly directed against plakins (envoplakin, periplakin, desmoplakins), also against Dsg3 and Dsg1, plectin and BP230α-2-macroglobulin-like 1. Bladder mucosa is the most suitable IIF substrate for autoantibody detection in PNP, since it is rich in various plakins.

Pemphigoid Diseases

Pemphigoid diseases are a heterogeneous group of autoimmune diseases with subepidermal blister formation. Different types are bullous pemphigoid (BP), pemphigoid gestationis, mucous membrane pemphigoid, linear IgA dermatosis and p200 pemphigoid. Autoantibodies are directed against the components of hemidesmosomes and structural filaments. The autoimmune reactions cause the epidermis to peel away from the underlying dermis.

Tissue-bound complexes (immune complexes) can be detected along the basement membrane using direct immunofluorescence based on tissue samples of the skin. IIF for identification of the antibody specificity is often performed on oesophagus tissue sections and salt-split skin. The target antigens BP180 and BP230 are located on the epidermal side of salt-split skin. The antigens collagen type VII, laminin 332 and laminin γ1 (p200), however, remain on the dermal side after skin splitting.

BP is the most frequently occurring AIBD and proceeds with an episodic, relapsing course. It has an incidence of three to 43 cases per million inhabitants per year and is more frequent in the elderly. It is characterised by tense, bulging blisters at the integument, while the mucous membrane is rarely affected. Autoantibodies are directed against BP180 and BP230. Anti-BP180 represents the most important autoantibody marker for BP. Anti-BP230 is positive in 40% of anti-BP180 negative cases, making it an important additional marker. Pemphigoid gestationis is considered the manifestation of BP in pregnant women. Linear IgA dermatosis is the most frequent form of AIBD in children and is characterised by IgA autoantibodies against the ectodomain of BP180.

Epidermolysis Bullosa Acquisita

Epidermolysis bullosa acquisita (EBA) is a severe autoimmune blistering dermatosis that affects the skin and the mucous membranes. The disease is divided into inflammatory and non-inflammatory forms. The target antigen of autoantibodies characteristic of EBA is collagen type VII (NC1 domain).

Dermatitis Herpetiformis

Dermatitis herpetiformis (DH) is a special form of AIBD. Blisters are formed subepidermally as in pemphigoid diseases and EBA, while the mucous membranes generally do not show any blistering. DH is considered as the cutaneous manifestation of coeliac disease (gluten intolerance) and is similarly characterised by antibodies against endomysium (EMA IgA), the enzyme (tissue/epidermal) transglutaminase (anti-tTG/-eTG, IgA) and/or deamidated gliadin (IgA/IgG).

Designer Antigens

Many of the target antigens used for antibody detection in IIF and ELISA have been adapted and enhanced by molecular methods to improve their diagnostic specificity and sensitivity. For example, in BP the vast majority of patients demonstrate antibody binding to epitopes clustered within the 16^th noncollagenous domain NC16A of BP180. Therefore, a recombinant antigen was developed which contains only the pathogenically relevant target structure NC16A (Figure 2). This, moreover, is present as a tetramer (4X), increasing the number of antibody binding sites and optimising the immunoreactivity.

The C-terminal peptide used for detection of anti-BP230 was selected from various overlapping BP230 fragments as the antigenic substrate with the highest reactivity in BP sera. For detection of anti-Dsg1 and anti-Dsg3 the ectodomains of the antigens are used. Further optimised antigen substrates include an N-terminal fragment of envoplakin and the N-terminal collagenous domain NC1 of collagen type VII for detection of the corresponding antibodies.

Mutiplex IIF

IIF substrates for the detection of autoantibodies in AIBD encompass tissue substrates e.g. oesophagus, salt-split skin, bladder mucosa, as well as transfected cells and purified antigen substrates for monospecific antibody detection (Figure 3). Dermatology biochip mosaics provide combinations of different substrates for efficient antibody screening and characterisation in one test. For example, the Dermatology Mosaic 7 includes the substrates oesophagus, salt-split skin, transfected cell substrates (BP230, Dsg1, Dsg3) and BP180-NC16A-4X antigen. The Dermatology Mosaic 11 provides an extended analysis, including in addition bladder mucosa and special substrates for DH diagnostics.

A published study on the Dermatology Mosaic 7 confirmed the high sensitivity and specificity of the substrates. 98.8% of BP sera reacted with the basement membrane of the tissue substrates, 100% with the BP180-NC16A-4X substrate and 55% with the BP230-transfected cells. The Dsg1-transfected cells had a sensitivity of 90% for PF, whereas 98.5% of PV sera reacted with the Dsg3-transfected cells. The specificity of the substrates was between 98.2% and 100%.

Multiplex ELISA

ELISA is used to confirm autoantibody specificities in AIBD. Moreover, ELISA allows quantitative measurement of antibody titers, making it a suitable method for therapy monitoring. For example, antibody titers correlate with the disease activity in BP (anti-BP180) and in pemphigus (anti-Dsg1 and anti-Dsg3).

A newly developed profile ELISA provides a combination of six relevant antigens (BP180-NC16A-4X, BP230, Dsg1, Dsg3, envoplakin, collagen type VII), enabling multiparameter monospecific detection of the corresponding antibodies. Each substrate is present in a separate well of the ELISA strip for convenient parallel analysis. Thus, patients with suspected autoimmune bullous dermatosis can be quickly and reliably investigated for different dermatological diseases at the same time.

In a clinical evaluation of the profile ELISA, sensitivities of between 60% (anti-BP230 in BP) and 100% (anti-Dsg3 in PV) and specificities of between 97.3% (anti-BP180-NC16A) and 100% (anti-collagen VII) were obtained with sera from different AIBD and disease controls. In a further prospective study using consecutive sera from patients with suspected AIBD, the ELISA yielded an agreement of 87% with conventional stepwise diagnostics (histology, direct and indirect immunofluorescence on biopsies and skin substrates, as well as monospecific tests like ELISA or immunoblots with cellular extracts). Discrepant results were attributed to the absence of certain target structures (e.g. p200 antigen, BP180 ectodomains) and the lack of IgA autoantibody detection.

Multi-Step Strategy

Serological testing for autoantibodies against skin proteins allows diagnostic confirmation and differentiation of different forms of AIBD, aiding therapy decisions and prognosis. With multiplex antibody tests, different antibodies occurring in pemphigus diseases, pemphigoid diseases, EBA and DH can be analysed in parallel. These assays provide an ideal alternative to a multi-step single testing strategy. In many cases, diseases such as BP, PV, PF can be diagnosed without any further testing.

Figure Captions

Figure 1. Structure of A. desmosomes and B. hemidesmosomes

Figure 2. BP180-NC16A-4X antigen construct

Figure 3. Examples of positive reactions in IIF

According to the World Health Organisation (WHO) more than one million STIs are acquired worldwide every day. Untreated, they can lead to serious long-term sequelae, especially infertility. They also pose a risk during pregnancy, causing intrauterine death, premature birth or foetal damage. Moreover, they can be transmitted to the newborn during birth, causing severe postnatal infections.

Diagnosing STIs can be challenging. STIs are in many cases asymptomatic, and may only be identified when irreversible damage has already occurred. Infections with multiple pathogens are also possible, adding to the complexity of diagnosis. Thus, laboratory tests play a key role in identifying infections. PCR-based direct detection is one of the most important methods, particularly for pathogens that cannot be effectively cultivated. PCR-based detection allows the identification of both manifest and silent infections, and is thus suitable for diagnosis of symptomatic patients as well as for general screening. Further, due to amplification of the pathogen DNA, infections with a reduced pathogen number can also be reliably identified.

A broad screening for STIs is important, especially in asymptomatic or clinically ambiguous cases. Microarray technology provides an ideal platform for simultaneous direct detection of a wide range of relevant pathogens, for example, Chlamydia trachomatis, Neisseria gonorrhoea, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum, Haemophilus ducreyi, Treponema pallidum, Trichomonas vaginalis and herpes simplex viruses 1 and 2.

Chlamydia trachomatis is a very small intracellular energy-parasitic bacterium and comprises different serotypes, which cause different diseases. Serotypes D to K cause urogenital infections and represent one of the most common STIs, with 131 million new infections worldwide per year according to the WHO. Infections are often asymptomatic, but can nevertheless lead to sterility. If symptoms develop they are urethritis, epididymitis and prostatitis in men and urethritis, and cervicitis and salpingitis/adnexitis in women. Perinatally transmitted infections manifest with conjunctivitis and pneumonia in the newborn and can lead to life-long health problems. Serotypes L1, L2 and L3 cause lymphogranuloma venereum, a sexually transmitted disease, which mainly occurs in tropical regions. Serotypes A, B and C infect the conjunctiva and cornea of the eye causing trachoma which can lead to blindness. These serotypes are transmitted by infectious eye secretions.

Neisseria gonorrhoeae is the causative agent of gonorrhoea, a worldwide distributed infectious disease which occurs exclusively in humans. According to the WHO, around 78 million new infections occur per year. The bacterium infects predominantly the epithelial cells of the female and male urethra, the cervical canal, the rectum and the conjunctiva. An ascending infection can lead to prostatitis, funiculitis, vesiculitis or epididymitis in men and pelvic inflammatory disease in women.

Treponema pallidum is the pathogenic agent of venereal syphilis, a widely distributed, chronic cyclic infectious disease. Humans are the only reservoir for the bacterial pathogen. The disease is divided into different stages encompassing localised symptoms (primary stage), generalised systemic manifestation (secondary stage), attacks on different organs (tertiary stage), and neurosyphilis with brain damage (quaternary stage). The stages do not always occur successively and some stages may be absent or recurrent. According to the WHO there are 5.6 million new infections worldwide per year. The main transmission route is sexual intercourse, while diaplacental transmission is also significant. In pregnancy, untreated early syphilis is responsible for one in four stillbirths and 14% of newborn deaths worldwide.

Mycoplasma and Ureaplasma are genera of very small, independently reproducing bacteria, which are distributed worldwide. They are mostly transmitted by droplet infection and sexual intercourse. To date, twelve species of Mycoplasma and two species of Ureaplasma have been described. 40–80% of women and 5–20% of men of sexually active age have a Ureaplasma urealyticum or Ureaplasma parvum infection of the lower genital tract. Mycoplasma hominis has a prevalence of 20–50% and Mycoplasma genitalium of 1–3% in sexually active adults. Since the infections are often asymptomatic, they frequently remain unnoticed and untreated.

Haemophilus ducreyi is the causative agent of ulcus molle, also known as chancroid, which occurs predominantly in tropical regions in Africa, South-East Asia and Latin America and is exclusive to humans. It is transmitted by sexual intercourse, and spreads particularly in population groups with poor personal hygiene. The disease manifests with single or multiple soft genital ulcers, which are usually painful.

Trichomonas vaginalis is a parasitic protozoan, which causes trichomoniasis. The parasite can survive for a long time in the vagina and urethra of women, particularly when the vaginal flora is disrupted. In men it infects the urethra and prostate gland. According to the WHO around 143 million people worldwide become infected per year. Infections can proceed symptomatically, with symptoms resembling other urinary tract infections, or asymptomatically.

Herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) are worldwide distributed human pathogenic viruses of the family Herpesviridiae. It is assumed that 70–90% of the population becomes infected with HSV-1 and 7–20% with HSV-2 during their lifetime. Facial and lip herpes is generally caused by HSV-1, with infection often occurring already in childhood through close bodily contact with infected persons. Genital herpes is caused predominantly by HSV-2, but also by HSV-1, and is generally acquired at a later time point via sexual contact. According to the WHO, more than 500 million people worldwide are living with genital herpes infection. Primary infections manifest with ulcers or inflammatory skin blisters. Complications of herpes include encephalitis, meningitis and disseminated HSV infection in immunodeficient patients.

The eleven STI pathogens described above can be directly detected in parallel in one reaction by microarray based on established EUROArray technology. The detection is highly specific and sensitive and offers a huge time advantage over pathogen cultivation. In the procedure (Figure 1), specific sections of the pathogen DNA from patient samples are amplified by one multiplex PCR using highly specific primers. During this process, generated PCR products are labelled with a fluorescent dye. The PCR reaction is then incubated with a biochip microarray slide containing immobilised complimentary probes. The PCR products hybridise with their complimentary probes and are subsequently detected by means of their fluorescence signals (Figure 2). Integrated controls verify correct performance of the test and absence of PCR contamination. The evaluation, interpretation and archiving of the results is fully automated and thus highly standardised and objective. A detailed result report is produced for each patient. A human papillomavirus (HPV) microarray based on the same technology can be performed in parallel if required.

The lower detection limit of the microarray analysis amounts to 10-100 DNA copies per reaction, depending on the pathogen. Template DNA in concentrations ranging from the lower detection limit to two million copies can be used in the PCR without any cross reactions with probes from other pathogens. Moreover, cross reactivity with 28 further anogenital microorganisms has been excluded experimentally.

In an evaluation study, 325 swab samples and 134 urine samples were analysed with the microarray. There was a very good agreement with the precharacterisation. Additionally, in many cases pathogens that were not included in the precharacterisation were detected. The additional findings were verified by further independent tests. Thus, the microarray provides reliable results and exceptionally broad screening capabilities.

Timely diagnosis of STIs is critical for preventing life-changing consequences such as infertility, miscarriage and foetal disorders. The risk of acquiring and transmitting HIV is, moreover, increased with STIs such as syphilis, chancroid and herpes. Once identified, the most common STIs such as chlamydia, gonorrhoea, syphilis and trichomoniasis can be cured with antibiotics, while HSV infections can be modulated through antiviral therapy. Due to the increasing spread of STIs, screening programmes, e.g. for chlamydia and gonorrhoea, have been introduced in some countries, especially for young people, in whom infections are most prevalent. STI testing is, moreover, an important preventative medical examination in pregnant women and immunosuppressed patients, for example HIV patients. Sexual partners of infected persons should always be tested and treated at the same time. Microarrays with a broad range of parameters are a simple and highly effective technique to screen for the many different STIs circulating in the population, especially in cases with multiple asymptomatic infections. The extensive information obtained from the microarray analysis can help to limit the sequelae and curtail the spread of these highly prevalent infections.

Companies associated to ABIMO (Brazilian Medical Devices Manufacturers Association) and which are part of the Brazilian Health Devices project, carried out by the entity itself in partnership with Apex-Brasil (Brazilian Trade and Investment Promotion Agency), will attend Medlab between February 6th and February 9th, a trade fair completely focused on the Middle East laboratory sector. It will be the first year when Medlab will take place out of Arab Health, the largest event of the Middle East health sector, which takes place in the Dubai Convention Center.

The region has high per capita income, population with high rates of consumption, progressive economy based on liberalization and diversification. The Brazilian companies Bioclin, Biomedtech, DK Diagnostics, Indrel, Labtest, LB Diagnóstica and Lupetec will have the opportunity to participate of an important business platform searching for new markets. The companies will present to the Middle East: diagnosis or laboratory reagents, in vitro diagnosis, devices for medical tests, laboratory tests, laboratory refrigerators and products for hematology.

According to Clara Porto, ABIMO’s marketing and exports manager, the Arabic countries has general demand for products and devices in the health area. “There is almost no national production of the sector, the region is quite dependent on imports. There is great acceptance of Brazilian products, so we expect good contacts and profitable deals’, she says.

The numbers in the last three years raise the expectations regarding the Brazilian sales of the health sector to the Middle East. Comprised by Saudi Arabia, Afghanistan, Bahrain, United Arab Emirates, Yemen, Iraq, Iran, Jordan, Qatar, Syria, Turkey, Kuwait, Lebanon and Oman, the region imported an amount of US$ 11,911,462 from the Brazilian companies in 2015, amount 12% greater than the sum of the imports in 2014.

“In general, the perspectives to export to the Middle East are always positive, because they mean a market diversification and also because this region has been sympathetic to Brazilian products and the way of negotiating that the Brazilian culture carries with itself”, evaluates.

In accordance with the numbers of 2015, four countries are responsible for 95% of the Brazilian exports to Middle East: United Arab Emirates, Turkey, Iran and Saudi Arabia.

Exhibitors expectations

Bioclin already works in the region with reagents for human and veterinary diagnostics, mainly focused on biochemistry and molecular biology. “For the first time, we will present molecular biology and equine anemia products in the veterinarian area. The company intends to consolidate and expand its transatlantic present”, said Danilo Andrade, responsible for the company’s foreign trade area.

“Identifying the requirements to work in the Asian market and raising the potential customers” are Labtest’s main goals during the trade fair, according to the international business manager, Renata de Almeida. The company will take products of the basic biochemistry line, aimed at the measurement of glucose, cholesterol, triglycerides, among others.

According to Caio Martins, Lupetec’s administrative director, the company’s intention, during Medlab, is the business prospection at the location, which has a strong growth in the sector. “We have already attended Arab Health and Medlab. In the next edition, we will take our Microtomes’ line used to produce sequential cuts in samples included in paraffin and other materials in the laboratory, industrial and research segment”, tells Martins.

“The expectations are good, the region has demonstrated a higher capacity of absorbing our products, and these are being looked for by new customers, which we have met during previous trade fairs”, highlights Paulo Francisco Windlin, DK Diagnostics commercial relations and exports manager, a company that already works in the Arabic territory, through kits to detect parasites in feces and kit for Pap test. “We will be presenting, definitively, our GPT - Green Pap Test, which was presented last year, but it was not in the market yet. In the next year, this new product will already be marketed for the entire region”, he adds.

With the participation at the event, Biomedtech technical and commercial director, Carlos Benzoni, aims at meeting new commercial partners and distributors in order to expand the customers’ universe around the world. “We manufacture hematology reagents for clinical analysis in our factory in Guarulhos, São Paulo”, points out the director, who still complements: “We are going to promote our products complete line, including reagents for hematology counters from the Coulter line, Abbott Laser (5 Diff) and for almost all hematology equipment on the world market”.

ABOUT BRAZILIAN HEALTH DEVICES

The SP (Sectorial Project) (PS – Projeto Setorial), Brazilian Health Devices, carried out by ABIMO in partnership with Apex-Brasil, has as its mission to foster the exports from industries of goods and healthcare devices. Brazilian Health Devices is the brand that brings together the export sector industries and represents them internationally.

ABOUT ABIMO

ABIMO (Brazilian Medical Devices Manufacturers Association) is the representative organization of the Brazilian industry of health products that seeks to promote the sustainable growth of the sector in national and international markets.

ABOUT APEX-BRASIL

Apex-Brasil (Brazilian Trade and Investment Promotion Agency) has the mission to develop the competitiveness of Brazilian companies, promoting the internationalization of their businesses and attracting foreign direct investments. Apex-Brasil currently supports more than 12,000 companies from 80 productive sectors of the Brazilian economy, exporting to more than 200 markets. The Agency also coordinates the efforts of attracting foreign direct investment (FDI) to the country.

For more information to the press:

Dehlicom – Soluções em Comunicação Empresarial
Deborah Rezende
deborah@dehlicom.com.br | 11 4106 4127 | 11 970206159
Elaine Cristina Alves
elaine@dehlicom.com.br | 11 4106-4127 |11 98719-6918

Dubai, December 2016 – Sysmex has never been your standard healthcare company. And as the years progress, we continue to set ourselves apart from others. We’re the global leaders in haematology. We are known around the world for our expertise in urinalysis and haemostasis. In lab automation. The world of oncology is increasingly taking on our specialised solutions in areas such as liquid biopsies, OSNA and innovative treatments for chemotherapy patients. And importantly, we are known for the dedication and excellent support from our service network. But how? What makes us so strong?

Quite simply, our strength stems from the firm belief that, through our knowledge and its use and application, we can stay ahead of our competition. We do not claim to be an all-round solution provider. Instead, we focus on specific issues to which we can apply our knowledge and expertise and offer solutions to real issues for real clients, so that you can improve the work you do for your clients. We are dedicated to helping you Stay ahead with Sysmex…

We’re greatly looking forward to meeting you all at this year’s Medlab as we believe we have again managed to devise solutions to issues that will help you. In haematology, for example, the time has come in which we can now truly make a difference on a clinical level. Far more than just a blood count, our analysers now offer genuine insight into clinical conditions, which will benefit both labs in terms of offering clients more added value, and clinicians in terms of diagnostic support.

One of the major developments this year is our new urinalysis series. For the first time, we can offer an ‘all-in-one’ series of analysers that will allow you to analyse both through chemistry and sediment, followed by imaging and validation. All automatically, with no hands-on work at all. This is a must-see.

In terms of newness, urinalysis is only beaten by the fact that, for the first time, we will be presenting our flow cytometry division. Purchased in 2013, Sysmex Partec is now Sysmex Flow Cytometry, and we have our first improved analysers on the market, coupled with antibodies dedicated to research and industry. This area promises much for the future, so at this year’s MEDLAB you have the chance to get on board on ground level.
Last but not least, come and talk to us about the latest developments in Life Science. We truly understand the importance of cross-functional communication in oncology, where the best solutions are achieved by experts from different areas working together. You’ll find a special focus on our liquid biopsy, which eliminates the need for patient tissue samples and will significantly help you improve patient’s quality of life. OSNA delivers the sensitivity and standardisation needed to improve your cancer staging. Ask our experts. They will give you the details.

The Medlab exhibition is one of our key platforms in the region for showcasing our development, and we greatly look forward to discussing with you how we can help you Stay Ahead. You will find us at booth number Z5.A10.

About Sysmex

Sysmex Corporation, based in Kobe, Japan, is one of the leading international providers of solutions for systemizing processes for medical laboratories, including laboratory diagnostics and laboratory automation. For over 45 years Sysmex has been setting new standards with its technologies and os contributes significantly to improvements in terms of health: Shaping the Advancement of Healthcare.

The company has regional offices in North America, Latin America, Europe, China and Asia-Pacific region and employs more than 6000 employees worldwide. Sysmex Corporation is listed on the Tokyo stock exchange

To learn more about Sysmex Corporation and Sysmex Europe as a whole, please go to www.sysmex-europe.com. For more information about Sysmex Middle East and Africa, please go to www.sysmex-mea.com/

Pediatricians can use our method to know about changes in the baby’s health at early stages of diseases, to begin treatment in a timely manner, and to prevent disease progression and complications. The mother can easily perform this simple procedure at home whenever it is needed.

Our method uses the diaper GUARDERS© for biologic sampling (the diaper is patented, patent № 11 01 37 from 26.09.2016) and allow determined pH level, presence of ketons and glucose in baby’s urine. Information about parameters is stored in Companion App .

We are developing methods for determining parameters such as proteins, erythrocytes, bilirubin and leukocytes in the baby’s urine.

Why do babies cry?

All babies cry. Weeping is the only opportunity for them to address adults. The main reasons for newborn’s crying relate to basic needs and problems, such as hunger, pain, fear, thirst, discomfort, hypothermia or overheating, fatigue and a desire to communicate.

But what if the baby has some health problems? How can this be diagnosed quicker and at home?

GUARDERS© will analyze the urine at home in the shortest time possible. With our technology, you can:

• find abnormalities in biochemical indicators of urine to detect problems with the baby’s health
• use simple colorimetric indicators to find abnormalities in the baby’s health before the onset of clinical symptoms to consult a pediatrician immediately
• log changes of parameters in a cloud service with Companion App 
• send pediatrician data of the latest analysis with Companion App 
• maintain online communication mother — pediatrician with Companion App 

How doesGUARDERS©work?

We developed a technology to collect 2-3 ml of the baby’s urine from the diaper without additional anxiety for the baby or the parents. While urine collector is removed, the diaper can be used later.

GUARDERS© are simple, convenient and fast.Diagnostic diaper, GUARDERS©, is intended for situations, when parents notice abnormalities and immediately consult with pediatrician, who will perform further medical examination.About Palma Group SA: the company has 25 years of experience in development of new goods and sales technologies. We strive to achieve exceptional results in promotion of goods and services for healthy, comfortable and active life.We invite you to visit our stand  Z4 C48 and obtain additional information about GUARDERS© and You can also visit our site www.guarders.ch.For more questions, please contact: Natalya Gordiyevska, Business development manager, nvg@palma-group.com.

GUARDERS© are simple, convenient and fast.

Diagnostic diaper, GUARDERS©, is intended for situations, when parents notice abnormalities and immediately consult with pediatrician, who will perform further medical examination.

About Palma Group SA: the company has 25 years of experience in development of new goods and sales technologies. We strive to achieve exceptional results in promotion of goods and services for healthy, comfortable and active life.

We invite you to visit our stand  Z4 C48 and obtain additional information about GUARDERS© and 

 

You can also visit our site www.guarders.ch.

For more questions, please contact: Natalya Gordiyevska, Business development manager, nvg@palma-group.com.

Dubai, 8 December 2016 -- Tosoh and DiaSys announce a collaboration for clinical laboratory testing with the combination of Tosoh’s new generation analysers (AIA-CL1200 for immunoassay and G11 for HbA1c) and DiaSys’ BioMajesty® JCA-BM6010/C. Instruments are linked through Evoline and Evoline Manager, Tosoh’s open laboratory automation and middleware solution. The collaboration takes place to address current requirements regarding clinical testing.

Tosoh AIA-CL1200 and G11

Tosoh has a significant experience with the development of high-specific and high-sensitive immunoassays. The company is also a pioneer in the field of automated HPLC-analysis for the measurement of HbA1c. During Medlab Middle East, Tosoh will be showing the AIA-CL1200, the newest generation of midsize chemiluminescence immuno-analysers, as well as the G11, the latest model of HbA1c analysers. Both instruments excel in sensitivity, stability and speed (1 minute per HbA1c analysis).

Like all other Tosoh automated immunoassay analysers, the AIA-CL1200 utilises the unique CL-AIA Pack twin cup format. The AIA-CL1200 is an easy-to-use, very fast, high sensitive and precise instrument. First results are available within 15 minutes, with an equivalent of up to 120 tests per hour. The principle of “one cup – twice the immunoassay power” ensures time and money saving (1 cup = 1 test).

DiaSys BioMajesty JCA-BM6010/C

The BioMajesty® JCA-BM6010/C is designed to increase the performance of medium-sized laboratories. It is also the ideal system for speciality laboratories. The throughput of up to 1,200 tests/hour, 43 reagent and 84 sample positions are a guarantee for flexibility in everyday use. It handles a full menu of photometric and immunoturbidimetric assays as well as Na, K, Cl determinations by indirect ISE methods.

Special emphasis has been spent on the software to combine highest user friendliness with optimally secured results. A special feature is the integrated on-board hemolysis function for optimized HbA1c determination. Dynamic range extension avoids additional dilutions and a dedicated STAT port allows for immediate STAT processing. Clot detection and liquid level sensor technology ensures confidence in results. The analyser works with very small sample volumes, making it the perfect instrument in pediatric and geriatric settings. The BioMajesty® JCA-BM6010/C is the system with the smallest footprint in its class hence saving precious laboratory space. DiaSys supplies ready-to-use reagents well known for their excellent on-board stability with the instrument. The result in conjunction with extremely low reagent consumption is cost efficiency on the highest order.

Open Lab Automation

The integration of a Tosoh and DiaSys analyser into the automation implementation of a clinical laboratory offers significant benefits to the working processes and is intended to achieve the following goals:

• Integration of multi competence technologies;
• Improvement of laboratory turnaround time with consistent throughput over time;
• Simultaneous management of routine and emergency workloads;
• Automation of repetitive manual procedures;
• Elimination of the need for the pre-sorting of specimens;
• Qualification of operators’ work, taking them off tasks associated with pre-analysis;
• Simple connection and a sophisticated data transmission system ensure analytical quality with minimal maintenance.

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About DiaSys Diagnostic Systems

DiaSys Diagnostic Systems is a leading specialist in development and manufacturing of diagnostic system solutions of high quality combined with ease of use and reduced environmental burden. Focusing on clinical chemistry and immunoturbidimetric tests, DiaSys has introduced more than 90 optimized reagents in user-friendly kits for manual or automated use. The products give reliable results in routine and special diagnostics as e.g. in diabetes, metabolic syndrome, lipid disorders, iron metabolism, pancreatic, kidney or liver diseases.

The analytical systems portfolio comprises automated clinical chemistry analysers for small to mid-size labs as the respons® 910 line and the BioMajesty®JCA-BM 6010/C. For the point of care DiaSys provides devices and rapid tests under the QDx® brand as well as analysers InnovaStar® and SensoStar®. Additionally, DiaSys offers a broad range of quality control material (TruLab®).

DiaSys is an ISO certified company since 1996 (ISO 13485:2012). To date, customers and partners in more than 100 countries around the world rely on DiaSys quality. Beside the headquarters in Holzheim, Germany, DiaSys maintains production sites and holdings in China, India, Indonesia, Brazil, Japan, France and USA. The international development department continuously enhances the test portfolio and provides innovative and user-friendly system solutions for the diagnostic lab.

About Tosoh Diagnostics Europe

Tosoh Bioscience has throughout the years demonstrated Technological Leadership in a number of Diagnostics niche markets including Immunochemistry, HPLC based diabetes and thalassemia screening and Molecular Biology. This leadership is based on an in-depth understanding of the ever growing clinical demand for faster and more precise diagnosis of a number of life threatening pathologies (e.g. tumour, cardiac, diabetes etc).

It is also based on the analysis of operational requirements emanating from laboratories worldwide, where quality of results, be it essential, is just not good enough anymore. Tosoh Bioscience reconciles quality of results and workflow optimisation through standardisation across platforms with a unitary dry chemistry reagent concept, workload management through flexible capacity loading options, connections to most automated production units, extended calibration stability and our analysers have one of the industry's best "up-time" performance.

We are dedicated to provide high quality instruments as well support the challenges facing the modern laboratory environment. We give you solutions providing time and cost savings, offering you a total laboratory automation, and bringing you efficiency and productivity.