Multiple analytes on one instrument
Multiple sample types
All-in-one test cartridge
Automatic self-check system
No additional calibration necessary
Throughput: 480 tests/hour 580 tests/hour with ISE
Test items on board: 36 items + ISE 3 items
Reaction volume: 120– 300 micro-liter
Patient samples on board: 72 patient samples, 30 STAT samples
Reaction volume: 140– 300 micro-liter
Test items on board: 24 items + ISE 3 items / 36 items + ISE 3 items
Patient samples on board: 30 patient samples
Throughput: 270 tests/hour 450 tests/hour with ISE
R1: 140 ～ 300μl (1μl step）
R2: 20 ～ 260μl (1μl step）
News and Announcements
The identification of novel biomarkers associated with Alzheimers disease (AD) could provide key biological insights and permit targeted preclinical prevention. Circulating metabolites associated with incident dementia and AD has been investigated using metabolomics. Alzheimers disease is the most common form of dementia responsible for a slow and progressive deterioration of memory and leads to frailty and dependence in elderly people. There is currently no effective preventive or curative treatment for AD, which could result in a public health crisis given the continuous aging of populations worldwide.
Scientists at the Boston University School of Medicine (Boston, MA, USA) and their colleagues measured plasma levels of 217 metabolites and were assessed in 2,067 dementia-free Framingham Offspring Cohort participants whose mean age was 55.9 ± 9.7 years; and 52.4% were women. They studied their associations with future dementia and AD risk in multivariate Cox models. The team found 93 participants who developed incident dementia with a mean follow-up of 15.6 ± 5.2 years. Higher plasma anthranilic acid levels were associated with greater risk of dementia (hazard ratio [HR] = 1.40). Higher glutamic acid and lower taurine and hypoxanthine, a precursor of uric acid, levels were also associated with increased risk of subsequent dementia. The authors concluded that they had identified four biologically plausible, candidate plasma biomarkers for dementia. Association of anthranilic acid implicates the kynurenine pathway, which modulates glutamate excitotoxicity. The associations with hypoxanthine and taurine strengthen evidence that uric acid and taurine may be neuroprotective.
Sudha Seshadri, MD, a professor of neurology and senior investigator, sad, “First anthranilic acid is produced during the degradation of tryptophan, an essential amino acid. Interestingly, other compounds produced through the same reactions have been reported as protective or deleterious for neurons and could constitute valuable drug targets. Second, this potential marker could also be used to identify groups of persons at higher risk of developing dementia, which could improve the efficiency of clinical trials and in the future, detect persons that would benefit the most from a preventive treatment.” The study was published on June 8, 2017, in the journal Alzheimer and Dementia.
Related Link: Boston University School of Medicine
From educational sessions in the rapid advancements in molecular haematology to the different aspects of haematopathology, coagulation and haemostasis amongst others, the Haematology track at the MEDLAB Americas Exhibition and Congress will also address everyday quality challenges in the haematology lab.
As the Chair of the Haematology track, it is my great pleasure and a privilege to welcome you to the MEDLAB Americas Exhibition and Congress, that will take place in a few short months in sunny Orlando, Florida, USA. The overarching theme of this session is “Improving Efficiency in the Haematology Laboratory” and we were fortunate in securing a roster of content experts who will describe their experience in achieving more streamlined diagnostic processes, that ultimately lead to improved patient care.
The topics that will be covered in the Haematology track are varied, and touch upon several broad diagnostic categories, as well as different areas of the Haematology laboratory. I will summarise some of the highlights in the remainder of this article. Our first featured speaker is Dr Stephanie Mathews, an assistant professor of Haematopathology from the University of North Carolina School of Medicine in Chapel Hill, North Carolina, USA. Dr Mathews specialises in the diagnosis of chronic myeloid neoplasms and is a consummate educator in her work with several professional societies, including the American Society for Clinical Pathology and the Society for Haematopathology. Dr Mathews will provide an overview of the updated classification and nomenclature of myelodysplastic syndromes, that will be listed in the upcoming 2016 version of the WHO Classification of Tumors of Haematopoietic and Lymphoid Tissue, and she will discuss the best practices in working up myelodysplastic syndromes, based on state-of-the-art best diagnostic approaches.
This is a timely topic of practical utility, since haematologic malignancies comprise a unique spectrum of disorders as they are associated with significant morbidity and mortality, and the diagnostic algorithm is complex and involves a multidisciplinary approach, including clinical, morphologic, immunophenotypic, and cytogenetic findings, as outlined in the current WHO classification of haematolymphoid neoplasms. There is a constant process of improving and refining diagnostic, prognostic, and therapeutic modalities, in order to maximise favourable outcomes in this group of patients. Because of the amount of rapidly changing information in the specialties of Haematopathology and Haematology/Oncology, it is necessary for practitioners to be knowledgeable of the most recent developments in these fields, in order to provide the most optimal patient care.
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Autoantibody determination plays an important role in the diagnosis and differentiation of autoimmune bullous dermatoses (AIBD). 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 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.
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Advances in medicine in the 17th century provided the foundation for diagnostic laboratory testing. The discovery of the circulation of blood by William Harvey and subsequent development of procedures to withdraw blood from a patients vein for therapeutic purposes have enabled physicians to utilise blood to detect and monitor disease. Today, laboratory medicine remains an integral component of patient care. An estimated 60-70% of medical decisions are based on the results from laboratory testing. Therefore, timely receipt of test results may enable more rapid diagnosis and treatment, which can impact patient outcomes. Yet, laboratory test turnaround time (TAT) has been cited as a primary source of dissatisfaction among physicians and nurses. In surveys conducted by the College of American Pathologists involving physicians and nurses from 138 and 182 institutions, respectively, satisfaction with TAT received below average ratings. Many physicians believed that laboratory TAT caused delays in treatment in the Emergency Department (ED) (42.9%) as well as increased the length of stay in the ED more than 50% of the time (61.4%).
As such, improving turnaround time has become a key barometer of laboratory performance and an addition to quality improvement initiatives in hospitals and institutions. To meet these objectives, laboratories may consider utilising plasma instead of serum for clinical chemistry testing.
While serum has typically been used for clinical chemistry testing due to the ability to test a wide range of assays, it may compromise the time to test receipt due to the required clotting (generally ranging from 30-60 minutes). The clotting time for patients on anticoagulant therapy may be longer. Serum is also subject to latent fibrin formation when clotting is inadequate or may be present in samples from patients receiving anticoagulant or thrombolytic therapy. Inadequate tube mixing or incomplete or delayed clotting may cause fibrin, which may range from thin strands to large cloud-like masses. It may also contribute to obstruction of the sample probe in automated instruments and subsequent instrument downtime.
Plasma offers distinct advantages over serum. Plasma—the liquid component of blood—contains blood cells and anticoagulant following centrifugation of whole blood. Heparin is the most commonly used anticoagulant in plasma, which acts primarily through a complex that it forms with anti-thrombin III, a protein that helps to control blood clotting. It also prevents the formation of fibrin from fibrinogen. Conversely, clotting is not required for plasma, enabling plasma to be centrifuged upon receipt of the specimen in the laboratory. Specimens can be processed more quickly, shortening the turnaround time for test results. There is a potentially higher sample volume yield with plasma, with approximately 15-20% more plasma obtainable from whole blood than with serum.This helps laboratories to adhere to ISO standard 15189, in which laboratories should periodically review sample volume requirements to ensure that excessive amounts of blood samples are not collected.
In addition, interference due to coagulation is eliminated, as coagulation post centrifugation does not occur in plasma.There is also a lower risk of haemolysis and thrombocytolysis. In a healthy population, free haemoglobin is about 10 times less concentrated in plasma than in serum.In anticoagulated blood, there is no obstruction to upward gel movement; therefore, the time required for gel to complete its upward course is generally shorter with plasma tubes. This may result in more reproducible gel barrier formation. Most significantly, it is imperative that the in vivo state of a constituent remains unchanged after withdrawal from the body fluid of a patient. Constituents in plasma are more accurately representative of the in vivo status of the patient than those in serum.
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