Manufacturers

Axis-Shield Diagnostics Ltd

The Technology Park , DD2 1XA Dundee
United Kingdom

Telephone +44 1382 422000
Fax +44 1382 422088
axd.axis-shield@alere.com

This company is co-exhibitor of
The Gambica Association Limited

Trade fair hall

  • Hall 1 / F12
 Interactive Plan

Hall map

MEDICA 2016 hall map (Hall 1): stand F12

Fairground map

MEDICA 2016 fairground map: Hall 1

Our range of products

Product categories

  • 03  Diagnostics
  • 03.01  Clinical chemistry
  • 03.01.12  Units and systems for clinical chemical determination

Units and systems for clinical chemical determination

  • 03  Diagnostics
  • 03.01  Clinical chemistry
  • 03.01.12  Units and systems for clinical chemical determination
  • 03.01.12.05  Reagents for clinical chemistry

Reagents for clinical chemistry

Our products

Product category: Units and systems for clinical chemical determination

Active-B12

Three binding proteins are involved in the transport of vitamin B12 around the body – Intrinsic Factor (IF), transcobalamin (TC) and haptocorrin (HC). These binding proteins ensure the efficient uptake of the very small amounts of vitamin B12 available from the diet. When TC and HC bind vitamin B12 the resulting complexes are known as holotranscobalamin (HoloTC) and holohaptocorrin (HoloHC) to distinguish them from the proteins carrying no vitamin.

The major fraction in the circulation, HoloHC, represents 70-90% of vitamin B12 in the blood but is biologically inert. HoloTC represents only 10-30% of vitamin B12 in the blood but is the only form of vitamin B12 that can be taken up by cells in the body hence it’s alternative name Active-B12. The TC protein alone transports vitamin B12 from its site of absorption in the ileum to tissues and cells. The vitamin is then internalised as the Active-B12 complex via a specific receptor-mediated uptake. This process delivers vitamin B12 into the cells of the body and provides the vitamin as a co-enzyme for essential cellular functions such as DNA synthesis.

The measurement of Total Serum B12 suffers from some limitations; in particular, most of the measured B12 is bound to biologically inert HC. Several studies have been published which conclude that HoloTC would be a better indicator of vitamin B12 status than Total Serum B12.

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Product category: Units and systems for clinical chemical determination

HbA1c

Glycated haemoglobin or HbA1c is formed by the reaction of glucose with normal haemoglobin. The amount of HbA1c in red blood cells therefore increases with the average blood glucose concentration.

Poor control of blood glucose levels in diabetes increases the risk of serious complications such as cardiovascular disease, neuropathy and retinopathy.

Measurement of HbA1c is the method of choice for monitoring control of blood glucose levels in diabetic patients.

The Axis-Shield HbA1c turbidimetric immunoassay provides a highly accurate and precise method for measurement of HbA1c in whole blood on any clinical chemistry analyser with a number of convenient features.

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Product category: Units and systems for clinical chemical determination, Reagents for clinical chemistry

Heparin Binding Protein

Sepsis is the body’s systemic inflammatory response to infection and can progress to severe sepsis, septic shock and ultimately multiple organ failure and death. Early diagnosis and appropriate treatment of severe sepsis is vital to improve the patient’s chance of survival.

Heparin Binding Protein (HBP), also known as Cationic Antimicrobial Protein of 37kDa (CAP37) and azurocidin, is a 37kDa glycoprotein synthesised in neutrophils.

HBP is released from the secretory vesicles of activated neutrophils on contact with the endothelium. Once released, it induces a calcium-dependent rearrangement of the endothelial cell cytoskeleton, resulting in cell contraction and increased permeability of the endothelium. It is also internalised by the endothelial cells to protect them from apoptosis. HBP is also released from the secretory vesicles when M-protein/fibrinogen complexes, which are formed when M-proteins are released from bacterial cell surfaces, interact with ί2-integrins on the neutrophil cell surface. At the site of infection, HBP is also secreted from the azurophil granules during phagocytosis, where it exhibits antimicrobial activity and is responsible for the recruitment and activation of monocytes and other inflammatory mediators. It is also internalised by monocytes to prolong survival and enhance cytokine production.

HBP therefore directly contributes to the maintenance and progression of inflammation and it has been demonstrated in several major publications that measurement of HBP could be useful in identifying patients on admission to the Emergency Department who are at risk of developing sepsis with circulatory failure.

Published data also suggests that Heparin Binding Protein exhibits superior performance over existing biomarkers for the assessment of severe sepsis.

Part Number: FMHBP100

Method: ELISA

Description: 96-well microtire plate, liquid reagents, 6 calibrators, 3 controls

- Easy-to-use ELISA technology, compatible with automated systems for higher throughput
- Early identification of patients at risk of developing severe sepsis
- Published data shows improved performance over existing biomarkers
 
Intended Use

The Axis-Shield Heparin Binding Protein (HBP) assay is an enzyme immunoassay (EIA) for the quantitative determination of Heparin Binding Protein in human plasma.

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Product category: Units and systems for clinical chemical determination

Anti-CCP ELISA

The measurement of anti-CCP antibodies has become the method of choice in the accurate diagnosis of Rheumatoid Arthritis.

Assays using the second-generation CCP2 peptide are as sensitive as the rheumatoid factor (RF) test but with much higher specificity. Additionally anti-CCP2 positivity can predict future development of RA in both asymptomatic individuals and in patients with undifferentiated arthritis. It has also been shown that antibody levels at presentation can correlate with progression to erosive disease.

Part Number: FCCP600

Method: ELISA

Description: 96-well microtire plate, liquid reagents, 6 calibrators, 2 controls

- Proven, reliable CCP2 technology
- CE-marked and FDA 510k-cleared
- Excellent Clinical Specificity of 99%
- Low Total Imprecision
- Linear up to 300 U/mL
 
Intended Use

The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate). Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA), and should be used in conjunction with other clinical information.  Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments.

Assay Principle
The wells of the microtitre strips are coated with a highly purified synthetic cyclic citrullinated peptide containing modified arginine residues. During the first incubation, specific autoantibodies in diluted serum or plasma bind to the antigen-coated surface.  The wells are then washed to remove unbound components.  In the second incubation the Conjugate, an enzyme-labelled polyclonal antibody to human IgG, binds any surface-bound autoantibodies.  After further washing, specific autoantibodies are traced by incubation with the Substrate.  Addition of Stop Solution terminates the reaction, resulting in a coloured end-product and the amount of Conjugate bound is measured in absorbance units.  In the qualitative protocol, the amount of Conjugate bound by the sample is compared with that bound by the Reference Control.  In the semi-quantitative protocol, the concentration of anti-CCP autoantibody can be estimated by interpolation from a dose-response curve based on Calibrators.

Our Anti-CCP technology is also used on Abbott ARCHITECT and Siemens CENTAUR systems.

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Product category: Units and systems for clinical chemical determination, Reagents for clinical chemistry

Homocysteine EIA

Homocysteine (Hcy) is a thiol-containing amino acid produced by the intracellular demethylation of methionine. Hcy is exported into plasma where it circulates mostly in its oxidized forms bound to plasma proteins. Smaller amounts of reduced homocysteine and disulfide homocystine (Hcy-SS-Hcy) are present. Total homocysteine represents the sum of all Hcy species found in plasma and serum (free plus protein-bound).

Epidemiological studies have investigated the relationship between Hcy levels in blood and ­cardiovascular disease (CVD). A meta analysis of 27 epidemiological studies, including more than 4000 patients, estimated that a 5 µmol/L increase in Hcy was associated with an odds ratio for coronary artery disease (CAD) of 1.6 for men and 1.8 for women, or the same that is associated with 0.5 mmol/L (20 mg/dL) increase in cholesterol. Peripheral arterial disease also showed a strong association.

Patients with chronic renal disease experience an excess morbidity and mortality due to arteriosclerotic CVD. Elevated concentration of Hcy is a frequently observed finding in the blood of these patients. Although such patients may lack some of the vitamins involved in the metabolism of Hcy, the increased levels of Hcy are mainly due to impaired removal of Hcy from the blood by the ­kidney.

Drugs such as methotrexate, carbamazepine, phenytoin, nitrous oxide and penicillamine interfere with the Hcy metabolism and may give elevated levels of Hcy.

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About us

Company details

At Axis-Shield, innovation is fundamental to our business.

Our expertise encompasses the development of novel proprietary diagnostic tests in areas of clinical need and their incorporation onto the menus of the high throughput analysers of our partners, using a variety of assay technologies.

We specialise in proprietary markers for the early diagnosis and management of critical illnesses:

Cardiovascular and neurodegenerative diseases
Rheumatoid Arthritis
Sepsis
Vitamin deficiencies
Diabetes
Our proprietary tests and technologies to measure HbA1c, Homocysteine, anti-CCP (for early detection of rheumatoid arthritis) and Active-B12 (for better detection of vitamin B12 deficiency) are driving revenues and there has also been much interest in our newer markers such as Heparin Binding Protein for diagnosis and prediction of severe sepsis.

There is an increasing need for new diagnostic tests in many disease areas, including those associated with an increasingly ageing population. Identifying these diseases quickly and efficiently can be vital in maintaining a patient's quality of life. New drug modalities are evolving alongside innovative diagnostics, which is leading to improved patient management and monitoring of treatment efficacy.

The core focus of our business continues to be on innovation and the development of new markers that will increase testing and improve patient care.

Since our inception, we have successfully implemented our strategy of growth through the development and marketing of novel diagnostic tests in areas of clinical need.

We welcome discussion with organisations or individuals wishing to accelerate development, clinical evaluation and commercialisation of any novel markers with potential clinical utility.

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