cambridge-live-sciences

Autoimmunity
diagnostics -
Autozyme®
ELISA assays

CLS provides diagnostic tests for three autoimmune diseases:

AUTOZYME® RF for Rheumatoid Arthritis
AUTOZYME® ACL for Antiphospholipid Syndrome
AUTOZYME® IFAB for Pernicious Anaemia.
These can be used in conjunction with other laboratory tests and clinical findings.

An autoimmune condition causes the immune system to react abnormally, so that the antibodies that attack disease cells in normal circumstances instead start attacking the body’s healthy cells and tissue. There are many autoimmune conditions, each with a broad spectrum of symptoms, that means diagnosis may need a range of testing.

‘Trusted by hospitals and research labs for more than 40 years.’

AUTOZYME® RF - Rheumatoid Arthritis

Rheumatoid Arthritis (RA) is a chronic, progressive systemic autoimmune disease characterised by persistent joint inflammation. If left untreated, the disease leads to systemic complications, irreversible joint damage and invalidity. Serological markers can detect early stage RA to lead to improved outcome of RA therapy and reduction of severity of joint damage.

AUTOZYME® RF is for the quantitative detection of IgA, IgM or IgG Rhuematoid Factors in human sera or plasma to aid the diagnosis of rheumatoid arthritis in conjunction with other laboratory tests and clinical findings.

The AUTOZYME™ method employs antigen-coated microwell technology, which is ideal for batch screening of large and small numbers of samples for rheumatoid factor IgA, IgM and IgG. The method employs a sandwich enzyme immunoassay (EIA) principle.

Arthritis
  • Antigen: horse IgG
  • Calibration: 5 calibrators (quantitative), related to WHO W1066 for Rheumatoid Factor which replaced the 1st British Standard 64/2.
  • Serum samples, Dilution: 1/100 (10μl sample+ 990μl diluent)
  • No interferencefrom Bilirubin, Haemoglobin, Lipids, Ascorbic Acid
  • Assay Time: 30’, 30’ 30’
Serolgical markers include Rheumatoid Factor (RF) and antibodies against cyclic citrullinated peptides (Anti-CCP).

AUTOZYMETM RF IgA, IgG and IgM Elisa assays provide excellent quantification, ideal for routine use on Elisa processors such as the Dynex DS2.

Product Codes:
Z9196: AUTOZYME® RF IgA
Z9296: AUTOZYME® RF IgG
Z9396: AUTOZYME® RF IgM
CLS also can provide RF and anti-CCP elisa assays and assays that are suitable for clinical chemistry analysers.

AUTOZYME® ACL - Antiphospholipid Syndrome

Anti-cardiolipin antibodies are a heterogeneous group of antibodies directed towards negatively charged phospholipids. Of the various tests available for the detection of antiphospholipid antibodies, the anti-cardiolipin antibody test has been recognised as the method of choice.

The presence of antiphospholipid (aPL) antibodies and its cofactor β2-glycoprotein I help to identify patients at risk for antiphospholipid syndrome (APS). APS may involve venous and/or arterial thrombosis, thrombocytopenia and recurrent foetal loss. Significantly raised IgA and IgM anti-cardiolipin antibodies are associated with thrombotic events (although not to the same extent as IgG). All three isotypes should be individually assessed when evaluating patients in whom APS is suspected.

AUTOZYME® ACL is for the quantitative detection of anti-cardiolipin IgA, IgG or IgM autoantibodies in human sera or plasma to aid the diagnosis of antiphospholid syndrome (APS) in conjunction with other laboratory tests and clinical findings.

It employs a unique antigen-coated microwell technology, which is ideal for the batch screening of large and small numbers of samples for ACL. The method utilises a non-competitive sandwich enzyme immunoassay system.

AUTOZYME® ACL, anti-cardiolipin IgA, IgG and IgM Elisa assays provide excellent quantification, ideal for routine use on Elisa processors.

  • Antigen: high purity cardiolipin and ß2-glycoproetin 1cofactor
  • Unique antigen-coated microwell technology
  • Calibration: 6 calibrators (quantitative), to internationally recognised Reference Standards IRP 97/656 (IgG) from Dr E N Harris, Louisville, USA, and HCAL (IgG) / EY2C9 (IgM)
  • Serum samples, Dilution: 1/100 (10μl sample+ 990μl diluent)
  • No interferencefrom Bilirubin, Haemoglobin, Lipids, Ascorbic Acid
  • Assay Time: 30’, 30’ 30
Product Codes:
Z4496: AUTOZYME® ACL IgA
Z4596: AUTOZYME® ACL IgG
Z4696: AUTOZYME® ACL IgM
These assays are complemented with assays for anti-β2-glycoprotein 1, phosphatidyserine, oxLDL antibodies and annexin-V.

AUTOZYME® IFAB - Pernicious Anaemia

Pernicious anaemia, or folate (Vit B12) deficiency anaemia is accompanied by the development of autoantibody to intrinsic factor, a secretory product of gastric parietal cells.

Intrinsic factor autoantibodies, present in serum and gastric juice, can block intrinsic factor from binding vitamin B12 and hinder the absorption by receptors in the ileum.

AUTOZYME® IFAB is for the quantitative or semi-quantitative detection of antibodies to Intrinsic factor in human sera or plasma to aid the diagnosis of pernicious anaemia in conjunction with other laboratory tests and clinical findings.

It is a solid phase immunoassay. The wells are coated with recombinant intrinsic factor antigen followed by blocking the untreated sites to reduce non-specific binding.

The AUTOZYME® IFAB Anti-Intrinsic Factor Antibodies Assay is an easy, rapid and sensitive method allowing the detection of total anti-intrinsic factor antibodies. The use of recombinant intrinsic factor as antigen ensures the specificity of the method.

  • Easy, rapid and sensitive method
  • Solid phase immunoassay
  • Antigen: recombinant intrinsic factor – no cross reactivitywith Parietal Cell Antibodies
  • Calibration: 6 calibrators (quantitative) or cut-off control (semi-quantitative)
  • Dilution: 1/100 (5μl sample+ 495μl diluent)
  • No interferencefrom Direct and Total Bilirubin, Haemoglobin, Triglycerides, RF
  • Serum and Plasma(EDTA, citrate, heparin) samples
  • TMB Substrate
  • Multiple use: microplates suitable for small and large users – no waste
Product Codes: Z4396: AUTOZYME® IFAB

Quality assurance

Download U1021 IFU

Download U1021 IFU

Download K9001 IFU

Download K8100 IFU

Download K8003 IFU

Download K8002 IFU

Download Z9296 IFU

Download Z9196 IFU

Download Z4396 IFU

Download Z4696 IFU

Download Z4596 IFU

Download Z4496 IFU