090-70-8812

Anti-Cardiolipin IgM, ELISA

Blood/ Plain blood (Red top) 6 mL, 1 tube

Serum, minimum volume 0.5 mL

Plastic tube

Hemolysis: Mild OK, Gross reject
Lipemia: Mild OK, Gross reject
Icteric: Mild OK, Gross reject

Specimen Type	Temperature	Time
Serum	Refrigerated, 2oC to 8oC	14 days

090-70-8812

Anti-Cardiolipin IgM, ELISA

Enzyme-linked Immunosorbent Assay (ELISA)

Test daily, at 01:00 p.m.

Received specimen to reported within 2 days.

Molecular biology & Genetics, Laboratory Department
Tel.14168

7 days

090-70-8812

Anti-Cardiolipin IgM, ELISA

Anti-phospholipid syndrome (APS), also called Hughes syndrome, is an autoimmune disease which is characterised by thrombophilia. Cumulative haematological signs are mainly venous (37%) or arterial (27-49%) thrombosis, haemocytopenia (30-38%), pregnancy complications (55-74%), neurological failures (66%) and cardiological (27%), pulmonary (20-30%) or cutaneous (40%) tissue damage due to the above-mentioned circulatory disorders.
APS is an immunocoagulopathy and the most frequently acquired hypercoagulability. 82% of APS
patients are women and 18% men. Around 10% of APS cases are familial.  APS is divided into primary APS (pAPS) and secondary APS (sAPS). These are characterised by the same haematological immune responses. In sAPS, however, they occur during the course of the disease as secondary reactions, most frequently in connection with rheumatic diseases (e.g. SLE). 
According to the "International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS) 2006 " the presence of anti-cardiolipin antibodies is a serological criterion in APS diagnostics. ACA have a high prevalence of 60 to 90% (ACA-IgG 44%, ACA-IgM 12%, ACA IgG/IgM 88%) and persist for more than 12 weeks in APS patients. ACA can be found in the serum of 15 to 30% of sAPS patients. In persons with thrombosis in their anamnesis the prevalence is 20% to 30%. 

< 12 MPL u/ml

The specificity of ACA is slightly limited since ACA can also be detected in infections. They occur temporarily in for example syphilis, borreliosis or malaria without the cofactor β2-GP1, which means that they are not associated with APS. A positive ACA result should always be assessed after 12 weeks to confirm APS diagnosis.
Persisting high ACA titers are considered as a risk factor for thrombosis and vascular complications such as cardiac or cerebral infarction, which develop with a probability of 80%. The serological detection rate in APS diagnostics can be increased to almost 100% by parallel investigation of ACA and β2-GP1 antibodies. In suspected cases of APS that are negative for IgG and IgM isotypes of ACA and anti-β2-GP1, the IgA isotope should also be determined for both autoantibodies. 

Manufacturer’s reagent package insert, Anti-Cardiolipin ELISA (IgM) Test instruction, February 2016, EUROIMMUN, Lübeck, D-23560 Germany.