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Test Code:
090-70-8805

Order Name:
Anti-Beta2-Glycoprotein 1, IgM

 
Useful For:
Diagnosis of Anti-phospholipid syndrome (APS) in the suspected patient.
 
Methodology:
Enzyme-linked Immunosorbent Assay (ELISA)
 
AliasesName:
Beta-2 GP1 Ab, IgM 
Beta-2 Glycoprotein 1 antibodies, IgM
 
 
 
Test Code:
090-70-8805

Order Name:
Anti-Beta2-Glycoprotein 1, IgM

 
Collection Specimen Or Container:
Blood/ Plain blood (Red top) 6 mL, 1 tube
 
Specimen Testing Type:
Serum, minimum volume 0.5 mL
 
Sub Mission Container:
Plastic tube
 
Rejection Criteria:
Hemolysis: Mild OK, Gross reject
Lipemia: Mild OK, Gross reject
Icteric: Mild OK, Gross reject
 
Specimen Stabillity:
Specimen Type Temperature Time
Serum Refrigerated, 2oC to 8oC 14 days
 
 
 
Test Code:
090-70-8805

Order Name:
Anti-Beta2-Glycoprotein 1, IgM

 
Method detail:
Enzyme-linked Immunosorbent Assay (ELISA)
 
Schedule:
Test daily, at 01:00 p.m.
 
Turnaround Time:
Received specimen to reported within 2 days.
 
Performing Location:
Molecular biology & Genetics, Laboratory Department
Tel.14168
 
Specimen Retention Time:
7 days
 
 
 
Test Code:
090-70-8805

Order Name:
Anti-Beta2-Glycoprotein 1, IgM

 
 
Clinical Information:
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 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). Anti-β2-GP1 antibodies are a highly specific marker for pAPS and sAPS, the latter of which is frequently associated with collagenosis. According to the "International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS) 2006“ the serological detection of β2-GP1 antibodies (strongest APS association of all detectable APS antibodies) is indicated as a serological criterion in APS diagnostics. The determination of anti-β2-GP1 antibodies is indispensable in suspected cases of APS that are negative for antibodies against cardiolipin or lupus anticoagulans. This is generally the case in 3%-14% of APS patients. Furthermore, anti-β2-GP1 antibodies are a biological marker for APS-induced pregnancy complications with a prevalence of approx. 6%. 
 
Reference Value:
< 20 RU/mL
 
Interpretation:
The prevalence of class IgG and/or IgM antibodies against β2-GP1 in APS patients is 30% to 80%. They can be detected in 50% of asymptomatic patients. This implies a prognosis of potential/probable thromboembolism, which could be prevented by early phrophylaxis. Retrospectively, there is a significant correlation between antibody concentration and past venous thrombosis. IgM antibodies correlate with arterial thrombosis. In APS patients with SLE, the severity of thrombosis correlates with the level of antibodies against β2-GP1. The serological detection rate in APS diagnostics can be significantly increased to almost 100% by parallel investigation of antibodies against β2-GP1 (specificity approx. 98%, sensitivity approx. 60 %) and cardiolipin (specificity >85 %, sensitivity significantly >60 %). In suspected cases of APS that show a negative result for IgG and IgM isotypes of anti-β2-GP1 and anti-cardiolipin, the IgA isotope should also be determined for both autoantibodies. The use of the anti-cardiolipin antibody test as the only serological detection method is limited since cardiolipin antibodies also occur in tumours and in some infections (e.g. syphilis, borreliosis, AIDS, hepatitis or tuberculosis). A positive β2-GP1 antibody result should always be assessed after at least 12 weeks to confirm diagnosis. 
 
Clinical Reference:
Manufacturer’s reagent package insert, Anti-2-Glycoprotein 1 ELISA (IgM) Test instruction, September 2011, EUROIMMUN, Lübeck, D-23560 Germany.