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Test Code (รหัสการทดสอบ):
090-70-8812

Order Name (ชื่อการทดสอบ):
Anti-Cardiolipin IgM, ELISA

 
Specimen / Container (สิ่งส่งตรวจ/ภาชนะ):
Blood/ Plain blood (Red top) 6 mL, 1 tube
 
Turnaround Time (ระยะเวลารอผล):
Received specimen to reported within 2 days.
 
Useful For (ประโยชน์การทดสอบ):
Diagnosis of Anti-phospholipid syndrome (APS) in the suspected patient.
 
Methodology (วิธีการทดสอบ):
Enzyme-linked Immunosorbent Assay (ELISA)
 
AliasesName (ชื่อเรียกอื่นๆ) :
Antiphospholipid Antibodies
Cardiolipin Antibodies, IgM
Anticardiolipin Antibodies
Anti-Cardiolipin IgM
 
 
 
Test Code (รหัสการทดสอบ):
090-70-8812

Order Name (ชื่อการทดสอบ):
Anti-Cardiolipin IgM, ELISA

 
Collection Specimen Or Container (สิ่งส่งตรวจ/ภาชนะ):
Blood/ Plain blood (Red top) 6 mL, 1 tube
 
Specimen Testing Type (สิ่งส่งตรวจที่ใช้ในการทดสอบ):
Serum, minimum volume 0.5 mL
 
Sub Mission Container (ภาชนะส่งตรวจ):
Plastic tube
 
Rejection Criteria (เกณฑ์ปฏิเสธสิ่งส่งตรวจ):
Hemolysis: Mild OK, Gross reject
Lipemia: Mild OK, Gross reject
Icteric: Mild OK, Gross reject
 
Specimen Stabillity (ความคงตัวของสิ่งส่งตรวจ):
Specimen Type Temperature Time
Serum Refrigerated, 2oC to 8oC 14 days
 
 
 
Test Code (รหัสการทดสอบ):
090-70-8812

Order Name (ชื่อการทดสอบ):
Anti-Cardiolipin IgM, ELISA

 
Method detail (วิธีการทดสอบ):
Enzyme-linked Immunosorbent Assay (ELISA)
 
Schedule (ตารางการทดสอบ):
Test daily, at 01:00 p.m.
 
Turnaround Time (ระยะเวลารอผล):
Received specimen to reported within 2 days.
 
Performing Location (หน่วยงานที่ทำการทดสอบ):
Molecular biology & Genetics, Laboratory Department
Tel.14168
 
Specimen Retention Time (ระยะเวลาเก็บสิ่งส่งตรวจ):
7 days
 
 
 
Test Code (รหัสการทดสอบ):
090-70-8812

Order Name (ชื่อการทดสอบ):
Anti-Cardiolipin IgM, ELISA

 
 
Clinical Information (ข้อมูลทางคลินิก):
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%. 
 
Reference Value (ค่าอ้างอิง):
< 12 MPL u/ml
 
Interpretation (การแปลผล):
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. 
 
Clinical Reference (เอกสารอ้างอิง):
Manufacturer’s reagent package insert, Anti-Cardiolipin ELISA (IgM) Test instruction, February 2016, EUROIMMUN, Lübeck, D-23560 Germany.