Cardiolipin Antibody (ACL) -IgM

Immunity

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Details

Used for diagnosing antiphospholipid syndrome (APS) — an autoimmune disorder characterized by: Blood clots (venous/arterial), Recurrent miscarriages, Thrombocytopenia

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Cardiolipin Antibody (ACL) -IgM Test Information Guide

Why is it done?
- Test measures IgM antibodies against cardiolipin, a phospholipid component found in cell membranes, helping identify antiphospholipid syndrome (APS)
- Primarily ordered to detect and diagnose antiphospholipid syndrome, an autoimmune disorder that increases risk of thrombosis and pregnancy complications
- Indicated when patients present with unexplained thrombosis (blood clots), recurrent miscarriages, stroke, or pulmonary embolism
- Used to evaluate patients with systemic lupus erythematosus (SLE) or other autoimmune diseases for associated antiphospholipid antibodies
- Typically performed when acute infection or recent autoimmune activation is suspected, as IgM antibodies indicate recent or acute response
Normal Range
- Normal Result: Negative or <1.0 Unit (mL) or <20 mPL (Unit), depending on laboratory methodology and reference standards
- Unit of Measurement: mPL (milli Phospholipid Units), Units (U), or Index value; laboratories may report as Negative, Borderline, Low-Moderate, Medium, or High Positive
- Interpretation Framework: Negative = No detectable antibodies; Borderline = Low-positive (1.0-1.5 Units); Low-Moderate = 1.5-3.0 Units; Medium/High = >3.0 Units; clinically significant usually ≥40 mPL
- Normal Interpretation: Negative or low results typically indicate no significant antiphospholipid antibodies; lower risk for thrombotic events unless other factors present; may indicate recent clearance of acute infection
Interpretation
- Negative/Low Results (<1.0 Unit): Indicates absence of significant IgM cardiolipin antibodies; antiphospholipid syndrome unlikely unless other antibodies (IgG or anti-β2 glycoprotein) are positive; lower thrombotic risk
- Borderline Positive (1.0-1.5 Units): Equivocal result; may represent early immune response, resolving infection, or false positive; repeat testing in 12 weeks recommended for APS diagnosis; clinical significance depends on symptoms and other findings
- Low-Moderate Positive (1.5-3.0 Units): Suggests presence of IgM cardiolipin antibodies; may indicate recent acute infection or emerging antiphospholipid syndrome; modestly increased thrombotic risk; should correlate with clinical presentation and other test results
- Medium-High Positive (>3.0 Units or >40 mPL): Strongly indicative of antiphospholipid antibody presence; significant thrombotic risk; meets criteria for APS diagnosis if persistent on repeat testing; associated with increased pregnancy morbidity and vascular thrombosis
- Factors Affecting Results: IgM levels may transiently elevate with acute infections (including viral infections); can be present in SLE, other autoimmune diseases, or infections like syphilis; transient positivity may occur post-vaccination; repeat testing after 12 weeks recommended for APS diagnosis confirmation
- Clinical Significance: IgM antibodies represent acute or recent immune response; less commonly associated with clinical thrombotic events compared to IgG antibodies; high titers warrant investigation for underlying autoimmune or infectious conditions
Associated Organs
- Primary Organ Systems Involved: Vascular system (veins and arteries), hematologic system (blood and coagulation), reproductive system (placenta), central nervous system, and immune system
- Antiphospholipid Syndrome (APS): Autoimmune disorder characterized by thrombosis and/or pregnancy complications with persistent antiphospholipid antibodies; can be primary or secondary to SLE
- Associated Diseases/Conditions: Systemic lupus erythematosus (SLE); Sjögren's syndrome; rheumatoid arthritis; infectious conditions (syphilis, Lyme disease, HIV, hepatitis C, EBV); acute viral infections; malignancies; thrombotic events
- Thrombotic Complications: Deep vein thrombosis (DVT), pulmonary embolism (PE), arterial thrombosis, stroke, myocardial infarction, valve thrombosis, mesenteric thrombosis, retinal vein occlusion
- Pregnancy-Related Complications: Recurrent miscarriages (≥3 consecutive), intrauterine fetal death, intrauterine growth restriction, placental insufficiency, preeclampsia, preterm birth, maternal thrombosis during pregnancy
- Potential Complications: Catastrophic antiphospholipid syndrome (CAPS) with multiple simultaneous thrombotic events; increased morbidity and mortality if not managed; hemorrhagic complications with anticoagulation therapy; recurrent thrombosis despite treatment
Follow-up Tests
- Confirmatory Testing if Positive: Repeat ACL-IgM testing after 12 weeks to confirm persistent positivity for APS diagnosis; ACL-IgG testing; anti-β2 glycoprotein-I antibodies (IgG and IgM); lupus anticoagulant (LA) testing
- Coagulation Assessment: Prothrombin time (PT); activated partial thromboplastin time (aPTT); thrombin time (TT); platelet count; bleeding time if clinically indicated
- Thrombosis Investigation: Duplex ultrasound (DVT screening); CT pulmonary angiography (PE evaluation); D-dimer testing; imaging studies as clinically indicated based on symptom presentation
- Associated Autoimmune Workup: Antinuclear antibody (ANA); anti-dsDNA antibodies; anti-Smith (Sm) antibodies; complement levels (C3, C4); complete metabolic panel; liver and kidney function tests
- Infectious Disease Evaluation if Indicated: Syphilis screening (RPR/VDRL, FTA-ABS); HIV antibody test; Hepatitis C antibody; EBV serology; other infectious markers based on clinical presentation
- Pregnancy Monitoring (if applicable): Serial ultrasound imaging; Doppler studies; fetal heart rate monitoring; preeclampsia screening; frequent clinical assessment
- Monitoring Frequency: Repeat testing at 12 weeks for diagnosis confirmation; periodic monitoring (annually or as clinically indicated) for diagnosed APS; more frequent assessment during pregnancy or if thrombotic events occur
Fasting Required?
- Fasting: NO - Fasting is not required for this test
- Specimen Collection: Blood draw can be performed at any time of day; no dietary restrictions; patient can eat and drink normally before testing
- Medications: Continue all regular medications unless otherwise instructed by healthcare provider; anticoagulant therapy (warfarin, heparin, DOACs) does not affect test results; NSAIDs, corticosteroids, and immunosuppressants may be continued
- Patient Preparation: Wear loose-fitting, short-sleeved clothing to facilitate venipuncture; remain hydrated; sit comfortably and relax for 5-15 minutes before blood draw; inform phlebotomist of any bleeding disorders or needle anxiety
- Specimen Requirements: Serum specimen collected in standard serum separator tube (SST) or non-anticoagulated vial; typically 5-10 mL of blood required; specimen must be properly labeled with patient identification
- Special Instructions: Inform provider if acute infection or illness is present; recent vaccinations should be noted; report all current medications and supplements; if repeat testing needed after 12 weeks, maintain consistent time of day for testing; avoid venipuncture from arm with active IV lines or edema when possible

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