Beta 2 Glycoprotein 1 - IgM

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The IgM is used for: Suspected early APS, Patients with mild or unexplained clotting symptoms, Evaluating recurrent pregnancy losses

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Beta 2 Glycoprotein 1 - IgM Test Information Guide

Why is it done?
- Detects IgM antibodies against beta 2 glycoprotein 1 (β2GP1), a blood protein involved in anticoagulation and immune regulation
- Used to diagnose antiphospholipid syndrome (APS), an autoimmune disorder that increases blood clotting risk
- Helps identify patients with unexplained thrombosis (blood clots) or recurrent pregnancy loss
- Ordered when patients present with venous or arterial thromboembolism, recurrent miscarriages, or systemic lupus erythematosus (SLE)-like symptoms
- Typically performed during initial diagnostic evaluation or when monitoring patients with established antiphospholipid syndrome
- May be repeated to confirm diagnosis, as positive results should ideally be confirmed 12 weeks apart
Normal Range
- Normal/Negative Result: Less than 1.0 unit/mL or negative (units may vary by laboratory)
- Borderline/Gray Zone: 1.0-1.5 unit/mL (may require repeat testing)
- Positive Result: Greater than 1.5 unit/mL (clearly positive)
- Units of Measurement: Unit/mL (units per milliliter); reference ranges may differ slightly between laboratories
- Interpretation: Negative result suggests absence of anti-β2GP1 IgM antibodies; positive result indicates presence of these antibodies, which may be associated with antiphospholipid syndrome
Interpretation
- Negative Result: No detectable anti-β2GP1 IgM antibodies; patient unlikely to have antiphospholipid syndrome based on this test alone, though other antiphospholipid antibodies (IgG, IgA) or lupus anticoagulant may still be present
- Borderline Positive (1.0-1.5 unit/mL): Equivocal result requiring clinical correlation and repeat testing after 12 weeks to confirm persistently elevated levels
- Positive Result (>1.5 unit/mL): Indicates presence of anti-β2GP1 IgM antibodies; associated with increased thrombotic risk and pregnancy complications; meets criteria for APS diagnosis when combined with clinical features and confirmed on repeat testing
- Clinical Significance: IgM antibodies typically represent acute or more recent immune response; IgM positive patients may have higher risk of acute thrombotic events compared to IgG-only positivity
- Factors Affecting Results: Infections (acute bacterial or viral); malignancy; certain medications; SLE and other autoimmune diseases; recent vaccinations; pregnancy; oral contraceptive use; smoking; laboratory methodology variations
- Diagnosis Criteria: Positive anti-β2GP1 antibodies alone do not diagnose APS; diagnosis requires positive serology confirmed on repeat testing 12 weeks later PLUS clinical features (thrombosis, pregnancy morbidity, or other APS-related manifestations)
Associated Organs
- Primary Organ Systems: Vascular system (blood vessels); blood and coagulation system; reproductive system (uterus, placenta)
- Associated Conditions: Antiphospholipid syndrome (primary and secondary); deep vein thrombosis (DVT); pulmonary embolism (PE); arterial thrombosis; stroke; myocardial infarction; recurrent pregnancy loss; placental insufficiency; systemic lupus erythematosus (SLE)
- Organ Complications: Brain: stroke, transient ischemic attack; Heart: myocardial infarction, valve disease; Lungs: pulmonary embolism, pulmonary hypertension; Limbs: thrombosis; Kidneys: renal artery thrombosis, renal microangiopathy; Placenta: infarction, insufficiency leading to miscarriage or intrauterine growth restriction
- Associated Autoimmune Diseases: Systemic lupus erythematosus (SLE); Sjögren syndrome; rheumatoid arthritis; inflammatory bowel disease; other connective tissue disorders
- Potential Complications: Catastrophic antiphospholipid syndrome (CAPS) - rare, life-threatening multiorgan thrombosis; thrombotic storms; long-term anticoagulation complications; medication side effects from anticoagulant therapy
Follow-up Tests
- Confirmatory Tests: Repeat anti-β2GP1 IgM testing 12 weeks after initial positive result to confirm persistent positivity for APS diagnosis
- Related Antiphospholipid Panel Tests: Anti-β2GP1 IgG; Anti-β2GP1 IgA; Anticardiolipin antibodies (IgM, IgG, IgA); Lupus anticoagulant (LA); Prothrombin time (PT)
- Coagulation Studies: Activated partial thromboplastin time (aPTT); Complete blood count (CBC); Platelet count; D-dimer; Fibrinogen level
- Thrombotic Risk Assessment: Deep vein thrombosis (DVT) ultrasound; Computed tomography pulmonary angiography (CTPA); Arterial Doppler studies; Stroke imaging (MRI/CT brain)
- SLE Screening: Antinuclear antibody (ANA); Anti-double stranded DNA (anti-dsDNA); Complement levels (C3, C4); Erythrocyte sedimentation rate (ESR); C-reactive protein (CRP)
- Pregnancy-Related Monitoring: Obstetric ultrasound; Placental assessment; Fetal monitoring; Human chorionic gonadotropin (hCG) levels in pregnancy
- Long-term Monitoring: Periodic repeat antiphospholipid antibody panel (every 1-3 years); INR monitoring if on warfarin therapy; Periodic assessment for new thrombotic events or pregnancy complications
Fasting Required?
- Fasting Requirement: No
- Special Instructions: No fasting required; test can be performed at any time of day; food and fluid intake do not affect test results
- Sample Collection: Blood draw via venipuncture; serum sample required; collected in standard red-top or serum separator tube
- Medications: No medications need to be withheld; anticoagulants (warfarin, heparin, DOACs) do not affect serology results; continue all regular medications as prescribed
- Timing Considerations: Avoid testing during acute infection if possible, as this may cause false-positive results; if repeat testing needed for confirmation, wait minimum 12 weeks after initial positive test
- Patient Preparation: Wear comfortable, loose-fitting clothing to facilitate blood draw; stay hydrated; inform phlebotomist of any recent infections, vaccinations, or recent thrombotic events; inform healthcare provider of all current medications

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