Anti Hepatitis E Virus (HEV) - IgM

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Anti-HEV IgM test detects IgM class antibodies produced early in response to infection with the Hepatitis E virus

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Anti Hepatitis E Virus (HEV) - IgM: Comprehensive Test Guide

Why is it done?
- Test Purpose: Detects IgM antibodies against Hepatitis E Virus to identify acute or recent HEV infection. IgM antibodies are the first antibodies produced in response to primary viral infection.
- Primary Indications: Acute hepatitis symptoms (jaundice, fatigue, abdominal pain, nausea); Suspected acute HEV infection; Evaluation of unexplained liver enzyme elevation; Investigation of acute liver failure; Screening in endemic regions; Pre/post-transplant assessment.
- Typical Timing: During acute phase of illness (within 1-2 weeks of symptom onset); When acute hepatitis is clinically suspected; IgM remains detectable for approximately 3-6 months after infection onset; Best sensitivity during early symptomatic period.
Normal Range
- Normal/Negative Result: Anti-HEV IgM Negative or Non-Reactive; Typical expression: < 0.8 Index (varies by laboratory); Units: Index value, S/CO (signal-to-cutoff ratio), or qualitative negative.
- Abnormal/Positive Result: Anti-HEV IgM Positive or Reactive; Typical expression: ≥ 0.8 Index or > 1.0 S/CO; Indicates presence of IgM antibodies against HEV.
- Borderline/Equivocal Result: Intermediate Index values (0.8-1.2 depending on assay); May require repeat testing or confirmatory testing (anti-HEV IgG, HEV-RNA PCR); Clinical correlation recommended.
- Interpretation Framework: Negative = No evidence of acute HEV infection (but does not exclude recent/resolved infection); Positive = Consistent with acute or recent HEV infection; Most reliable when correlated with clinical presentation and liver function tests.
Interpretation
- Positive Anti-HEV IgM: Indicates acute HEV infection (within 3-6 months); Suggests viral replication is or was recently occurring; Patient likely infectious; Correlates with acute phase of illness; Highest sensitivity in first 2-4 weeks of illness.
- Negative Anti-HEV IgM: Does NOT exclude HEV infection if tested early (< 1 week); May indicate past infection beyond IgM detection window; Could represent resolved infection; Does not indicate immunity status (check IgG if needed); Repeat testing may be warranted if high clinical suspicion.
- Clinical Context Factors: Timing of symptom onset relative to testing; Immunocompromised status (immunocompromised patients may have delayed or absent IgM response); Geographic location and HEV prevalence; Exposure history (contaminated water, travel); Liver enzyme levels (ALT/AST elevation); Jaundice presence.
- Result Patterns and Significance: IgM positive + IgG negative = Acute infection (early); IgM positive + IgG positive = Acute infection (later phase); IgM negative + IgG positive = Past/resolved infection; Both negative = No HEV infection or too early to detect; High IgM titers = More recent infection.
- Sensitivity and Specificity: Sensitivity approximately 80-90% in acute phase; Specificity approximately 95-99%; Varies by laboratory assay platform (ELISA, chemiluminescence); Earlier testing (< 2 weeks) provides highest detection rates.
Associated Organs
- Primary Organ System: Liver (hepatic system); Hepatitis E Virus primarily targets hepatocytes causing inflammation and damage.
- Diseases/Conditions Associated with Abnormal Results: Acute Hepatitis E; Acute liver failure (fulminant hepatic failure); Chronic HEV infection (especially in immunocompromised); Cirrhosis (if chronic infection develops); Cholestasis; Autoimmune hepatitis-like syndrome.
- Secondary/Extrahepatic Manifestations: Neurological: Encephalitis, Guillain-Barré Syndrome, neuropathy; Renal: Acute kidney injury, glomerulonephritis; Hematologic: Thrombocytopenia, hemolytic anemia; Pancreatic: Acute pancreatitis; Cardiac: Myocarditis; Musculoskeletal: Arthralgia, myalgia.
- Complications from Acute HEV Infection: Fulminant hepatic failure (1-3% in general population, up to 30% in pregnant women); Portal hypertension; Hepatic encephalopathy; Coagulopathy; Hemorrhage; Acute respiratory distress; Organ failure; Maternal complications during pregnancy (increased mortality in third trimester).
- High-Risk Patient Populations: Pregnant women (higher morbidity/mortality); Immunocompromised patients (transplant recipients, HIV); Chronic liver disease patients; Elderly patients; Those with pre-existing hepatitis; Patients in endemic areas; Healthcare workers; Travelers to endemic regions.
Follow-up Tests
- Immediate Follow-up Tests if IgM Positive: Anti-HEV IgG (to assess immune response progression); HEV-RNA PCR (viral load, genotyping if available); Liver Function Tests (ALT, AST, bilirubin, ALP, GGT); PT/INR (prothrombin time for coagulation); Serum albumin; Complete blood count; Creatinine/BUN (renal function).
- Additional Diagnostic Tests: Liver ultrasound (assess hepatic architecture, exclude other pathology); Abdominal imaging if complications suspected; Serologies for other viral hepatitis (HAV, HBV, HCV); Autoimmune markers (if autoimmune hepatitis suspected); Imaging for complications (brain MRI if encephalitis, renal ultrasound if AKI).
- If IgM Negative but High Clinical Suspicion: Repeat anti-HEV IgM in 1-2 weeks; HEV-RNA PCR (can detect virus before antibodies); Anti-HEV IgG; Consider other etiologies of hepatitis; Liver function test monitoring.
- Monitoring During Acute Infection: Liver function tests: Weekly to every 2 weeks during acute phase; Coagulation studies if INR elevated; Renal function and electrolytes; INR/PT for fulminant hepatitis monitoring; Anti-HEV IgG seroconversion (typically 1-2 months).
- For Immunocompromised/Transplant Patients: HEV-RNA PCR (primary marker since IgM/IgG response may be absent); Repeated HEV-RNA at 1-2 week intervals; Liver transplant virology monitoring if needed; Assessment for chronic infection (HEV-RNA persistently positive > 6 months).
- Long-term Follow-up: Anti-HEV IgG at 3 months (confirms seroconversion); Clinical reassessment at 1-3 months; Liver function test normalization confirmation; HEV-RNA PCR clearance verification; Screen for chronic infection if immunocompromised.
Fasting Required?
- Fasting Status: NO - Fasting is NOT required for Anti-HEV IgM testing.
- Specimen Collection: Blood draw via venipuncture (serum collection); Can be performed non-fasting (food/drink intake does not affect results); Patient may eat and drink normally before test; No dietary restrictions.
- Medications: No medications need to be withheld or avoided; Continue all routine medications as prescribed; Antiviral medications do not interfere with antibody detection; Immunosuppressants should be noted but do not preclude testing.
- Patient Preparation: Arrive well-hydrated to facilitate blood draw; Inform phlebotomist of any bleeding disorders or anticoagulation therapy; Inform of recent vaccinations (not relevant to this test); Arm position: keep arm extended during venipuncture; Apply pressure to puncture site after collection.
- Specimen Handling: Serum sample preferred (5-10 mL blood in SST tube); Allow blood to clot at room temperature (20-30 minutes); Centrifuge at 1000-1500 G for 10 minutes; Separate serum promptly; Store at 2-8°C if delay in testing; Avoid hemolysis; Handle carefully to prevent specimen degradation.
- Timing Considerations: Test can be ordered any time during clinical evaluation; Optimal timing: 1-2 weeks after symptom onset; Earlier testing (first week) may yield false negatives; Can be collected during hospitalization or as outpatient; No specific time of day requirement; Urgent/stat testing available based on clinical severity.
- Special Conditions: Pregnancy: Test can be performed at any time; Critical timing if HEV infection suspected (maternal/fetal risk); Immunocompromised: Test appropriate but may need earlier repeat testing or HEV-RNA PCR; Hospitalized patients: Can be tested regardless of feeding status; Intensive care patients: No special preparation needed.

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