HbsAg (Rapid Card test)

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The HBsAg Rapid Card Test is a qualitative immunochromatographic assay used to quickly detect the Hepatitis B surface antigen (HBsAg) in whole blood, serum, or plasma

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HbsAg (Rapid Card Test) - Comprehensive Medical Information Guide

1. Why is it done?
- Test Description: Detects hepatitis B surface antigen (HBsAg) in blood serum using a rapid immunochromatographic card method; indicates current or past hepatitis B infection
- Primary Indications: Screening for acute or chronic hepatitis B infection; blood bank screening; pre-vaccination assessment; occupational health screening; contact tracing; prenatal screening; diagnostic workup of jaundice or liver disease
- Typical Timing/Circumstances: Emergency departments and point-of-care settings for rapid screening; routine health check-ups; when hepatitis B symptoms appear (fatigue, jaundice, abdominal pain); after potential occupational or sexual exposure; during pregnancy screening; prior to immunosuppressive therapy; before blood or organ donation
2. Normal Range
- Normal Result: NEGATIVE (or Non-reactive); indicates absence of hepatitis B surface antigen; means patient has no current hepatitis B infection
- Abnormal Result: POSITIVE (or Reactive); indicates presence of hepatitis B surface antigen; suggests acute or chronic hepatitis B infection
- Units of Measurement: Qualitative (Positive/Negative or Reactive/Non-reactive); no quantitative units; rapid card test provides binary result interpretation
- Reference Values: Negative/Non-reactive: < 0.05 ng/mL (below detection threshold); Positive/Reactive: ≥ 0.05 ng/mL (detectable antigen present); sensitivity approximately 95-99%; specificity approximately 95-99%
- Interpretation Guide: Negative = No hepatitis B antigen detected (likely not infected); Positive = Hepatitis B antigen present (likely infected - requires confirmatory testing); Weak positive = Borderline result requiring repeat or confirmatory lab testing
3. Interpretation
- NEGATIVE Result: No hepatitis B surface antigen detected; indicates patient is likely not infected with hepatitis B virus; or if recently exposed, may be in window period (too early for antigen detection); or previously vaccinated with immunity; or never exposed to infection
- POSITIVE Result: Hepatitis B surface antigen present; indicates current HBV infection (acute or chronic); patient is infectious and can transmit virus to others; requires immediate confirmatory testing with HBV serology panel (anti-HBc, anti-HBs, HBeAg, HBeAb, HBV DNA); assess for acute vs. chronic infection
- Factors Affecting Results: Window period after exposure (before antigen becomes detectable); vaccine-induced immunity (negative despite vaccination); immunosuppression (may show false negative); pregnancy (hormonal changes may affect interpretation); blood transfusion (may contain HBsAg); improper sample collection or storage; operator technical error in performing rapid card test; recent HBV vaccination (no antigen present)
- Clinical Significance of Result Patterns: HBsAg+ with symptoms = Acute hepatitis B infection (observe for fulminant hepatitis); HBsAg+ persistent > 6 months = Chronic hepatitis B (requires ongoing monitoring and possible antiviral therapy); HBsAg+ asymptomatically = Chronic carrier state (transmissible); HBsAg- with exposure history = Window period or resolved infection (order HBcore antibody, HBsurface antibody for clarification); HBsAg- in vaccinees = Successful vaccination (protective immunity)
- Limitations: Rapid card tests have 5% false negative and 5% false positive rates; cannot distinguish acute from chronic infection; does not detect mutant HBV strains with altered epitopes; qualitative only (not quantitative); positive results must be confirmed by laboratory HBsAg or serology panel
4. Associated Organs
- Primary Organ System: Hepatic system (liver); hepatitis B virus targets and replicates in hepatocytes; causes inflammation and injury of liver parenchyma; affects liver function and structure
- Medical Conditions Associated with Abnormal Results: Acute hepatitis B (acute viral hepatitis); chronic hepatitis B (persistent infection > 6 months); asymptomatic HBV carrier state; cirrhosis secondary to HBV; hepatic fibrosis; hepatocellular carcinoma (HCC); coinfection with hepatitis D (delta); coinfection with hepatitis C or HIV; autoimmune hepatitis (if HBsAg+); alcoholic liver disease with concurrent HBV
- Diseases This Test Helps Diagnose/Monitor: Hepatitis B virus infection (acute or chronic); HBV transmission risk assessment; liver disease etiology; occupational exposure follow-up; blood/plasma product safety; population screening for endemic areas; pregnant women assessment for perinatal transmission risk; immunocompromised patient screening; response to HBV vaccination
- Potential Complications/Risks of Abnormal Results: Progression to cirrhosis (20-30% of chronic HBsAg+ patients); development of hepatocellular carcinoma (increased in HBsAg+ cirrhotic patients); fulminant hepatic failure (acute HBsAg+); transmission to sexual partners, blood contacts, or vertically to infants; decompensated liver disease; portal hypertension with variceal bleeding; hepatic encephalopathy; need for liver transplantation; social stigma and employment discrimination; requirement for lifelong monitoring and possible treatment
- Extrahepatic Manifestations: Polyarteritis nodosa; membranous nephropathy; glomerulonephritis; cryoglobulinemia; arthralgia; skin manifestations (urticaria, rash); thrombocytopenia; lymphadenopathy
5. Follow-up Tests
- Confirmatory Testing if HBsAg Positive: HBsAg (quantitative serum test to confirm rapid card result); HBcore antibody (anti-HBc) to confirm HBV exposure; HBsurface antibody (anti-HBs) to assess immunity; HBeantigen (HBeAg) to assess viral replication activity; HBeantibody (anti-HBe) to assess disease phase; HBV DNA (quantitative PCR for viral load - determines if patient meets treatment criteria)
- Further Investigations for HBsAg+ Patients: Liver function tests (AST, ALT, bilirubin, alkaline phosphatase, albumin); prothrombin time (PT/INR); platelet count; ultrasound of liver to assess cirrhosis and HCC risk; FibroScan (transient elastography) to assess fibrosis stage; liver biopsy if indicated for staging; hepatitis D (delta) serology if high-risk; hepatitis C antibody; HIV serology; coinfection screening
- Monitoring Frequency for Chronic HBsAg+ Patients: Baseline: Complete HBV serology panel and liver assessment; Immune-tolerant phase: Monitor every 12 months; Immune-active phase: Every 3-6 months or as clinically indicated; If cirrhosis present: Every 3-4 months plus ultrasound every 6 months for HCC surveillance; Post-antiviral therapy: Ongoing monitoring for virological breakthrough; Vaccinated individuals: Check anti-HBs titers 1-2 months after series completion
- Related/Complementary Tests: Complete hepatitis B serology panel; HBV genotyping (determines response to treatment); hepatitis A, C, D, E serology; HIV, syphilis, tuberculosis screening; liver imaging (CT, MRI); immunoglobulin M HBcore antibody (IgM anti-HBc) for acute HBV; hepatitis B rapid tests variants (immunochromatographic cassettes)
- Special Considerations: If rapid test is positive, do NOT rely solely on rapid card result for clinical decisions; confirm with laboratory testing; all positive results must trigger contact tracing and preventive measures for exposed individuals; vaccination status of household contacts and sexual partners should be verified and updated if needed
6. Fasting Required?
- Fasting Requirement: NO - Fasting is NOT required for HBsAg rapid card testing; test can be performed at any time of day; food and fluid intake do not affect test accuracy or antigen detection
- Patient Preparation: No special preparation needed; patient may eat and drink normally before test; no dietary restrictions; normal daily activities may be continued; inform healthcare provider of current medications (generally not contraindicated); no need to avoid coffee, tea, or other beverages
- Medications: No medications need to be held or avoided before HBsAg rapid card test; continue all regular medications as prescribed; antiviral medications for HBV (if patient already diagnosed) do not interfere with test; immunosuppressive agents do not contraindicate testing; herbal remedies and supplements do not affect results
- Specimen Collection Requirements: Blood sample (serum or plasma); obtained via venipuncture or finger stick for point-of-care testing; sample must be collected with proper aseptic technique; use sterile collection tubes or lancets; allow blood to clot if serum test; store at room temperature for rapid card testing; do not refrigerate unless delayed testing; protect from light and heat; use test within specified time frame (usually 15-30 minutes after sample collection)
- Timing Considerations: Test may be performed at any time of day; morning or evening collection equally acceptable; results typically available within 10-20 minutes; if recent exposure suspected, may need repeat testing as early detection window exists; avoid testing during acute illness if possible (though doesn't affect accuracy)
- Post-Test Instructions: No dietary or activity restrictions after test; normal activities may resume immediately; result review should occur with healthcare provider for positive results; if positive, patient should avoid blood/body fluid exposure to others; sexual partners and household contacts should seek testing; if positive, patient should not donate blood, organs, or tissues; pregnant patients with positive results need specialist consultation for transmission prevention

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