HCV – RNA PCR (Qualitative)

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The HCV RNA PCR (Qualitative) test detects the presence (but not the quantity) of Hepatitis C virus (HCV) RNA in a person’s blood using Polymerase Chain Reaction (PCR)

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HCV – RNA PCR (Qualitative) Test Information Guide

Why is it done?
- Test Purpose: Detects the presence of Hepatitis C Virus (HCV) RNA in blood, confirming active viral infection and replication
- Primary Indications: Confirm HCV infection in patients with positive HCV antibody results; determine if infection is active; assess viral status before and during antiviral treatment; evaluate suspected acute HCV infection
- Clinical Circumstances: After positive HCV antibody screening; during direct-acting antiviral (DAA) therapy monitoring; post-treatment surveillance; assessment of healthcare workers or patients with occupational exposure; evaluation of patients with unexplained liver disease or abnormal liver function tests
Normal Range
- Normal Result: Negative or Undetectable; indicates absence of detectable HCV RNA in the blood
- Units of Measurement: International Units per milliliter (IU/mL); Detection limit typically 15 IU/mL or lower depending on assay used
- Result Interpretation: Negative/Undetectable = No active HCV infection; Positive/Detectable = Active HCV infection present; Borderline/Indeterminate = Result near detection threshold, may require repeat testing or confirmation with alternative method
- Qualitative Vs Quantitative: Qualitative PCR provides Yes/No answer (presence or absence of viral RNA), does not measure viral load amount
Interpretation
- Negative/Undetectable Result: Indicates no detectable HCV RNA; may represent: recovered from past infection, never infected, spontaneous viral clearance, or successful treatment response (sustained virologic response - SVR)
- Positive/Detectable Result: Confirms active HCV infection with ongoing viral replication; indicates patient is infectious and treatment is needed; requires follow-up with genotyping and assessment of liver fibrosis
- Timing Considerations: Window period (1-2 weeks after infection before RNA detectable); early infection may show negative HCV antibody but positive RNA; late-stage resolved infection may show positive antibody but negative RNA
- Treatment Response Monitoring: Rapid virologic response (RVR) at week 4; early virologic response (EVR) at week 12; end-of-treatment response (ETR) at treatment completion; sustained virologic response (SVR) at 12 weeks post-treatment (SVR12) or 24 weeks post-treatment (SVR24)
- Factors Affecting Results: Assay sensitivity and specificity; patient's immune status; HCV genotype variations; possible occult HCV infection (RNA detectable in liver but not serum); testing methodology differences between laboratories
Associated Organs
- Primary Organ System: Hepatic system (liver); HCV is hepatotropic and primarily replicates in hepatocytes
- Associated Diseases and Conditions: Chronic hepatitis C; cirrhosis; hepatocellular carcinoma (HCC); hepatic fibrosis and steatosis; liver failure; mixed cryoglobulinemia; membranoproliferative glomerulonephritis; lymphoma; porphyria cutanea tarda
- Extrahepatic Manifestations: Systemic immune complications; vasculitis; arthralgia; glomerulonephritis; thyroid disease; cognitive dysfunction; neuropathy
- Potential Complications: Liver cirrhosis (20-30% of chronically infected patients); hepatic decompensation; esophageal varices; ascites; hepatic encephalopathy; development of HCC; liver transplantation requirement; increased cardiovascular disease risk; kidney disease
- Diagnostics for Associated Conditions: This test confirms active HCV infection, foundation for diagnosing all HCV-related hepatic and systemic complications
Follow-up Tests
- Immediate Follow-up (if Positive): HCV genotyping (determines viral genotype for treatment selection); HCV quantitative RNA PCR (viral load measurement for baseline assessment and treatment decisions)
- Liver Assessment Tests: Liver function tests (AST, ALT, ALP, bilirubin, albumin); platelet count; prothrombin time/INR; elastography (FibroScan/transient elastography) or other fibrosis markers (FIB-4 score, APRI score); abdominal ultrasound or CT imaging
- Treatment Monitoring: Qualitative HCV RNA PCR at week 4 (assess RVR); week 12 (assess EVR); end of treatment (ETR); and 12-24 weeks post-treatment (SVR confirmation)
- Post-Treatment Surveillance: Periodic HCV RNA PCR for 5+ years if cirrhosis present; liver function tests every 6-12 months; AFP (alpha-fetoprotein) and imaging for HCC screening in cirrhotic patients
- Screening for Comorbidities: HIV and HBV co-infection screening; immunoglobulin levels; thyroid function tests; kidney function assessment; metabolic panel for metabolic disease risk
- Complementary Tests: HCV antibody confirmation (if not already done); HCV core antigen testing (alternative marker of viral replication); liver biopsy (if non-invasive fibrosis assessment contradictory)
Fasting Required?
- Fasting Requirement: No - Fasting is NOT required for this test
- Sample Collection: Blood draw can be performed at any time of day; patient can eat and drink normally before the test
- Medications: No specific medications need to be avoided; continue all regular medications as prescribed; inform laboratory if patient is on anticoagulation therapy
- Patient Preparation: Minimal preparation required; wear loose-fitting shirt with short sleeves for easier blood draw access; inform phlebotomist of any bleeding disorders or difficulty with needle sticks; stay hydrated before appointment; arrive for appointment with minimal stress if possible
- Special Considerations: Test timing may be relevant (avoid collection in acute illness if possible); document date of potential exposure or symptoms for clinical interpretation; for treatment monitoring, consistent timing relative to dose administration may be important

How our test process works!