Hepatitis C Virus

Testing site      

Alaska State Virology Laboratory (ASLV) - Fairbanks 

Fairbanks Lab Request Form

Diseases 

Acute or chronic contagious liver disease 

Organisms 

Hepatitis C virus 

Test Method 

• Antibody Screen: Chemiluminescent Immunoassay (CLIA) 
• Viral Load:  transcription mediated amplification (TMA) 

Availability

• Routine testing
• Available for patients at least 2 years old
• Please contact the Alaska State Virology Laboratory if requesting testing to be added for a previously submitted specimen. 

Specimen type 

Serum   

• Minimum volume required: 1.5mL  
• Blood collected in a serum separator tube (SST) is recommended.  

Specimen collection instructions 

1. Collect the blood aseptically by venipuncture in SST and centrifuge from red blood cells within 2 hours.  
2. Store spun SST frozen at <-20°C to stage for shipping.  Self-defrosting freezers are not recommended for sample storage.  
3. Indicate date shipped and date frozen on the Fairbanks Lab Request Form.  

Storage and transport  

Ship on dry ice or many frozen cold packs.  

• Ambient temperature shipping is not recommended per reagent manufacturer guidelines.   
• Refrigerated specimens are also not recommended due to manufacturer limitations on completing testing within 5 days (including transit time) if stored at 2-8°C.  
• Samples received warm, grossly hemolyzed, highly lipemic or turbid, or collected in other collection devices may be rejected.  

Ship to: Fairbanks Public Health Laboratory, ATTN: Clinical Virology   

Results  

Serology Results (EIA) 

• Non-Reactive: No antibodies to HCV detected 
• Reactive: Antibodies to HCV detected 
  • Specimens with reactive antibody results automatically reflex to HCV viral load testing 
• Equivocal: Request resubmission of patient serum in 1-2 weeks 
• A normal result is non-reactive  

Viral Load Testing Results (TMA) 

• HCV RNA Qualitative: Detected/Not Detected 
• Log10 calculation: Value 
• IU/mL concentration: Value 
  • Linear range of assay is 10 to 100,000,000 IU/mL.  

Interpretation

• Clinical Screening and Diagnosis for Hepatitis C
• HVC Guidance and Recommendations

Viral Load Interpretation 

• Not Detected: HCV RNA not detected 
• < 10 IU/mL and <1.00 Log10 detected: HCV RNA detected but not quantified. HCV RNA concentration is below the Lower Limit of Quantification (LLoQ) of the assay. 
• 10-25 IU/mL and 1.00-1.40 Log10 detected: HCV RNA detected and quantified. HCV RNA concentration is within linear range of the assay ≥ 10 IU/mL and < 25 IU/mL. 
• 25-100,000,000 IU/mL and 1.40-8.00 Log10 detected: HCV RNA detected and quantified. HCV RNA concentration is within the linear range of 25 to 100,000,000 IU/mL. 
• > 100,000,000 IU/mL and > 8.00 Log10 detected: HCV RNA is detected above the Upper Limit of Quantification (ULoQ) 

Turnaround time  

Serology Results 

Turnaround time for EIA results 1-3 days 

Viral Load Results 

Turnaround time for TMA results 3-10 days 

CPT code and fee

Viral load only: 87522 

ASPHL Fee Agreement Form

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