The Bloodborne Viruses Laboratory performs hepatitis C virus (HCV) RNA testing on specimens that are reactive for HCV antibodies to confirm the presence of an active HCV infection. Qualitative HCV RNA testing is currently offered to HCV rapid testing programs that have been enrolled and trained by staff from the NYSDOH. For information on enrolling your agency for HCV DBS testing, contact RTPAI@health.ny.gov_[1].

After receiving approval from the Laboratory Director to submit specimens, complete the Infectious Disease Requisition Form (DOH-4463)_[2] and follow the instructions at Collection, Shipping and Reporting_[3].

HCV Tests Available

Qualitative HCV RNA Testing:  The BVL conducts qualitative HCV RNA testing by real-time transcription-mediated amplification (TMA) using a modified FDA-approved method. The BVL has validated this method for qualitative detection of HCV RNA on plasma and dried blood spots (DBS) and has received approval from the NYSDOH Clinical Laboratory Evaluation Program. The BVL has determined the limit of detection (LOD) for plasma* (3.9 IU/mL) and DBS (250 IU/mL). HCV qualitative RNA results are reported as detected or not detected. 

*Plasma must be separated from cells within 6 hrs of collection and stored refrigerated (2-8°C) until shipped.  The LOD of 3.9 IU/mL applies to plasma stored at 2-8°C for ≤72 hrs. The LOD for plasma under extended storage conditions (up to 6 days at 2-8°C) is 15.6 IU/mL. The BVL recommends shipping plasma on cold packs, if ambient temperatures may exceed 25°C (77°F).

Quantitative HCV RNA Testing: The BVL conducts quantitative HCV RNA testing by real-time transcription transcription-mediated amplification (TMA) using a kit that has been approved by the FDA for aiding the diagnosis of HCV infection and for management of HCV-infected patients.  Plasma or serum must be separated from blood cells within 6 hrs of collection and stored at 2-25°C for ≤24 hrs and at 2-5°C for ≤5 days including shipping. Plasma or serum meeting these storage conditions may also be frozen and shipped on dry ice.  Contact the BVL for more information.