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.
After receiving approval from the Laboratory Director to submit specimens, complete the Infectious Disease Requisition Form (DOH-4463) and follow the instructions at Collection, Shipping and Reporting.
HCV Tests Available
Qualitative HCV RNA Testing: The BVL conducts HCV RNA testing by real-time transcription-mediated amplification (TMA) using the FDA-approved qualitative method on serum and plasma specimens. In addition, the BVL has conducted validation studies and has received NYSDOH CLEP approval for:
- qualitative detection of HCV RNA on dried blood spots (DBS)
- BVL has determined the limit of detection in DBS to be 250 copies/ml
- the use of smaller volumes of pediatric serum and plasma specimens
- BVL has determined the limit of detection for volumes of 100 to 500ul to be 18 IU/ml for serum and 55 IU/ml for plasma
- extended temperature stability in whole blood, serum, plasma and DBS specimens for qualitative detection of HCV RNA
Quantitative HCV RNA Testing: The BVL conducts quantitative HCV RNA testing by real-time 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 2-8°C for ≤5 days including shipping. Contact the BVL for more information.