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 AIDS Institute’s Bureau of Hepatitis Healthcare. Contact the laboratory for more information on accessing HCV testing for public health purposes or special projects.
- After receiving approval from the Laboratory Director to submit specimens:
- Follow the collection and shipping guidelines for the test requested
- Complete the DOH-49 test requisition form in full
- Check the appropriate HCV test from the selections
HCV Tests Available
Qualitative HCV RNA: A laboratory-developed Real-Time PCR assay to detect HCV RNA in human plasma. The assay detects a conserved region of the HCV 5’ untranslated region. Results are reported as HCV RNA Detected or HCV RNA Not detected. The limit of detection is 5 international units (IU)/ml for 900µl of plasma and 31 IU/ml for 140µl of plasma. This assay is approved for clinical use by the Clinical Laboratory Evaluation Program.
Quantitative HCV RNA: A laboratory-developed Real-Time PCR assay for quantifying HCV RNA in human plasma. The assay principle is the same as the qualitative HCV RNA assay except that calibrated standards are included to allow for accurate quantification of HCV RNA. The quantitative range of the assay is 26.7 – 29,888,888 IU/ml for 900µl of plasma and 171.4 – 192,142,857 IU/ml for 140µl of plasma. Results are reported as IU/ml and Log IU/ml. This assay is approved for clinical use by the Clinical Laboratory Evaluation Program.
HCV Sequencing: Two HCV sequencing methods are available to assist with outbreak investigations and surveillance activities: 1) Next generation sequencing (NGS) of the HCV hypervariable region 1 using the Centers for Disease Control and Prevention’s Global Hepatitis Outbreak and Surveillance Technology (GHOST) for sample preparation and NGS data analysis; 2) Sanger sequencing of the 5’ untranslated region (UTR) and the NS5b region for genotype and subtype determination.