Hepatitis C RNA, Quantitative

The Hologic Aptima HCV Quant Dx assay is a nucleic acid amplification test that uses real-time Transcription-Mediated Amplification (TMA) technology to detect and quantify HCV RNA. It targets a conserved region of the 5' Untranslated Region (UTR) of the HCV genome, enabling detection and quantification of genotypes 1, 2, 3, 4, 5, and 6. This assay is standardized against the 2nd WHO International Standard for Hepatitis C Virus (NIBSC code: 96/798).

The lower limit of quantitation is 10 IU/mL (1.00 log IU/mL). The limit of detection, defined as the minimum virus level that yields a positive result in 95% of replicates, is 3.9 IU/mL for plasma and 3.4 IU/mL for serum.

For Tissue Biopsy, Bone Marrow, Swab, or Cellular fluid (e.g., BAL or washing that contain visible cellular material), refer to Hepatitis C Qualitative PCR, Tissue [HCVQLT].

For HCV genotyping, refer to Hepatitis C RNA Genotyping by PCR [HCPCGT].

Blood: Collect 5 mL of blood in a pearl top tube (PPT).

Also Acceptable: 5 mL of blood in a gold SST, red, or lavender (EDTA) tube.

Note: Separate specimens must be submitted when both serology and PCR testing are ordered.

Unacceptable Samples: Plasma collected in sodium or lithium heparin is not acceptable.

Note: Separate specimens must be submitted when both serology and PCR testing are ordered.

Blood: Separate plasma or serum from whole blood within 6 hours of collection, following the manufacturer’s instructions for the tube used. Freeze at -20°C or colder and ship on dry ice. If a freezer and/or dry ice is not available, ship immediately at 2 to 8°C with an ice pack. Samples may be stored in the primary tube or a secondary tube at 2 to 8°C (with an ice pack) for up to 5 days post-collection. Samples stored at 2 to 8°C for more than 5 days will be rejected. Do not freeze and thaw.

Outside Laboratory: Freeze at -20°C or colder and ship on dry ice. If a freezer and/or dry ice is not available, ship immediately at 2 to 8°C with an ice pack. Samples may be stored in the primary tube or a secondary tube at 2 to 8°C (with an ice pack) for up to 5 days post-collection. Samples stored at 2 to 8°C for more than 5 days will be rejected. Do not freeze and thaw.