Hepatitis C Qualitative PCR, Tissue

The modified Hologic Aptima HCV Quant Dx assay is a nucleic acid amplification test that uses real-time Transcription-Mediated Amplification (TMA) technology to detect HCV RNA. It targets a conserved region of the 5' Untranslated Region (UTR) of the HCV genome, enabling detection 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 limit of detection, defined as the minimum virus level that yields a positive result in 95% of replicates, has not been established for several specimen types, including tissue biopsy, paraffin-embedded tissue, bone marrow, swabs, or cellular fluids.

This test was developed and its performance characteristics determined by the University of Washington Department of Laboratory Medicine and Pathology. It has not been cleared or approved by the US Food and Drug Administration.

For Blood samples, refer to Hepatitis C RNA, Quantitative [HCVQNT].

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

Tissue Biopsy: Pea-sized specimen in a sterile tube or universal transport media.

Bone Marrow: 5 mL of blood in an EDTA (lavender top) tube; no heparin aspirate in the syringe.

Swab: In a sterile tube or universal transport media (UTM).

Cellular Fluid: 1 mL in a sterile tube.

Unacceptable Samples: Buffy coat collected with a heparin syringe; paraffin samples.

Tissue Biopsy: Freeze at -20°C or colder. Ship on dry ice. The sample may be stored at 2 to 8°C (ice pack) within 48 hours of collection. Do not freeze and thaw.

Bone Marrow: Ship at room temperature within 24 hours of collection.

Swabs: Freeze at -20°C or colder. Ship on dry ice. If a freezer and/or dry ice is not available, ship immediately at 2 to 8°C (ice pack). The sample may be stored at 2 to 8°C (ice pack) for up to 48 hours after collection. Samples stored at 2 to 8°C for more than 48 hours will be rejected. Do not freeze and thaw.

Cellular Fluid: Freeze at -20°C or colder. Ship frozen samples on dry ice. The sample may be stored at 2 to 8°C (ice pack) for up to 48 hours from collection. Do not freeze and thaw.

Outside Laboratories:

Buffy Coat: Separate the buffy coat from bone marrow within 24 hours of collection. Freeze at -20°C or colder.

Tissue/Cellular Fluid/Swab: Ship samples on dry ice. If a freezer and/or dry ice is not available, ship immediately at 2 to 8°C (ice pack). Shipment time must not exceed 48 hours from collection. The sample may be stored at 2 to 8°C (ice pack) for up to 48 hours after collection. Samples stored at 2 to 8°C for more than 48 hours will be rejected. Do not freeze and thaw.