HCV Genotype by Sequencing

There are six major genotypes of HCV with numerous characterized subtypes. The most accurate determination of HCV genotype is to sequence the viral genome. This has been done in a variety of ways, including the determination of the entire genome, the 5’ untranslated region, or the core, E1, NS3, or NS5b genes. The most commonly used sequences are from the core and the NS-5 region. The RNA concentration detected with a probability of 95% or greater is 500 IU/mL (2.70 log IU/mL). The sequence is compared to HCV core region sequence to determine the closest related genotype.

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 HCV genotyping, see Hepatitis C RNA Genotyping by PCR [HCPCGT].

For HCV quantitation, see Hepatitis C RNA, Quantitative [HCVQNT].

Blood: 5 mL blood in PPT (PEARL TOP) tube.

Also Acceptable: 5 mL blood in GOLD SST, RED, or EDTA (LAVENDAR TOP) tube.

Unacceptable samples: Plasma collected in sodium or lithium heparin.

Note: Separate specimens MUST be submitted when both Viral Culture/Serology and PCR testing are ordered.

Minimum sample requirement: 1 mL

Blood: Separate serum or plasma from whole blood within 6 hours of collection. Freeze plasma at -10°C or colder and ship on dry ice. Serum or plasma may be stored at 2-8°C (ice pack) for up to 48 hours from collection. Do not freeze/thaw.

Outside Laboratory: Ship samples on dry ice. If freezer and/or dry ice is not available, ship immediately at 2-8°C (ice pack). Shipment time must not exceed 48 hours from collection. Sample may be stored at 2-8°C (ice pack) for up to 48 hours of collection. Samples stored at 2-8°C greater than 48 hours old may be rejected. Do not freeze/thaw.