Hepatitis C Qualitative PCR, Tissue

General Information

Lab Name

Lab Code

HCVQLT

Epic Name

Hepatitis C Qualitative PCR, Tissue

Description

The detection of Hepatitis C virus (HCV) performed using a modified version of the FDA-approved Hologic Aptima HCV Quant Dx assay. This in vitro nucleic acid amplification test utilizes real-time Transcription-Mediated Amplification (TMA) technology on the Panther system to detect HCV RNA.

The assay 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 lower limit of detection (LoD), defined as the lowest viral concentration that yields a positive result in 95% of replicates has not been established for certain specimen types, including tissue biopsies, paraffin-embedded tissues, bone marrow, swabs, or cellular fluids. Results are reported as Not Detected or Positive.

This assay was developed, and its performance characteristics were determined, by the University of Washington Department of Laboratory Medicine and Pathology. It has not been cleared or approved by the U.S. 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].

Synonyms

HCV RNA Qualitative, Hepatitis C by PCR, PCR-Hepatitis C

Components

Code	Name
HCVQLS	Hepatitis C Qualitative PCR Specimen Type
HCVQLR	Hepatitis C Qualitative PCR Result
HCVQLI	Hepatitis C Qualitative PCR Interpretation

Interpretation

Method: Real-time Polymerase Chain Reaction.
Reference Range: See individual components

Ordering & Collection

Specimen Type: Tissue Biopsy, Bone Marrow, Swab or Cellular fluid (ex: BAL or Washing)
Collection: 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.
Handling Instructions: Bone Marrow: 5 mL of bone marrow in an EDTA (lavender top) tube should be sent to the laboratory at room temperature within 24 hours of collection.
Quantity: Requested: See Collection
Minimum: 0.5 mL

Processing

Receiving Instructions: 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.

Misc Sendout

Performance

Lab Department

Virology, Eastlake(EVIR)

Frequency

Wednesday. Results following Thursday.

Available STAT?

Performing Location(s)

Other	Virology, Molecular 206-685-6656 Virology Laboratory, Ste 320 1616 Eastlake Ave E. Seattle, WA 98102

Billing & Coding

CPT Codes: 87521
LOINC: 5011-2
Interfaced Order Code: UOW3763