Hepatitis C RNA, Quantitative
General Information
Lab Name
Hepatitis C RNA, Quant
Lab Code
HCVQNT
Epic Name
Hepatitis C RNA, Quantitative
Description
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].
Synonyms
HCV RNA Quant, Hepatitis C by PCR, PCR-Hepatitis C, Viral Load-Hepatitis C
Components
| Code | Name |
|---|---|
| HCQNR | Hepatitis C Quant Result |
| HCVLOG | HCV RNA IU/mL (Log 10) |
| HCQNI | Hepatitis C Quant Interp |
Interpretation
Method
Real-time Polymerase Chain Reaction.
Reference Range
See individual components
Guidelines
Ordering & Collection
Specimen Type
Collection
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.
Handling Instructions
Whole blood can be stored at 2 to 30°C for up to 6 hours. Plasma or serum must be separated via centrifugation in a primary tube prior to processing. Separate the plasma or serum from the red blood cells following the manufacturer’s instructions for the tube used. Plasma or serum can be tested on the Panther system in the primary tube or transferred to a secondary tube. To obtain the 500 µL reaction volume, the minimum volume of plasma or serum required for primary collection tubes is 2000 µL, while for secondary tubes, the minimum volume is 800 µL.
Quantity
requested: 2.0 mL plasma/serum
minimum: 0.8 mL Plasma/Serum secondary container
Processing
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.
Performance
LIS Dept Code
Central Lab Virology (RVIR)
Performing Location(s)
| CL |
Virology, Renton
206-685-6656 1602 Raymond Ave SW Renton, WA 98057-3356 |
206-685-6656 opt 4 |
|---|
Frequency
Monday and Thursday
Available STAT?
No