Hepatitis B Quantitative

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General Information

Lab Name
Hepatitis B Quantitative
Lab Code
HBVQNT
Epic Ordering
Hepatitis B Quantitative
Description

The Hologic Aptima HBV Quant assay is an in vitro nucleic acid amplification test that utilizes real-time Transcription-Mediated Amplification (TMA) technology on the Panther system to quantify HBV DNA from genotypes A, B, C, D, E, F, G, and H. The Aptima HBV Quant assay targets two highly conserved regions in the polymerase and surface genes, ensuring increased tolerance to potential mutations. This assay is standardized to the 3rd WHO International Standard for Hepatitis B Virus (NIBSC code: 10/264).

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 4.8 IU/mL for plasma and 5.9 IU/mL for serum.

Synonyms
HBV, Hep B, Hepatitis B Quant
Components

Interpretation

Method

TMA

Reference Range
See individual components
Guidelines

Ordering & Collection

Specimen Type
Serum, Plasma
Collection

Blood: Collect 3 mL of blood in an EDTA (lavender top) tube.

Also Acceptable: 3 mL of blood in a gold SST, red, or PPT (pearl top) tube.

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 24 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 primary collection tube
minimum: 0.8 mL Plasma/Serum secondary container

Processing

Processing

Blood: Separate plasma or serum from whole blood within 24 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
Tuesday and Friday
Available STAT?
No

Billing & Coding

CPT codes
87517
LOINC
42595-9
Interfaced Order Code
UOW2389