Hepatitis B Virus (HBV) Quantitative DNA PCR
Alternate Name: HBV_PCR
SAL Code:
841
CPT:
87517
Department:
Hepatitis B Virus (HBV) Quantitative DNA PCR
Performing Laboratory:
Sherman Abrams Laboratory
Specimen Requirements:
Primary Tube:
SST
Primary Substance:
Serum
Rejection Criteria:
REJECTION CRITERIA:
- Improper Labeling
- Gross hemolysis
- Improper collection container
Clinical Info:
CLINICAL INFORMATION:
The cobas® HBV assay is a fully automated, quantitative molecular test performed on the cobas® 6800/8800 systems to detect and quantify HBV DNA in EDTA plasma or serum for routine clinical practice and clinical trials. This test serves as an aid in managing chronic HBV patients undergoing anti-viral therapy by measuring viral load at baseline and during treatment to assess response, all results must be interpreted alongside relevant clinical and laboratory findings. Utilizing magnetic glass particles for automated nucleic acid extraction, the system simultaneously purifies viral DNA and an internal non-HBV DNA Quantitation Standard (DNA-QS) to monitor the process, with results traceable to the 2nd WHO International Standard and automatically reported as Not Detected, ULoQ, or a quantified value.
Sample Collection:
SPECIMEN COLLECTION:
Collect patient samples using a BD Vacutainer® SST™ Serum Separation Tube, allowing it to clot for 30 minutes before centrifuging for 10 to 15 minutes to isolate the serum. Alternatively, collect whole blood into a BD Vacutainer® PPT™ Plasma Preparation Tube and centrifuge within two hours to create a secure gel barrier that isolates undiluted K2EDTA plasma for molecular PCR diagnostic test.
Test Limitations:
TEST LIMITATIONS:
- This test has been validated only for use with EDTA plasma and serum. Testing of other sample types may result in inaccurate results.
- Though rare, mutations within the highly conserved regions of a viral genome covered by cobas ® HBV, may affect primers and/or probe binding resulting in the under-quantitation of virus or failure to detect the presence of virus.
- Quantitation of HBV DNA is dependent on the number of virus particles present in the samples and may be affected by sample collection methods, patient factors (i.e., age, presence of symptoms), and/or stage of infection.
- Due to inherent differences between technologies, it is recommended that, prior to switching from one technology to the next, users perform method correlation studies in their laboratory to qualify technology differences. Users should follow their own specific policies/procedures.
- Reliable results depend on proper sample collection, storage and handling procedures.
Specimen Handling Instructions:
SPECIMEN HANDLING & STORAGE:
Whole blood collected in Serum Separation Tubes (SST) and/or BD Vacutainer® Plasma Preparation Tubes (PPT) for Molecular Diagnostic Test Methods may be stored and/or transported for up to 24 hours at 2°C - 25°C prior to plasma/serum preparation. Centrifugation should be performed according to manufacturer instructions. Following preparation, isolated plasma or serum specimens stored in secondary tubes remain stable for a duration of up to 6 days when refrigerated at 2°C to 8°C, or may be maintained for up to 12 weeks when kept at temperatures = -18°C.
Test Information:
Components:
| Component Name | CPT | Loinc |
| HBV PCR Quantitative | 42595-9 | HBV PCR Viral Log | 48398-2 |