Test Code LAB2951 Hepatitis B Virus (HBV) DNA Detection and Quantification by Real-Time PCR, Serum
Additional Codes
SQ: HEPQTM
MAYO: HBVQN
Shipping Instructions
1. Ship specimen frozen on dry ice only.
2. If shipment will be delayed for more than 24 hours, freeze serum at -20 to -80° C (up to 84 days) until shipment on dry ice.
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 1.5 mL
Collection Instructions:
1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot serum into plastic vial.
Secondary ID
65555Useful For
Detection and quantification of hepatitis B virus (HBV) DNA in serum of patients with chronic HBV infection (ie, hepatitis B surface antigen-positive)
Monitoring disease progression in chronic HBV infection
Monitoring response to anti-HBV therapy
Testing Algorithm
The following algorithms are available:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
-HBV Infection-Monitoring Before and After Liver Transplantation
Special Instructions
Method Name
Real-Time Polymerase Chain Reaction (PCR)
Reporting Name
HBV DNA Detect/Quant, SSpecimen Type
Serum SSTSpecimen Minimum Volume
0.8 mL
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Serum SST | Frozen (preferred) | 84 days | |
Refrigerated | 6 days |
Reject Due To
Gross hemolysis | OK |
Gross lipemia | OK |
Gross icterus | OK |
Reference Values
Undetected
Method Description
The cobas HBV is a US Food and Drug Administration-approved in vitro nucleic acid amplification test for the quantification of hepatitis B virus (HBV) DNA in human serum, using the using the cobas 6800 or 8800 instrument for automated viral nucleic acid extraction (silica-based capture technique), purification, amplification, and detection of the viral nucleic acid target. This assay targets the highly conserved pre-Core/Core region of the HBV genome and generates amplification products that are detected real-time by a sequence-specific TaqMan probe during amplification. The probe contains a reporter fluorophore and a quencher dye that absorbs light emitted by the reporter. Cleavage of the probe physically separates the quencher from the reporter, enabling light emitted by the latter to be detected by a photomultiplier tube. Because amplification and detection are performed simultaneously, amplification products are measured during the exponential phase of DNA amplification regardless of the initial target concentration.(Package insert: cobas HBV-Quantitative nucleic acid test for use on the cobas 6800/8800 Systems. Roche Molecular Systems, Inc., Doc rev. 2.0, 12/2020)
Day(s) Performed
Monday through Saturday
Report Available
1 to 3 daysPerforming Laboratory
Mayo Clinic Laboratories in RochesterTest Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
87517
LOINC Code Information
Test ID | Test Order Name | Order LOINC Value |
---|---|---|
HBVQN | HBV DNA Detect/Quant, S | 42595-9 |
Result ID | Test Result Name | Result LOINC Value |
---|---|---|
65555 | HBV DNA Detect/Quant, S | 42595-9 |
Forms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
-General Request (T239)
-Gastroenterology and Hepatology Test Request (T728)
-Microbiology Test Request (T244)