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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

65555

Useful 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

Method Name

Real-Time Polymerase Chain Reaction (PCR)

Reporting Name

HBV DNA Detect/Quant, S

Specimen Type

Serum SST

Specimen 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 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test 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)