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Test Code LAB951 Hepatitis B Virus (HBV) DNA Detection and Quantification by Real-Time PCR, Serum


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 a 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
Serum SST Frozen (preferred) 84 days
  Refrigerated  6 days

Reject Due To

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Reference Values

Undetected

Cautions

This test is not licensed by the US Food and Drug Administration as a screening test for hepatitis B virus (HBV) infections.

 

Laboratory evaluation of HBV infection status should begin with HBV serologic testing, including testing for the presence of hepatitis B surface antigen. A diagnosis of chronic HBV infection should not be based solely on the presence of detectable or quantifiable HBV DNA in a single serum specimen.

 

An "Undetected" HBV DNA test result in conjunction with a positive anti-HBV antibody status does not exclude the possibility of a resolved HBV infection. When clinically indicated, patients should be retested for HBV DNA in 1 to 2 months, to distinguish between past and resolved HBV infection and chronic HBV infection with episodic viral replication.

 

Patient care providers are encouraged to use the same HBV DNA quantification assay for serial monitoring of HBV DNA levels in individual patient.

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

NY State Approved

Yes

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)