Hepatitis B Virus DNA, Quantitative, PCR with Reflex to HBV, Genotype

Hepatitis B Virus DNA, Quantitative, PCR with Reflex to HBV, Genotype

Test Code

16694
87517
16694
87517
Not offered in Quest Nichols Institute - Chantilly, VA. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection is not available in your area through Quest Mobile.

Clinical Significance

Hepatitis B Virus DNA, Quantitative, PCR with Reflex to HBV, Genotype - This test is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of patients with chronic HBV infection undergoing antiviral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment.

The cobas® HBV Test is not intended for use as a screening test for the presence of HBV in blood products or as a diagnostic test to confirm the presence of HBV infection.

Reportable range is 10 to 1,000,000,000 IU/mL
(1.00 to 9.00 Log IU/mL).
(1.00 Log IU/mL to 9.00 Log IU/mL).

Test Resources

Clinical Focus

Viral Hepatitis: Laboratory Support for Diagnosis and Management

Test Details

Includes

  • If Hepatitis B Virus DNA, Quantitative, Real-Time PCR is ≥600 IU/mL, then Hepatitis B Virus Drug Resistance, Genotype, and BCP/Precore Mutations will be performed at an additional charge (CPT code(s): 87912).

Methodology

Real-Time Polymerase Chain Reaction • Sequencing

Assay Category

The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Reference Range(s)

Hepatitis B Virus DNANot DetectedIU/mL
Hepatitis B Virus DNANot DetectedLog IU/mL

Alternative Name(s)

Hep B DNA PCR Quant,HBV DNA PCR QT,Hep B Viral Load,Quantitative PCR,HBV Resistance

LOINC® Codes, Performing Laboratory

Service Area must be determined
If Hepatitis B Virus DNA, Quantitative, Real-Time PCR is ≥600 IU/mL, then Hepatitis B Virus Drug Resistance, Genotype, and BCP/Precore Mutations will be performed at an additional charge (CPT code(s): 87912).

Methodology

Real-Time Polymerase Chain Reaction • Sequencing
The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Reference Range(s)

Hepatitis B Virus DNANot DetectedIU/mL
Hepatitis B Virus DNANot DetectedLog IU/mL

Alternative Name(s)

Hep B DNA PCR Quant,HBV DNA PCR QT,Hep B Viral Load,Quantitative PCR,HBV Resistance
Service Area must be determined

Preferred Specimen(s)

2 mL plasma collected in each of two separate EDTA (lavender-top) tubes

Alternative Specimen(s)

Serum collected in each of two separate tubes

Minimum Volume

1.4 mL in each tube

Collection Instructions

Do not freeze whole blood or any samples stored in primary tube. Freshly drawn specimens (whole blood) may be stored at 2-25°C for up to 24 hours prior to centrifugation. Separate plasma or serum from cells within 24 hours of collection by centrifugation. Follow manufacturer's instructions for collection tube handling.

Transport Container

Transport tube(s)

Transport Temperature

Frozen

Specimen Stability

  • Room temperature: Unacceptable
  • Refrigerated: 6 days
  • Frozen: 30 days

Reject Criteria

Unspun PPT tube • Sodium heparin (green-top) tube • Lithium heparin (green-top) tube

Setup Schedule

Service Area must be determined
2 mL plasma collected in each of two separate EDTA (lavender-top) tubes
Serum collected in each of two separate tubes
1.4 mL in each tube
Do not freeze whole blood or any samples stored in primary tube. Freshly drawn specimens (whole blood) may be stored at 2-25°C for up to 24 hours prior to centrifugation. Separate plasma or serum from cells within 24 hours of collection by centrifugation. Follow manufacturer's instructions for collection tube handling.
Transport tube(s)
Frozen
Room temperature: Unacceptable
Refrigerated: 6 days
Frozen: 30 days

Unspun PPT tube • Sodium heparin (green-top) tube • Lithium heparin (green-top) tube

Service Area must be determined
Not offered in Quest Nichols Institute - Chantilly, VA. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection is not available in your area through Quest Mobile.
Test Details

Clinical Significance

Test Resources

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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