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Test Code:
HBVDNAVL

Order Name:
Viral Load (HBV DNA), Quantitative method

 
Useful For:
Quantification of hepatitis B virus (HBV) DNA in serum of patients with chronic HBV infection to monitor disease progression and response of anti-HBV therapy.
 
Methodology:
Real Time Polymerase chain reaction (Real-Time PCR)
 
Test List In Profile:
Viral Load (HBV DNA), Quantitative
Viral load Log equivalence HBV
 
AliasesName:
HBV DNA
HBV Quantification
HBV DNA Quantitation
HBV Viral load
Hepatitis B Viral Load
Hepatitis B Quantitation
 
 
 
Test Code:
HBVDNAVL

Order Name:
Viral Load (HBV DNA), Quantitative method

 
Collection Specimen Or Container:
Blood/ Plain blood (Red top) 6 mL, 1 tube
 
Specimen Testing Type:
Serum, minimum volume 1 mL
Separate plasma within 24 hours of collection.
 
Sub Mission Container:
Plastic tube
 
Rejection Criteria:
Hemolysis: N/A
Lipemia: N/A
Icterus: N/A
Other: Heparin, anticoagulant blood
 
Specimen Stabillity:
Specimen Type Temperature Time
Whole blood At temperature, 2oC to 25oC 24 hours
Serum At temperature, 25oC to 30oC 3 days
Refrigerated, 2oC to 8oC 7 days
Frozen, -20oC to -80oC 6 weeks
 
 
 
Test Code:
HBVDNAVL

Order Name:
Viral Load (HBV DNA), Quantitative method

 
Method detail:
Real Time Polymerase chain reaction (Real-Time PCR)
 
Schedule:
Monday through Saturday, at 07:00 p.m.
 
Turnaround Time:
Received specimen to reported within 3 days.
 
Performing Location:
Molecular biology & Genetics, Laboratory Department Tel.14168
 
Specimen Retention Time:
2 months
 
 
 
Test Code:
HBVDNAVL

Order Name:
Viral Load (HBV DNA), Quantitative method

 
 
Clinical Information:
Hepatitis B Virus (HBV) is one of several viruses known to cause viral hepatitis. Over two billion people throughout the world have been infected with HBV and over 350 million of them are chronically infected carriers. Serologic markers are commonly used as diagnostic and/or prognostic indicators of acute or chronic HBV infection. The most common marker of HBV infection is the presence of HBV surface antigen (HBsAg). HBV e antigen (HBeAg) is generally used as a secondary marker to indicate active HBV replication associated with progressive liver disease. Failure to clear HBeAg appears to increase the risk of end stage liver disease. Variant strains of HBV can either produce HBeAg that is not detectable in serum or the strain can lose the ability to make HBeAg even when an active infection is present. Therefore, using this marker to monitor disease progression may be of limited utility. The ability to detect HBV DNA in serum has been reported to have prognostic value for the outcome of acute and chronic HBV infections. The methodology can allow the detection of HBV DNA after HBsAg clearance or detection of HBV lacking serologic markers. However, a relationship between serologic markers and HBV DNA levels has not yet been established. The efficacy of antiviral therapy used to treat patients with HBV can also be assessed by serologic markers or by measurement of liver enzyme function. However, the most direct and reliable measurement of viral replication is thought to be quantitation of HBV viral DNA in blood. A rapid and sustained drop in HBV DNA levels in patients receiving treatment has been shown to be a predictive factor for a favorable treatment outcome. Therefore, a quantitative test for the measurement of HBV DNA is a valuable tool that can be used in conjunction with other serological markers in the management of HBV infection.
 
Reference Value:
Test Reference Value
Viral Load (HBV DNA), Quantitative Not detected
Viral load Log equivalence HBV Not detected
 
Interpretation:
The quantification range of this assay is 116 to 989,400,000 copies/mL (2.07 log to 9.00 log copies/mL).
An "Not detected" result indicates that hepatitis B virus (HBV) DNA was not detected in the serum specimen.
A result of "<116 copies/mL (<2.07 log copies/mL)" indicates that HBV DNA is detected, but the HBV DNA level present cannot be quantified accurately below this lower limit of quantification of this assay. When clinically indicated, follow-up testing with this assay is recommended in 1 to 2 months.
A quantitative result expressed in copies/mL and log copies/mL indicates the degree of active HBV viral replication in the patient. Monitoring HBV DNA levels over time is important for assessing disease progression or monitoring a patient's response to anti-HBV therapy.
A result of "989,400,000 copies/mL (>9.00 log copies/mL)" indicates the presence of active HBV viral replication, and the HBV DNA level present cannot be quantified accurately above this upper limit of quantification of this assay.
 
Clinical Reference:
Manufacturer’s package insert, COBAS®AmpliPrep/COBAS®TaqMan®HBV Test,version 2.0, September 2019, Roche Molecular Systems, NJ 08876 Branchburg, USA.