Download SuperQuant™ HBV PCR - National Genetics Institute

SuperQuant™ HBV PCR
Use
Detect and quantify Hepatitis B Virus DNA (HBV DNA).
Clinical Benefits
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Direct measurement of viral load.
Detect as few as 100 copies of HBV DNA per mL of plasma or serum.
May be used to monitor drug therapy.
Higher HBV DNA levels while on anti-HBV therapy may indicate antiviral resistance.
Assists in an improved clinical workup for patients with hepatocellular carcinoma.
Clinical Indications
The direct measurement of HBV load through quantitation of HBV DNA is a valuable tool for monitoring
HBV infection and the efficacy of anti-HBV therapy. Hepatic enzymes (e.g., ALT, AST, GT) and other
markers reflect consequences of HBV infection and may not be as beneficial in predicting HBV disease
progression.
Methodology
SuperQuant™ PCR
Quantitation Range
Low
100
29
High
5,000,000,000
1,450,000,000
Units
copies/mL HBV DNA
IU/mL HBV DNA
Reference Range
Undetected
Interpretation: an undetected result indicates absence of the target viral nucleic acid
References
1.
2.
3.
4.
Baginski, I. Et al. (1990). Detection of hepatitis B virus. In: Innis, M.A. et al. eds. PCR Protocols: A Guide to Methods and
Applications. San Diego: Academic Press. pp 348-355.
Baker, B.I., et al. (1991). Determination of Hepatitis B virus DNA in serum using the polymerase chain reaction: clinical
significance and correlation with serological and biochemical markers. Hepatology. 13: 632-636.
Pao, C.C. et al. (1991). Serum hepatitis B virus DNA in hepatitis B virus seropositive and seronegative individuals with
normal liver function. Am J. Clin Pathol. 95:540-546.
Paterlini, P., et al. (1990). Polymerase chain reaction to detect hepatitis B virus DNA and RNA sequences in primary liver
cancers from patients negative for hepatitis B surface antigen. N Engl J Med. 323:80-85
National Genetics Institute
2440 S. Sepulveda Blvd., Suite 235  Los Angeles, California 90064 888-4-NGI-LAB (888-464-4522)
310-996-0036 FAX 888-PCR-TEST (888-727-8378)
MK 05.9 03/04/15
Page 1 of 2
SuperQuant™ HBV PCR
Ordering Information
NGI Test Code: 2020
When ordering through Laboratory Corporation of America use Test Code: 140810
CPT Code
87517
Description
Hepatitis B Quantitation
Test performed utilizing National Genetics Institute’s validated, proprietary PCR methodology.
Specimen Collection & Handling
I.
Type of Specimen*
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
One 7 mL PPT Tube or
1.0mL frozen serum or EDTA or ACD plasma. Do not use heparinized samples.
* During a clinical trial the same type of specimen should be used throughout the trial.
II.
Method of Collection:
When using PPT Tubes
a. Collect blood directly into PPT tubes.
b. Centrifuge to separate plasma from cells as soon as possible within 1 hour of draw.
c. Ship the separated PPT tube at room temperature.
When not using PPT Tubes
a. Blood should be collected in EDTA, ACD, CPD or SST tubes. Do not use heparin.
b. Centrifuge to separate plasma or serum from the cells. Centrifugation should be
performed within 1 hour of draw.
c. Transfer the plasma or serum to a screw-cap cryo tube.
d. Ship frozen serum or plasma on dry ice.
Do not send frozen specimens in Glass Containers
III.
Shipping
a. Ship by overnight courier (e.g., FED EX, etc.)
b. Package according to regulations regarding shipment of infectious material.
c. When shipping frozen specimens, ship on enough dry ice to last 48 hours.
“This test performed pursuant to a license agreement with Roche Molecular Systems, Inc.”
National Genetics Institute
2440 S. Sepulveda Blvd., Suite 235  Los Angeles, California 90064 888-4-NGI-LAB (888-464-4522)
310-996-0036 FAX 888-PCR-TEST (888-727-8378)
MK 05.9 03/04/15
Page 2 of 2