UlttraQua
al® 1000 2X
X HBV PCR
Use
e
Detec
ct Hepatitis B Virus DNA (HBV DNA))
Clin
nical Ben
nefits



Detect prese
ence of Hepatitis B Virus
s.
Assists
A
in de
etermining iff a patient un
ndergoing th
herapy has ccleared HBV
V.
Assists
A
in determining
d
if blood or blood prod ucts are fre
ee of detecttable Hepatitis B
Virus.
V
Clin
nical Indications
s
The direct
d
detectiion of virus is a valuablle tool in de
etermining w
whether a pa
atient underg
going
therap
peutic treatm
ment has cle
eared virus. It is also u
useful in determining wh
hether blood
d and
blood products arre virus free
e prior to dis
stribution to patients. P
PCR is able to directly d
detect
HBV RNA and do
oes not rely
y on later markers
m
such
h as antigen
ns or antibod
dies that arre not
produced in newly
y infected ind
dividuals.
Methodolog
gy
UltraQ
Qual® (PCR)
Ass
say Sens
sitivity


Me
ean Detectio
on:
0.1
19 IU/mL (0
0.62 copies/m
mL)
95
5% Detection
n Cutoff: 0.9
90 IU/mL (2
2.89 copies/m
mL)
Refe
erences
s
1.
2.
3.
4.
Ba
aginski, I. Et al. (1990). Detec
ction of hepatitiis B virus. In: In
nnis, M.A. et all. eds. PCR Prrotocols: A
Gu
uide to Methods
s and Applications. San Dieg
go: Academic Press. pp 348--355.
Ba
aker, B.I., et al. (1991). Determination of He
epatitis B virus DNA in serum
m using the polyymerase chain
rea
action: clinical significance an
nd correlation with
w serologica
al and biochem ical markers. Hepatology.
13: 632-636.
Pa
ao, C.C. et al. (1991). Serum
m hepatitis B virus
v
DNA in he
epatitis B virus seropositive and seronegativve
ind
dividuals with normal
n
liver function. Am J. Clin
C Pathol. 95::540-546.
Pa
aterlini, P., et all. (1990). Poly
ymerase chain reaction to dettect hepatitis B virus DNA and
d RNA
seq
quences in prim
mary liver canc
cers from patien
nts negative fo
or hepatitis B su
urface antigen.. N Engl J Med
d.
323:80-85
National Genetics
s Institute
2440 S. Sepulveda
S
Blvd.,, Suite 235  Los
s Angeles, Califo
ornia 90064 88 8-4-NGI-LAB (88
88-464-4522)
310-996-0036
3
F
FAX 888-PCR-T
TEST (888-727-8
8378)
MK 20.2
2 06/17/15
Page 1 of 2
UltraQual® 1000 2X HBV PCR
Ordering Information
UltraQual® HBV 1000 2X PCR
CPT Code
87516
Description
Hepatitis B, Amplified Probe Technique.
Test performed utilizing National Genetics Institute’s validated, proprietary PCR methodology.
Specimen Collection & Handling
I.
Type of Specimen*


One 7 mL PPT Tube or
2.5 mL 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 the plasma from cells 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 the 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. Ship on enough dry ice to last at least 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 20.2 06/17/15
Page 2 of 2