What is the interest of having a high level of sensitivity ?Higher sensitivity means you are able to offer better patient monitoring, particularly
in the low viral load values. This ensures patients can benefit from enhanced quality of life through better adapted therapy
and rapid detection of resistance to treatment.
Why is flexibility important ?A test that is flexible will adapt more readily to the needs of the different types
of laboratories and patients. It ensures you will be able to monitor patients using the same technology and platform whatever the setting or lab configuration.
Teamed with Dry Blood Spot (DBS), a simple, safe transport medium, viral load monitoring of patients in remote areas is now possible enabling patients who could previously
not be monitored to receive treatment.
Maximum Flexibility
Simple Solutions for Patient Monitoring
BOOM® 1
The Gold Standard in efficient nucleic acid extraction
0
Molecularbeacon
Specific targetedsequence
Fluorescent signal (real-time)
10 20 30 40 50 60
Time (minutes)
Inte
nsity
RNA5‘
5‘
5‘
5‘
3‘
3‘
5‘
5‘
3‘ 5‘
3‘ 5‘
3‘
5‘
5‘3‘
5‘
3‘
3‘ 5‘ 3‘
5‘
5‘3‘
3‘
5‘
5‘
5‘
3‘
3‘
5‘3‘5‘
5‘3‘5‘3‘
3‘
3‘
5‘ 3‘
3‘
3‘Primer 1 hybridizationcontaining T7
RNA
RTRT
Primer 1
Primer 2RNase H (2) &Primer 2 hybridization
(1) cDNA synthesis - (2) RNA Degradation - (3) ds DNA synthesis
ReverseTranscriptase (RT) (1)
RT (3)
Molecular beaconhybridization
RNase H + Primer 1 containing T7 promotor
3‘5‘3‘
FOR TRANSCRIPTIONT7 RNA Polymerase
(1) (3)
(2)RNase H
1- bioMérieux’s proprietary technology.2- NASBA: Nucleic Acid Sequence Based Amplification.
�
�
Time <
3 hrs
Plasma Tube Dry Blood Spot (DBS)
�
�NASBA® 1, 2
Real-time Amplification & DetectionIsothermal : 41°C
NASBA Amplification Real-Time Detection with Molecular Beacons
OR
2 Configuration: 8 to 1000 viral load tests/day2 Sample: Plasma/DBS
BM-NUCLISENS HIV-VA.qxp:BM-NUCLISENS HIV-VA 25/08/09 9:54 Page 1
Performance
NucliSENS EasyQ HIV v1.2 and NucliSENS EasyQ HIV 2.0 on EDTA plasma
Subtypes: A, B, C, D, F, G, H, J, CRF01_AE and CRF02_AG
Measuring range: 10-10 000 000 copies/ml
Sample: 0.1 - 0.5 - 1 ml human plasma and DBS
High Level of Sensitivity
Test Features
Correlation
NucliSENS EasyQ® HIV-1 v2.0: validated input volumes plasma and DBS
Sample Volumes
TND
< 10
1
1.5
2
2.5
3
3.5
4
4.5
5
5.5
6
6.5
7
> 10n7
< LDL 1 2 3 4 5 6 7 8
Qua
nt re
sults
of v
2.0
- pla
sma
1 m
l (lo
g cp
s/m
l)
Quant results of v1.2 (log IU/ml)
NucliSENS EasyQ HIV 2.0 on plasma versus NucliSENS EasyQ HIV 2.0 on DBS
TND
> 100
2
2.5
3
3.5
4
4.5
5
5.5
6
6.5
7
7.5
> 10n8
Qua
nt re
sults
of v
2.0
- DBS
0.1
ml (
log
VQA
cps/
ml)
Quant results of v2.0 - plasma 0.1 ml (log VQA cps/ml)< LDL 2 3 4 5 6 7 > 10n8< 100 2.5 3.5 4.5 5.5 6.5 7.5
Claimed LoD (95% detection level)Flexible Input Limit of Detection (LoD)1 ml plasma 25 cps/ml0.5ml plasma 50 cps/ml
0.1 ml plasma 292 cps/ml
Dry Blood Spot (0.1 ml) 802 cps/ml
BM-NUCLISENS HIV-VA.qxp:BM-NUCLISENS HIV-VA 25/08/09 9:54 Page 2
Why Choose NucliSENS EasyQ®HIV-1 ?V
2.0
2 Rapid, Simple ResultsTurn-around-time from sample to result is < 3 hoursper run, with less than 1 hour hands-on time, allowingfast reporting and optimal workflow planning. Results arealso expressed clearly and simply.
2 Sensitive TestingThe unrivaled, proprietary magnetic BOOM® extractioncombined with the highly efficient real-time NASBA®
reaction of only one hour ensures very sensitive test results.
2 Flexible And ScalableThe NucliSENS system configuration is fully adaptable to individual laboratory needs with a testing capabilitygoing from 8 up to over 1000 tests per day per technician with extraction being performed on either themanual NucliSENS® miniMAG® or automated NucliSENS® easyMAG®. Both plasma and DBS samplescan be used ensuring both routine and remote patientmonitoring can be performed.
2 Internally CalibratedReliable and accurate quantification is achieved throughan individual, internal calibrator that is already added atthe sample lysis step. This calibrator validates each samplemaking external controls superfluous.
2 Space Saving & No ContaminationThe NucliSENS EasyQ system fits easily into every laboratory and is a closed system preventing contamination.
BM-NUCLISENS HIV-VA.qxp:BM-NUCLISENS HIV-VA 25/08/09 9:54 Page 3
2009NucliSENS EasyQ® HIV-1 v2.0
Real-time HIV viral load using plasma and Dry Blood Spot
VIDIA® HIV DUO4th generation automated test
Vironostika® HIV Ag/Ab4th generation microplate screening test
2007VIKIATM HIV 1/2
Simple hand-held device for rapid testing
2004VIDAS® HIV DUO Ultra
VIDAS® HIV DUO QuickAdvanced 4th generation automated tests
2002NucliSENS EasyQ® HIV-1
First real-time HIV-1 viral load assay
1998VIDAS® HIV DUO
First 4th generation automated test
Vironostika® HIV Uni-Form II Ag/AbFirst 4th generation microplate test
1995Vironostika® HIV Uni-Form II plus O
Group O detection
NASBA® HIV-1 QTFirst HIV-1 viral load assay
1994VIDAS® HIV P24 Ag
Quantitative Ag detection in automated format
1993VIDAS® HIV-1 anti P24
First automated HIV-1 p24 Ab test
NucliSENS® HIV-1 QLQualitative HIV-1 RNA
1992Vironostika® HIV Uni-Form II
3rd generation microplate test
1991VIDAS® HIV-1+2
First automated HIV assay
1989Vironostika® HIV MIXT
HIV-1 and HIV-2 detection
1988Vironostika® HIV-1 Antigen
p24 antigen detection
1987Vironostika® HIV Uni-Form
One-step microElisa assay
1985Vironostika® anti-HTLV III
First screening tests available
1983Discovery of the virus
From the very beginning…bioMérieux – your innovative partner in HIV testing
Viro
nost
ika®
rang
e de
velo
ped
by O
rgan
on T
ekni
ka, a
com
pany
acq
uire
d by
bio
Mér
ieux
in 2
001.
BM-NUCLISENS HIV-VA.qxp:BM-NUCLISENS HIV-VA 25/08/09 9:54 Page 4
bioMérieux S.A.69280 Marcy l’EtoileFranceTél. : 33 (0)4 78 87 20 00Fax : 33 (0)4 78 87 20 90
www.biomerieux-diagnostics.com/hivwww.biomerieux.com
Committed to the fight for 25 years
bioMérieux's commitment to HIV testing started 25 years ago, at the very beginning of the epidemic.
Our research teams developed one of the first screening tests available in 1985, following the discovery of the HIV virus.
Today, bioMérieux diagnostics play an essential role in HIV management, for screening, preventing mother-to-child transmission and improving patient care. We are committed to making innovation in HIV testing accessible to all types of healthcare settings and systems.
To further this goal, bioMérieux will bring viral load monitoring to patients in remote areas through one of the latest breakthroughs in HIV testing, the Dry Blood Spot.
A COMPLETE RANGE
Prevention and Diagnosis
• VIKIATM HIV 1/2
• VIDAS® HIV DUO ULTRA• VIDAS HIV DUO QUICK
• VIDAS HIV P24 II• VIDAS HIV P24 II Confirmation
• Vironostika® HIV Uniform II plus 0• Vironostika HIV Ag/Ab
• VIDIA® HIV DUO
Monitoring
• NucliSENS EasyQ® HIV-1 v2.0
Ref: 28 5033 (48 tests)Ref: 28 5043 (480 tests)
04-0
9/ 0
07GB
9902
9A /
This
docu
men
t is n
ot le
gally
bin
ding
, bio
mér
ieux r
eser
ves t
he ri
ght t
o m
odify
spec
ificat
ions
with
out n
otice
- bi
oMér
ieux,
the
blue
logo
, BO
OM
, eas
yMAG
, min
iMAG
, NAS
BA, N
ucliS
ENS,
Nucli
SEN
S Ea
syQ
, VID
IA, V
IKIA
, VID
AS, a
nd V
irono
stika
are
use
d,
pend
ing
and/
or re
giste
red
trade
mar
ks b
elong
ing
to b
iom
érieu
x S.A
. or o
ne o
f its
subs
idiar
ies /
Mol
ecul
ar b
eaco
ns a
re lic
ense
d fro
m P
HRI P
rope
rties
, Inc
. und
er P
HRI P
rope
rties
pat
ent r
ights
/ bio
Mér
ieux S
.A. R
CS Ly
on 6
73 6
20 3
99. P
hoto
s: C.
Gan
et, N
. Bou
chut
, V. V
edre
nne,
P. To
urna
ire, N
. Rob
in, G
etty
/ Prin
ted
in F
ranc
e / T
HERA
Con
seil
/ RCS
Lyon
B 3
98 16
0 24
2.
Some of these reagents are under development or have not yet obtained regulatory clearance in some countries. Please contact your local bioMérieux representative for further information and product availability.
BM-NUCLISENS HIV-VA.qxp:BM-NUCLISENS HIV-VA 25/08/09 9:54 Page 5
H I V I N F E C T I O N
PREVENTION
D I A G N O S I S
MONITORING
Simple Solutions for Patient Monitoring
BM-NUCLISENS HIV-VA.qxp:BM-NUCLISENS HIV-VA 25/08/09 9:54 Page 6