simple solutions for patient monitoring - biomérieux india · plasma tube dry blood spot (dbs)...

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‘

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5‘3‘

5‘

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5‘

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5‘3‘5‘3‘

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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

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


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.


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

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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)

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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.


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


simple solutions for patient monitoring - biomérieux india · plasma tube dry blood spot (dbs)...

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