Simple Solution for Patient monitoring

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RNase H. 1- bioMérieux's proprietary technology. 2- NASBA: Nucleic Acid ... DBS 0.1 ml (log VQA cps/ml). Quant results of v2.0 - plasma 0.1 ml (log VQA cps/ml).
Simple Solutions for Patient Monitoring 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 2 Configuration: 8 to 1000 viral load tests/day 2 Sample: Plasma/DBS M

Plasma Tube

Dry Blood Spot (DBS) Time < 3 hrs

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BOOM® 1 The Gold Standard in efficient nucleic acid extraction

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NASBA® 1, 2 Real-time Amplification & Detection Isothermal : 41°C

M NASBA Amplification

Real-Time Detection with Molecular Beacons Fluorescent signal (real-time)

RNase H + Primer 1 containing T7 promotor

Primer 1 hybridization containing T7

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Reverse Transcriptase (RT) (1)

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RNase H (2) & Primer 2 hybridization

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RT (3)

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Primer 1 Specific targeted sequence

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(3) 5‘ 3‘ 5‘

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RNA 3‘ 3‘ 3‘

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Primer 2

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RNase H

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Molecular beacon

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FOR TRANSCRIPTION T7 RNA Polymerase (1) cDNA synthesis - (2) RNA Degradation - (3) ds DNA synthesis

1- bioMérieux’s proprietary technology. 2- NASBA: Nucleic Acid Sequence Based Amplification.

Molecular beacon hybridization

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Performance High Level of Sensitivity

Sample Volumes NucliSENS EasyQ® HIV-1 v2.0: validated input volumes plasma and DBS Claimed LoD (95% detection level) Flexible Input Limit of Detection (LoD) 25 cps/ml* 50 cps/ml * 292 cps/ml * 802 cps/ml

1 ml plasma 0.5ml plasma 0.1 ml plasma Dry Blood Spot (0.1 ml) * Performance still subject to regulatory approval

Correlation NucliSENS EasyQ HIV v1.2 and NucliSENS EasyQ HIV 2.0 on EDTA plasma

NucliSENS EasyQ HIV 2.0 on plasma versus NucliSENS EasyQ HIV 2.0 on DBS > 10n8

Quant results of v2.0 - DBS 0.1 ml (log VQA cps/ml)

Quant results of v2.0 - plasma 1 ml (log cps/ml)

> 10n7 7 6.5 6 5.5 5 4.5 4 3.5 3 2.5 2 1.5 1 < 10 TND < LDL

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Quant results of v1.2 (log IU/ml)

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Quant results of v2.0 - plasma 0.1 ml (log VQA cps/ml)

Test Features 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

NucliSENS EasyQ®HIV-1

V 2.0

Why Choose 2 Rapid, Simple Results Turn-around-time from sample to result is < 3 hours per run, with less than 1 hour hands-on time, allowing fast reporting and optimal workflow planning. Results are also expressed clearly and simply.

2 Sensitive Testing The unrivaled, proprietary magnetic BOOM® extraction combined with the highly efficient real-time NASBA® reaction of only one hour ensures very sensitive test results.

2 Flexible And Scalable The NucliSENS system configuration is fully adaptable to individual laboratory needs with a testing capability going from 8 up to over 1000 tests per day per technician with extraction being performed on either the manual NucliSENS® miniMAG® or automated NucliSENS® easyMAG®. Both plasma and DBS samples can be used ensuring both routine and remote patient monitoring can be performed.

2 Internally Calibrated Reliable and accurate quantification is achieved through an individual, internal calibrator that is already added at the sample lysis step. This calibrator validates each sample making external controls superfluous.

2 Space Saving & No Contamination The NucliSENS EasyQ system fits easily into every laboratory and is a closed system preventing contamination.

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From the very beginning… bioMérieux – your innovative partner in HIV testing 2009

NucliSENS EasyQ® HIV-1 v2.0 Real-time HIV viral load using plasma and Dry Blood Spot VIDIA® HIV DUO 4th generation automated test Vironostika® HIV Ag/Ab 4th generation microplate screening test

2007

VIKIATM HIV 1/2 Simple hand-held device for rapid testing

2004

VIDAS® HIV DUO Ultra VIDAS® HIV DUO Quick Advanced 4th generation automated tests

2002

NucliSENS EasyQ® HIV-1 First real-time HIV-1 viral load assay

1998

VIDAS® HIV DUO First 4 generation automated test th

Vironostika® HIV Uni-Form II Ag/Ab First 4th generation microplate test

1995

Vironostika® HIV Uni-Form II plus O Group O detection NASBA® HIV-1 QT First HIV-1 viral load assay

1994

VIDAS® HIV P24 Ag Quantitative Ag detection in automated format

1993

VIDAS® HIV-1 anti P24 First automated HIV-1 p24 Ab test

Vironostika® range developed by Organon Teknika, a company acquired by bioMérieux in 2001.

NucliSENS® HIV-1 QL Qualitative HIV-1 RNA

1992

Vironostika® HIV Uni-Form II 3rd generation microplate test

1991

VIDAS® HIV-1+2 First automated HIV assay

1989

Vironostika® HIV MIXT HIV-1 and HIV-2 detection

1988

Vironostika® HIV-1 Antigen p24 antigen detection

1987

Vironostika® HIV Uni-Form One-step microElisa assay

1985

Vironostika® anti-HTLV III First screening tests available

1983 Discovery of the virus

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.

04-09/ 007GB99029A / This document is not legally binding, biomérieux reserves the right to modify specifications without notice - bioMérieux, the blue logo, BOOM, easyMAG, miniMAG, NASBA, NucliSENS, NucliSENS EasyQ, VIDIA, VIKIA, VIDAS, and Vironostika are used, pending and/or registered trademarks belonging to biomérieux S.A. or one of its subsidiaries / Molecular beacons are licensed from PHRI Properties, Inc. under PHRI Properties patent rights / bioMérieux S.A. RCS Lyon 673 620 399. Photos: C. Ganet, N. Bouchut, V. Vedrenne, P. Tournaire, N. Robin, Getty / Printed in France / THERA Conseil / RCS Lyon B 398 160 242.

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.

Ref: 28 5033 (48 tests) Ref: 28 5043 (480 tests)

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 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.

bioMérieux S.A. 69280 Marcy l’Etoile France Tél. : 33 (0)4 78 87 20 00 Fax : 33 (0)4 78 87 20 90 www.biomerieux-diagnostics.com/hiv www.biomerieux.com

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Simple Solutions for Patient Monitoring