Tải bản đầy đủ - 0 (trang)
Cobas® 4800 System V2.0 Keeping Pace With Changing Needs

Cobas® 4800 System V2.0 Keeping Pace With Changing Needs

Tải bản đầy đủ - 0trang

984



Concise Book of Medical Laboratory Technology: Methods and Interpretations



:Cobas x 480 instrument



Efficiency

¾¾ By fully automated sample preparation and PCR set-up

(for HPV and CT/NG)

¾¾ By bidirectional connectivity with your LIS for

automated results reporting.



Cobas z 480 analyzer



¾¾ Cobas KRAS mutation test

¾¾ Cobas EGFR mutation test

¾¾ Cobas PIK3CA mutation test (for research use only).



Hospital Aquired Infections



Flexibility



¾¾ Cobas MRSA/SA test

¾¾ Cobas Cdiff test



¾¾ Possibility to use multiple primary vial types

¾¾ User defined workflow software for free programmable

PCR applications.



Viral Infections

¾¾ Cobas HSV 1 and 2 test.



Load-and-go Reagents

¾¾ Save time and labor

¾¾ Low daily maintenance requirements.



TEST MENU

Cobasđ 4800 HPV Test

ắắ Only FDA approved hr HPV assay which simultaneously

detects 14 high-risk HPV genotypes, including

individual identification of HPV genotypes 16 and 18.



Cobasđ 4800 CT/NG Test

ắắ Test is designed to run as CT only.



NG Only or as CT/NG Combination

¾¾ Highest specificity for NG and detection of Swedish CT

mutant and other variants due to dual target detection



Oncology Tests

¾¾ Cobas 4800 BRAF V600 mutation test



PRODUCT CHARACTERISTICS

¾¾

¾¾

¾¾

¾¾



Processes up to 376 samples in 10 h

Bidirectional connectivity to LIS

Easy to use software

Automated result interpretation for HPV and CT/NG.



Components:

Cobas x 480 Instrument

¾¾ Fully automated nucleic acid purification

¾¾ Automated PCR set up

¾¾ Dimensions: 166 cm width, 90 cm depth, 101 cm high.



Cobas z 480 Analyzer

¾¾

¾¾

¾¾

¾¾



Based on LightCycler® 480 technology

6 detection channels

96 well plate format

Dimensions: 57 cm width, 59 cm depth, 50 cm high.



World’s Latest and Best Technologies by Roche



THE COBAS® HPV TEST

Know the Risk

Almost all cervical cancer is attributable to HPV, so knowing

a woman’s HPV status is important to ascertain her risk of

cervical cancer and to determine clinical management.

The cobas 4800 HPV test is the only clinically validated

CE-marked, and FDA-approved assay, that simultaneously

provides results on “high-risk” genotypes, including

individual results on the highest-risk genotypes, HPV

16 and HPV 18, giving three results in just one test. HPV

genotypes 16 and 18 are known to be responsible for more

than 70 percent of all cervical cancer cases.

This test enables physicians to focus on the few

patients who need more aggressive treatment or careful

management, and reassures the vast majority of women

they are at very low-risk, protecting them from potentially

unnecessary interventions.



YOUR BENEFIT

Evidence Based

¾¾ Clinically validated in Roche’s landmark ATHENA trial,

the largest US based registration study for cervical

cancer screening, including more than 47,000 women

¾¾ One in 10 women in the landmark ATHENA study who

tested positive for either HPV genotype 16 or 18 had

evidence of cervical pre-cancer, even though their pap

was normal.



985



45, 51, 52, 56, 58, 59, 66 and 68) at clinically relevant

infection levels.



Sample Material

¾¾ Cervical cells collected in cobas PCR cell collection

media (Roche Molecular Systems, Inc.), PreservCyt

solution (Cytyc Corp.) and SurePath preservative fluid

(not approved in the US) (BD Diagnostics-TriPath)

¾¾ Sample volume of 1 mL is sufficient.



Test Principle

¾¾ Multiplex assay to detect 12 pooled high risk genotypes,

with simultaneous individual genotyping for highest

risk HPV 16 and 18

¾¾ Beta-globin acts as control for extraction and

amplification.



Throughput

¾¾ up to 282 tests in less than 12 hours.



Absolute Risk of ≥CIN2 by Screening Strategies

Assessed in ATHENA at Baseline



Clinically Relevant Results

¾¾ Knowing the patients HPV 16/18 status may impact

patient management and allow better risk stratification

of the patients at the highest risk.



Reort with Confidence

¾¾

¾¾

¾¾

¾¾

¾¾



Internal control for assurance of sample integrity

No cross reactivity with low risk HPV genotypes

Efficiency

Suited for high volume screening programs

By fully automated sample preparation workflow

process, and unique efficiency feature.



PRODUCT CHARACTERISTICS

Coverage

¾¾ Identifies (types) HPV 16 and HPV 18 while concurrently

detecting the rest of the high risk types (31, 33, 35, 39,



:1 in 10 women ≥30 years of age with negative cytology who

tested positive for HPV 16/18 using the cobas HPV test had

underlying precancerous lesions. Women with negative pap

cytology who are HPV 16+ and/or HPV 18+ and women with

ASC-US who are pooled hrHPV+ share a similar absolute risk of

precancer and should be managed similarly with immediate

referral to colposcopy.



THE COBAS® ONCOLOGY TESTS

7–10 days is a Long Time to Wait when

Everyday Counts

The cobas oncology portfolio exemplifies Roche’s

commitment to personalized healthcare. The tests detect

mutations in key biomarkers which helps identify patients

who are most likely to respond to certain drug treatments.



986



Concise Book of Medical Laboratory Technology: Methods and Interpretations



These clinically validated companion diagnostics help

physicians make therapy decisions for patients suffering

from metastatic melanoma, colorectal cancer, and nonsmall cell lung cancer. Due to the short testing time

physicians can make decisions in hours instead of days

when using alternative methods. The cobas oncology

menu will be expanded during the next years.



YOUR BENEFIT

Reliable Results

¾¾ Complete and controlled IVD system consisting of

cobas DNA sample Preparation Kit, cobas BRAF, KRAS,

EGFR, and PIC3CA (RUO) mutation tests, and the

cobasđ 4800 system, v2.0.



Consistent, Objective and Reproducible Results

ắắ Automated result interpretation and test reporting

provide from laboratory to laboratory.



Fast Result Reporting

¾¾ Delivering patient results in <8 hours.



TEST MENU

cobas 4800 BRAF V600 Mutation Test

¾¾ Identifies which metastatic melanoma patients can be

considered for BRAF inhibitor therapy, e.g. Zelboraf



* In US, coverage is Exon 19 and 21 only



¾¾ Detects V600E mutations of the BRAF gene (<5%

mutant copies in formalin-fixed, paraffin-embedded

tissue [FFPET]); also sensitive to V600K and V600D

¾¾ 24 reportable results from a single test kit

ắắ Only requires one 5 àm tissue section with >50 % tumor

area for the PCR reaction.



cobas KRAS Mutation Test (CE-IVD)

¾¾ Offers broad mutation coverage of KRAS codons 12, 13

and 61 to identify colorectal cancer patients not likely to

respond to anti-EGFR monoclonal antibody therapies,

e.g. erbitux, vectibix

¾¾ Detects all of the reported mutations in codons 12, 13

and 61 of the EGFR gene (<5 % mutant copies in FFPET)



World’s Latest and Best Technologies by Roche

¾¾ 24 reportable results from a single test kit

ắắ Only requires one 5 àm tissue sections with ≥10%

tumor area for the PCR reaction.



Cobas EGFR Mutation Test

¾¾ Identifies patients with non-small cell lung cancer who

benefit from anti-EGFR TKI therapy, e.g. Tarceva

¾¾ Specific detection of 41 mutations (insertions and

deletions) in exons 18, 19, 20 and 21* of the EGFR gene

(≤5% mutant copies in FFPET)

¾¾ 24 reportable results from a single test kit

ắắ Only one 5 àm tissue section with ≥10% tumor area for

the PCR reaction.



Cobas DNA Sample Preparation Kit

¾¾ Clearly defined workflow

¾¾ Validated with FFPET samples

¾¾ Isolation time: 3–4 hours only.



Assay Specific Analysis Packages

¾¾ Software package containing cycling conditions,

algorithms and calculations for automated interpretation and report of results.



COBAS® MRSA/SA TEST

Faster than a Spreading Infection

Staphylococcus aureus (SA) and methicillin-resistant

Staphylococcus aureus (MRSA) infections represent a

critical threat to public health. The cobas MRSA/SA test,

performed on the cobas 4800 system, provides innovative

solutions for detecting both organism variances from

a single nasal swab specimen, providing timesaving

efficiencies and lifesaving answers.



987



YOUR BENEFIT

Exceptional Performance

¾¾ Quickly identify colonized patients and take decisive

action

¾¾ Get the sensitivity and specificity that only PCR

technology can deliver.



Greater Workflow Efficiencies

¾¾ Save time with first-of-its-kind primary sample vial

loading

¾¾ Run MRSA/SA, Cdiff, and HSV 1 and 2 samples at the

same time, on the same system

¾¾ Simplify data interpretation with patented, state-ofthe-art software algorithms.



Automated Efficiency

¾¾ Run 6 to 94 specimens using the fastest, most advanced

real-time PCR amplification and detection available

today.



COBAS® CDIFF TEST

The Right Result the First Time

Clostridum difficile (C. difficile) infection is a major cause

of diarrhea in healthcare facilities. By rapidly detecting

Cdiff in patient stool samples, the cobas C diff test, which

is performed on the cobas 4800 system, provides accurate

information for timely treatment and prevention.



YOUR BENEFIT

Exceptional Performance

¾¾ Selectively detects a specific C diff toxin gene directly

from unformed stool samples using real-time PCR



988



Concise Book of Medical Laboratory Technology: Methods and Interpretations



¾¾ Generates robust results automatically, using patented,

state-of-the art algorithms

¾¾ Detects the presence of 31 Cdiff toxinotypes and

20 ribotypes.



Confidence in Results

¾¾ Minimizes invalids and need for repeat testing resulting

in cost efficiency

ắắ Reduces possibilities for errors.



COBASđ HSV 1 AND 2 TEST



Multiple Assays, One System

¾¾ Efficiency at its best – 3 assays in one run: HSV 1 and 2,

MRSA/SA and C diff.



Time-saving Flexibility—Use Different Primary Vials

and/or Sample Types

¾¾ Confident patient tracking—from primary vial to final

result.



Mixed Batch Testing on cobas® 4800 System



Bring More to Your Sexually Transmitted

Infections Menu

Due to extremely different outcomes regarding recurrence,

it is essential to determine whether a patient has type 1 or

type 2 herpes simplex virus. The cobas HSV 1 and 2 test,

which runs on the cobas 4800 system, offers exceptional

sensitivity while delivering reliable answers that result in

optimal patient treatment and management decisions.



YOUR BENEFIT

Amplified Reliability

¾¾ Robust, dual-target detection amplifies two separate

regions on each of the HSV-1 and HSV-2 genomes

¾¾ Optimizes sensitivity and specificity

¾¾ Ensures reliable results as new HSV strains emerge.



Reduced Hands-on Time

¾¾ Just load your primary sample vials on the cobas 4800

system and you’re ready to go.



Parallel Sample Processing Offers the Flexibility to

Run Different Tests and Sample Types, Including:

¾¾ Stool (cobas C diff test)

¾¾ Nasal (cobas MRSA/SA test)

¾¾ Anogenital lesions (cobas HSV 1 and 2 test).



COBAS S 201 SYSTEM

The First Multi-dye Nucleic Acid Testing (NAT)

Screening System

The cobas s 201 system is a complete NAT solution able

to meet both current and future needs of blood screening

laboratories.



World’s Latest and Best Technologies by Roche

This system provides the efficiency and reliability of

real-time polymerase chain reaction (RT-PCR) technology,

modular automation, convenient ready-to-use reagents

and a robust menu selection. New assays utilize multichannel capabilities to provide real-time discrimination of

major viruses.

The system is backed by world-class service and strong

local support in over 140 countries.



YOUR BENEFIT

¾¾ Full automation including optional pooling and

archiving with minimal hands-on time for the entire

testing process

¾¾ Confidence in the test results through full process

control

¾¾ Most comprehensive assays on the market with

ready-to-use reagents

¾¾ Built-in viral target resolution through multi-dye

technology makes confirmation testing obsolete



PRODUCT CHARACTERISTICS

Scalable, Modular System

¾¾ Flexible, mix-and-match scalability helps NAT labs

work more efficiently

¾¾ Supports simultaneous multiple assay processing

¾¾ Accommodates integrated backup to maximize

laboratory productivity.



989



Pooling and Data Management Server

¾¾ Single server, accommodating multiple instrument

configurations and providing the added security of

built-in redundancy.



TEST MENU

¾¾ Reagents are ready-to-use with built-in contamination

control

¾¾ No freezers required, reagents are stored at 2–8°C

¾¾ Stabilized reagents obsoletes calibrations.



Cobas TaqScreen MPX Tests

¾¾ Covers 5 critical viral targets (HIV-1 Group M, HIV1 group O, HIV-2, HCV and HBV) in one easy-to-use

assay

¾¾ Immediate virus discrimination in a single assay, no

need for virus discriminatory testing.



Cobas® TaqScreen DPX Test

¾¾ Simultaneous quantitative detection

¾¾ of parvovirus B19V DNA and qualitative detection of

HAV

¾¾ B19V target values are traceable to the WHO B19V

International standard.



Cobas TaqScreen WNV Test

¾¾ Qualitative in vitro test for the direct detection of West

Nile virus (WNV) RNA in human plasma



990



Concise Book of Medical Laboratory Technology: Methods and Interpretations



¾¾ Screening test for donations of whole blood and blood

components

¾¾ Capable of detecting other members of flavivirus that

have been implicated in fusion transmitted infectious

disease.



LIGHTCYCLER® SYSTEMS

Excellence in Real-time PCR

Whether your interest is in gene expression profiling

or in detecting genetic variations, there is a member

of the LightCycler system family offering the analytical

performance and throughput you need for your research.

Supported by a broad range of software tools, real-time

PCR based analysis can be performed in 32 capillaries

or plastic tubes, interchangeable 96-/384-well plates, or

using the unique 1536-well format or tube based formats.

For additional information see www.roche-appliedscience.com



YOUR BENEFIT



High Flexibility

¾¾ Suitable for all common assay formats and dyes.



High Sensitivity

¾¾ Even single copies can be detected.



High Operator Convenience



High Precision



¾¾ Data analysis according to your needs.



¾¾ Reproducible results independent of the sample

position.



Versatility

¾¾ Absolute or relative quantification, melting curve

analysis or genotyping—the software offers all options.



Available Reagents

¾¾

¾¾

¾¾

¾¾



Generic kits for PCR and RT-PCR

Parameter-specific kits research use only

Parameter-specific kits IVD

Ready to use custom assays and panels for all available

LightCycler systems (e.g. Universal ProbeLibrary and

RealTime ready).



World’s Latest and Best Technologies by Roche



991



PRODUCT CHARACTERISTICS

Throughput



LightCycler® 2.0 Instrument



LightCycler® 480 System (96/384)



LightCycler® 96 System



1– 32 reactions



1–96 or 1–384 reactions



1–96 reactions



Hardware



6 detection channels



5 excitation and 6 detection filters



Disposable



Capillaries



96 or 384 multiwell plates



System features



• Excellent temperature homogeneity in all

wells/vessels

• No need for passive reference dyes

• 40 cycles are possible in 40 minutes

• Freely programmable protocols, data import

and export, creation of macros and templates.



Assay formats



SYBR Green I, hydrolysis and hybridization SYBR Green I, hydrolysis and hybridization SYBR Green I, hydrolysis

probes

probes

probes



Reagents



• Generic kits for PCR and RT-PCR

• Ready-to-use custom assays

• Parameter-specific kits



96 multiwell plates or

tube strips



• Generic kits for PCR and RT-PCR Readyto-use custom assays and panels

• Parameter-specific kits

• Generic kits for PCR and RT-PCR

Ready-to-use custom assays and panels

Parameter-specific kits



LightCyclerđ 2.0 Instrument is available as IVD in many countries.

Information about the low throughput LightCycler® Nano System and the high-throughput LightCycler® 1536 System is available on request.



LIGHTCYCLER® 2.0 INSTRUMENT

High Performance that Meets the Needs of IVD

The LightCycler 2.0 System is an innovative real-time PCR

platform that uses a fluorescence detection system and

high-quality reagents for a wide range of applications in in

vitro diagnostics and in medical research.

It offers a multitude of innovative features, ranging from

optimized validated software to six different detection

channels.



YOUR BENEFIT

¾¾ Safety and ease of use in the IVD mode, including

test-specific reagent kits, and PCR macros that can

automate instrument programming, test analysis and

result reporting

¾¾ The research mode offers flexible programming,

editing and user evaluation - Versatility in application

options, e.g. qualitative and quantitative detection,

mutation detection by melting curve analysis and SNP

genotyping

¾¾ Broad choice of detection formats



PRODUCT CHARACTERISTICS

¾¾ Compact desktop model

¾¾ 35 cycles in about fast 40 minutes

¾¾ Reaction batch of 1–32 samples 20 μL100 μL capillaries



992



Concise Book of Medical Laboratory Technology: Methods and Interpretations



¾¾ 6 detection channels for 530, 560, 610, 640, 670, and

710 nm

¾¾ Versatile detection formats: SYBR Green, hybridization probes, hydrolysis probes, SimpleProbe probes,

Scorpion primers, and other FRET-based detection

formats

¾¾ Online display of the PCR kinetics.



TEST KITS, VALIDATED FOR IVD

¾¾

¾¾

¾¾

¾¾

¾¾

¾¾

¾¾

¾¾

¾¾



CMV quantification

EBV quantification

HSV 1/2 detection and differentiation

VZV detection

MRSA advanced detection

SeptiFast identification of bacteria and fungi

SeptiFast mec A resistance screening

Factor V mutation detection

Factor II mutation detection.



For Medical Research

¾¾

¾¾

¾¾

¾¾



HAV quantification

Parvo B19 quantification

VRE resistance screening

Translocation (9;22) quantification



LIGHTCYCLER® SEPTIFAST TEST

Rapid Identification of Sepsis Pathogens

Sepsis is a leading, infectious complication for critically

ill patients. It represents about 15% of all nosocomial



:Genotyping analysis



infections. Despite improvements in medical care, sepsis

is still a challenge for internal medicine. Any delay in

the management of infection is deleterious, especially in

patients whose illness is severe. Shortening this delay is of

paramount importance. In the LightCycler SeptiFast test,

Roche offers a molecular test that detects the presence of

microorganisms responsible for approximately 90% of all

sepsis cases seen on intensive care units.



YOUR BENEFIT

Broad Coverage of Sepsis Pathogens

¾¾ Approximately 90% of all potential sepsis pathogens

are detected in a single PCR.



Fast Results with Minimal Sample Volume

¾¾ Detection within 6 hours starting with just 1.5 mL of

whole blood.



Broad Application

:Data display for a qualitative detection analysis



¾¾ DNA detection also possible during antibiotic therapy

¾¾ Resistance screening possible with the LightCycler®

SeptiFast mecA test.



Tài liệu bạn tìm kiếm đã sẵn sàng tải về

Cobas® 4800 System V2.0 Keeping Pace With Changing Needs

Tải bản đầy đủ ngay(0 tr)

×