Choose only what you really need

Transcription

1 The LightMix Modular Assays Choose only what you really need PICK CREATE RUN

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3 The LightMix Modular Assays ONE simple concept, THREE big benefits Easy to Use Select from a huge range of ready-to-use individual assays for pathogen detection Modular Design Create a custom panel specific for your needs and expand your menu by including rare targets Simultaneous Detection Increase throughput and improve workflow efficiency by multiplexing up to 5 targets plus 1 control in a single well The LightMix Modular Assays Choose only what you really need! The LightMix Modular Assays are the building blocks to create a panel for your specific needs. Detect up to 5 targets plus a control in one well on Roche qpcr instruments to maximize your multiplexing capacity and increase throughput. Step 1 Pick your targets of interest Choose from more than 30 assays Step 2 Create your multiplex panel Detect up to 5 targets plus a control in a single well Step 3 Run your experiment Rely on a seamless workflow Standardized qpcr protocols Can be combined with in-house assays Recommended for use with Roche instruments and reagents

4 Instrument Compatibility Wavelength LightCycler nm 530 nm 580 nm 610 nm 640 nm 660 nm LightCycler 96 cobas z 480 Gastro Panel 500 nm 530 nm 580 nm 610 nm 640 nm 660 nm Gastro Parasites Giardia (CE-IVD) 96 rxn Dientamoeba (CE-IVD) 96 rxn Cryptosporidium (CE-IVD) 96 rxn Blastocystis (CE-IVD) 96 rxn Entamoeba histolytica (CE-IVD) 96 rxn Gastro Bacteria Aeromonas (CE-IVD) 96 rxn Yersinia (CE-IVD) 96 rxn Campylobacter (CE-IVD) 96 rxn Shigella (CE-IVD) 96 rxn Salmonella (CE-IVD) 96 rxn Plesiomonas 96 rxn Gastro Viruses Norovirus GG1 (500) (CE-IVD) 96 rxn Norovirus GG1 (530) (CE-IVD) 96 rxn Norovirus GG2 (CE-IVD) 96 rxn Adenovirus F (40/41) 96 rxn Rotavirus A 96 rxn Enterovirus 96 rxn Astrovirus 96 rxn Sapovirus (GGI to GGV) 96 rxn EHEC Panel 500 nm 530 nm 580 nm 610 nm 640 nm 660 nm EAE-EHEC 96 rxn STX1-EHEC 96 rxn STX2-EHEC 96 rxn STI Panel 500 nm 530 nm 580 nm 610 nm 640 nm 660 nm Coming soon Mycoplasma genitalium 96 rxn Coming soon Mycoplasma hominis 96 rxn Coming soon Ureaplasma parvum 96 rxn Coming soon Ureaplasma urealyticum 96 rxn Coming soon Trichomonas vaginalis 96 rxn Newborn Panel 500 nm 530 nm 580 nm 610 nm 640 nm 660 nm TREC 1 96 rxn KREC 2 96 rxn 1 T-cell-receptor excision circle. 2 kappa-deleting recombination excision circles.

5 Instrument Compatibility Wavelength LightCycler nm 530 nm 580 nm 610 nm 640 nm 660 nm LightCycler 96 cobas z 480 Respiratory Panel 500 nm 530 nm 580 nm 610 nm 640 nm 660 nm Respiratory Panel Virus Influenza A (CE-IVD) 96 rxn Influenza B (CE-IVD) 96 rxn Influenza A H1 (H1N1 sw) (CE-IVD) 96 rxn Influenza A H7 (H7N9) 96 rxn Parainfluenza1 HNgene 96 rxs Parainfluenza 2 L gene 96 rxs Parainfluenza 3 M gene 96 rxs Parainfluenza 4 NP gene 96 rxs Parainfluenza (PIV 1-4) L gene 96 rxs Respiratory Syncytial Virus 96 rxs Coronavirus HKU1 96 rxs Coronavirus OC43 96 rxs Coronavirus 229E 96 rxs Coronavirus NL63 96 rxs pancoronavirus 96 rxs MERS - CoV upe 96 rxn MERS - CoV Orf1a 96 rxn Metapneumovirus 96 rxs Enterovirus 96 rxs Bocavirus 96 rxs Parechovirus 96 rxs Adenovirus 96 rxs Rhinovirus 96 rxs Respiratory Panel Bacteria Bordetella pertussis 96 rxs Bordetella parapertussis 96 rxs Respiratory Panel Atypical Pneumonia Pneumocystis jirovecii 96 rxs Chlamydia pneumoniae 96 rxs Mycoplasma pneumoniae 96 rxs Legionella spp/pn 96 rxs Legionella pneumophila 96 rxs Chlamydophila psittaci 96 rxs Non-Culturable Assays 500 nm 530 nm 580 nm 610 nm 640 nm 660 nm Tropheryma whipplei 96 rxn

6 Instrument Compatibility Wavelength LightCycler nm 530 nm 580 nm 610 nm 640 nm 660 nm LightCycler 96 cobas z 480 Carbapenemase Panel 500 nm 530 nm 580 nm 610 nm 640 nm 660 nm KPC 96 rxn NDM1 96 rxn OXA rxn IMP (640) 96 rxn VIM (500) 96 rxn Bacterial Meningitis Panel 500 nm 530 nm 580 nm 610 nm 640 nm 660 nm Escherichia coli uida 96 rxn Listeria monocytogenes 96 rxn Streptoc pneumoniae 96 rxn Neisseria meningitidis 96 rxn Streptococ agalactiae 96 rxn Haemophilus Influenzae 96 rxn Hemorrhagic Fever 500 nm 530 nm 580 nm 610 nm 640 nm 660 nm Ebola Virus Zaire 96 rxs Tropical Panel 500 nm 530 nm 580 nm 610 nm 640 nm 660 nm Zika Virus (CE-IVD) 96 rxn Zika Virus (CE-IVD) 96 rxn Dengue Virus 96 rxn Chikungunya Virus 96 rxn Controls 500 nm 530 nm 580 nm 610 nm 640 nm 660 nm RNA Process Control Kit 600 rxs RNA Process Control Kit Trial Pack 200 rxs RNA Process Control Detection Kit 400 rxs DNA Process Control Kit 600 rxs DNA Process Control Kit Trial Pack 200 rxs DNA Process Control Detection Kit 400 rxs Reagents & Color Compensation LightCycler Multiplex RNA Virus Master 200 rxs LightCycler Multiplex RNA Virus Master 2000 rxs LightCycler Multiplex DNA Master 200 rxs LightCycler Multiplex DNA Master 1000 rxs LightCycler 480 Probes Master 5 x 1 ml LightCycler 480 Probes Master 10 x 5 ml LightCycler 480 Probes Master 1 x 50 ml Color Compensation Hexaplex 480 II 1 Kit

7 Microbiology IVD Testing on the cobas 4800 system cobas MRSA/SA Test Methicillin Resistant Staphylococcus aureus and Staphlococcus aureus Sample type Sample processing Sample versatility Contamination control PCR target region Internal control Analytical sensitivity Analytical specificity SCCmec coverage Nasal swab specimen Primary vial loading with MSwab TM System directly on the cobas 4800 system Molecular or culture capability AmpErase Staph aureus: Capsular Polysaccharide Enzyme (CPE) MRSA: Right Extremity (RE) Junction Yes 99% diverse global panel (n=292) 100% no cross reactivity observed of 118 closely related or normal flora organisms I, II, III, IV, IVa, V, VI, VIII Clinical sensitivity* MRSA: 93%; SA: 95% Clinical specificity* MRSA: 98%; SA: 95% Inhibition rate <0.1% * Compared to direct and enrichment culture. cobas Cdiff Test Clostridium difficile Sample type Unformed stool specimen Sample processing Simple handling, automated processing on the cobas 4800 system Contamination control AmpErase Target region C. difficile Toxin B (tcdb) Internal control Yes Analytical sensitivity 100% (31 toxinotypes and 20 ribotypes detected) Analytical specificity 100% (no cross reactivity across 98 bacteria, virus, fungi) Clinical sensitivity** 96.7% Clinical specificity** 97.3% Limit of detection (LOD) 225 CFU/mL ** Compared with direct culture cytotoxicity test. cobas HSV 1 and 2 Test Herpes Simplex Virus 1 and 2 Sample type Sample processing Sample versatility Contamination control Anogenital lesion swab specimens Primary vial loading with MSwab TM System directly on the cobas 4800 system Molecular or culture capability AmpErase Target region Dual-target detection for each of the HSV-1 and HSV-2 genomes optimizes sensitivity and specificity: HSV 1 - Thymidine Kinase, DNA polymerase HSV 2 - Glycoprotein B, Thymidine Kinase Limit of detection (LOD) HSV 1 TCID 50 Units/mL; HSV 2 TCID 50 Units/mL Analytical specificity No cross reactivity (evaluated 6 herpes family viruses and 31 organisms associated with anogenital specimens) Clinical sensitivity*** HSV 1: 100%; HSV 2: 100% Clinical specificity*** HSV 1: 99.7%; HSV 2: 97.8% *** Direct comparison of anogenital swab specimens to BD ProbeTec HSV-1/2 Test includes discrepant resolution with sequencing (n=370 for HSV 1 and n=369 for HSV 2). Mixed batch capability: Run MRSA/SA, Cdiff, and HSV 1 and 2 samples at the same time, on the same system.

8 LightMix Modular Kits are developed and manufactured by TIB MOLBIOL GmbH, Berlin, Germany For Life Science Research Use Only. Not for use in diagnostics procedures. Not available in the US. In-vitro diagnostics reagent. For in vitro use only. Published by Roche Diagnostics (Switzerland) Ltd Industriestrasse 7 CH-6343 Rotkreuz 2016 Roche Diagnostics. All rights reserved. LIGHTCYCLER, TAQMAN and COBAS are trademarks of Roche. Other brands or product names are trademarks of their respective holders.