Roche Diagnostics are excited to announce the launch of a new clinical laboratory system designed to deliver new standards in laboratory testing efficiency and medically relevant diagnostic information with increased testing throughput.
The cobas 4800 System consists of the cobas x 480 instrument for state-of-the-art, fully automated sample preparation directly from primary sample tubes and the cobas z 480 analyser for real-time PCR based amplification and detection, supporting CE-marked in vitro diagnostic testing for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and human papillomavirus (HPV). The system is completed by the intuitive, easy-to-use software which integrates sample preparation, amplification and detection, and result management.
The cobas x 480 instrument is an automated multi-channel pipetting instrument used to extract, purify, and prepare target nucleic acid for subsequent PCR testing on the cobas z 480 analyser. After completion of sample preparation the cobas x 480 instrument automatically sets up the PCR in a microwell plate. The microwell plate with the PCR-ready samples is then manually unloaded, sealed, and transferred to the cobas z 480 analyser for amplification and detection using real-time PCR.
The cobas x 480 instrument features several built-in safety features to avoid cross-contamination between samples:
- CO-RE tip technology
- Total Aspirate and Dispense Monitoring system
- Anti-droplet Control
- Capacitance Liquid Level Detection
The cobas z 480 analyser is a rapid thermal block cycler with integrated real-time detection capabilities. Simultaneous detection on 4 detection channels allows analysis of signals from multiple dyes in multiplex real-time PCR assays. As a benefit of this, multiple results can be reported from a single run. The cobas z 480 analyser is the most advanced edition of the highly regarded LightCycler® analyser line. It was specifically developed for in vitro diagnostic (IVD) applications, offering faster amplification for higher throughput and superior fluorescence signal detection.
The cobas® 4800 CT/NG Test is a qualitative in vitro nucleic acid amplification test for the qualitative detection of CT and/or NG in patient. The cobas® 4800 CT/NG Test will detect CT only, NG only or simultaneously detect CT and NG DNA from endocervical swab and urine specimens collected from symptomatic or asymptomatic individuals using the cobas® PCR Female Swab Sample Kit or cobas® PCR Urine Sample Kit. Swab and urine samples collected with cobas® PCR Sample Kits can be processed together in the same run. The software allows the user to select only the test requested for each sample, therefore the operator only gets the results requested by the physician.
The cobas® 4800 HPV Test is a qualitative in vitro test for the detection of 14 high-risk (HR) HPV types in a single analysis in patient specimens. The test specifically identifies (types) HPV 16 and HPV 18 – the two genotypes that put women at highest risk for cervical cancer – while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) at clinically relevant infection levels. Specimens are limited to cervical cells collected in cobas® PCR Cell Collection Media, PreservCyt® Solution and SurePath® Preservative Fluid. The software allows the user to select only the test requested for each sample – HPV-HR only (which provides qualitative result) or HPV-HR + Genotype (GT) 16/18 (which provides HPV-HR result and separate qualitative result for Type 16 and Type 18) –, therefore the operator only gets the results requested by the physician.
With a throughput of up to 288 HPV tests or up to 384 CT and NG tests in 8 hours, the cobas 4800 System is designed to meet the needs of a majority of clinical laboratories. The first 94 CT/NG results can be obtained in less than 4 hours, while the first 94 HPV results can be obtained in less than 5 hours.
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COBAS, COBAS Z and COBAS Z are trademarks of Roche.
PreservCyt is a trademark of Hologic, Inc.
SurePath is a trademark of Becton, Dickinson and Company.