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Dx Focus: Roche Cobas p 630; Abbott Plex-ID System; Trio of New C. Diff Tests; MDI's MRSA Panel

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Roche last week said that it has received US Food and Drug Administration approval of a new pre-analytical instrument that integrates primary tube handling into its Cobas molecular testing platform.

The instrument, called the Cobas p 630, unites primary tube handling with fully automated sample preparation, nucleic acid amplification, and detection on the Cobas AmpliPrep or Cobas TaqMan analyzers, Roche said

The Cobas p 630 comes with AmpliLink 3.3 series software, and is designed to "protect the integrity of the primary patient tube" by combining automated primary tube handling with full sample traceability, process surveillance, and bi-directional connectivity, the company said.

The instrument also features other automation features to ensure full sample traceability while reducing hands-on labor time, Roche said.

Meantime, the AmpliLink 3.3 series software, which runs on the Windows operating system, offers a graphical user interface that manages the operation of connected Cobas instruments and analyzers. One AmpliLink data station will connect one Cobas p 630 to up to three Cobas AmpliPreps and three analyzers (a combination of Cobas TaqMan and Cobas TaqMan 48 analyzers), helping to maximize throughput capabilities and optimize laboratory efficiencies, Roche said.

"The complete system provides molecular laboratories with a flexible and integrated solution for automated pre-analytics and real-time PCR diagnostic testing," Paul Brown, head of Roche Molecular Diagnostics, said in a statement.

The Cobas p 630 received CE marking in October 2009 and is used in Europe, Africa, Asia, and South America, the company said.


Abbott last week said that it has obtained CE marking in the EU to market its Plex-ID instrument along with three assays: Plex-ID Viral IC Spectrum, Plex-ID BAC Spectrum BC, and Plex-ID Flu.

The Plex-ID system combines automated sample preparation, PCR amplification, electrospray ionization mass spectrometry, and information management to rapidly characterize known and unknown organisms. It provides results in less than eight hours, and can characterize a wide range of microorganisms directly from clinical specimens, the company said.

Plex-ID Viral IC Spectrum is designed to detect and identify 11 viral families with more than 250 species of important systemic viral pathogens — including herpes simplex virus, cytomegalovirus, Epstein-Barr virus, human adenovirus, human enterovirus, BK and JC polyomaviruses, and parvovirus B19 — directly from plasma specimens. These viruses represent a significant threat to vulnerable patients with weakened immune systems, and such systemic viral infections occur in one out of every six transplant patients, Abbott said.

Plex-ID BAC Spectrum BC can detect and identify nearly 400 species of bacteria, and also can detect the presence of genetic markers that determine bacterial resistance to certain antibiotics. In addition, the test can identify and classify species of Candida. The assay performs this analysis on blood culture positive specimens. Abbott said that it plans to introduce a modified version of the assay in Europe later this year designed to analyze the blood sample immediately after it reaches the lab rather than having to first wait for the organism to grow in culture.

Plex-ID Flu is intended to detect and identify known influenza A viruses, newly emerging influenza A strains, and influenza B.


BD Diagnostics, a division of Becton Dickinson, said last week that it has obtained CE marking for its BD Max Cdiff Assay, which is designed to rapidly and accurately identify patients with Clostridium difficile infection, including those caused by hypervirulent strains.

The assay detects the toxin B gene, which has been shown to be present in all toxigenic C. difficile and which is essential for disease.

The assay runs on the fully automated BD Max system, and is the third assay for the system to receive CE marking, BD said.


Quidel said this week that it has received the CE mark for its Quidel Molecular Direct C. difficile Tox A/B assay to detect toxigenic Clostridium difficile bacterial DNA.

The Quidel Molecular product line includes PCR reagent kits for use by molecular diagnostic laboratories with their existing thermocyclers. These reagents feature refrigerated storage (no freezer required), ready-to-use reagents, a short time to result, and other benefits that favorably affect diagnostic test outcome, Quidel said.

The Quidel Molecular Direct C. difficile Tox A/B assay kit includes an extraction-free, three-step sample preparation process that requires no heat step, no timed step, and no centrifugation. This direct-to-amplification procedure allows the assay to generate a result in less than 60 minutes.

Quidel sells other CE-marked real-time PCR-based molecular tests for influenza A+B, human metapneumovirus (hMPV), and respiratory syncytial virus + hMPV. The C. difficile assay is Quidel's fifth molecular product offering in the last seven months to receive authorization to market in Europe.


Australian molecular diagnostics firm Genetic Signatures has obtained CE marking for its EasyScreen C. difficile detection kit.

The real-time multiplex PCR assay can be used directly from patient stool samples and yields a result in approximately three hours, Genetic Signatures said. The kits detect the more dangerous hypervirulent forms of C. difficile such as ribotype 027 and 078.

The assays are compatible with routine hospital purification systems such as those from Qiagen, Roche, and Thermo Fisher; and have been validated on a wide range of thermocyclers including the Bio-Rad CFX96, Agilent Mx3000, Qiagen Rotor-Gene, Roche LightCycler 480, Cepheid SmartCycler, and the ABI 7500 Fast.

The CE IVD approval paves the way for CE IVD marking of the company's EasyScreen C. difficile Reflex Kit, expected in coming weeks, Genetic Signatures said.


Molecular Detection launched a new version of its Detect-Ready MRSA Panel at the annual European Congress of Clinical Microbiology and Infectious Diseases, held in London last week.

The existing Detect-Ready MRSA Panel is a CE-marked qualitative real-time PCR in vitro diagnostic test to detect methicillin-resistant Staphylococcus aureus and methicillin-sensitive S. aureus from patient nasal swabs, and is the only marketed PCR-based MRSA screening test that can distinguish between these pathogens and other related bacteria, MDI said.

The new version of the panel increases the number of MRSA strains it can detect, adding strains known to be missed "by at least one other market-leading assay," the company said without elaborating. The new kit also shortens sample preparation time and minimizes required hands-on time, MDI said.

Detect-Ready kits are compatible with a number of real-time PCR platforms currently found in hospitals. The kits' ready-to-use pre-mixed reagents require only the addition of patient sample to run the test, and provide results in less than three hours. The kits are off-the-shelf room temperature-stabilized and require no refrigeration, the company said.

The Detect-Ready MRSA Panel is currently available in the UK, Germany, Ireland, Switzerland, Spain, Austria, the Netherlands, Belgium, Luxembourg, Australia, and Israel; and is in late-stage development in the US.

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