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6th August 2012  Content supplied by: Quidel

CE Mark for Quidel Direct Specimen Rapid PCR Test for Toxigenic C. difficile

Quidel Corporation has received CE mark for the Quidel Molecular(TM) Direct C. difficile Tox A/B assay for the detection of toxigenic Clostridium difficile bacterial DNA.'A recent study by the CDC1 suggested that nucleic acid amplification tests can be as much as twice as sensitive as enzyme immunoassays,' said Dr. Timothy Stenzel, M.D., Ph.D., chief scientific officer of Quidel. 'Preventing transmission of C. difficile by early and accurate detection in order to isolate and properly treat patients with Clostridium difficile infection is essential to reducing the overall disease burden.'

This Quidel Molecular Direct C. difficile Tox A/B assay is part of Quidel's expanding line of molecular diagnostics products. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing thermocyclers. These reagents provide attractive features that include refrigerated storage (no freezer required), convenient ready-to-use reagents, a short time to result, and other benefits that favorably affect diagnostic test outcome.

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 as an added benefit. This fast and easy direct-to-amplification procedure allows the assay to generate a result in less than 60 minutes by an efficient and economical method.

Reference: 1. Vital Signs: Preventing Clostridium difficile Infections Weekly March 9, 2012 / 61(09);157-162 Morbidity and Mortality Weekly Report (MMWR)


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Date Published: 6th August 2012

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