Download Verigene CDF Package Insert

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and prevention of a PCR ribotype 027 outbreak, and may aid in the identification of possible sources of a
hypervirulent outbreak.
Traditionally, cell cytotoxicity assays and enzyme immunoassays (EIA) have been used to detect CDI-causing C.
difficile. Cell cytotoxicity assays provide sensitive results, but are labor intensive and time consuming. EIAs, on
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the other hand, typically have low sensitivity. Comparatively, molecular testing has demonstrated high accuracy
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and expedient assay turnaround times allowing for higher rates of C. difficile detection in a clinically meaningful
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timeframe.
PRINCIPLES AND PROCEDURES OF CDF AND THE VERIGENE SYSTEM
CDF is performed using the Verigene System, which is a bench-top sample-to-result molecular diagnostics
workstation consisting of two modules: the Verigene Processor SP and the Verigene Reader. The Verigene
Processor SP automates CDF sample analysis steps including: (i) Specimen Preparation - magnetic bead-based
bacterial DNA extraction from prepared stool specimens obtained from patients; (ii) Target Amplification –
multiplex PCR-based amplification to generate specific amplicons; (iii) Hybridization – amplicon hybridization to
target specific capture DNA in a microarray format and mediator and gold-nanoparticle probe hybridization to
captured amplicons. Silver enhancement of the bound gold nanoparticle probes at the capture sites results in
gold-silver aggregates that are assessed optically with high efficiency by the Verigene Reader. The Verigene
Reader also serves as the user interface and central control unit for the Verigene System, storing and tracking
information throughout the assay process.
The Verigene Processor SP utilizes single-use consumables to perform CDF, including an Extraction Tray,
Amplification Tray, and Verigene Test Cartridge. A separate Tip Holder Assembly contains two pipette tips that
are used to transfer and mix reagents during the assay. The user tests a specimen by loading the single-use
disposables into the Verigene Processor SP, pipetting the prepared specimen into the Extraction Tray, and
initiating the protocol on the Verigene Reader by scanning or entering Test Cartridge ID and specimen
information. Following assay completion, the user inserts the Test Cartridge into the Verigene Reader for optical
analysis and generation of CDF test results.
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Verigene Clostridium difficile Nucleic Acid Test (CDF)
027-00035-01, Rev. A; December 2012