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The artus C. difficile QS-RGQ MDx Kit is an in vitro polymerase chain reaction (PCR) assay for use on the QIAsymphony RGQ MDx system for the qualitative detection of toxigenic Clostridium difficile toxin A and toxin B genes in human liquid or soft stool specimens from patients suspected of having Clostridium difficile associated disease. The test is intended to be used directly on patient samples. The artus C. difficile QS-RGQ MDx Kit is intended to be used to aid in diagnosis of Clostridium difficile infection.

The artus C. difficile QS-RGQ MDx Kit assay uses PCR to generate an amplified product from the tcdA and tedB/tedBv genes of toxigenic C. difficile DNA in clinical specimens. Samples are extracted and prepared using the Q1Asymphony SP instrument with the QIAsymphony DSP Virus/Pathogen Mini Kit, followed by assay setup on the OIAsymphony AS. Amplification and detection are carried out using the artus C. difficile OS-RGQ MDx Kit with the Rotor-Gene Q MDx (RGQ MDx) and Rotor-Gene AssayManager software. The presence of a toxigenic C. difficile target sequence is indicated by the fluorescent signal generated through the use of fluorescently labeled oligonucleotide probes. The probes do not generate a signal unless they are specifically bound to the amplified product. The amplification cycle at which fluorescent signal is detected by the RGQ MDx is inversely proportional to the toxigenic C. difficile DNA target concentration present in the original specimen. A bacterial species unrelated to toxigenic C. difficile is introduced into each specimen during sample preparation to serve as an internal control. The internal control bacteria are lysed simultaneously with toxigenic C. difficile in the specimen. and amplified in the same reaction as the C. difficile targets using PCR, and serve to demonstrate that the entire assay process has proceeded correctly for each specimen.

The Rotor-Gene Q MDx instrument with Rotor-Gene Q software version 2.1.0 or higher is a real-time nucleic acid amplification and detection system which measures nucleic acid signals from amplified DNA using fluorescent detection. The Rotor-Gene Q MDx instrument is intended for in vitro diagnostic use with FDA cleared or approved nucleic acid tests in clinical laboratories.

The Rotor-Gene® Q MDx is a real-time PCR analyzer designed for rapid thermal cycling and real-time detection of PCR assays. The Rotor-Gene Q MDx uses a centrifugal rotary design for thermal cycling where each tube spins in a chamber of moving air, keeping all samples at a uniform temperature. Detection is performed as each tube aligns with the detection optics, where the sample is illuminated and the fluorescent signal is rapidly collected from a single, short optical pathway.

The artus® Infl A/B RG RT-PCR Kit is a multiplex real time PCR in vitro diagnostic test for the qualitative detection and identification of Influenza A and Influenza B virus RNA in nasopharyngeal swab specimens using the Rotor-Gene® Q MDx instrument. The test is intended for use as an aid in the differential diagnosis of Influenza A and Influenza B viral infections in patients symptomatic for respiratory tract infection in conjunction with clinical and epidemiological risk factors. It is not intended to detect Influenza C virus. Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Performance characteristics for Influenza A were established during the 2009/2010 and 2010/2011 flu seasons when Influenza A (H3N2) and Influenza A/2009 (H1N1) were the predominant Influenza A viruses in circulation. When other Influenza A viruses emerge, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The artus Infl A/B RG RT-PCR Kit contains reagents and instructions for the detection and differentiation of Influenza A and Influenza B viral RNA in nasopharyngeal swabs of symptomatic patients. The assay utilizes the EZ1 Advanced XL instrument with the EZ1 Advanced XL DSP Virus Card v. 1.0. and the EZ1 DSP Virus Kit (QIAGEN) for viral nucleic acid extraction. The Rotor-Gene Q MDx instrument with the artus Influenza Assay Software Package (QIAGEN) is used for amplification and detection. Pathogen detection by the reverse transcription polymerase chain reaction (RT-PCR) is based on the reverse transcription of the RNA into complementary DNA (cDNA) and subsequent amplification of specific regions of the pathogen genome. In real-time PCR the amplified product is detected via fluorescent dyes. These are linked to oligonucleotides that bind specifically to the amplified product. Monitoring the fluorescence intensities during the PCR run (i.e., in real time) allows the detection of the accumulating product without having to re-open the reaction tubes after the PCR run. The Influenza A/B Master contains primers, probes, enzymes, and other reaction components (except Mg solution) needed for the specific amplification of a 141 bp region of the Influenza A virus genome and a 95 bp region of the influenza virus B genome, and for the direct detection of the specific amplicons in two fluorescence channels of the Rotor-Gene O MDx instrument. The primers are complementary to highly conserved regions of the Matrix gene locus within the influenza B virus genome. The probes are dual-labeled with a reporter dye attached to the 5'-end and a quencher dye attached to the 3'-end. Detection is performed on the Rotor-Gene O MDx instrument at wavelengths listed in Table 5.1. In addition, the Master contains a second heterologous primer/probe set to detect the Influenza A/B Internal Control (IC). The IC result identifies possible failure of RNA extraction or the presence of PCR inhibition. The Internal Control is detected in a third fluorescence channel. An Influenza A Control and an Influenza B Control comprised of in vitro transcripts representing the amplified regions of the Influenza A virus genome and the Influenza B virus genome, respectively, are provided. PCR grade water is provided as a negative (notemplate) control. The procedure consists of four consecutive steps: 1. Sample collection: Collect nasopharyngeal swab specimens from symptomatic patients using a polyester, nylon, or rayon swab and place it into virus transport medium. 2. Nucleic acid extraction: Add the Influenza IC to the carrier RNA before starting the extraction procedure. Extract viral RNA using the EZ1 DSP Virus Kit in combination with the EZ1 Advanced XL instrument. 3. Real-time RT-PCR: Add the extracted RNA and positive and negative control material to Influenza A/B Master mix. Perform real-time RT-PCR using the Rotor-Gene O MDx instrument. 4. Result interpretation: The Influenza Assay Package evaluates the results of the positive and negative controls to determine if the run is valid. If the run is valid, the internal control and target-specific results of each specimen are evaluated.