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The Xpert® C. difficile/Epi test is a qualitative in vitro diagnostic test for detection of toxin B gene sequences and for presumptive identification of 027/NAP1/BI strains of toxigenic Clostridioides difficile from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of 027/NAP1/BI strains of C. difficile is by detection of binary toxin (CDT) gene sequences and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the GeneXpert® Instrument Systems and utilizes automated real-time polymerase chain reaction (PCR) to detect toxin gene sequences associated with toxin producing C. difficile. The Xpert® C. difficile/Epi test is intended as an aid in the diagnosis of CDI. Detection of 027/NAP/Bl strains of C. difficile by the Xpert® C. difficile/Evi test is presumptive and is solely for enidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.

The Xpert C. difficile/Epi test is an automated in vitro diagnostic test for qualitative detection of toxin producing Clostridioides difficile (formerly known as Clostridium difficile) directly from unformed (liquid or soft) stool specimens of patients suspected of having Clostridioides difficile infection (CDI). The test detects the toxin B gene (tcdB), the binary toxin (CDT) gene, and the single base pair deletion at nucleotide 117 (tcdCΔ117) within the gene encoding TcdC, a negative regulator of toxin production. The combined presence of the genes encoding toxin B and binary toxin and the tcdCA117 deletion has been associated with a hypervirulent C. difficile strain known as 027/NAP1/BI, which has been associated with severe disease outbreaks in healthcare facilities worldwide. The test is performed on the GeneXpert® Instrument Systems (comprised of the GeneXpert® Dx System. GeneXpert® System with Touchscreen, and GeneXpert® Infinity System). In the GeneXpert® Instrument Systems, sample preparation, amplification, and real-time detection are all fully automated and completely integrated. The single-use disposable Xpert C. difficile/Evi cartridge, required by the platform for use, holds the PCR reagents and hosts the PCR process. Because the cartridge is self-contained, cross-contamination between samples is minimized. The Xpert C. difficile/Epi test includes reagents for the detection of toxigenic C. difficile and the detection of sequences for presumptive identification of 027/NAP 1/BI strains. In addition, the test reagents include an internal sample processing control (SPC) to ensure adequate processing of the target bacteria and to monitor the presence of inhibitor(s) in the PCR Assay. The SPC also ensures that the PCR conditions (temperature and time) are appropriate for the amplification reaction and that the PCR reagents are functional. The Probe Check Control (PCC) verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability. The Xpert C. difficile/Evi test system performs sample preparation and real-time, multiplex polymerase chain reaction (PCR) for detection of target-specific DNA. A swab is inserted into the stool specimen and then placed in a tube containing Sample Reagent. Following brief vortexing, the content of the Sample Reagent is transferred to the Sample Chamber of the disposable fluidic cartridge (the Xpert C. difficile/Epi cartridge). The user initiates a test from the system user interface of the GeneXpert® Instrument Systems and places the cartridge with sample into a GeneXpert® instrument system which performs hands-off real-time PCR for detection of C. difficile DNA. Depending on the specific instrument, a GeneXpert® instrument system may contain 1-80 modules, each of which are randomly accessible and capable of performing separate sample preparation and real-time PCR tests for the detection of gene sequences for C. difficile toxin B and binary toxin and the tcdCA117 deletion in less than 45 minutes. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE® thermocycler for performing real-time PCR and detection. Each instrument in the GeneXpert® instrument family is equipped with a Windows OS-based personal computer that is preloaded with software applications for running the tests and viewing the results, as described in Table 1.

The Great Basin Toxigenic C. difficile Direct Test, performed on the Great Basin PA500 Analyzer, is a qualitative in vitro diagnostic test for the detection of toxigenic Clostridioides difficile in unformed (liquid or soft) stool samples collected from patients suspected of having C. difficile infection (CDI). The automated assay utilizes polymerase chain reaction (PCR) to detect a conserved region of the toxin gene (tcdB) associated with toxin-producing C. difficile. The Toxigenic C. difficile Direct Test is intended for use as an aid in the diagnosis of CDI in conjunction with clinical and epidemiological risk factors.

The Great Basin Toxigenic C. difficile Direct Test (CDF2) performed on the PA500 Analyzer utilizes automated, hot-start PCR amplification technology to amplify specific nucleic acid sequences that are then detected using hybridization probes immobilized on a modified silicon chip surface, in a single-use, self-contained test cartridge. A swab volume of the specimen (raw stool) is first processed using the Sample Preparation Device (SPD). During processing through the SPD the specimen is infused with a synthetic bacterial sample processing control (SPC). An aliquot (250 µL) of the eluate obtained from the SPD, containing diluted specimen mixed with SPC, is loaded into the sample port of the CDF2 Test Cartridge. Genomic DNA is extracted from microbial cells and diluted to reduce potential inhibitors of PCR. During the PCR process, biotin-labeled primers direct the amplification of specific nucleic acid sequences within a conserved region of the C. difficile Toxin B (tcdB) gene. Following PCR, biotin-labeled, amplified target DNA sequences are hybridized to sequence specific probes immobilized on the silicon chip surface and incubated with antibody conjugated to the horseradish peroxidase enzyme (HRP). The unbound conjugate is washed away, and then tetramethylbenzidine (TMB) is added to produce a colored precipitate at the location of the probe/target sequence complex. The resulting signal is detected by the automated PA500 Optical Reader within the PA500 Analyzer System. The SPC undergoes the same extraction, and detection steps as the sample in order to monitor for inhibitory substances, as well as process inefficiency due to instrument or reagent failure. No operator intervention is required once the sample is loaded into the sample port and the Toxigenic C. difficile Direct Test cartridge is loaded into the PA500 Analyzer. The Great Basin System is a fully automated in vitro diagnostic system that includes: the PA500 Analyzer, single-use SPDs, single-use Toxigenic C. difficile Direct Test Cartridges, and the PA500 Data Analysis Software Program. The PA500 Analyzer is designed to perform automated sample preparation, target amplification via PCR, chip-based (optical) target detection, and integrated data analysis in less than two hours.

The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is an automated, qualitative in vitro diagnostic test, that uses real-time polymerase chain reaction (PCR), for the detection of the toxin B (tcdB) gene of toxigenic Clostridioides difficile (C.difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile Infection (CDI). The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is intended for use as an aid in the diagnosis of CDI in humans in conjunction with clinical and epidemiological risk factors.

The cobas® Cdiff Nucleic Acid Test for use on the cobas® Liat® System (cobas® Cdiff) is a rapid, automated in vitro diagnostic test for qualitative detection and differentiation of C. difficile DNA in human stool specimens. The cobas® Liat® is for in vitro diagnostic use. The system is designed to identify and/or measure presence of genetic material in a biological sample. The system automates all nucleic acid amplification test (NAAT) processes, including reagent preparation, target enrichment, inhibitor removal, nucleic acid extraction, amplification, real-time detection, and result interpretation in a rapid manner. The cobas® Cdiff test uses silica magnetic particle-based nucleic acid extraction and TaqMan probe-based real-time PCR amplification and detection. The cobas® Liat® Analyzer automates and integrates sample purification, nucleic acid amplification and detection of the target sequence in biological samples. Other than adding the sample to the cobas® Cdiff assay tube, no reagent preparation or additional steps are required. The cobas® Cdiff assay tube that holds all of the sample purification and PCR reagents and hosts the sample preparation and PCR process specific for the Cdiff analyte. The test uses the assay tube as both the sample and reaction vessel. The assay tube comprises flexible tubing containing all required unit dose reagents pre-packed in tube segments, separated by pressure-sensitive seals, in the order of reagent use. During the testing process, multiple sample processing actuators of the analyzer compress the cobas® Cdiff assay tube to selectively release reagents from tube segments, move the sample from one segment to another, and control reaction conditions such as reaction volume, temperature, pressure, and incubation time. Precise control of all these parameters provides optimal conditions for assay reactions, allowing the test to achieve high performance similar to or better than that of currently available molecular assays. The cobas® Liat® Analyzer software controls and coordinated these actions to perform all required assay processes, including sample preparation, nucleic acid extraction, target enrichment, inhibitor removal, nucleic acid elution, and real-time PCR. All assay steps are performed within the closed and self-contained cobas® Cdiff assay tube, thereby eliminating the potential for cross-contamination between samples. The collected data are automatically analyzed and the result is displayed in the assay report on the integrated LCD touch screen of the cobas® Liat® Analyzer.

The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is an automated, qualitative in vitro diagnostic test that uses real-time polymerase chain reaction (PCR) for the detection of the toxin B (tcdB) gene of toxigenic Clostridioides difficile (C.difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is intended for use as an aid in the diagnosis of CDI in humans in conjunction with clinical and epidemiological risk factors.

The cobas® Cdiff Nucleic Acid Test for use on the cobas® Liat® System (cobas® Cdiff) is a rapid, automated in vitro diagnostic test for qualitative detection and differentiation of C. difficile DNA in human stool specimens. The cobas® Liat® is for in vitro diagnostic use. The system is designed to identify and/or measure presence of genetic material in a biological sample. The system automates all nucleic acid amplification test (NAAT) processes, including reagent preparation, target enrichment, inhibitor removal, nucleic acid extraction, amplification, real-time detection, and result interpretation in a rapid manner. The cobas® Cdiff test uses silica magnetic particle-based nucleic acid extraction and TaqMan probe-based real-time PCR amplification and detection. The cobas® Liat® Analyzer automates and integrates sample purification, nucleic acid amplification and detection of the target sequence in biological samples. Other than adding the sample to the cobas® Cdiff assay tube, no reagent preparation or additional steps are required. The cobas® Cdiff assay tube that holds all of the sample purification and PCR reagents and hosts the sample preparation and PCR process specific for the Cdiff analyte. The test uses the assay tube as both the sample and reaction vessel. The assay tube comprises flexible tubing containing all required unit dose reagents pre-packed in tube segments, separated by pressure-sensitive seals, in the order of reagent use. During the testing process, multiple sample processing actuators of the analyzer compress the cobas® Cdiff assay tube to selectively release reagents from tube segments, move the sample from one segment to another, and control reaction conditions such as reaction volume, temperature, pressure, and incubation time. Precise control of all these parameters provides optimal conditions for assay reactions, allowing the test to achieve high performance similar to or better than that of currently available molecular assays. The cobas® Liat® Analyzer software controls and coordinates these actions to perform all required assay processes, including sample preparation, nucleic acid extraction, target enrichment, inhibitor removal, nucleic acid elution, and real-time PCR. All assay steps are performed within the closed and self-contained cobas® Cdiff assay tube, thereby eliminating the potential for cross-contamination between samples. The collected data are automatically analyzed and the result is displayed in the assay report on the integrated LCD touch screen of the cobas® Liat® Analyzer.

The GenePOC CDiff assay performed on the revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile( C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The GenePOC CDiff assay is intended to aid in the diagnosis of CDI.

The GenePOC™ CDiff assay is a single-use test for the qualitative detection of the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens. The GenePOC™ CDiff assay kit is comprised of the disposable CDiff microfluidic cartridges (PIE), Disposable Transfer Loops (DTL), Sample Buffer Tubes (SBT), and Disposable Transfer Tools (DTT; pipette). These components are used to suspend the sample, extract, amplify, and detect C. difficile nucleic acid. A Process Control (PrC) is also incorporated into each PIE to verify sample processing and amplification steps. The PrC allows for the verification of potential inhibitor substances as well as microfluidic, instrument or reagent failure. The GenePOC™ CDiff assay is designed to be used on the revogene™. The revogene™ is an instrument that automates sample homogenization, sample dilution, cells lysis, DNA amplification and detection of the amplified PCR products. Each GenePOC™ CDiff assay kit provides components for 24 tests. User intervention is required for sample preparation, transferring the stool specimen with the DTL into the SBT, using the DTT to transfer the sample into the PIE, and loading/unloading the PIE into the revogene™ carousel. Each PIE is a completely integrated closed device in which a sample is dispensed and processed through different microfluidic chambers and channels that allow for the sample processing and subsequent real-time PCR steps. Upon completion of a run, the results are computed by the revogene™ from measured fluorescent signals and embedded calculation algorithms. The output results include positive, negative, indeterminate, and unresolved. Upon completion of a run, the user removes the used cartridges and disposes of them in normal biological waste. Results may be viewed, printed, transferred, and/or stored by the user.

The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the detection of the toxin B (tcdB) gene of toxigenic Clostridium difficile in unformed (liquid or soft) stool specimens suspected of having C. difficile infection (CDI). The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is intended for use as an aid in the diagnosis of CDI in humans in conjunction with clinical and epidemiological risk factors.

The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (cobas® Cdiff ) is a rapid, automated in vitro diagnostic test for the qualitative detection of C. difficile DNA in human stool specimens. The cobas® Liat® System is for in vitro diagnostic use. The system is designed to identify and/or measure the presence of genetic material in a biological sample. The system automates all nucleic acid amplification test (NAAT) processes, including reagent preparation, target enrichment, inhibitor removal, nucleic acid extraction, amplification, real-time detection, and result interpretation in a rapid manner. The cobas® Cdiff test uses silica magnetic particle-based nucleic acid extraction and TaqMan probe-based real-time PCR amplification and detection. The cobas® Liat® Analyzer automates and integrates sample purification, nucleic acid amplification and detection of the target sequence in biological samples. Other than adding the sample to the cobas® Cdiff assay tube, no reagent preparation or additional steps are required. The cobas® Liat® System consists of an cobas® Liat® Analyzer with integrated software for running tests and analyzing the results, and a single-use disposable cobas® Cdiff assay tube that holds all of the sample purification and PCR reagents and hosts the sample preparation and PCR processes specific for the Cdiff analyte. The test uses the assay tube as both the sample and reaction vessel. The assay tube comprises flexible tubing containing all required unit dose reagents pre-packed in tube segments, separated by pressure-sensitive seals, in the order of reagent use. During the testing process, multiple sample processing actuators of the analyzer compress the cobas® Cdiff assay tube to selectively release reagents from tube segments, move the sample from one segment to another, and control reaction conditions such as reaction volume, temperature, pressure, and incubation time. Precise control of all these parameters provides optimal conditions for assay reactions, allowing the test to achieve high performance similar to or better than that of currently available molecular assays. The cobas® Liat® Analyzer software controls and coordinated these actions to perform all required assay processes, including sample preparation, nucleic acid extraction, target enrichment, inhibitor removal, nucleic acid elution, and real-time PCR. All assay steps are performed within the closed and self-contained cobas® Cdiff assay tube, thereby eliminating the potential for cross-contamination between samples. The collected data are automatically analyzed and the result is displayed in the assay report on the integrated LCD touch screen of the cobas® Liat® Analyzer.

The ARIES® C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of toxigenic Clostridium difficile (C. difficile) nucleic acid in unpreserved, unformed (liquid or soft) stool specimens obtained from patients suspected of having Clostridium difficile infection (CDI). The test targets the C. difficile toxin A gene (tcdA) and toxin B gene (tcdB) and is indicated for use as an aid in the diagnosis of C. difficile infection (CDI). The ARIES® C. difficile Assay is indicated for use with ARIES® Systems.

The ARIES® C. difficile Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system which consists of the ARIES® System or the ARIES® M1 System with their included ARIES® Software, a stool resuspension kit, an assay-specific cassette, and an assay-specific protocol file. The ARIES® C. difficile Assay cassette is a disposable, single-use cassette containing nucleic acid purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES® C. difficile Assay cassette directly detects toxigenic Clostridium difficile (C. difficile) from unformed stool specimens obtained from patients suspected of having Clostridium difficile infection. Specifically, the ARIES® C. difficile Assay cassette detects the C. difficile toxin A gene (tcdA) and toxin B gene (tcdB) and a DNA Sample Processing Control. Unpreserved raw stool is processed using the ARIES® Stool Resuspension Kit. The ARIES® Stool Resuspension Kit includes a flocked swab, a tube containing preprocessing beads, and Stool Resuspension Buffer. The preprocessing method involves transfer of a swab of stool specimen into a tube containing preprocessing beads and Stool Resuspension Buffer. The swab is mixed in the tube by vortexing and then centrifuged. Finally, the preprocessed sample is added to the ARIES® C. difficile Assay cassette. The specimen is lysed and nucleic acid is extracted using an ARIES® instrument. An extractable sample processing control (SPC) target is also present in the ARIES® C. difficile Assay cassette and is processed with the specimen. The SPC controls for recovery of extracted nucleic acid, for inhibitory substances and for PCR reagent and instrument integrity. The Ct value of the SPC is designed to verify nucleic acid extraction, to identify PCR inhibition, if any, and verify proper function of the extraction system and real-time instrument. The Tm value of the SPC is used as a reference for determining the Tm of the tcdA and tcdB targets (if present). The extracted nucleic acid and SPC are transferred via magnetic beads through the cassette to the ARIES® C. difficile Assay lyophilized PCR reagents in the PCR tube that contain primer pairs specific to tcdA, tcdB, and the SPC sequence. Each of the primer pairs is labeled with a distinct fluorophore and detected in distinct channels of an ARIES® System. PCR amplification is performed and assay fluorescence is monitored. Incorporation of a quencher-labeled nucleotide results in a decrease in fluorescence for the associated primer pair. Following amplification, the reaction is slowly heated to separate the fluorescent-labeled strand from the quencher-labeled strand, a process that results in an increase in the fluorescence signal. The reaction fluorescence is measured during this process and the temperature at which the change in fluorescence is the maximum Tm of the amplicon. The strands of the amplicons will separate at a specific melting temperature (Tm) and an increase in fluorescence is observed. The instrument fluorescence output is analyzed and test results are determined using the ARIES® System software and the ARIES® C. difficile Assay protocol and run files. ARIES® C. difficile Assay results may be reported from the ARIES Software or from the optional SYNCT® Software.

The Solana® C. difficile Assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specients of patients suspected of having Clostridium difficile-infection (CDI). The Solana C. difficile Assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase-dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with the Solana® instrument.

The Solana C. difficile Assay combines simple sample processing and Helicase-Dependent Amplification (HDA) performed in Solana for the detection of toxigenic Clostridium difficile directly from CDI-suspected diarrheal specimens. A small amount of specimen is transferred to a Lysis Tube using a swab. The Lysis Tube is then subjected to heat-treatment at 95°C for 5 minutes. The heat-treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of target sequence. In Solana, the target sequence is amplified by specific primers and detected by a specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC is amplified by the target-specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. Upon annealing to target or PRC amplicons, the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on-board method-specific algorithms. Solana then report the test results to the user on its display screen, and it can print out the results via a printer.

Simplexa C. difficile Direct: The Focus Diagnostics Simplexa™ C. difficile Direct assay is intended for use on the Integrated Cycler instrument for the detection of Clostridium difficile toxin B gene (tcdB) present in liquid or unformed stool samples from individuals suspected of C. difficile infection (CDI). This test aids in the diagnosis of illness resulting from CDI. The assay is for professional and prescription use only. Simplexa C. difficile Positive Control Pack: The Simplexa™ C. difficile Positive Control Pack is intended to be used as a control with the Simplexa™ C. difficile Direct kit. This control is not intended for use with other assays or systems.

The Simplexa™ C. difficile Direct assay system is a real-time PCR system that enables the direct amplification and detection of toxigenic C. difficile DNA from unprocessed liquid or unformed stool specimens that have not undergone nucleic acid extraction. The system consists of the Simplexa™ C. difficile Direct assay, the Integrated Cycler (with Integrated Cycler Studio Software), the Direct Amplification Disc and associated accessories. In the Simplexa™ C. difficile Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify C. difficile and DNA internal control targets. The assay targets a sequence which is in a well conserved region of C. difficile toxin B gene (todB). A DNA internal control is used to detect PCR failure and/or inhibition

The cobas® Cdiff Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes realtime polymerase chain reaction (PCR), for the direct detection of the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The cobas® Cdiff Test is intended for use as an aid in the diagnosis of CDI in humans in conjunction with clinical and epidemiological risk factors.

The Roche Molecular Systems (RMS) cobas® Cdiff Test utilizes real-time polymerase chain reaction (PCR) for the detection of Clostridium difficile (C. difficile) DNA from unformed (liquid or soft) stool specimens to aid in the diagnosis of Clostridium difficile infections in humans. The cobas Cdiff Test contains two major processes: (1) automated sample preparation to extract nucleic acids from the unformed stool specimens; (2) PCR amplification of target DNA sequences using C. difficile specific primers, and real-time detection of cleaved fluorescentlabeled C. difficile specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to automated sample preparation and is amplified and detected simultaneously with each sample to monitor the entire process. The cobas® Cdiff Test utilizes six reagent kits and is used with the cobas® 4800 System, which includes the cobas x 480 Instrument for sample preparation and the cobas z 480 Analyzer for amplification and detection, controlled by the cobas® 4800 System Software.