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The SensiTox C. difficile Toxin Test is an immunofluorescence assay intended for the qualitative detection of Clostridioides difficile toxins A and/or B in human stool specimens. The test is intended as an aid in the diagnosis of C. difficile infection (CDI) in patients exhibiting symptoms of CDI. Negative results do not preclude toxigenic C. difficile infection. The SensiTox C. difficile Toxin Test should not be used as the sole basis for treatment or other management decisions. The test can only be used with the MultiPath platform.

The SensiTox C. difficile Toxin Test detects toxins A and B in stool samples using an immunofluorescence assay and the proprietary MultiPath detection technology. The assay is performed on the proprietary MultiPath Analyzer. A stool sample is added to Stool Specimen Diluent, processed through a spin column, and the filtrate is added to the SensiTox C. difficile Cartridge. The Cartridge is loaded onto the MultiPath Analyzer for processing. The Analyzer reads barcodes, heats the cartridge, splits the sample into aliquots, mixes with antibody conjugated fluorescent and magnetic particles, and incubates. Magnetic particles and tethered fluorescent particles are drawn to the bottom imaging surface by magnets and imaged and quantified using non-magnified digital imaging. Results are interpreted by the MultiPath applications software.

The OSOM C. difficile Toxin A/B Test is an immunochromatographic assay intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C. difficile-associated disease (CDAD) in patients with symptoms of CDAD.

The OSOM C. difficile Toxin A/B Test is a rapid test which can detect the presence of Clostridium difficile toxins A and B in human stool samples. A test kit contains 25 OSOM test stick devices and 25 disposable pipettes. The OSOM C. difficile Toxin A/B Test is a qualitative assay that employs immunochromatographic, dipstick technology. The test format is a sandwich immunoassay, with a single test zone on the nitrocellulose dipstick to detect Toxin A and/or Toxin B ("blue/gray" line) and a single control line zone to indicate proper sample flow ("red" line). The test procedure involves binding of C. difficile Toxin A and/or Toxin B from a patient stool sample to blue colored latex particles conjugated to a monoclonal antibody against Toxin B or a polyclonal antibody against Toxin A. When Toxin A and/or B is present in the sample, it will form a partial immune complex with the antibody-conjugated colored particles. The OSOM C. difficile Toxin A/B Test stick, when placed in the sample mixture, initiates sample migration along the nitrocellulose membrane. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears.

The Cepheid Xpert® C. difficile Assay, performed on the Cepheid GeneXpert® Dx System, is a qualitative in vitro diagnostic test for rapid detection of toxin B gene sequences from unformed (liquid or soft) stool specimens collected from patients suspected of having Clostridium difficile infection (CDI). The test utilizes automated real-time polymerase chain reaction (PCR) to detect toxin gene sequences associated with toxin producing C. difficile. The Xpert C. difficile Assay is intended as an aid in the diagnosis of CDI. Concomitant culture is necessary only if further typing or organism recovery is required.

The Cepheid Xpert C. difficile Assay is a rapid, automated in vitro diagnostic test for qualitative detection of Clostridium difficile directly from unformed (liquid or soft) stool specimens of patients suspected of having Clostridium difficile infection (CDI). The assay detects the toxin B gene (tcdB), and is performed on the Cepheid GeneXpert Dx System. The Xpert C. difficile Assay system performs sample preparation and real-time, multiplex polymerase chain reaction (PCR) for detection of target-specific DNA. The GeneXpert Dx System consists of a GeneXpert® instrument, personal computer, and disposable fluidic cartridges. Each instrument contains 1-16 randomly accessible modules that are each capable of performing separate sample preparation and real-time PCR tests for detection of C. difficile toxin B gene sequences in less than 45 minutes. Each module contains a syringe drive for dispensing fluids, an ultrasonic horn for lysing cells or spores, and I-CORE® thermocycler for performing real-time PCR and detection. A swab is inserted into the stool specimen and then is placed in a tube containing elution reagent. Following brief vortexing, the eluted material and two single-use reagents (Reagent 1 and Reagent 2) that are provided with the Assay are transferred to different, uniquely-labeled chambers of the disposable fluidic cartridge (the Xpert C. difficile cartridge). The user initiates a test from the system user interface and places the cartridge into the GeneXpert® Dx System instrument platform, which performs hands-off realtime, multiplex polymerase chain reaction (PCR) for detection of DNA. In this platform, additional sample preparation, amplification, and real-time detection are all fullyautomated and completely integrated. The Xpert C. difficile Assay includes reagents for the detection of toxin B gene (tcdB). In addition, the assay 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 ProGastro™ Cd Assay is a Real Time PCR in vitro diagnostic test for the qualitative detection of toxigenic Clostridium difficile nucleic acids isolated and purified from liquid or soft stool specimens obtained from symptomatic patients. This test targets the Clostridium difficile toxin B gene (tcdB) and is intended for use to aid in the diagnosis of toxigenic Clostridium difficile infections.

The ProGastro Cd Assay detects toxigenic Clostridium difficile and an Internal Control by a process of nucleic acid extraction from patient specimens followed by PCR amplification and detection. Following collection of a soft or liquid stool sample from a symptomatic patient, a portion of the sample is diluted in Stool Transport and Recovery (S.T.A.R.) Buffer and the solids separated via centrifugation (Stool Clarification). The Internal Control is added to the sample prior to extraction to monitor for PCR inhibitors that may be present. The nucleic acids from the sample are extracted and purified using the bioMérieux NucliSENS easyMAG automated extractor. Nucleic acids are added to the C. diff Mix for subsequent PCR amplification and detection using the Cepheid SmartCycler II. The C. diff Mix contains oligonucleotide primers and probes that target the tcdB gene of toxigenic strains of C. diff. The probes are dual-labeled with a reporter dye attached to the 5'-end and a quencher dye attached to the 3'-end (see table below). During PCR amplification the primers and probes anneal to the template (if present) followed by primer extension and template amplification. The 5'-3' exonuclease activity of the Taq polymerase cleaves the probe thus separating the reporter dye from the quencher and generating an increase in fluorescent signal. The amount of fluorescence at any given cycle is dependent on the amount of amplification product present. The SmartCycler II instrument and software monitors the process, interprets the data, and presents a report upon completion.

The C. DIFF QUIK CHEK COMPLETE™ test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.

The C. DIFF QUIK CHEK COMPLETE™ test uses antibodies specific for qlutamate dehydrogenase (GDH) and Toxins A and B of C. difficile. The device contains a Reaction Window with two solid lines and a dotted line of immobilized antibodies. The Antigen line ("Ag") contains antibodies against C. difficile GDH. The Toxin line ("Tox") contains antibodies against C. difficile toxins A and B. The dotted line, representing a control line ("C"), contains anti-HRP antibodies. The Conjugate consists of antibodies to GDH, toxin A, and toxin B coupled to horseradish peroxidase. To perform the test, the fecal specimen is diluted with Diluent, and Conjugate is added to the diluted sample. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, any GDH, toxin A or toxin B in the sample binds to the corresponding antibody-peroxidase conjugate. The antigen-antibody complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-GDH, anti-toxin A or Anti-toxin B antibody in the line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10-minute incubation, the "Ag" and "Tox" reaction is examined visually for the appearance of a blue line. A blue line indicates a positive test. A positive "C" reaction, indicated by a blue dotted line, confirms that sample and all reagents were added in proper sequence and volume, that reagents were active at the time of performing the assay, and that proper sample migration occurred.

The BD GeneOhm™ Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (todB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.

The BD GeneOhm™ Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (todB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. A liquid or soft stool specimen is collected and transported to the laboratory. A sterile dry swab is dipped into the liquid or soft stool material and processed. For testing, the swab is eluted in sample buffer and the specimen is lysed. An aliquot of the lysate is added to PCR readents which contain the tcdB specific primers used to amplify the genetic target of Clostridium difficile, if present. The assay also includes an internal control (IC) to detect PCR inhibited specimens and to confirm the integrity of assay reagents. Amplified targets are detected with hybridization probes labelled with quenched fluorophores (molecular beacons). The amplification, detection and interpretation of the signals are done automatically by the Cepheid SmartCycler® software. The entire procedure takes about 75 to 90 minutes, depending on the number of specimens processed.

VIDAS® C. difficile Toxin A & B (CDAB) assay is an automated test for use on the VIDAS instruments for the qualitative detection of Clostridium difficile toxin A and toxin B in stool specimens using the ELFA technique (Enzyme-Linked Flurorescent Assay). The VIDAS C. difficile toxin A & toxin B (CDAB) assay is an aid for diagnosing Clostridium difficile associated disease (CDAD).

VIDAS® C. difficile Toxin A & B (CDAB) assay is an automated test for use on the VIDAS instruments for the qualitative detection of Clostridium difficile toxin A and toxin B in stool specimens using the ELFA technique (Enzyme-Linked Fluorescent Assay). The assay principle combines a two-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. The assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs). Each of the four reaction steps are performed automatically by the VIDAS instrument. The reaction medium (sample/conjugate mixture) is cycled in and out of the SPR several times. Each step is followed by a wash cycle which eliminates unbound components. At the end of the VIDAS CDAB assay, results are automatically calculated by the VIDAS instrument. A test value as well as the qualitative result (positive, negative or equivocal) are provided on the result sheet for each sample.

VIDAS® C. difficile Toxin A & B (CDAB) assay is an automated test for use on the VIDAS instruments for the qualitative detection of Clostridium difficile toxin A and toxin B in stool specimens using the ELFA technique (Enzyme-Linked Flurorescent Assay).

VIDAS® C. difficile Toxin A & B (CDAB) assay is an automated test for use on the VIDAS instruments for the qualitative detection of Clostridium difficile toxin A and toxin B in stool specimens using the ELFA technique (Enzyme-Linked Fluorescent Assay). The assay principle combines a two-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. The assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs). Each of the four reaction steps are performed automatically by the VIDAS instrument. The reaction medium (sample/conjugate mixture) is cycled in and out of the SPR several times. Each step is followed by a wash cycle which eliminates unbound components. At the end of the VIDAS CDAB assay, results are automatically calculated by the VIDAS instrument. A test value as well as the qualitative result (positive, negative or equivocal) are provided on the result sheet for each sample.

The TOX A/B QUIK CHEK™ test is a rapid immunoassay for detecting Clostridium difficile toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.

The TOX A/B QUIK CHEK™ test uses antibodies specific for toxins A and B of C. difficile. The device contains a Reaction Window with two lines of immobilized antibodies. The test line ("T") contains antibodies against C. difficile toxins A and B. The other, representing a control line ("C"), contains anti-IgG antibodies. The Conjugate consists of antibodies to toxins A and B coupled to horseradish peroxidase. To perform the test, the fecal specimen is diluted with Diluent, and Conjugate is added to the diluted sample. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, any toxin A and toxin B in the sample bind to anti-toxin antibody-peroxidase conjugate. The toxin-antibody complexes migrate through a filter pad to a membrage where they are captured by the immobilized anti-toxin antibodies in the line. The Reaction Well is subsequently washed with Wash Buffer, followed by the addition of Substrate. After up to a 10 minute incubation, the "T" reaction is examined visually for the appearance of a blue line. A blue line indicates a positive test. A positive "C" reaction, indicated by a blue line, onfirms that sample and all reagents were added in proper sequence and volume, that reagents were active at the time of performing the assay, and that proper sample migration occurred.

REMEL's Xpect™ Clostridium difficile Toxin A/B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test is intended for use as an aid in diagnosis of CDAD. The test can also be used for confirmation of toxigenic Clostridium difficile from Brain Heart Infusion (BHI) broth culture.

The Xpect™ Clostridium difficile Toxin A/B test is a qualitative immunochromatographic assay that detects C. difficile Toxin A and Toxin B in stool specimens or cultures of toxigenic C. difficile. In performing the test, a specimen is first diluted with Specimen Diluent to help solubilize the toxins. A portion of the diluted sample is then mixed with a volume of Conjugate 1 containing antibodies to Toxin A and Toxin B coupled to colored microparticles, plus a volume of Conjugate 2 containing biotinylated antibodies to Toxin A and Toxin B. A volume of this mixture is transferred to a test device having immobilized streptavidin as a test line and goat antiimmunoqlobulin antibody a as a control line. Immunocomplexes of toxin and conjugated antibodies form a visible band as they flow across the test line. Excess colored particle conjugates form a visible band at the control line to document that the test is functioning properly.