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The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simultaneous detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with cultures derived from human stool specimens to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC) infections. Test results are to be used in conjunction with the patient's clinical symptoms and history.

The Curian® Shiga Toxin assay is a qualitative in vitro diagnostic test for the detection of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in cultures derived from human stool specimens. The Curian® Shiga Toxin assay utilizes fluorescence technology with the cleared Curian® Analyzer (K192817) to detect Stx1 and Stx2 in cultures derived from human stool.

The SHIGA TOXIN QUIK CHEK test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with human fecal samples from patients with gastrointestinal symptoms to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC). It may be used with fecal specimens, or broth or plate cultures derived from fecal specimens. The test results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.

The SHIGA TOXIN QUIK CHEK test utilizes specific antibodies against Stx1 and Stx2. The Membrane Device contains a Reaction Window with three vertical lines of immobilized antibodies. The "1" test line contains monoclonal antibodies against Stx1. The control line ("C") is a dotted line that contains anti-horseradish peroxidase (HRP) antibodies. The "2" test line contains monoclonal antibodies against Stx2. The Conjugate consists of antibodies to Stx1 and Stx2 coupled to horseradish peroxidase. To perform the test, the sample is added to a tube containing a mixture of Diluent and Conjugate. The diluted sample-coniugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, any Stx1 and/or Stx2 present in the sample binds to the antibodyperoxidase conjugates. The toxin-antibody-peroxidase complexes migrate through a filter pad to a membrane where they are captured by the immobilized Stx1 and Stx2 specific monoclonal antibodies in the test lines. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10 minute incubation period, the Reaction Window is examined visually for the appearance of vertical blue lines on the "1" and "2" sides of the Reaction Window. A blue line on the "1" side of the Reaction Window is a positive result indicating the presence of Stx1. A blue line on the "2" side of the Reaction Window is a positive result indicating the presence of Stx2. A positive "C" reaction, indicated by a vertical dotted blue line under the "C" portion of the Reaction Window, confirms that the test is working properly, the procedure was followed, and the results are valid.

The SHIGA TOXIN CHEK test is an enzyme immunoassay for the simultaneous qualitative detection of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test. It is intended for use with human fecal samples from patients with gastrointestinal symptoms to aid in the diagnosis of disease caused by Shiga Toxin producing Escherichia coli (STEC). It may be used directly with human fecal specimens, or broth or plate cultures derived from fecal specimens. The test results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.

The SHIGA TOXIN CHEK test uses antibodies to Stx1 and Stx2. The microassay wells supplied with the kit contain immobilized monoclonal antibodies against Stx1 and Stx2. The detecting antibody consists of a mixture of anti-Stx1 and anti-Stx2 polyclonal antibodies conjugated to horseradish peroxidase. In the assay, an aliquot of a fecal specimen or culture is emulsified in the Diluent and the diluted specimen is then transferred to the microassay well containing the detecting antibody. If Stx1 and/or Stx2 are present in the specimen, they will bind to the detecting antibody and to the immobilized monoclonal antibodies during the incubation phase. Any unbound material is removed during the washing steps. Following the addition of substrate, a color is detected due to the enzyme-antibody-antigen complexes that form in the presence of toxin.

ImmunoCard STAT! EHEC is an immunochromatographic rapid test for the qualitative detection of Shiga toxins 1 and 2 (also called Verotoxins) produced by E. coli in cultures derived from clinical stool specimens. ImmunoCard STAT! EHEC is used in conjunction with the patient's clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterohemorrhagic E. coli (EHEC) infections.

ImmunoCard STAT! EHEC is an immunochromatographic rapid test utilizing monoclonal antibodies labeled with red-colored gold particles. The test device has a circular sample port and an oval-shaped test (Toxin 1, Toxin 2) and control (Control) window. The sample is applied to the chromatography paper via the circular sample port. The sample is absorbed through the pad to the reaction zone containing colloidal, gold-labeled antibodies specific to Shiga toxins. Any Shiga toxin (ST1 and ST2) antigen present complexes with the gold-labeled antibody and migrates through the pad until it encounters the binding zones in the test (Toxin 1, Toxin 2) area. The binding zones (Toxin 1 and Toxin 2) contain another anti-ST1 or -ST2 antibody, which immobilizes any Shiga toxin-antibody complex present. Due to the gold labeling, a distinct red line is then formed. The remainder of the sample continues to migrate to another binding reagent zone within the control zone, and also forms a further distinct red line (positive control). Regardless of whether any Shiga toxin is present or not, a distinct red line should always be formed in the control zone and confirms that the test is working correctly.

The BioStar® OIA® SHIGATOX assay is an Optical Immunoassay (OIA) test for the qualitative, rapid detection of the presence of Shiga Toxins in human diarrheal fecal specimens, broth cultures, and swab sampling of colonies from a culture plate. This test is intended for in vitro diagnostic use as an aid in the diagnosis of infection by Shiga Toxinproducing Escherichia coli (STEC), both 0157 and all non -- 0157 Shiga toxin producing strains.

The BioStar OIA SHIGATOX device is based on a novel thin film optical detection technology that relies on the interaction of white light with thin films to create a destructive interference phenomenon. Characteristic of this phenomenon is the generation of a reflective surface that changes color as a function of the change in optical thickness (refractive index x thickness) of the films on the surface of the device. To take advantage of this phenomenon for monitoring biological binding events, the optical surface with a special background color is coated with a capture reagent specific to the analyte of interest. In the OIA SHIGATOX device, the biological capture film is a combination of affinity-purified polyclonal antibodies to Shiga toxins 1 and 2 (Stx 1 and Stx 2). Samples suspected of containing either or both of the toxins are mixed with cocktail containing polyclonal antibodies to Stx 1 and Stx 2 that have been covalently conjugated to horseradish peroxidase (HRP). Once a sample containing toxins or either toxin is applied to the surface, the immune complex of toxin(s) and the anti-toxin-HRP conjugate(s) are bound to the surface antibodies. Following a wash step, a precipitating substrate for HRP is added, and a thin film generated by the immobilized immune complex is enhanced by the precipitation of the HRP product. Once washed and dried, a simple color change relative to the gold background color is observed as an indication of the presence of Stx 1 or Stx 2 in the original specimen. The OIA SHIGATOX device produces a qualitative result for the presence or absence of Shiga toxin as the device output. Input to the device is the simple addition of an aliquot of fecal material or broth culture to the reagents contained in the kit. Fecal samples are routinely collected, and no special collection requirements exist beyond the elimination of the use of fecal transport media. Test devices within the kit are single use devices, and disposal instructions are provided in the Package Insert. The kit contains all components necessary for analysis of the direct stool sample with the exception of a timer.

The ImmunoCard STAT! E.coli O157 Plus is a rapid test for the detection of antigens from shiga toxin producing E.coli O157 as an aid in the diagnosis of E.coli O157:H7 infection. The test can be used to directly test stool specimens, stool in modified Cary-Blair medium or confirmatory stool cultures grown in MacConkey broth or sorbitol MacConkey (SMAC) plates.

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The Immunocard STAT! STEC O157 is a rapid test for the detection of antigens from shiga toxin producing E. coli O157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, or confirmatory stool cultures grown in MacConkey broth or sorbitol MacConkey (SMAC) plates.

Stool or culture material are prepared / diluted and added to the sample port of the device. The sample mobilizes gold particles, coated with monoclonal antibody specific for the O157 lipopolysacchride, and migrates along the membrane through the Test and Control zones. The test zone contains immobilized monoclodal antibody specific for an epitope common to shiga toxin producing E. coli. After ten minutes the Test and Control zones are observed for the presence of red/purple lines across the membrane surface. If a shiga toxin producing E. coli O157 is present in the sample, a complex is formed between the capture antibody, the shiga toxin producing E. coli O157, and the monoclonal antibody-gold conjugate which can be seen visually as a red/purple line in the Test zone. No red/purple line in the Test zone indicates a negative result. The Control line serves as a procedural control, to assure that the sample has migrated the appropriate distance along the membrane.

The ProSpecT® Shiga Toxin Microplate Assay is an in vitro microwell EIA for the qualitative detection of Shiga Toxins (Stx 1 and Stx 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures. ProSpecT® Shiga Toxin Microplate Assay is intended for use as an aid in the diagnosis of enterohemorrhagic E.coli ( EHEC) infections.

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The E. coli 0157 Latex Agglutination Test is a rapid test for E. coli serogroup 0157 detection in all primary cultures suspected to be E. coli spp.

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Wellcolex E.coli 0157:H7 is a rapid latex agglutination test for the presumptive identification of Escherichia coli 0157:H7 isolates on laboratory media.

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