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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.

The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Giardia cyst antiqen and Cryptosporidium oocyst antigen in a single test device. It is intended for use with human fecal specimens from patients with gastrointestinal symptoms to aid in the diagnosis of Giardia and/or Cryptosporidium gastrointestinal infection. The test results should be considered in conjunction with the patient history.

The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test is a rapid membrane immunoassay for the simultaneous detection of Giardia cyst antigen and Cryptosporidium occyst antigen in a single test device. It is performed with a 25 to 30-minute total incubation time. The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test uses monoclonal and polyclonal antibodies to cell-surface antigens of the device contains a Reaction Window with three vertical lines of immobilized antibodies. The Giardia test line ("Giar") contains mouse monoclonal antibodies against Giardia. The Crypto test line ("Cryp") contains mouse monoclonal antibodies against Cryptosporidium. The control line ("C") is a dotted line that contains anti-horseradish peroxidase (HRP) antibodies. The Conjugate consists of polyclonal antibodies 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-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, cyst antigens in the sample bind the antibody-peroxidase conjuqates. The antigen-antibody-conjugate complexes migrate through a filter pad to a membrane where they are captured by the immobilized Giardia and/or Cryptosporidium-specific 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 is examined visually for the appearance of a vertical blue line on either side of the Reaction Window. A blue line indicates a positive "control" reaction, indicated by a vertical dotted blue line under the "C" portion of the Reaction Window. confirms that the test is working properly and the results are valid.

The LEUKO EZ VUE™ test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE™ test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing. FOR IN VITRO DIAGNOSTIC USE.

The LEUKO EZ VUE™ test is a 10 minute immunochromatographic device for the detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test utilizes the same polyclonal antibodies against human lactoferrin as our previously cleared LEUKO-TEST assay. The polyclonal antibodies to human lactoferrin are immobilized on nitrocellulose and the conjugate consists of the same antibodies linked to colloidal gold particles. The membrane cassette contains two stripes of immobilized antibodies. One stripe contains anti-lactoferrin antibodies. The other, representing a control stripe, contains anti-IgG antibodies. The diluted sample and gold conjugate migrate by capillary action when the sample is added to the well. If elevated lactoferrin is present in the sample, gold conjugate-lactoferrin complexes form and are captured by the immobilized anti-lactoferrin antibodies in the stripe. The lactoferrin-conjugate-antibody complexes appear as a single red line in the test portion of the Results window. In the control stripe, conjugate binds to the immobilized anti-IgG antibodies, demonstrating correct migration of the sample and conjugate along the membrane. The conjugate-anti-IgG antibodies appear as a single red line in the control portion of the Results window.

The ASCA-CHEK test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces and serum. The test result is used as an aid in the diagnosis of Crohn's disease in combination with clinical and other laboratory findings. FOR IN VITRO DIAGNOSTIC USE.

The ASCA-CHEK test is an ELISA for the measurement of human anti-S. cerevisiae antibodies in feces and serum as an indicator of Crohn's disease in combination with other clinical and laboratory findings. The assay utilizes antigens of S. cerevisiae for capture and a polyvalent anti-human immunoglobulin conjugate. For feces, a specimen dilution of 1:10 and an OD 450 cut-off ≥0.150 or OD450620 ≥0.110 are used for the analysis. For serum, a specimen dilution of 1:1000 and an OD450 cut-off ≥0.110 or OD450620 ≥0.080 are used for the analysis. When human ASCA is present in fecal or serum specimens, the specific immunoglobulins bind to the S. cerevisiae antigens that are immobilized in the test well. Following this binding step, the polyvalent anti-human horseradish peroxidase (HRP) conjugate binds to the ASCA and reacts with the substrate to produce a positive result. The measurement of fecal and serum ASCA is an indicator of Crohn's disease within the setting of differentiating Crohn's disease from ulcerative colitis and IBS. This diagnostic method offers a simple to perform assay that may be used with either fecal or serum specimens.