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Curian Campy, for use with the Curian Analyzer, is a rapid, qualitative fluorescent immunoassay for the detection of a Campylobacter-specific antigen in human fecal specimens. Curian Campy is intended to detect C. jejuni, C. coli, C. upsaliensis, and C. lari in human stool from patients with signs and symptoms of gastroenteritis. The test is intended for use with unpreserved fecal specimens or preserved fecal specimens in transport media. Test results are to be used in conjunction with information available from the patient clinical evaluation and other diagnostic procedures. Curian Campy is intended to aid in the diagnosis of Campylobacter infection.

The Curian® Campy assay is a qualitative in vitro diagnostic test for the detection of Campylobacter-specific antigens in human stool samples collected from individuals with signs and symptoms of gastroenteritis. Curian Campy is intended to detect C. jejuni, C. coli, C. upsaliensis, and C. lari in unpreserved or preserved stool in Cary-Blair or C&S transport media. The Curian® Campy assay utilizes fluorescence technology with the cleared Curian® Analyzer (K192817) to detect Campylobacter-specific antigens in human stool.

Sofia 2 Campylobacter FIA employs immunofluorescence for the rapid qualitative detection of a Campylobacter-specific antigen in human fecal specimens. Sofia 2 Campylobacter FIA is designed to detect C. jejuni, C. coli, C. lari and C. upsalients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

The Sofia 2 Campylobacter FIA employs immunofluorescence technology that is used with Sofia 2 for the rapid qualitative detection of Campylobacter jejuni, Campylobacter lari, and Campylobacter upsaliensis specific antigens in fecal samples. The patient's sample is placed in the Specimen Tube containing the Specimen Solution to dilute, making the antigenic components more accessible to the specific antibodies. An aliquot of the diluted sample is dispensed through a filter to remove particulates, making them more compatible for testing, into the Test Cassette sample well. From the sample well, the sample migrates through a test strip containing various unique chemical environments. If Campylobacter jejuni, Campylobacter coli, Campylobacter lari, or Campylobacter upsaliensis specific antigens are present, they will be bound by antibodies coupled to fluorescent microparticles that migrate through the test strip. The fluorescent microparticles containing bound proteins will be captured by antibodies at a defined location on the test strip where they are detected by Sofia 2. If Campylobacter jejuni, Campylobacter coli, Campylobacter lari, or Campylobacter upsaliensis specific antigens are not present, the fluorescent microparticles will not be trapped by the capture antibodies nor detected by Sofia 2. The Test Cassette is placed inside of Sofia 2 for automatically timed development (WALK AWAY Mode), or pre-incubated on the bench top prior to loading into Sofia 2 (READ NOW Mode), where Sofia 2 will scan, measure, and interpret the immunofluorescent signal using method-specific algorithms. Sofia 2 will display the test results (Positive, Negative, or Invalid) on the screen. The fluorescence signal obtained with this assay is invisible to the unaided eye. The test results can only be obtained with the proper use of Sofia 2.

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The CAMPYLOBACTER QUIK CHEK™ test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER QUIK CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

The CAMPYLOBACTER QUIK CHEK™ test uses antibodies that recognize a Campylobacter-specific antigen in human fecal samples. The device contains a Reaction Window with two vertical lines of immobilized antibodies. The test line ("T") contains antibodies against a Campylobacter-specific antigen. The control line ("C"), contains anti-IgG antibodies. The Conjugate consists of antibodies to a Campylobacter-specific antigen coupled to horseradish peroxidase. To perform the test, a fecal specimen 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, the Campylobacter-specific antigens in the sample bind to the antibody-peroxidase conjugate. The antigen-antibody complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-Campylobacter antibodies in the line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10-minute incubation, the "T" reaction is examined visually for the appearance of a vertical blue line. A blue line indicates a positive "C" reaction, indicated by a vertical blue line, monitors/confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay and that the results are valid.

The CAMPYLOBACTER CHEK™ test is an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

The CAMPYLOBACTER CHEK™ test uses antibodies that recognize a Campylobacter-specific antigen. The Microassay Plate in the kit contains immobilized capture monoclonal antibodies against a Campylobacter-specific antigen. The Conjugate consists of polyclonal antibodies to a Campylobacter-specific antigen conjugated to horseradish peroxidase. In the assay, an aliquot of a diluted fecal specimen is transferred to a microassay well containing the Conjugate. If the antigen is present in the specimen, it will bind to the Conjugate and to the immobilized capture antibody 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 formed in the presence of antigen.

ImmunoCard STAT! CAMPY is an immunochromatographic rapid test for the qualitative detection of specific Campylobacter antigens in human stool. ImmunoCard STAT! CAMPY detects C. jejuni and C. coli in human stool, where stool may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information available from the patient's clinical evaluation and other diagnostic procedures. ImmunoCard STAT! CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings.

ImmunoCard STAT! CAMPY is an immunochromatographic, rapid test for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of Campylobacteriosis. The assay is intended to be used by hospital and reference laboratories to test for bacterial colonization. It is used in conjunction with information obtained from the patient's clinical symptoms and with other tests to diagnose Campylobacter infection. The assay consists of ImmunoCard STAT! Test Devices (containing specific capture antibodies and colloidal gold-antibody conjugate detector antibodies), ImmunoCard STAT! CAMPY Sample Diluent/Negative Control and ImmunoCard STAT! CAMPY Positive Control. No calibrators are used with this device.

Premier™ CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures. Premier CAMPY is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

Premier CAMPY is an in vitro diagnostic, microwell-based enzyme-linked immunoassay for the detection of common antigens found on Campylobacter jejuni and C. coli in stool samples from patients with signs and symptoms of Campylobacteriosis. The assay is intended to be used by hospital and reference laboratories to test for bacterial colonization. It is used in conjunction with information obtained from the patient's clinical symptoms and with other tests to diagnose Campylobacter infection. The assay consists of Premier CAMPY microwells coated with specific antibodies (capture antibodies). Premier CAMPY Enzyme Conjugate, Premier CAMPY Sample Diluent/Negative Control, Premier 20X Wash Buffer III, Premier Substrate Solution I, Premier Stop Solution I and Premier CAMPY Positive Control. No calibrators are used with this device.

The ProSpecT® Campylobacter Microplate Assay is an in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen in fecal specimens and broth enriched fecal cultures. ProSpecT Campylobacter Microplate Assay is intended for use as an aid in the diagnosis of Campylobacter infections.

in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen