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Trinity Biotech Uni-Gold™ Giardia is a single use rapid immunoassay for the qualitative detection of Giardia lamblia ( G. lamblia ) antigens in human stool specimens. This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Giardia gastrointestinal infections. As with other Giardia tests, results should be considered in conjunction with the clinical evaluation and medical history. For In-Vitro Diagnostic use.

The Trinity Biotech Uni-Gold™ Giardia was designed as a single use, rapid, lateral flow immunoassay test device to detect the presence of Giardia lamblia antigen in unpreserved (fresh & frozen), preserved and media containing human stool specimens. The Trinity Biotech Uni-Gold™ Giardia test strip (5mm x 60mm) combines a Nitrocellulose Membrane with designated fiber pads (conjugate, sample and absorbant). The test strip is then placed into a plastic housing and is sealed constituting the Test Device. The Giardia Nitrocellulose Membrane Test Strip - above consist of - A) Mouse anti-Giardia lamblia antibody is coated onto the Test Line region of the test strip. - B) Rabbit anti-Goat IgG antibody is coated onto the Control Line region of the Test Strip. - C) Goat anti- Giardia lamblia antibodies and Goat IgG antibodies are conjugated to red latex particles and dried onto the inert glass fiber (Conjugate Pad) which is inserted into the test strip below the nitrocellulose zone. When Giardia antigens are present in the sample they combine with the antibody/red latex complex. As the complex migrates it binds to the antibodies in the test region forming a visible pink/red band. (Picture B) This forms the basis for the double antibody sandwich assay. Excess conjugate forms a second pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device. This internal control line is to ensure and indicate that the test device is functioning correctly. The plastic housing device contains a window where the diluted stool sample is added (Sample Well) and a window above where the results are read in 15 minutes. The test concept: Mouse anti-Giardia lamblia is coated onto the test line region of the nitrocellulose zone of the test strip. Rabbit anti- Goat IgG is coated onto the control line region. Goat anti-Giardia lamblia antibodies are conjugated to red latex particles and dried onto inert glass fiber. This is inserted into the test strip below the nitrocellulose zone. A buffered solution is added to a dilution tube followed by the addition of the stool specimen (2 drops) via a disposable pipette. This mixture is then dispensed in total into the sample well of the lateral flow cartridge device with a dropper pipette and migrates through a pad containing red microspheres that have been coated with a antibody specific for the Giardia antigen. If the antigen is present, an immune complex forms. The migration continues along the membrane, which contains a striped down anti Giardia capture antibody. If Giardia antigen is present, the immune complex reacts with the anti-Giardia antibody at the test line on the membrane. Thus Giardia antigens present in the sample combine with the antibody/red latex. As this complex migrates it binds to the antibodies in the test region forming a visible pink/red band. Excess conjugate forms a second pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device to indicate that the test device is functioning correctly.

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 IVD Research, Inc. Giardia Fecal Antigen Detection Lateral Flow Kit is a qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved human fecal specimens. This test is indicated as an aid in the clinical laboratory diagnosis of suspected Giardia infections. For in vitro diagnostic use.

The IVD Research, Inc. Giardia Fecal Antigen Detection Lateral Flow Kit is an immunochromatographic assay for the detection of Giardia lamblia antigen in human fecal samples. The test uses sample wicking to capture Giardia antigen on a discrete test line containing antibodies specific for Giardia antigen. A specimen is added to a dilution tube and mixed with a buffer solution. The mixture is dispensed into the sample well of the device which resolubilizes the Giardia specific mouse monoclonal antibody that has been conjugated to colored microparticles. This solution wicks along a membrane containing capture antibodies bound to the membrane at the Test and Control lines. The Giardia immune complex, if present, reacts with antibody at the Test line. Unbound conjugate not captured at the test line is captured at the Control line containing anti-mouse antibody. If Giardia antigens are present in the fecal sample, two pink-to-purple bands (one at the Sample line and one at the Control line) will appear in the test window. If no Giardia antigen is present, or if the level of antigen is below the detection limit of the assay, only one pink-to-purple band at the Control line will appear in the test window. For the test to be valid, a pink-to-purple band must always appear at the Control line position of the device test window regardless of whether the sample is positive or negative. This Control line indicates that the test is working properly.

REMEL's Xpect™ Giardia kit is an in vitro qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Giardia infections.

The Xpect™ Giardia Lateral Flow Assay is a chromatographic immunoassay that detects the presence of Giardia antigen. The test utilizes sample wicking to capture Giardia antigen on a discrete test line containing antigen-specific antibodies for Giardia. A specimen is added to a dilution tube containing a buffered solution. A conjugate containing colored micro-particles linked to murine monoclonal antibody specific for Giardia is added. The mixture is dispensed into the sample well of the device and wicks along a membrane containing capture antibody stripes. The Giardia immune complex, if present, reacts with anti- Giardia antibody at the test line. Antibody-labeled microparticles not bound at the test line are later captured at the control line containing anti-mouse antibody. A blue line of any intensity (light blue to black) will appear at the Giardia test position if Giardia antigen is present. A complete line at the Control position indicates that the test is working properly.

REMEL's Xpect™ Giardia/Cryptosporidium kit is an in vitro qualitative immunoassay for the detection of Giardia and Cryptosporidium antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Giardia and Cryptosporidium infections.

The Xpect™ Giardia/Cryptosporidium Lateral Flow Assay is a chromatographic immunoassay that detects the presence of Giardia and Cryptosporidium antigens. The test utilizes sample wicking to capture Giardia and Cryptosporidium antigens on discrete test lines containing antigen-specific antibodies for each organism. A specimen is added to a dilution tube containing a buffered solution. A conjugate containing colored micro-particles linked to monoclonal antibodies specific for Giardia and Cryptosporidium is added. The mixture is dispensed into the sample well of the device and wicks across a membrane containing capture antibody stripes. The Giardia/Cryptosporidium immune complexes if present react with anti-Giardia antibody and/or anti-Cryptosporidium antibody at the test line. Conjugates not bound at the test lines are later captured at the control line containing anti-mouse antibody. A blue line will appear at the Giardia test position if Giardia antigen is present and a pink line will appear at the Cryptosporidium test position if Cryptosporidium antigen is present. A line in the Control position indicates that the test is working properly.

The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children. FOR IN VITRO DIAGNOSTIC USE.

The GIARDIA II test is an enzyme immunoassay.

This direct fluorescent antigen (DFA) detection kit is an in vitro diagnostic (IVD) immunoassay for the detection of Cryptosporidium oocysts and Giardia Cysts in human feces using fluorescent microscopic visualization. This IVD assay is intended to be used with stools preserved in 10% formalin, SAF or Medical Chemical Corporation's (MCC's) Universal fixative. Such samples may be concentrated or unconcentrated.

This IVD Research, Inc. Cryptosporidium/Giardia Direct Fluorescent Antigen Detection Kit (DFA Assay) is intended for use as an in vitro diagnostic (IVD) fluorescent immunoassay for the qualitative determination of Cryptosporidium oocysts and Giardia cysts in stool feces. This assay may be used with stool samples that are preserved in 10% formalin, SAF, or Medical Chemical Corporation's (MCC's) Universal Fixative. This DFA Assay corresponds to FDA Classification Name: Entamoeba Histolytica Serological Reagent, a class II (non-exempt) Device, within the Microbiology Classification Panel, having FDA Reg. Citation Number: 21 CFR 866.3220, and FDA Product Codes: MHI and MHJ, and, as such, utilizes the principle of direct immunofluorescence microscopy. The conjugate contains a mixture of FITC-labeled monoclonal antibodies (derived from hybridized mouse B-cells) directed against Cryptosporidium oocysts and Giardia cysts, which, if present, are affixed to a treated slide (provided). The slide with sample material is then rinsed with wash solution to remove unbound conjugate and debris, and air-dried. The prepared slide is then examined using a fluorescent microscope, looking for an apple-green color and the characteristic morphology of the Cryptosporidium oocysts and the Giardia cysts.

This ELISA is an in vitro immunoassay for the qualitative determination of Giardia antigen in feces.

It is a double antibody (sandwich) ELISA using an anti-Giardia antibody to capture the antigen from the stool supernatant. A second antibody is then added which sandwiches the captured antigen. This reaction is visualized by the addition of an anti-second antibody conjugated to peroxidase and the chromogen tetramethylbenzidine (TMB). The resulting blue color development indicates the presence of Giardia antigens being bound by the anti-Giardia antibodies.

This is an immunochromatographic assay for the simultaneous qualitative detection and distinguishing of Giardia and Cryptosporidium specific antigens in aqueous extracts of fecal specimens. It is intended for professional laboratory use. For In Vitro Diagnostic Use.

Immunoassay for Giardia and Cryptosporidium Antigens

The Premier Giardia enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Giardia antigens in human stool. Test results are intended to aid in the diagnosis of Giardia infection (giardiasis).

The Premier Giardia test utilizes polyclonal anti-Giardia capture antibody adsorbed to microwells.