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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.

This microwell enzyme-linked immunoabsorbant assay (ELISA) detection kit (C. difficile Toxin A+B ELISA Kit) is an in vitro diagnostic (IVD) immunoassay intended for use as an aid in the diagnosis of C. difficile associated disease. The kit detects C. difficile toxin A and B in human feces using peroxidase as the indicator enzyme. The assay may be read visually or with an ELISA reader. This IVD C. difficile Toxin A+B ELISA Kit is intended to be used with human stools that are fresh, frozen or in Cary Blair transport media in a clinical laboratory use setting. The kit may also be used with IVD Research's Quick'N'Easy fecal dilution device.

C. difficile Toxin A+B Fecal Antigen Detection Microwell ELISA

This microwell enzyme linked immunoabsorbant assay (ELISA) detection kit is an in vitro diagnostic (IVD) immunoassay for the detection of Cryptosporidium antigen in human feces using peroxidase as the enzyme. The assay may be read visually or with an ELISA reader. This IVD assay is intended to be used with stools that are fresh, frozen or preserved in 10% formalin, SAF or Medical Chemical Corporation's (MCC) Universal fixative. Concentrated samples cannot be used with this IVD.

This microwell enzyme-linked immunoabsorbant assay (ELISA) detection kit (Cryptosporidium ELISA Kit) is an in vitro diagnostic (IVD) immunoassay for the detection of antigen to Cryptosporidium species in human feces using peroxidase as the indicator enzyme. The assay may be read visually or with an ELISA reader. Concentrated fecal samples cannot be used with this immunoassay. Rather, this IVD Cryptosporidium ELISA Kit is intended to be used with human stools that are fresh, frozen or preserved in 10% formalin, SAF or Medical Chemical Corporation's (MCC's) Universal fixative in a clinical laboratory use setting. This ELISA is an in vitro immunoassay for the qualitative determination of Cryptosporidium species antigen in feces. The ELISA uses a rabbit anti-Cryptosporidium antibody to capture the antigen from the stool supernatant. A second goat anti-Cryptosporidium 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 Cryptosporidium species antigens being bound by the anti-Cryptosporidium antibodies.

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.