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The TECHLAB® E. HISTOLYTICA QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of adhesin from Entamoeba histolytica in a single use cassette. It is intended for use with human fecal specimens from patients with diarrhea or dysentery as an aid in the diagnosis of E. histolytica gastrointestinal infection. Test results should be considered in conjunction with patient history. FOR IN VITRO DIAGNOSTIC USE

The E. HISTOLYTICA QUIK CHEK™ test uses antibodies to adhesin. The device contains a Reaction Window with two vertical lines of immobilized antibodies. The test line ("T") contains monoclonal antibodies specific for E. histolytica adhesin. The control line ("C") contains antibodies to horseradish peroxidase (HRP). The Conjugate consists of polyclonal antibodies to E. histolytica adhesin 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, E. histolytica adhesin in the samples bind to the antibodyperoxidase conjugate. The antigen-antibody complexes migrate through a filter pad to a membrane where they are captured by the immobilized antibodies in the Reaction Window is subsequently washed with Wash Buffer, and the test is developed with the addition of Substrate. After a 10 minute incubation period, the "T" reaction is examined visually for the appearance of a vertical blue line on the "T" side of the Reaction Window. A blue line indicates a positive test. A positive "C" reaction, indicated by a vertical blue line on the "C" side of the Reaction Window, 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.

The E. histolytica II is an enzyme immunoassay for the rapid detection of the adhesin of E. histolytica in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea or dysentery to determine the presence of E. histolytica gastrointestinal infection. The test can be used for fecal specimens submitted for routine clinical testing from adults or children. Conventional microscopy is not a routine prerequisite for use of the test. FOR IN VITRO DIAGNOSTIC USE.

The E. histolytica II can be used to detect adhesin (also referred to as galactose-inhibitable lectin) produced by strains of E. histolytica. It does not cross-react with the adhesin from E. dispar (formerly known as nonpathogenic E. histolytica). The test can be used to detect the adhesin in fecal specimens from persons suspected of having amebiasis. The kit, which includes ready-to-use reagents, contains microtiter wells coated with polyclonal antibody, positive control reagent, monoclonal-antibody conjugate, diluent, one component substrate, wash solution, and stop solution. The microtiter wells coated with polyclonal antibody "capture" the adhesin and the monoclonal antibody conjugate serves as the "detecting" antibody. The polyclonal antibody used to coat the wells is prepared from hyperimmune antiserum developed in goats. The monoclonal antibody used to prepare the conjugate is prepared from mouse ascites fluid. The E. histolytica II is to be used in an ELISA format.

The E. histolytica Test can be used to detect adhesin (also referred to as galactose-inhibitable lectin) produced by strains of E. histolytica. It does not cross-react with the adhesin from E. dispar (formerly known as nonpathogenic E. histolytica). The test can be used to detect the adhesin in fecal specimens from persons suspected of having amebiasis.

The kit, which includes ready-to-use reagents, contains microtiter wells coated with polyclonal antibody, positive control reagent, monoclonal-antibody conjugate, diluent, two component substrate, wash solution, and intensifier. The microtiter wells coated with polyclonal antibody "capture" the adhesin and the monoclonal antibodyconjugate serves as the "detecting" antibody. The polyclonal antibody used to coat the wells is prepared from hyperimmune antiserum developed in rabbits. The monoclonal antibody used to prepare the conjugate is prepared from mouse ascites fluid. The E. histolytica Test is to be used in an ELISA format.

The intended use of the device is for the qualitative and/ or quantitative determination of serum IgG antibodies to Entamoeba histolytica using an Enzyme-Linked Immunosorbent Assay (ELISA) technique.

The device is an Enzyme Linked Immunosorbent Assay (ELISA). The antigen capture takes place in microwells. During the first incubation, antibodies in the patient's serum binds to antigen attached to the test wells. After washing the excess antibodies away, an enzyme complex binds to the antigen-antibody complex. After washings that remove unbound enzyme, a substrate is added which develops a blue color in the presence of the enzyme complex and peroxide. The stop solution ends the reaction and turns the The blue color to yellow. results read may be be spectrophotometrically with a microplate reader or visually.