Uncut Sheet HCG Urine/Serum Rapid Test SPECIMEN: Whole Blood/ Serum/ Plasma INTENDED USE The One Step TOXO IgG/IgM Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Toxoplasma gondii in Whole Blood /Serum / Plasma to aid in the diagnosis of TOXO infection. Toxoplasma gondii is an obligate intracellular protozoan parasite with a worldwide distribution. Serological data indicates that approximately 30% of the population of most industrialized nations is chronically infected with the organism. A variety of serologic tests for antibodies to Toxoplasma gondii have been used as an aid in diagnosis of acute infection and to assess previous exposure to the organism. These tests are the Sabin-Feldman dye test, direct agglutination, indirect hemagglutination, latex agglutination, indirect immunofluorescence, and ELISA. Recently, lateral flow chromatographic immunoassay, such as The Toxo IgM/IgG Rapid Test (Whole Blood/Serum/Plasma) was introduced into the clinic for the serodiagnosis of Toxoplasma gondii infection. One step TOXO IgG/IgM Test is a simple, visual qualitative test that detects TOXO antibodies in human Whole Blood/serum/plasma. The test is based on immunochromatography and can give a result within 15 minutes. Storage and Stability Store as packaged in the sealed pouch at room temperature or refrigerated (4-30â?? or 40-86â??). The test device is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use.
