INTRODUCTION

The TOXO IgG/IgM Rapid Test Kit 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. Recently,lateral flow chromatographic immunoassay, such as TOXO IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma) was introduced into the clinic for the serodiagnosis of Toxoplasma gondii infection.

INTENDED USE

The TOXO IgG/IgM Rapid Test Kit is a qualitative membrane strip based immunoassay for the detection of TOXO antibodies (IgG and IgM) in Whole Blood /Serum / Plasma. The test device consists of: 1) a burgundy colored conjugate pad containing TOXO recombinant envelope antigens conjugated with Colloid gold (TOXO conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with the antibody for the detection of IgM anti-TOXO, T2 band is coated with antibody for the detection of IgG anti-TOXO, and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgG anti-TOXO, if present in the specimen, will bind to the TOXO conjugates. The immunocomplex is then captured by the reagent pre-coated on the T2 band, forming a burgundy colored T2 band, indicating a TOXO IgG positive test result and suggesting a recent or repeat