Description

INTENDED USE
The DIAGNOSTIC AUTOMATION, Toxoplasma IgM is intended for use in the detection of IgM to
Toxoplasma gondii.

SUMMARY AND EXPLANATION OF THE TEST

Toxoplasmosis is caused by the intracellular parasite Toxoplasma gondii and may be contracted by consuming contaminated meat or by contact with cat feces containing oocysts. In adolescence and adulthood, most infections are subclinical. However, if a pregnant woman contracts toxoplasmosis, it may be passed through the placenta to the fetus, resulting in congenital toxoplasmosis, which is a cause of mortality and malformation. Asymptomatic infants may develop anomalies later in life.

PRINCIPLE OF THE TEST

Purified Toxoplasma gondii antigen is coated on the surface of microwells. Diluted patient serum is added to wells, and the Toxoplasma gondii IgM specific antibody, if present, binds to the antigen. All unbound materials are washed away. After adding enzyme conjugate, it binds to the antibody antigen complex. Excess enzyme conjugate is washed off and TMB Chromogenic substrate is added. The enzyme conjugate catalytic reaction is stopped at a specific time. The intensity of them color generated is proportional to the amount of IgM specific antibody in the sample. The results are read by a microwell reader compared in a parallel manner with calibrator and controls.