REF:

C1303 (Cassette)

INTENDED PURPOSE:

NOVAtest® Toxoplasma IgM Antibody Test is an immunochromatographic assay that use immuno-capture method for qualitative detection of anti-Toxoplasma gondii IgM antibodies from serum or plasma specimens of human. It’s used as an aid in the diagnosis of the toxoplasma infection. This device is performed manually.

INTENDED USER:

Performance of the test is limited to laboratory professional use.

SUMMARY:

Toxoplasma gondii (T. gondii) is a protozoan parasite that infects almost all warm-blooded animals, including humans. Approximately 30 % of human population worldwide is chronically infected with T. gondii. Human infections are primarily obtained by ingesting undercooked or raw meat containing viable tissue cysts, or by ingesting food or water contaminated with T. gondii oocysts. Primary infections in adults are mostly asymptomatic, but lymphadenopathy or ocular toxoplasmosis can present in some patients. Severe acute, disseminated toxoplasmosis may occur in immunocompetent individuals when infected with some isolates. Infection acquired during pregnancy can cause severe damage to the fetus, such as long-term disabling sequelae, stillbirths or fetal death.

The traditional diagnosis of T. gondii infection usually depends on bioassays and serological tests. Molecular methods used for T. gondii infection is popular due to their high sensitivity and specificity.