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FDA clears toxoplasmosis parasite test for pregnant women
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The FDA has cleared a test to determine whether a pregnant woman or an individual with swollen lymph nodes who had a positive toxoplasmosis test has had the infection within the previous 4 months.
This is the first such test to gain clearance.
The primary use of the Vidas Toxo IgG Avidity assay (bioMérieux) is to rule out recent infection with Toxoplasma gondii. The test is based on the strength of the bond between immunoglobulin G avidity antibodies and T. gondii antigens in the assay. Antibodies from infections older than 4 months bind tightly with the antigens, whereas those from infections acquired within a 4-month period form weaker bonds.
The assay is indicated for use in pregnant women or those with swollen lymph nodes who have had confirmed T. gondii infection using the Vidas Toxo IgG II test. The assay should not be the sole basis for clinical decisions, nor should it be used for prenatal screening, immunocompromised patients or cases of toxoplasmosis reinfection or relapse. The FDA has not cleared or approved the assay for the screening of blood or plasma donations.
Toxoplasmosis infection frequently affects immunocompromised individuals. Infection just before or during pregnancy can lead to vertical transmission of the parasite, which can, in turn, lead to miscarriage, stillbirth, or an abnormally small or large head. Children born under these circumstances also may experience vision loss, mental disability, seizures or other health complications later in life.
The parasite is often linked to cats — particularly infected cat feces or litter — but other species of animals, including birds, may also be hosts. Toxoplasmosis may also be a foodborne infection found in raw, undercooked or contaminated meat.
For more information, please visit the FDA website.
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