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FDA Clears Toxoplasmosis Test

A test to help determine whether a pregnant woman or a person with swollen lymph nodes has a recent Toxoplasma gondii infection has been cleared by the U.S. Food and Drug Administration.

The VIDAS TOXO IgG Avidity assay, manufactured by bioMérieux Inc. of  Hazelwood, Mo, can be used to rule out an infection within the last four months, the FDA said in a news release.

Toxoplasmosis, caused by the parasite Toxoplasma gondii, is considered a leading cause of death attributed to foodborne illness, according to the Centers for Disease Control and Prevention. More than 60 million people in the United States may be infected with Toxoplasma gondii. The parasite may be transmitted to people when they eat raw, undercooked or contaminated meat or come in contact with infected cat feces or litter.

The infection can cause serious health problems in people with compromised immune systems. Women who become infected just before or during pregnancy may pass the parasite on to their unborn child, resulting in miscarriage, stillbirth, or an abnormally small or large head. Infection can also lead to vision loss, mental disability, seizures or other health problems later in life for the child.

 Common symptoms of toxoplasmosis include swollen lymph nodes and flu-like symptoms.

“Toxoplasmosis can have serious and lasting health consequences for infants that acquire the infection in the womb,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA’s Center for Devices and Radiological Health. “This test gives doctors an additional tool to determine if women with confirmed cases of toxoplasmosis acquired the infection before or during pregnancy.”

 alone should not be used as a basis for clinical decisions.

The test alone should not be used to to determine toxoplasmosis, nor has it been established for prenatal screening, for immunocompromised patients, or for cases of toxoplasmosis reinfection or relapse, and the FDA said it has not cleared or approved the assay for blood or plasma donor screening. 

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