New Test Detects Recent Infection with Toxoplasmosis Parasite

Toxoplasmosis is considered to be a leading cause of death attributed to foodborne illness, according to the Centers for Disease Control and Prevention.

On May 18, the U.S. Food and Drug Administration cleared the first test to help determine whether a pregnant woman or a person with swollen lymph nodes testing positive for toxoplasmosis developed the infection within the past four months.

Toxoplasmosis is caused by the parasite Toxoplasma gondii. 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.

Toxoplasmosis is considered to be 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.

Cats are most often associated with the parasite, but many other species of animals and birds also serve as hosts. The parasite also is found in people worldwide. Common symptoms of toxoplasmosis include swollen lymph nodes and flu-like symptoms.

The VIDAS TOXO IgG Avidity assay can be used to rule out recent Toxoplasma gondii infection. The test works by detecting how strongly IgG avidity antibodies bind to the Toxoplasma gondii antigens in the assay. IgG avidity antibodies from infections older than four months bind tightly with the antigens, while IgG avidity antibodies from infections acquired in the past four months form weaker bonds.

“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.”

The VIDAS TOXO IgG Avidity Assay test is for use in people who have been confirmed with the Toxoplasma gondii infection by using the VIDAS TOXO IgG II test and who are pregnant or have swollen lymph glands. The VIDAS TOXO IgG Avidity Assay test alone should not be used as a basis for clinical decisions.

The performance of the VIDAS TOXO IgG Avidity Assay has not been established for prenatal screening, for immunocompromised patients, or for cases of toxoplasmosis reinfection or relapse, and the FDA has not cleared or approved the VIDAS TOXO IgG Avidity Assay for blood or plasma donor screening.

The VIDAS TOXO IgG Avidity assay is manufactured by bioMérieux Inc. of Hazelwood, Mo.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Comply with OSHA’s Electronic Recordkeeping Requirements

    Collect relevant incident data and generate accurate OSHA 300, 300A, and 301 regulatory reports, including 300A CSV files for easy electronic submission to OSHA.

  • Complete Online Safety Training Courses

    Deliver state-of-the art, online safety training courses to your organization with IndustrySafe Training Management Software. Generate reports to track training compliance and automatically notify learners of upcoming or overdue classes.

  • Easy to Use Safety Inspection App

    Conduct inspections on the go with IndustrySafe’s mobile app. Complete safety audits at job sites and remote locations—with or without web access.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Industry Safe
comments powered by Disqus