FDA Clears First Test for Recent Infection With Toxoplasmosis Parasite

/PRNewswire/ -- 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, sometimes known as cat scratch disease, 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.

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.

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.

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 bioMerieux Inc. of Hazelwood, Mo.

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FDA permits marketing of first test for most common cause of gastroenteritis outbreaks

The U.S. Food and Drug Administration allowed marketing of the first test for the preliminary identification of norovirus.

The Ridascreen Norovirus 3rd Generation EIA assay is for use when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission, such as a shared location or food.

Norovirus is a leading cause of food-borne disease outbreaks in the United States.

Acute gastroenteritis is an inflammation of the stomach and intestine that can cause diarrhea, vomiting and stomach pain. Norovirus contamination usually occurs in settings where there is close group contact, such as cruise ships, hospitals, long-term care facilities, and schools or child-care centers. It is a highly contagious virus that spreads rapidly through direct person-to-person contact, contaminated food or water, and by touching contaminated surfaces.

“This test provides an avenue for early identification of norovirus,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Early intervention can halt the spread of an outbreak.”

The test is not sensitive enough for use when only a single person has symptoms and should not be used for diagnosing individual patients.

The manufacturer demonstrated the performance of the Ridascreen test by comparing results of it to the results of a norovirus reference standard for 609 fecal samples. When the fecal samples were tested with Ridascreen, overall results on average were less sensitive than those of standard reference tests, detecting norovirus across samples about 2/3 of the time it was present.

The FDA reviewed data for Ridascreen via the de novo pathway, an alternative path to market for devices that are lower risk and may not require premarket approval (PMA), but are of a new type, and therefore may not be able to be cleared in a '510(k)' premarket notification.

In March, the U.S. Centers for Disease Control and Prevention will be updating management and disease prevention guidelines for norovirus outbreaks. These guidelines will likely reflect substantial advances made in norovirus epidemiology, immunology, diagnostic methods and infection control.

Ridascreen is made by R-Biopharm AG, located in Darmstadt, Germany.

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FDA Approves First Diagnostic Assay to Detect Both HIV Antigen and Antibodies

/USNewswire/ -- The U.S. Food and Drug Administration today approved the first assay to detect both antigen and antibodies to Human Immunodeficiency Virus (HIV). This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as two years old.

The highly sensitive assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. Since it actually detects the HIV-1 virus (specifically the p24 antigen) in addition to antibodies to HIV, the ARCHITECT HIV Ag/Ab Combo assay can be used to diagnose HIV infection prior to the emergence of antibodies. Most tests used today in the diagnostic setting detect HIV antibodies only. Although direct detection of the virus itself by nucleic acid testing is available, it is not widely used in diagnostic settings.

HIV is the virus that can lead to acquired immune deficiency syndrome, or AIDS. HIV damages a person's body by destroying specific blood cells, called CD4+ T cells, which are crucial to helping the body fight diseases. Two types of HIV have been identified: HIV-1 and HIV-2. HIV-1 is responsible for most HIV infections throughout the world. HIV-2 is found primarily in West Africa; however, cases of HIV-2 infection have been reported in North America and Europe.

The Centers for Disease Control and Prevention report that approximately 18 million people in the United States are tested for HIV each year. Most recent CDC estimates are that there are about 56,000 new HIV infections in the United States each year. In addition, there are more than 1 million people living with HIV in the United States, according to CDC.

"The approval of this assay represents an advancement in our ability to better diagnose HIV infection in diagnostic settings where nucleic acid testing to detect the virus itself is not routinely used," said Karen Midthun, M.D., acting director of FDA's Center for Biologics Evaluation and Research. "It provides for more sensitive detection of recent HIV infections compared with antibody tests alone."

The ARCHITECT HIV Ag/Ab Combo assay is not intended to be used for routine screening of blood donors. However, it is approved as a donor screening assay for HIV-1/HIV-2 infection in urgent situations where licensed blood donor screening tests are unavailable or their use is impractical.

The ARCHITECT HIV Ag/Ab Combo assay will be used in clinical laboratories and in public health laboratories, and is the first assay approved in the United States to detect HIV antigen and antibodies simultaneously.

The ARCHITECT HIV Ag/Ab Combo assay is manufactured by Abbott Laboratories, Abbott Park, Illinois.

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