Toxoplasma gondii serological reagents are devices that use antigens and antisera to identify antibodies to the parasite Toxoplasma gondii in serum. These reagents are used in serological tests to diagnose toxoplasmosis, an infection that can be caused by the parasite. Some examples of serological tests for toxoplasmosis include:

TOXOPLASMA ICT IGG-IGM – A rapid point-of-care (POC) test that detects IgG/IgM antibodies. This test uses a nitrocellulose membrane with a test line and a control line. If the serum sample contains the specific antibodies, a red line appears at the test line and a blue line appears at the control line.

WESTERN BLOT – Also known as an immunoblot, this test shows the reaction of sera with T. gondii antigen on a membrane. The resulting banding patterns are compared with known molecular weights.

Toxoplasma Serological Profile (TSP) – A panel of tests that includes the Sabin-Feldman dye test (DT), double sandwich IgM ELISA, IgA ELISA, IgE ELISA, and AC/HS test. This panel can help determine if an infection is recent or more distant

Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum.

Some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoan Toxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.

Device Description: Toxoplasma gondii serological reagents are devices that use antigens and antisera to identify antibodies to Toxoplasma gondii in serum. These reagents are used in serological tests to diagnose infections caused by the parasite Toxoplasma gondii. Here are some examples of serological reagents and devices for detecting Toxoplasma gondii.

Toxoplasma ICT IgG-IgM: A rapid point-of-care (POC) test that detects Toxoplasma-specific IgG/IgM antibodies. It uses a nitrocellulose membrane with a test line containing T. gondii native antigen and a control line containing rabbit gamma globulin.

Toxocheck: A rapid, qualitative immunochromatographic test that detects IgM and IgG antibodies to Toxoplasma gondii in human serum or plasma. It can be used as a screening test or to aid in diagnosis.

Intended Use: Toxogen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total anti-toxoplasma antibodies in human serum. The test may be used with a single specimen to estimate the immunologic response of the individual or with paired acute and convalescent sera as an aid in the diagnosis of primary, acute or reactivated toxoplasmosis.

This assay is not FDA-cleared for use in blood or plasma donor screening.

Intended Use: The Access Toxo IgM II assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma using the Access Immunoassay Systems. The Access Toxo IgM II assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection in males and pregnant or non-pregnant females. It is recommended this assay be performed in conjunction with a Toxoplasma gondii-specific IgG antibody assay.

Note: This assay has not been cleared/approved by the FDA for the screening of blood or plasma donors in the United States.

Special Conditions for Use Statement(s): Rx – For Prescription Use Only, Performance has not been established for the use of bodily fluids other than human serum or plasma.

Device Description: The Access Toxo IgM II assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma using the Access Immunoassay Systems.  The Access Toxo IgM II assay consists of the reagent pack, calibrators, and quality controls (QCs), packaged separately. Other items needed to run the assay include substrate and wash buffer.

Intended Use: Toxoplasma IgG Positive Control is a human blood-based single analyte run control designed to be used as an independent run control with tests for the detection of IgG antibodies to Toxoplasma gondii. This control is not intended as a substitute for controls provided with test kits.

Device Description: Toxoplasma IgG Positive Control is manufactured from human serum or plasma containing IgG antibodies to Toxoplasma gondii, but is nonreactive for antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1 and 2), antibodies to Human T-Lymphotropic Virus Type I (HTLV I) and antibodies to Hepatitis C (HCV). This control contains stabilizers (EDTA, buffering agents) and 0.1% ProClin™ as preservative.

This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgG antibodies to Toxoplasma gondii in human serum and plasma.

• Stability Studies
• Precision/Reproducibility
• Detection studies
• Linearity/assay reportable range
• Detection limit
• Analytical specificity
• Traceability (controls, calibrators, or method)
• Retrospective Study
• Analytical Sensitivity
• Analytical Specificity (Cross-Reactivity)
• Interfering Substances
• Precision – Intra and Inter-assay
• Prozone effect study

The same is applicable for CE Marking under IVDR also.

Required for 510k submission.