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The RUBELLACOL™ TEST is to be used as an aid in the detection of anti-rubella virus antibodies in serum. This test is "For Professional Use Only".

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The Copalis™ TORC Total Antibody Assay uses Coupled Particle Light Scattering (Copalis™) technology in a microparticle agglutinationbased immunoassay for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and cytomegalovirus (CMV) in human serum using the CopalisTM One Immunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The results of this assay on a single serum specimen are used to determine the patient's immune status for rubella and to determine the patient's immunological experience for Toxoplasma gondii and CMV. When evaluating properly paired sera, the results of this assay are used to demonstrate seroconversion as evidence of recent infection. Both specimens should be tested simultaneously (see Interpretation of Results). This assay has not been FDA cleared or approved for the screening of blood or plasma donors.

The Copalis TORC Total Antibody Assay is based on the principle of antibodydependent particle aggregation as detected by measurement of changes in light scattering. Due to the unique measuring system, a sample can be tested for antibodies to Toxoplasma gondii, rubella and CMV using a single reagent and obtain results for the individual antibodies. Sized latex microparticles coated with inactivated Toxoplasma gondii, rubella and CMV antigens aggregate in the presence of antibodies to these infectious agents. After 10 minutes of agitation, the levels of aggregation are determined by discrimination of particle sizes and measurement of the number of reacted and unreacted particles as they flow past a detector. Reactivity is assessed by the level of aggregation per particle size relative to a cutoff value. The Copalis TORC Total Antibody Assay detects the presence of both IgM and IgG antibodies. Two levels of controls are used to monitor proficiency.

The Copalis™ TORC, Toxo, Rubella, and CMV Total Antibody Assays use Coupled Particle Light Scattering (Copalis) technology in microparticle agglutination-based immunoassays for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and/or cytomegalovirus (CMV) in human serum using the Copalis™ I Immunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The results of these assays on a single serum specimen are used to determine the patient's immune status for rubella and to determine the patient's immunological experience for Toxoplasma gondii and CMV. When evaluating properly paired sera, the results of these assays are used to demonstrate seroconversion as evidence of recent infection. Both specimens should be tested simultaneously (see Interpretation of Results). These assays has not been FDA cleared or approved for the screening of blood or plasma donors. The assay will also be offered as separate microparticle immunoassays for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and cytomegalovirus (CMV) in human serum using the Copalis™ One Immunoassay System. The intended use of the individual assays will be specific to the individual antibodies detected but, other than that, will remain the same as the combination assay.

Coupled Particle Light Scattering (Copalis) technology provides a rapid method for the measurement of antibodies to specific viral or protozoal pathogens. The Copalis™ TORC, Toxo, Rubella, and CMV Total Antibody Assays are based on the principle of antibody-dependent particle aggregation as detected by measurement of changes in light scattering. Due to the unique measuring system, a sample can be tested for antibodies to Toxoplasma gondii, rubella and CMV using a single TORC reagent and obtain results for the individual antibodies. Sized latex microparticles coated with inactivated Toxoplasma gondii, rubella and CMV antigens aggregate in the presence of antibodies to these infectious agents. After 10 minutes of agitation, the levels of aggregation are determined by discrimination of particle sizes (for the TORC assay) and measurement of the number of reacted and unreacted particles as they flow past a detector. Reactivity is assessed by the level of aggregation per particle size relative to a cutoff value. The Copalis TORC and individual Total Antibody Assays detect the presence of both IgM and IgG antibodies. Two levels of controls are used to monitor system performance.

The Murex Rub-ex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of rubella antibodies in serum.

The Murex Rub-ex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of rubella antibodies in serum. The rubella virus used to sensitize the Latex Reagent is inactivated and disrupted before use. Sera used in the preparation of controls are tested with FDA approved tests for hepatitis B virus surface antigen (Hosag) and antibodies to HIV and hepatitis C virus (HCV). Only units that are non-reactive for Hbsag and antibodies to HIV and HCV are selected.