Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum.

The identification aids in the diagnosis of rubella (German measles) or confirmation of a person’s immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).

Intended Use: It is intended as an aid in the determination of immune status to rubella.

Device Description: The assay principle combines a 2-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle serves as the solid phase as well as the pipetting device for the assay. It is coated with Rubella antigen. The other reagents for the assay are ready-to-use and pre-dispensed in the sealed reagent strips and are eliminated during the preliminary wash step. A second incubation step is then performed using alkaline phosphatase labelled monoclonal anti-human IgG antibodies (mouse), followed by a second wash step. During the final detection step, the substrate (4-methyl-umbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4Methyl-umbelliferone), the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antibodies present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory and then printed out.

Intended Use: It is a rapid latex particle agglutination test aiding in the diagnosis of recent or active rubella infection and the determination of immune status.  The assay’s performance characteristics have not been established for prenatal or newborn testing.

Device Description: This reagent is a suspension of deeply coloured polystyrene latex particles of uniform size coated with a soluble purified K2S antigen extract prepared from Rubella HPV-77 virus grown inthe  African Green Monkey Kidney Vero cell line.

Intended Use: This kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the determination of serological status. T’ gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors.

Device Description: This kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EJA, but permits simultaneous detection and identification of many antibodies in a single tube. “ToRC” is an acronym for individual tests to detect antibodies to Toxoplasma gondil (7′ gondli), Rubella, and Cytomegalovirus (CMV). Three (3) different populations of dyed beads are coated with cell lysates bearing T’ gondli, Rubella, or CMV antigens.

Intended Use: The Assay Kit is intended for use with the DYNEX Multiplier Analyzer. IgG Assay Kit is intended to be used as an aid in the determination of the serological status of Measles, Mumps, Rubella, and Varicella-Zoster Virus (VZV) in human serum from adults and paediatrics aged above 1 year. This kit is not intended for screening blood or plasma donors.

Device Description: Assay Kit uses multiplex immunoassay, a methodology that greatly resembles traditional ELISA while permitting simultaneous detection and identification of different antibodies in a single well. The reaction is processed in a 96-well microtiter plate, with six polystyrene beads embedded in each well of the plate. Four (4) different beads are coated with antigens for the detection of IgG antibodies to Measles, Mumps, Rubella and Varicella-Zoster Virus in human serum. Two additional beads are included in each reaction well as filler beads. Specimen processing is fully automated on the DYNEX Multiplier Analyzer.

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

The same is applicable for CE Marking under IVDR also.

No Guidance available  for 510k submission and IVDR CE Marking