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The Zeus Scientific, Inc. AtheNA Multi-Lyte® ToRCH IgG Plus Test System is intended for the qualitative detection of specific human IgG class antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and HSV 1 & 2 in human serum. The results of this assay are intended to be used as an aid in the assessment of serological status to Toxoplasma gondii, Rubella and CMV. For HSV 1 and HSV 2, the test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and Herpes Simplex 2. The test is not intended for use in screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonatal screening, immunocompromised or immunosuppressed patients or for use at point of care facilities.

The Zeus Scientific, Inc. AtheNA Multi-Lyte® ToRCH IgG Plus Test System is a multiplex immunoassav intended for the simultaneous qualitative detection and differentiation of specific human IgG class antibodies to Toxoplasma gondii, Rubella, Cytomegalovirus (CMV), Herpes Simplex 1 (HSV-1) and Herpes Simplex 2 (HSV-2) in human serum. The results of this assay are intended to be used as an aid in the assessment of a patient's serological status to infection with Toxoplasma gondii, Rubella, CMV, HSV 1 and HSV 2 and in the determination of immune status of individuals including pregnant women. The test system is comprised of the AtheNA Multi-Lyte test kit, software and the Luminex Corp instrument. The AtheNA Multi-Lyte ToRCH IgG Plus Test System provides the following components: Reactive Reagents: All reactive reagents contain sodium azide as a preservative at a concentration of 0.1% (w/v). 1. Multiplexed bead suspension 1. Ready to use, 5.5 mL bottle. The suspension contains separate distinguishable 5.6 micron polystyrene beads that are conjugated with: . Toxo grade 2 antigen . Rubella K2S grade antigen CMV grade 2 . HSV-1 type-specific recombinant gG-1 protein antigen . HSV-2 gG-2 type-specific recombinant gG-2 protein antigen The bead mix also contains one bead set designed to detect non-specific antibodies in the patient sample (if present) and four separate bead sets used for assay calibration. 2. Conjugate: Phycoerythrin conjugated goat anti-human IgG (y chain specific). Ready to use, 15 mL amber bottle. 3. Human positive serum control 1. One, 0.2 mL vial. 4. Human positive serum control 2. One, 0.2 mL vial. 5. Human negative serum control. One, 0.2 mL vial. 6. SAVe Diluent®. One 50 mL bottle containing phosphate-buffered-saline. Ready to use. NOTE, the sample diluent will change color in the presence of serum. 7. Wash Buffer Concentrate: dilute 1 part concentrate + 9 parts deionized or distilled water. One bottle containing 10 X concentrate of phosphate buffered saline. Non-Reactive Reagents 1. One, 96-well filtration plate for rinsing the microspheres 2. Data Labels: One label is adhered to the inside lid of the kit box and a second label is inside the kit box. 3. Package Insert providing instructions for use 4. Calibration CD: a compact disc that includes all lot-specific kit calibration values required for specimen analysis and assay quality control