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Assay: ZEUS IFA™ ANA HEp-2 Test System is an indirect immunofluorescence assay for the qualitative detection and semiquantitative determination of IgG anti-nuclear antibodies in human serum by manual fluorescence microscopy or with ZEUS dlFine®. The presence of anti-nuclear antibodies can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of systemic lupus erythematosus and other systemic rheumatic diseases. All suggested results obtained with ZEUS dIFine® must be confirmed by a trained operator. Instrument: ZEUS dIFine® is an automated instrument consisting of a fluorescent microscope and software that acquires, interprets, stores and displays digital images of stained indirect immunofluorescence slides. ZEUS dlFine can only be used with FDA cleared or approved ZEUS in vitro diagnostic assays that are indicated for use on this instrument. All suggested results obtained with ZEUS dIFine must be confirmed by a trained operator

ZEUS dIFine® is an automated instrument consisting of a fluorescent microscope and software that acquires, interprets, stores and displays digital images of stained indirect immunofluorescence slides.

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System: The ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of having Lyme disease. Positive and equivocal test results with the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following methods: (1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using one of the following three ELISA-based assays: - ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System - ZEUS ELISA Borrelia burgdorferi IgM Test System - ZEUS ELISA Borrelia burgdorferi IgG Test System Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data. Zeus ELISA Borrelia burgdorferi IgG/IgM Test System: The ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG and IgM class antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. Positive and equivocal test results with the ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following methods: (1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System. Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.

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The ZEUS ELISA Borrelia VLSe-1/PepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This kit is for in vitro diagnostic use.

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The ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System is intended for the in vitro, qualitative measurement of IgG, IgM and/or IgA antibodies directed to cardiolipin in human serum to aid in the diagnosis of primary antiphospholipid syndrome (PAPS) and secondary antiphospholipid syndrome (SAPS) in conjunction with other laboratory and clinical findings.

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The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing. The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients.

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The ZEUS ELISA Treponema pallidum IgG Test System is intended for the qualitative detection of specific IgG class antibodies to T. pallidum in human serum. The test may be used in conjunction with non treponemal testing and clinical findings to provide serological evidence of infection with T. pallidum. This test is for in vitro diagnostic use only. This test is not intended for screening blood or plasma donors.

The ZEUS ELISA Treponema pallidum IgG Test System is designed to detect IgG class antibodies in human sera to Treponema pallidum. Wells of plastic microwell strips are sensitized by passive absorption with T. pallidum antigen. The test procedure involves three incubation steps: 1. Test sera are diluted with SAVE Diluent. During sample incubation, any antigen specific lgG antibody in the sample will bind to the immobilized antigen. The plate is washed to remove unbound antibody and other serum components. 2. Peroxidase conjugated goat anti-human IgG is added to the wells and the plate is incubated. The conjugate will react with IgG antibody immobilized on the solid phase in step 1. The wells are washed to remove unbound conjugate. 3. The microwells containing immobilized peroxidase conjugate with peroxidase substrate solution. Hydrolysis of the substrate by peroxidase produces a color change. After ten minutes have elapsed, the reaction is stopped and the color intensity of the solution is measured photometrically. The color intensity of the solution depends on upon the antibody concentration in the original test sample.

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

The Zeus Scientific, Inc AtheNA Multi-Lyte Borrelia VISE-1/ pepC10 Plus Test System is a multiplexed sandwich immunoassay for the qualitative detection of IgG class antibody to recombinant VISE-1 and the IgM class of antibody to synthetic pepC10 in human serum. The AtheNA Multi-lyte Borrelia VISE-1/pepC10 Plus Test System is intended for use with the Luminex® 200 IS and the AtheNA Multi-Lyte data management package in testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive specimens should be tested with a second-tier test such as Western Blot which if positive, is supportive evidence of infection with B.burgdorferi. Diagnosis of Borreliosis should be made based on the presence of 8.burgdorferi antibodies, history, symptoms and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis.

The AtheNA Multi-Lyte Borrelia VlsE-1/pepC10 Plus Test System is a micro particle immunoassay intended for the qualitative detection of distinct IgG class antibody to VlsE-1 and distinct IgM antibody to pepC10. The assay is a multiplexed immunoassay designed to simultaneously detect, distinguish and identify IgG reactivity to recombinant VISE-1 antigen and IgM reactivity to synthetic pepC10 antigen. The test system is comprised of the AtheNA Multi-Lyte test kit and the Luminex Corp instrument model number Luminex™ 200 IS and software version 3.