Search Results

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.

The ImmuGlo HEp-2 Elite IFA is an indirect immunofluorescence antibody test for the qualitative or semi-quantitative detection of anti-nuclear antibodies (ANA) of the IgG isotype in human serum utilizing standard HEp-2 cells and engineered HEp-2 cells as a substrate. The ImmuGlo HEp-2 Elite IFA is intended for use as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.

The ImmuGlo™ HEp-2 Elite IFA is an indirect immunofluorescence antibody test for the qualitative detection of anti-nuclear antibodies (ANA) of the IgG isotype in human serum utilizing standard HEp-2 cells as a substrate. The HEp-2 Elite sides provided with this kit contain a 1:9 mixture of standard HEp-2 cells and engineered HEp-2 cells with the PSP1 gene knocked out. The engineered HEp-2 cells are able to detect all ANA specificities with the exception of the DF570/AC-2 pattern resulting from autoantibodies associated with PSP2. In DF570 positive reactions standard HEp-2 cells provide a positive reaction while engineered HEp-2 cells do not. The HEp-2 Elite substrate thereby provides additionality to aid in discriminating homogeneous, speckled, and dense fine speckled (DFS70/AC-2) patterns during the screening phase.

Instrument & Software: The HELIOS® AUTOMATED IFA SYSTEM is an automated system for immunofluorescence processing with an integrated fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions. All suggested results obtained with the HELIOS® AUTOMATED IFA SYSTEM must be confirmed by trained personnel. Assay: AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies (ANA) in human serum by manual microscopy or with HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS® AUTOMATED IFA SYSTEM instrument must be confirmed by trained personnel.

The HELIOS® AUTOMATED IFA SYSTEM is an automated system for immunofluorescence processing with an integrated fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions.

Instrument: The Immuno Concepts Image Navigator is an automated system consisting of a fluorescent microscope and software that acquires, interprets, stores, and displays digital indirect immunofluorescent slides. The Image Navigator can only be used with cleared or approved Immuno Concepts in vitro diagnostic assays that are indicated for use on the microscope. All suggested results generated by the Image Navigator software must be confirmed by trained laboratory personnel. Assay: This is an indirect fluorescent antibody test for the semi-quantitative detection of IgG antinuclear antibody (ANA) in human serum by manual fluorescent microscopy or with the Image Navigator Fluorescence Semi-Automated Microscope. This test system uses transfected HEp-2000® cells, which allow specific identification of autoantibodies to the SSA/Ro antigen. Autoantibodies to SSA/Ro may show a distinctive staining pattern on the transfected cells. When this pattern is present, it is considered to be confirmatory evidence that anti-SSA/Ro antibodies are present. Absence of this distinctive pattern does not rule out the possible presence of anti-SSA/Ro antibodies. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease in conjunction with other laboratory and clinical findings. A trained operator must confirm results generated with the Image Navigator semi-automated device and software.

The Immuno Concepts Image Navigator is an automated system consisting of a fluorescent microscope and software that acquires, interprets, stores, and displays digital indirect immunofluorescent slides.

Instrument: The EUROPattern Microscope and Software is an automated system consisting of fluorescent microscope and software that acquires, interprets, stores and displays digital indirect immunofluorescence slides. The EUROPattern Microscope and Software can only be used with cleared or approved EUROIMMUN in vitro diagnostic assays that are indicated for use on the device. All suggested results obtained with the EUROPattern Microscope and Software must be confirmed by trained personnel. Assay: The EUROIMMUN IFA 40: HEp-20-10 EUROPattern is an indirect immunofluorescence antibody test for the qualitative or semiquantitative determination of IgG antibodies against antibody (ANA) in human serum with the EUROPattern Microscope and Software automated instrument. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

The EUROPattern Microscope and Software is an automated system consisting of fluorescent microscope and software that acquires, interprets, stores and displays digital indirect immunofluorescence slides.

NOVA Lite® DAPI ANA Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-nuclear antibodies of the IgG isotype in human serum by manual fluorescence microscopy or with the NOVA View Automated Fluorescence Microscope. 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. A trained operator must confirm results when generated with the NOVA View device.

The NOVA Lite DAPI ANA Kit is an indirect immunofluorescence assay for the detection and semiquantitative determination of anti-nuclear antibodies in human serum. Kit components: - HEp-2 (human epithelial cell) substrate slides; 12 wells/slide, with desiccant. - FITC IgG Conjugate with DAPI, containing 0.09% sodium azide; ready to use. - Positive Control: ANA Titratable Pattern, human serum with antibodies to HEp-2 nuclei in buffer, containing 0.09% sodium azide; pre-diluted, ready to use. - . Negative Control: IFA System Negative Control, diluted human serum with no ANA present, containing 0.09% sodium azide; pre-diluted, ready to use. - PBS II (40x) Concentrate, sufficient for making 2000 mL of 1x PBS II. - Mounting Medium, containing 0.09% sodium azide ● - Coverslips

The EUROIMMUN IFA 40: HEp-20-10 is an indirect immunofluorescence antibody test for the qualitative or semi-quantitative detection of antibodies against cell nuclei (ANA) in human serum. This test system is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.

The test system consists of BIOCHIPs coated with HEp-20-10 cells. It includes a fluorescein-labeled goat anti-human IgG, a positive and negative control, salt for PBS, Tween 20, embedding medium, cover glasses and instruction booklet. Reagent trays for the TITERPLANE technique are required but ordered separately.

AESKUSLIDES ANA-HEp-2 is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum. AESKUSLIDES ANA-HEp-2 Test System is intended for use as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.

Not Found

The EUROIMMUN ANA IFA:HEp-20-10 is an indirect fluorescent antibody test for the qualitative or semiquantitative detection of antibodies against cell nuclei (ANA) in human serum and EDTA-plasma. This test system is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.

Not Found

The HEP-ANA Test System is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies in human serum. The HEP-ANA Test System is intended for use as an aid in the diagnosis of certain autoimument diseases.

The RhiGene HEP-ANA Test System is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate, similar to the predicate device. Diluted serum samples are incubated on substrate slides coated with HEP-2 (human epithelial) cells. Incubation allows the anti-nuclear antibodies (ANA) present in the samples to react with the antigen. After the removal of unbound serum proteins by washing, antibodies specific for human immunoglobulins, labeled with fluorescein isothiocyanate (FITC), are added forming complexes with the nuclear bound antibodies. Following another washing step, coverslips are mounted and then the slides are examined with a fluorescence microscope. The total incubation time (at room temperature in a moist chamber) of the assay is 40 minutes.