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Nova lite hep 2 ana slide with dapi kit

Manufactured by Inova Diagnostics
Sourced in United States

The NOVA Lite HEp-2 ANA slide with DAPI kit is a laboratory diagnostic product used for the detection of antinuclear antibodies (ANA) in human serum samples. The kit includes HEp-2 cells that are fixed on a slide and pre-stained with DAPI, a fluorescent dye that binds to DNA. The product is designed for in vitro diagnostic use.

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7 protocols using nova lite hep 2 ana slide with dapi kit

1

ANA Quantification via Fluorescence Microscopy

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ANA were measured across four time periods as described previously (1 (link)) with indirect immunofluorescence at a 1:80 dilution using the NOVA Lite HEp-2 ANA slide with DAPI kit (INOVA Diagnostics, San Diego, CA) with a highly specific fluorescein isothiocyanate (FITC)-conjugated secondary antibody (goat anti-human IgG). Images were captured via the NOVA View automated fluorescence microscope system (INOVA Diagnostics) and stored digitally. Staining intensities were graded from 0 to 4 relative to a standard reference gallery, with non-zero values (e.g., values 1-4) considered indicative of ANA positivity (1 (link)). All samples from all years were assayed at the same time, using the same methods in a single laboratory. Readings were made independently by at least two experienced evaluators (blinded to sample characteristics and time period), who agreed on >95% of the intensities and patterns; differences were resolved by consensus or adjudicated by a third blinded rater. Repeat testing of random samples showed >98% concordance.
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2

Standardized ANA Immunofluorescence Evaluation

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Serum samples were shipped with dry ice and stored at −80°C until evaluation by indirect immunofluorescence at a 1:80 dilution using the NOVA Lite HEp-2 ANA slide with DAPI kit (INOVA Diagnostics, San Diego, CA), with a highly specific fluorescein isothiocyanate (FITC)-conjugated secondary antibody (goat anti-human IgG). Images were captured via the NOVA View automated fluorescence microscope system (INOVA Diagnostics) and stored digitally. Immunofluorescence staining intensities were graded 0-4 compared to standard references (8 (link)). Values of 1-4 indicated ANA positivity; those graded 3 or 4 were further assessed by sequential ANA titers up to 1:1280 dilution. ANA patterns (including nuclear, cytoplasmic, or mitotic) were defined according to international consensus (15 (link)). All samples were assayed using the same methods in a single laboratory. Readings were made independently by at least two experienced evaluators (blinded to sample characteristics and time period), who agreed on >95% of the intensities and patterns; differences were resolved by consensus or adjudicated by a third blinded rater. Repeat testing of random samples showed >98% concordance.
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3

Standardized Indirect Immunofluorescence Assay

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Serum samples were evaluated by indirect immunofluorescence at a 1:80 dilution using the NOVA Lite HEp-2 ANA slide with DAPI kit (INOVA Diagnostics, San Diego, CA, USA) and a highly specific fluorescein isothiocyanate conjugated secondary antibody (goat anti-human IgG). Images captured via the NOVA View automated fluorescence microscope system (INOVA Diagnostics) were stored digitally. Immunofluorescence staining intensities were assigned integer grades from 0 to 4, relative to standard references, with nonzero grades indicating ANA positivity (Dinse et al. 2020 (link)). All samples were assayed in a single laboratory, using identical methods. At least two experienced evaluators made independent readings, blinded to participant characteristics and time period, and they agreed on over 95% of the grades; differences were resolved by consensus or adjudicated by a third blinded rater. Repeat testing of 200 random samples showed over 98% concordance.
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4

Standardized Indirect Immunofluorescence Assay

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Serum samples were evaluated by indirect immunofluorescence at a 1:80 dilution using the NOVA Lite HEp-2 ANA slide with DAPI kit (INOVA Diagnostics, San Diego, CA, USA) and a highly specific fluorescein isothiocyanate conjugated secondary antibody (goat anti-human IgG). Images captured via the NOVA View automated fluorescence microscope system (INOVA Diagnostics) were stored digitally. Immunofluorescence staining intensities were assigned integer grades from 0 to 4, relative to standard references, with nonzero grades indicating ANA positivity (Dinse et al. 2020 (link)). All samples were assayed in a single laboratory, using identical methods. At least two experienced evaluators made independent readings, blinded to participant characteristics and time period, and they agreed on over 95% of the grades; differences were resolved by consensus or adjudicated by a third blinded rater. Repeat testing of 200 random samples showed over 98% concordance.
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5

Standardized Indirect Immunofluorescence Assay

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Serum samples were evaluated by indirect immunofluorescence at a 1:80 dilution using the NOVA Lite HEp-2 ANA slide with DAPI kit (INOVA Diagnostics, San Diego, CA, USA) and a highly specific fluorescein isothiocyanate conjugated secondary antibody (goat anti-human IgG). Images captured via the NOVA View automated fluorescence microscope system (INOVA Diagnostics) were stored digitally. Immunofluorescence staining intensities were assigned integer grades from 0 to 4, relative to standard references, with nonzero grades indicating ANA positivity (Dinse et al. 2020 (link)). All samples were assayed in a single laboratory, using identical methods. At least two experienced evaluators made independent readings, blinded to participant characteristics and time period, and they agreed on over 95% of the grades; differences were resolved by consensus or adjudicated by a third blinded rater. Repeat testing of 200 random samples showed over 98% concordance.
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6

ANA Detection by Immunofluorescence Assay

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The study used existing data on ANA (12 (link)). Serum samples were shipped cold and stored at -80°C, until they were tested at the 1:80 dilution using the HEp-2 indirect immunofluorescence assay NOVA Lite HEp-2 ANA slide with DAPI kit (INOVA Diagnostics, San Diego, CA), and using a highly specific fluorescein isothiocyanate (FITC)-conjugated secondary antibody (goat anti-human IgG). Images were read using the NOVA View automated fluorescence microscope system (INOVA Diagnostics). Staining intensity was rated on a scale of 0 to 4; ANA positivity was defined as any signal above zero. Assays were performed in a single laboratory and evaluated independently by two experienced reviewers who agreed on > 95% of overall ratings, with differences revolved by consensus or a third reviewer. A random sample of samples were rated with over 98% concordance.
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7

ANA Immunofluorescence Staining Assay

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Serum samples were shipped with dry ice and stored at −80°C until evaluated by indirect immunofluorescence at a 1:80 dilution using the NOVA Lite HEp-2 ANA slide with DAPI kit (INOVA Diagnostics), with a highly specific fluorescein isothiocyanate-conjugated secondary antibody (goat anti-human IgG). Images were captured using the NOVA View automated fluorescence microscope system (INOVA Diagnostics) and stored digitally. Immunofluorescence staining intensities were graded using a 0-4 scale compared to standard references (8 (link)). Participants who had grades of 1-4 were positive for ANA; those with grades of 3 or 4 were further assessed by sequential ANA titers up to 1:1280 dilution. ANA patterns, including nuclear, cytoplasmic, or mitotic, were defined according to international consensus (15 (link)). All serum samples were assayed using the same methods in a single laboratory. Readings were made independently by at least 2 experienced evaluators (who were blinded with regard to sample characteristics and time period), who agreed on >95% of the intensities and patterns; differences were resolved by consensus or adjudicated by a third blinded rater (EKLC) who was also blinded with regard to sample characteristics. Repeat testing of random samples showed >98% concordance.
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