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Simultaneous Distinction of Monospecific and Mixed DFS70 Patterns During ANA Screening with a Novel HEp-2 ELITE/DFS70 Knockout Substrate
Published on: January 17, 2018
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Development and multi-center evaluation of a novel immunoadsorption method for anti-DFS70 antibodies
C Bentow1, R Rosenblum1, P Correia2
1Department of Research, Inova Diagnostics, Inc., San Diego, USA.
Lupus
|June 3, 2016
Summary
A new indirect immunofluorescence method effectively blocks anti-DFS70 antibodies, improving the diagnosis of ANA-associated rheumatic diseases by distinguishing them from healthy individuals. This enhances diagnostic accuracy for antinuclear antibodies (ANA).
Area of Science:
- Immunology
- Autoimmunity
- Diagnostic Assay Development
Background:
- Antinuclear antibodies (ANA) are key biomarkers for ANA-associated rheumatic diseases (AARD).
- Anti-DFS70 antibodies are frequently found in healthy individuals, complicating AARD diagnosis.
- Distinguishing anti-DFS70 from disease-specific ANAs is crucial for accurate diagnosis.
Purpose of the Study:
- To develop and evaluate a novel, highly specific indirect immunofluorescence (IIF) method.
- The method aims to block anti-DFS70 antibodies from binding to HEp-2 cells.
- To assess the method's performance in a multi-center study for improved AARD diagnostics.
Main Methods:
- An immunoadsorption method was developed using samples from SLE patients and healthy individuals.
- A multi-center evaluation involved 99 samples with a dense fine speckled (DFS) pattern.
- Samples were tested using IIF (NOVA Lite HEp-2 ANA, NOVA Lite HEp-2 Select) and chemiluminescent immunoassay (CIA) for anti-DFS70 confirmation.
Main Results:
- The immunoadsorption method reduced positive anti-DFS70 results in healthy individuals.
- A strong correlation was observed between IIF light intensity units (LIU) and CIA results for anti-DFS70 antibodies.
- The NOVA Lite HEp-2 Select method significantly decreased LIU values after DFS70 antigen inhibition, preserving other clinically relevant patterns.
Conclusions:
- The developed NOVA Lite HEp-2 Select kit effectively inhibits anti-DFS70 antibody binding.
- This inhibition preserves the detection of other clinically relevant ANA patterns.
- The method shows promise for improving the specificity of ANA testing in AARD diagnosis.
