Related Experiment Video
Updated: Apr 27, 2026
Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay
Published on: September 10, 2018
[Performance and clinical evaluation of antinuclear antibody test based on fluorescence enzyme immunoassay]
Insights
The new EliA CTD Screen assay shows superior diagnostic performance for antinuclear antibodies (ANA) screening in connective tissue diseases (CTD) compared to existing methods. This enzyme fluoroimmunoassay offers improved accuracy for ANA detection in patient serum.
Area of Science:
- Immunology
- Clinical Chemistry
Context:
- Antinuclear antibodies (ANA) are crucial biomarkers for screening connective tissue diseases (CTD).
- Current indirect immunofluorescence (IF) assays for ANA lack specificity for disease identification and antigen reactivity.
- There is a need for more accurate and specific methods for ANA detection in clinical diagnostics.
Purpose:
- To evaluate the performance of the novel EliA CTD Screen (EliA) enzyme fluoroimmunoassay for detecting ANA in human serum.
- To compare the diagnostic accuracy of EliA with conventional IF assays and a commercial MESACUP assay.
Summary:
- The study analyzed 732 serum samples, including healthy donors and patients with CTD and related conditions.
- EliA demonstrated a sensitivity of 73.7% and specificity of 78.7%, with an Area Under the Curve (AUC) of 0.821.
- EliA exhibited superior diagnostic performance and concordance compared to MESACUP and IF assays, indicating its potential for CTD screening.
Impact:
- The EliA assay shows promise as an effective tool for the initial screening of connective tissue diseases.
- Improved diagnostic accuracy of ANA detection can lead to earlier and more precise diagnosis of CTD.
- This evaluation contributes to the advancement of laboratory diagnostics for autoimmune and connective tissue diseases.
Background:
The measurement of antinuclear antibodies (ANA) is used for screening of connective tissue diseases (CTD) in the laboratory. ANA detection is performed by indirect immunofluorescence (IF) assay on HEp-2 cells from human larynx carcinoma. However, it lacks specificity for the identification of specific diseases and antigen reactivity. The aim of the present study was to evaluate the EliA CTD Screen (EliA), a new enzyme fluoroimmunoassay (Phadia AB, Uppsala, Sweden) for detection of ANA in human serum.
Patients And Methods:
The study involved a total of 732 serum samples, 200 from healthy donors, 297 from patients with CTD and 235 from patients with rheumatoid arthritis, vasculitis syndrome and relative disease of CTD. For all sera, ANA was measured by IF, commercial assay (MESACUP) and EliA.
Result:
The sensitivity and specificity of EliA were 73.7% and 78.7%, respectively, whereas those of MESACUP were 80.8% and 64.7%, respectively. Area under the receiver operating curves for EliA, MESACUP and IF were 0.821, 0.786 and 0.730, respectively. The concordance rate between EliA and MESACUP was 84.2%. These discrepancies between those 2 assays were found in 84 sera. Further investigation were done by each ANA antigen tests for the discrepant results of EliA in 83 sera. The discrepancies might be occurred by antigen difference or non-specific response.
Conclusion:
AUC results showed that the diagnostic performance of EliA was superior to MESACUP and IF. EliA had a good performance as method for screening of CTD.
Related Concept Videos
01:33Enzyme-Linked Immunosorbent Assay
There are many different types of ELISAs, but they all involve an antibody molecule whose constant region binds an enzyme, leaving the variable region free to bind its specific antigen. Enzyme-substrate reaction allows the antigen to be visualized or...
01:12Immunofluorescence Microscopy