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New Study Highlights the Diagnostic Power of CytoBead ANA 2
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The image features the title: “CytoBead® ANA 2 assay – a novel method for the detection of antinuclear antibodies.” Below the title, there is a list of authors with superscript numbers indicating their affiliations. The journal logo “scientific reports” is displayed in the upper left corner with the word “OPEN” indicating it is an open-access article. On the right side, there is a photograph of a female scientist wearing a white lab coat and looking into a microscope. The design incorporates a blue diagonal element at the bottom right and subtle dotted patterns in the background.
14.07.2025

New Study Highlights the Diagnostic Power of CytoBead ANA 2

We are pleased to share the results of a newly published peer-reviewed study in Scientific Reports that demonstrates the diagnostic performance of the CytoBead® ANA 2 assay1.

In clinical diagnostics, the detection of antinuclear antibodies (ANA) is crucial in identifying systemic autoimmune rheumatic diseases (SARDs). Traditional methods rely on a two-step algorithm: ANA screening by indirect immunofluorescence assay (IFA) on HEp-2 cells, followed by confirmatory testing for specific autoantibodies. However, this approach can be time-consuming, costly, and susceptible to human interpretation variability.

Study Results for CytoBead® ANA 2 and ANA DFS-70

The study, conducted at the prestigious Sheba Medical Center, evaluated 112 routine serum samples using CytoBead® ANA 2 and compared the results to conventional ANA IFA from Inova-Werfen and the BioPlex™ 2200 multiplex assay from Bio-Rad. The findings are compelling:

  1. Substantial agreement was found between CytoBead® ANA 2 and classical ANA IFA (Cohen’s κ = 0.74), with notable cases where CytoBead ANA 2 detected specific autoantibodies in ANA IFA-negative samples.
  2. Good to almost perfect agreement was observed between CytoBead® ANA 2 and the multiplex assay for ANA-specific autoantibody detection (κ values from 0.70 to 0.90).
  3. CytoBead® ANA 2 identified autoantibodies including anti-SS-A/Ro, anti-dsDNA, and anti-Sm in clinically relevant cases missed by conventional IIF.

HEp-2 nuclear speckled patter for anti-SS-A/Ro antibodies 

Additionally, the study also validated the CytoBead® Technology variant CytoBead® ANA DFS-70 for distinguishing the dense-fine speckled (DFS) pattern often seen in healthy individuals. CytoBead® ANA DFS-70 successfully detected 100% of anti-DFS70-positive samples confirmed by BIO-FLASH® (Inova-Werfen). In ANA-positive patients without SARDs, the assay confirmed anti-DFS70 antibodies in 68.9% of those showing a DFS pattern, underscoring its effectiveness in ruling out SARDs and minimizing unnecessary follow-up testing.

Conclusion

This publication confirms that CytoBead® Technology offers a powerful, one-step alternative to the conventional two-tier ANA testing workflow. By combining ANA screening and confirmatory testing in a single reaction, the CytoBead® Technology streamlines diagnostics, reduces costs, and enhances result reliability.

At Medipan & GA Generic Assays, we remain committed to providing innovative solutions that improve autoimmune diagnostics. We invite laboratories and clinicians to explore how available CytoBead® Technology dedicated to the ANA determination and how it can transform their ANA testing strategy.

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IFA for standard microscope8065 – CytoBead® ANADetermination of IgG antibodies in human serum against nuclear and cytoplasmic antigens, using slides coated with HEp-2 cells and beads coated with dsDNA, Scl-70, SS-A/Ro60, SS-A/Ro52, SS-B, Sm, and Sm/RNP, and CENP-B.
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IFA for standard microscope8220 – CytoBead® ANA 2Determination of IgG antibodies in human serum against nuclear and cytoplasmic antigens, using slides coated with HEp-2 cells and beads coated with dsDNA, Scl-70, SS-A/Ro60, SS-A/Ro52, SS-B, Sm, and Sm/RNP, and Jo-1.
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References

  1. Roei, et al. (2025), CytoBead ANA 2 assay – a novel method for the detection of antinuclear antibodies ↩︎