Population-based study of diagnostic assays for Borrelia infection: comparison of purified flagella antigen assay (Ideia™, Dako Cytomation) and recombinant antigen assay (Liaison®, DiaSorin)
2008

Comparing Tests for Borrelia Infection

Sample size: 897 publication Evidence: moderate

Author Information

Author(s): Eskild Petersen, Martin Tolstrup, Francesco Capuano, Svend Ellermann-Eriksen

Primary Institution: Aarhus University Hospital Skejby, Aarhus, Denmark

Hypothesis

Borrelia-specific assays using recombinant antigens perform differently from assays based on purified flagella antigen.

Conclusion

Diagnostic assays based on flagella antigen show more false-positive IgM and false-negative IgG results than assays based on recombinant antigens.

Supporting Evidence

  • The IDEIA™ system produced 21 false-positive IgM results, while the LIAISON® system produced only one.
  • The LIAISON® system identified more true IgG-positive samples than the IDEIA™ system.
  • The study included 357 consecutive samples for analysis of Borrelia IgM and IgG antibodies.

Takeaway

This study looked at two tests for a disease caused by Borrelia and found that one test is better at finding the disease without giving false alarms.

Methodology

The study compared the use of recombinant antigens and purified flagella antigen in assays for Borrelia-specific IgM and IgG antibodies on serum samples from general practice.

Potential Biases

Potential bias due to the selection of samples from general practice rather than from well-defined clinical cases.

Limitations

The study reflects results from unselected samples, which may not represent all clinical cases.

Participant Demographics

All patients were permanent residents in Denmark, with no selection based on sex or age.

Statistical Information

P-Value

<0.0001

Statistical Significance

p<0.0001

Digital Object Identifier (DOI)

10.1186/1472-6890-8-4

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