Is EliA dsDNA suitable for the monitoring of SLE?

Is EliA dsDNA suitable for the monitoring of SLE?

dsDNA as monitoring marker is not mentioned as intended use in our DfUs. However, it has been shown in several studies, that EliA dsDNA reflects the disease activity and the involvement of the kidney. Therefore it can be used as monitoring marker.  In the following, the references are sorted by publishing data:

Hernando M et al. Clinical Evaluation of a New Automated Anti-dsDNA Fluorescent Immunoassay.

 

Varelisa

EliA

Farr

CLIFT

Sensitivity for SLE (%)

44.7

39.5

31.6

13.2

Sens. for active SLE (%)

70.8

70.8

66.7

29.2

Sens. for nephritic SLE (%)

70.0

55.0

50.0

25.0

Specificity (%)

82.5

93.2

96.1

99.0

  • "In conclusion, the EliA™ dsDNA assay showed a very good specificity for SLE and a good sensitivity for active SLE. This assay can be used for diagnosing SLE and also for the follow-up of the disease activity."
  • "However, in clinical laboratories in which the Farr assay cannot be employed,the good sensitivity, high specificity, analytical accuracy, high degree of automation, and simplicity of execution of the EliA dsDNA test make it particularly appropriate for both the diagnosis and the monitoring of SLE patients."
  • "When compared with the ELISA, the newly developed FIA had better correlation with the serial changes of SLEDAI and C4, and was inversely correlated with the serum levels of C3. In addition, FIA had the advantage of better correlation with the occurrence of nephritis. It is worth developing this method for clinical evaluation of disease activity in SLE patients."
  • "In this retrospective study of a large cohort of patients, the new EliA dsDNA assay was demonstrated to be of slightly more diagnostic value for detecting lupus flares than the CLIFT. These data, together with the easier handling of the method, make EliA dsDNA a suitable tool for monitoring of SLE patients."
  • "CLIFT assay is likely to be accurate...; however, even though easy to perform, it is greatly operator-dependent and semiquantitative in antibody level measurement. Antibody quantitation by serum titration is considered inadequate in measuring changes in anti-dsDNA levels during disease course."
    "The ROC curves with our data showed that the EliA assay performs better than the Farrzyme dsDNA test."
  • "As regards SLE clinical monitoring, the assays gave meaningful results, generally concordant one to the other in realtion to global activity and organ specific involvement, mostly renal and haematologic, as expected. In addition, antibody levels correlated with global disease activity score measured by ECLAM score, in an independent manner."
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As in all diagnostic testing, the diagnosis is made by the physican based on both test results and the patient history.