aiSLE ^®DX:

Developing aiSLE® DX FRI

The aiSLE® DX tests were developed from studies of SLE patients presenting for treatment at several lupus Centers of Excellence in the United States. Studies were completed in both European and African Americans SLE patients, and indicated the ability of the assay to potentially provide a robust, predictive gauge of impending disease flare with high degrees of accuracy. Patients in each study with confirmed disease flares were matched after a baseline pre-flare assessment, with SLE patients without impending flare (non-flare), and healthy controls.

How it works

A well-defined set of immune modulatory soluble mediators, including cytokines, chemokines, and soluble receptors shown to be altered in plasma prior to disease flare in SLE patients, are examined in this test Although any one individual biomarker might not be universally correlated with the development of flares, the overall balance between inflammatory and regulatory mediators has demonstrated the potential to predict impending flares in SLE patients.

A number of soluble immune mediators were assessed in these SLE patients for baseline and follow up plasma levels. Subsequent work has refined and narrowed the number of immune mediators that are included in the aiSLE® DX Flare Risk Index. An algorithm using weighted levels of a panel of immune mediators is used to calculate a Flare Risk Index (FRI), which assigns an individual risk score indicative of the patient’s risk of an impending flare within the next 12 weeks.

Developing aiSLE® DX DAI

The aiSLE® DX tests were developed from studies of SLE patients presenting for treatment at several lupus Centers of Excellence in the United States. Studies to develop the disease activity test compared samples from patients with classified SLE with low disease activity (< 4, range 0-3) to active disease (≥4, range 4-30) as defined by the hybrid SLEDAI (hSLEDAI). The Disease Activity Index provides an objective measure of an SLE patient’s concurrent disease activity with high degrees of accuracy.

How it works

A well-defined set of immune modulatory soluble mediators, including cytokines, chemokines, and soluble receptors shown to be associated with disease activity in plasma are examined in this test. Although any one individual biomarker might not be associated with disease activity, the panel of immune mediators examined in this test accurately and distinguishes patients with active clinical disease from those with low activity or quiescent disease in a simple blood test.

Hybrid measures, like SELENA-SLEDAI and BILAG, are time consuming and require rheumatologists to assess physical symptoms and multiple laboratory tests. The aiSLE® DX Disease Activity Test supports clinicians in the measurement of lupus disease activity and the assessment of treatments.