VivaBioCell Autoimmune Angiopathy Test

Systemic sclerosis (SSc) is a chronic multisystem disorder of unknown etiology characterized clinically by thickening of the skin caused by accumulation of connective tissue and by structural and functional abnormalities of visceral organs, including the gastrointestinal tract, lungs, heart, and kidneys. Vascular damage, immune activation, and excessive synthesis and deposition of extracellular matrix are prominent features of SSc. Presence of serum autoantibodies has been established as strong predictor of disease outcome and the pattern of organ complications in patients; however, the pathogenetic role of autoantibodies in scleroderma remains unclear, although there is a growing body of evidence that they are not just markers of disease, but also have a role in pathogenesis. Improved methods to detect and evaluate autoantibodies offer a real opportunity for risk stratification in sclerodermic patients, most of whom can be defined by their serological profile at initial presentation.

Almost all patients develop Raynaud's phenomenon which, together with structural vasculopathy, results in ulceration and critical digital ischemia. Many of the severe internal organ complications of SSc are vascular, including pulmonary arterial hypertension (PAH) and scleroderma renal crisis. Structural vascular damage occurs in many vascular beds and contribute to pulmonary, renal, cardiac and gastrointestinal complications.

Systemic lupus erythematosus (SLE) is a prototypic autoimmune disease characterized by the production of antibodies to components of the cell nucleus in association with a diverse array of clinical manifestations. The primary pathological findings in patients with SLE are those of inflammation, vasculitis, immune complex deposition, and vasculopathy.

VivaBioCell provides a cell-extract based test (Autoimmune Angiopathy Test) which is capable of identify SSc and SLE patients with very high specificity. The method is also capable of identify, within SSc patients (limited cutaneous and diffuse forms), subjects showing vascular complications phenomena (endothelial cells injury, microvascular damage, microhemorrhages, digital ulcers) also at early stages; moreover, positivity to this test correlates with presence of Raynaud’s phenomenon in SLE subjects.