Biosensor for Diagnosis of Autoimmune Diseases Related to the Ro/SSA Complex

Universitat Politècnica de València Background
Currently, autoimmune diseases related to the Ro/SSA complex (like systemic lupus erythematosus (LES), discoid lupus, Sjögren’s Syndrome, rheumatoid arthritis, among others) are difficult to diagnose. In the normal procedure, the diagnosis is done based on the information gathered by the doctors from several sources: medical record, laboratory test results, and the largest contributor—the patient’s current symptoms. In this way, currently, it is only when the disease starts to show clear symptoms that it can be diagnosed.
As for using laboratory tests for diagnosis, several trials have been developed to determine the autoantibodies, including ELISA, immunoblotting immunoassays, multiplex immunoassays and protein matrices. The key advantages of these tests are based on them being easy to use, flexible and low-cost. However, their main limitation is their low sensitivity, which limits determining the extremely low concentrations of antibodies circulating in the serum.
Therefore, the development of highly sensitive biosensors, as is proposed with this technology, is of great interest in order to determine autoantibodies at very low concentrations.
Technology Overview
New sensor system for diagnosis and prognosis of autoimmune diseases related to the Ro/SSA complex, such as systemic lupus erythematosus (LES), discoid lupus, Sjögren’s Syndrome, rheumatoid arthritis and others.
The invention includes the rapid detection of anti-Ro/SSA autoantibodies (diagnosis) and measuring the level of activity of the disease (prognosis).
The final objective is to integrate all of the stages into one point-of-care device and a diagnostic methodology that allows quantifying the total and partial content of autoantibodies in human biological samples (fluids and secretions that contain antibodies). ( and ) .
The methodology developed is capable of establishing a useful standard of interaction for the rapid detection of anti-Ro/SSA autoantibodies (diagnosis), in addition to quantifying the activity of the disease (prognosis).
For this reason, the proposal is focused on identifying and quantifying the levels of autoantibodies toward the Ro/SSA complex and its three components (La proteins, TRIM21 and TROVE2) in blood, saliva, lacrimal secretion and other human fluids that contain antibodies:

is done through measuring the piezometric response of the probe/biomarker interaction by placing a blood sample on the piezoelectric surface of the device. As proof of concept, using samples from lupic patients, the previous tests showed a sensitivity of 1.51 U/ml of autoantibodies.
As for , the clinical interest of these results has been shown based on biostatistical data, which correlate the level of autoantibodies with the disease’s activity.

In the technology’s current state of development, the equipment could be used in hospitals or medical clinics to take a blood samples in order to obtain a precise result that helps diagnose this type of autoimmune disease.
Stage of Development: Laboratory Prototype.
Further Details:

Allows for an early diagnosis of the disease, even before symptoms are shown.
Rapid and objective detection of anti-Ro/SSA antibodies.
Prognosis, allows measuring the disease’s level of activity.
Diagnosis and prognosis on one single platform.
There is no replacing point-of-care as the best methodology.


Diagnosis and prognosis of autoimmune diseases related to the Ro/SSA complex, such as systemic lupus erythematosus, discoid lupus, Sjögren’s Syndrome, rheumatoid arthritis and others.
Equipment that helps in diagnoses, for use in hospitals or medical clinics.
Patient service points close to users for quick testing and diagnosis.

The inventors are looking for companies interested in establishing patent license agreements for its use, development, manufacture or sale.

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