Rapid test for rheumatoid arthritis

Chronic inflammatory processes of the musculoskeletal system within the framework of immune-mediated diseases can cause severe damage to joints, muscles and/ or tendons. Approximately 8% of the world's population is affected; in the German-speaking world alone, more than 5 million people suffer from immune-mediated diseases.

Rheumatoid arthritis (RA) is one of the most common chronic inflammatory joint diseases with a frequency of about 1% in Northern Europe. The formation of so-called autoantibodies e. g. against the protein CCP is associated with its occurrence. These antibodies may be detectable years before the onset of the disease.

Early diagnosis of immune diseases

The early diagnosis of immune diseases is of great importance as it leads to an earlier therapy and thus to the avoidance of long-term consequences. Unfortunately, the diagnosis is usually delayed, as the patient mostly first presents to the general practitioner or orthopaedic surgeon instead of the rheumatologist, where a specific diagnosis could be made.

Therefore, there is a great need for early diagnostic systems in order to identify affected patients at an early stage and to be able to refer them to a specialist for specialized care. However, a rapid test procedure, e. g. based on various antibody tests, does not yet exist.

Development of a rapid test system

The aim is to develop a rapid test system for the detection of specific antibodies of various immune-mediated diseases. The target group includes patients with non-specific complaints of the musculoskeletal system who can be quickly diagnosed by a rapid clarification of the antibody status.

In addition, this test system is intended to provide indications of a systemic inflammatory reaction in order to improve direct outpatient care by the family doctor or general practitioner. This would avoidwaiting for laboratory results from the central laboratory and decisions on further treatment could already be made at the initial presentation of the patient.

The early sensitive and specific detection of the named antibody profiles could simplify the diagnosis and accelerate the referral of the patient to the specialist, but could also identify patients for whom such a diagnosis can be ruled out.

Interdisciplinary expertise

Fraunhofer ISIT provides expertise on silicon-based biosensor technology and the development of multiparametric sensor chips (in cooperation with the external partner CAMPTON Diagnostics GmbH) as Fraunhofer-specific competencies. Fraunhofer ITMP provides medical expertise and access to patient cohorts and respective sample material.

Outlook

The entire point-of-care market has been growing steadily in recent years, as several studies have shown. There is a market for rapid on-site detection of e. g. rheumatoid arthritis, as this is an innovative test that no other provider has in its portfolio. The benefit for the patient is very high, because a suitable therapy can be started quickly.

A new market could be developed in particular in the area of general practitioners, as the point-of-care test can be carried out quickly and easily, and results are immediately available during the presentation of the patient. In addition, it is also possible to directly test the humoral inflammatory activity, which otherwise requires another expensive laboratory test with delayed results.

The project will develop an innovative ELISA test using a fully automated biochip detection system that can also be used on conventional microtiter platforms. The charm of the CAMPTON system is that this ELISA runs within a few minutes, which is not possible with the previous practice of an ELISA test in the laboratory.