New rapid point-of-care test for diagnosing RA
Novio Catalpa and researchers at Radboud University have developed an easy-to-perform, rapid test that can detect ACPA in whole blood using a method called hemagglutination. The test is user-friendly, making it suitable for point-of-care testing, without the need for laboratory infrastructure. The innovative technology is patented in various continents around the world.
- Testing can be done without special skills or sophisticated equipment
The patient can be tested and diagnosed at point-of-care
- The test can compete with the Gold Standard.
- Result of the test is available within 30 minutes via visual read-out
Visual read-out of test result readily available
The test uses a specially engineered protein that causes blood cells to clump together, or agglutinate, when ACPA are present. This clumping can be seen with the naked eye, eliminating the need for complex equipment. Key component of this test is a single-chain antibody fragment that binds to a protein on the surface of red blood cells and a citrullinated peptide that binds to ACPA. The test results are available within 2 to 30 minutes, without the need of a lab technician or sophisticated equipment.
Test can compete with current Gold Standard
The new method was tested on blood samples from 200 patients with RA and 100 patients with psoriatic arthritis (PsA), a condition used as a control group. The test successfully detected ACPA in 48-61% of the RA samples, showing a sensitivity close to that of the Gold Standard, CCP2 ELISA. In contrast, the test only caused agglutination in 9% of the PsA samples, confirming its specificity for RA. Further modifications to the agglutination assay will be made to enhance its sensitivity to the Gold Standard benchmark of 63% and beyond.
Extremely cost-effective testing
The costs for the new test are significantly lower than that of the Gold Standard. This applies not only to performing the test, but also to its production. The new test provides a rapid, efficient, and an easy-to-use method for detecting ACPA in blood, potentially improving drastically the approach to early diagnosis and treatment of RA.