Early diagnosis of rheumatoid arthritis (RA) can help to identify risk patients, prevent complications and progression, and help patients to recover more quickly. With wealthy experience in the in vitro diagnostic (IVD) immunoassay development, Creative Biolabs is proud to offer immunoassay development services targeting different autoantibody biomarkers, such as UH-RA.1, to improve the early diagnosis of RA.

Autoantibodies for RA Diagnosis

UH-RA.1 Marker-Creative Biolabs.

RA is a systemic inflammatory autoimmune disease characterized by the presence of various autoantibodies in serum and synovial fluid. The autoantigens recognized by these autoantibodies include cartilage components, chaperones, enzymes, nuclear proteins, and citrullinated proteins. Some of the autoantibodies, such as rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPAs), have demonstrated great clinical significance, due to their acceptable sensitivities and specificities, and prognostic values as disease biomarkers. However, despite the progress in biomarker discovery for RA diagnostics, still over one-third of RA patients, and even more in early disease, present without RF or ACPA. This makes it necessary to discover more autoantibody markers to improve the diagnostic accuracy of RA.

UH-RA.1 Autoantibody for RA Diagnosis

Recently, autoantibodies against novel HU-RA antigens have been identified as candidate biomarkers for patients with RA who are seronegative for the current diagnostic markers RF and ACPA. In the report, a total of four novel candidate biomarkers (UH-RA.1, UH-RA.9, UH-RA.14, and UH-RA.21) have been identified. About 300 people with Rheumatoid Disease (PRD) participate in the study, including some patients identified as otherwise seronegative. The results suggested that the UH peptides biomarkers enabled the identification of 26% of the RF-negative and ACPA-negative subpopulation. About 7% more PRD could be identified by adding this biomarker panel to the usual RF and ACPA. Within the patient group, the positive test confirmed the peptide’s ability to indicate reactivity in early disease. As early disease markers are of the utmost importance when aiming at preventing joint damage and disability, the discovery of these new biomarkers might reinforce current diagnostics and improve early diagnosis and intervention in RA.

IVD Immunoassay Development Services Provided by Creative Biolabs

Immunoassays, such as ELISA, are based on the specific recognition between the analytes and the pre-coated antigen or antibodies. Development of immunoassays can be difficult, with challenges including establishing method selectivity, specificity and range of quantitation as a result of nonspecific background signal, matrix interference, lack of linearity and antibody interference. With extensive experience in immunoassay development, Creative Biolabs offers services including but not limited to recombinant protein expression, antibody development, protocol establishment, assay validation, and manufacturing. Our professional project management team assists you throughout the entire course of a project. For more information please click the links below:

Workflow for production of an Immunoassay

High-quality antigens are of great importance for ensuring the sensitivity and specificity of diagnostic kits to detect autoantibodies in patient serum. Creative Biolabs is equipped with expertise in the production and purification of autoimmune antigens from native sources. Please feel free to contact us for more information if you are interested in our services.


  1. Song, Y. W., (2009). “Autoantibodies in rheumatoid arthritis: rheumatoid factors and anticitrullinated protein antibodies.” QJM: An International Journal of Medicine, 103(3), 139-146.
  2. De Winter, L. M., (2016). “Autoantibodies to two novel peptides in seronegative and early rheumatoid arthritis.” Rheumatology, 55(8), 1431-1436.

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