Technical Name Precision Test Kits for Diagnosis of Rheumatoid Arthritis (IgG anti-BR1 ELISA)
Project Operator China Medical University
Project Host 蔡嘉哲
The serological test (anti-BR1 IgG ELISA) is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-BR1 antibodies in patient seracitratedEDTA plasma. A novel serological test which can increase the sensitivityspecificity of original test. Compared to RFACPA, our serological test can increase the sensitivity from 66.3 to 87.1 The presence of these antibodies, when considered in conjunction with other laboratoryclinical findings, is an aid in the diagnosis of rheumatoid arthritis.
Scientific Breakthrough
The sensitivity of IgG anti-BR1 ELISA detection kit is higher than Roche, InovaIBL detection kit. Moreover, IgG anti-Anti-BR1 detection kit can screen out more than 50 Rheumatoid arthritis patients in RFACPA double negative patients. Our detection kit can help diagnosis of Rheumatoid arthritis,has potential to be the third serologic detection in the future.
Industrial Applicability
As one of the rheumatoid arthritis criteria, the sensitivity of RF plus ACPA is only 66.3. However, the sensitivity increase to 87.1 while RFACPA plus BR1 together. This result shows that Anti-BR1 detection kit can increase the sensitivity of diagnosis in Rheumatoid arthritis. And if BR1 become the third serologic detection in clinical, the sensitivity will be increasewill be supportive for clinical diagnosis of Rheumatoid arthritis. Moreover, since nearly 50 double negative of BR1ACPA patients can be detected by the anti-BR1 detection kit, this kit will be supportive for Rheumatoid arthritis patients to get appropriate therapy earlier. And this will elevate the medical industrial value chain of Rheumatoid arthritis.
Keyword Arthritis Rheumatoid arthritis Serologic diagnos In vitro diagnostic kit Class II medical device product Rheumatoid factor Antibodies against citrullinated protein antigens Sensitivity Specificity IgG anti-BR1 ELISA
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  • Hsin-Yi Peng
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