RHEUMATOID FACTORS

Primary DI

D-02B0029YZ

Basic UDI-DI Code

B-02B0029YZ

Reference

2U001

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Changsha Sinocare Inc.

The CRP/ASO/RF Reagent Kit is intended to quantitatively determine CRP, ASO, or RF in human serum. Clinically, it is mainly used for auxiliary diagnosis of rheumatic disease. CRP is an acute protein sharply rising in the blood in response to infection or damage. It plays a conditioning role by activating complement and strengthening phagocytosis of phagocytes, and eliminates pathogenic microorganisms invading the body and damaged, necrotic and apoptotic tissue cells. As an extremely sensitive index of acute phase response, the concentration of CRP in blood increases rapidly and significantly in response to acute myocardial infarction, trauma, infection, inflammation, surgery and tumor infiltration, up to 2000 times of the normal level. Combined with clinical history, it is helpful for follow-up. ASO serves as an anti-streptolysin "O" antibody produced after the body is infected by Streptococcus. Its increase is common in diseases caused by infection with Streptococcus hemolysin and post-infection immune response, such as rheumatoid, infective endocarditis, tonsillitis, acute glomerulonephritis and scarlet fever. Clinically, the increase of RF is common in rheumatoid arthritis. Positive RF can be seen in a variety of diseases, among which the positive rate is the highest in patients with rheumatoid arthritis. It is one of the serological markers for the diagnosis of rheumatoid arthritis.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).