Rheumatoid Arthritis Assays

 

Rheumatoid Arthritis (RA) is an autoimmune disease characterized by erosive arthritis that can occur at any age. The basic pathological manifestations of RA are synovitis, pannus formation, and gradually the destruction of articular cartilage and bone, eventually leading to joint deformity and loss of function, which can be complicated by lung diseases, cardiovascular diseases, malignant tumors and depression.

According to the 2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria, RF and Anti-CCP were included in the diagnosis and classification criteria. In 2021, Chinese Expert Consensus on the Clinical Application of Autoantibody Detection related to Rheumatoid Arthritis recommended the joint testing of Anti-CCP and RF serum biomarkers to improve the diagnostic sensitivity of RA.It can also be used to evaluate arthritis activity, treatment effect, and degree of joint damage, and to predict the risk of developing arthritis in patients with arthralgia in recent years and to guide the development of treatment plans.

 

Assay Name 

Methodology

Sample type

Anit-CCP

Latex enhanced immunoturbidimetry

Serum

RF

Immunoturbidimetry

Serum

ASO

Immunoturbidimetry

Serum

MMP-3

Latex enhanced immunoturbidimetry

Serum

 

Performance advantage of Anti-CCP:

  • Innovatively adopted "Flexible" long chain technology and patented “layers of aggressive" technology to fully expose the antigenic epitopes of irregular peptides, and further improve the detection sensitivity of Anti-CCP.
  • The clinical coincidence rate can reach 95%, if compared to anti-CCP assay of reference system with DiYalab’s anti-CCP.

Brand

R brand

E brand

DiYaLab

Biochemical Platform

Cobas e411

/

Hitachi 7180

Methodology

CLIA

ELISA

Latex enhanced immunoturbidimetry

Reference Range

17

5

45

True negative

35

35

False negative

3

3

True positive

41

41

False positive

1

1

Total number of samples

80

80

Negative Percentage Agreement NPA

97.22%

97.22%

Positive Percentage Agreement PPA

93.18%

93.18%

Total Percentage Agreement TPA 

95.00%

 95.00%