4085 – RF IgG

Pipetting on enzyme-immunoassay (ELISA) microplate at Medipan and GA Generic Assays Lab.

Highlights

  • Use of purified rabbit IgG as solid-phase antigen
  • Quantitative ELISA for the determination of rheumatoid factor IgG in human serum
  • Supports the diagnosis of rheumatoid arthritis in combination with clinical and laboratory findings
  • High diagnostic relevance for progressive and severe forms of rheumatoid arthritis
  • Ready-to-use reagents (exception: wash buffer)
  • Reliable and reproducible results for routine laboratory testing
  • Suitable for monitoring disease progression and extra-articular manifestations
  • Manual, professional in vitro diagnostic use
  • CE marked

Intended Use

The CRP Latex is a qualitative and semi-quantitative latex agglutination assay for the determination of C-reactive protein (CRP) in human serum. The CRP Latex is intended as an aid in the diagnosis and monitoring of inflammatory, infective, and ischemic conditions, in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.


Diagnostic Relevance

Rheumatoid arthritis is the most common inflammatory joint disease. About 0.5 to 1.0 % of the population is affected worldwide. Painful joints in the fingers or toes are characteristic of rheumatoid arthritis, but knees, shoulders, hips or other joints may be also affected. The pain is often most pronounced in the morning. As the disease progresses, the number of affected joints usually increases. The diagnosis of rheumatoid arthritis is based on the clinical symptoms, imaging methods and laboratory analysis. In routine diagnostic services, the serological determination of rheumatoid factors is one of the classic and most frequently performed analyzes initially. Rheumatoid factors are predominantly IgM antibodies that target IgG antibodies and occur in the majority of patients with rheumatoid arthritis. For this reason, clinicians regard them as a sensitive marker for the laboratory confirmation of rheumatoid arthritis.

High concentrations of RF often indicate a more severe disease course with faster joint destruction. Patients with elevated RF levels frequently develop extra-articular manifestations such as rheumatoid nodules, polyneuropathy, vasculitis, or Sicca syndrome. RF occurs as IgG, IgM, or IgA isotypes, with IgA RF showing a strong association with extra-articular involvement. Over the long term, IgA and IgG RF serve as prognostic markers for systemic manifestations of rheumatoid arthritis. Like RF of the IgM isotype, high concentrations of IgG RF seems to appear with patients suffering from more progressive erosions of joints.

Product Specifications

Title RF IgG
Product code 4085
Indication Rheumatoid Arthritis
Description Enzyme immunoassay for the quantitative determination of rheumatoid factor IgG in human serum
Format Microtiter plate coated with rabbit IgG
Total incubation time 105 min.
Sample volume 10 µL serum
No. of determinations 96 (89 x 1) + 5 x Calibrators + 2 x Controls

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.