ELITex Bicolor RF

Intended use

The Rheumatoid Factor is a high diagnostic interest biological marker for adult rheumatoid arthritis.

ELITex Bicolor RF is a latex slide agglutination test for the rapid detection of Rheumatoid Factor in serum samples.

Principle

ELITex Bicolor RF is an agglutination slide test. It consists of latex particles allowing the rapid qualitative or semi-quantitative detection of IgM Rheumatoid Factor in sera from most of patients with rheumatoid arthritis. The TEST LATEX is constituted by latex particles sensitized by human gamma-globulins, which agglutinate specifically Rheumatoid factor (FII-type reaction).

The presence of Rheumatoid Factor in sera is revealed by a red agglutination on a more or less intense blue background, visible to the naked eye. Otherwise, no agglutination is observed and the suspension remains homogeneous with a uniform purple color.

Handling is simple and fast. It is performed on pure serum and the results are obtained in 2 minutes.

Simple protocol

Easy-to-read and easy-to-interpret results

The kit contains an internal quality control which allows observing a positive and a negative reaction as described below:

Reagents and Material

• TEST LATEX:
  Dispenser vial containing 2.5 mL of sensitized latex
  Quantity: 1
• CONTROL +:
  Dispenser vial containing 0.2 mL of positive control
  Quantity: 1
• CONTROL -:
  Dispenser vial containing 0.2 mL of negative control
  Quantity: 1
• TEST CARD:
  Disposable reaction cards
  Quantity: 5

Stability and storage

• All reagents are ready-to-use.
• Reagents stored at 2-8°C, in their original state, are stable up to the expiry date indicated on the box.
• They must not be frozen.
• The shelf life of the product, from its manufacture, is 24 months.

Performance

• A study made on 369 human negative sera and 80 human positive sera has demonstrated that the test ELITex Bicolor RF has a sensitivity of 98.75% and a specificity of 98.37%.

Material required but not provided

• Automatic pipette(s) with a pipetting volume adapted to the volume that will be measured
• Haemolysis tubes
• Physiological water
• Contaminated waste container