PRODUCT

ELI.H.A RF

Quantitative detection of Rheumatoid Factor in serum samples by indirect haemagglutination.

ELI.H.A RF enables the quantitative determination, by indirect hemagglutination, of IgM Rheumatoid Factor in serum samples. It widens the performance of classical rapid tests by eliminating interferences due to natural anti-sheep agglutinins.

  • Cost-effective test
  • Easy and ready-to-use
  • No equipment needed
  • High sensitivity and specificity
  • Fast results for clinicians
  • Simple visual reading, without expert interpretation

 

Reference Name Quantity
04115 ELI.H.A RF 220 (20 x 11) tests

 

Benefits

Intended Use

The Rheumatoid Factor is a high diagnostic interest biological marker for adult rheumatoid arthritis. ELITech developed the ELI.H.A RF, an indirect hemagglutination assay, for the quantitative determination of IgM Rheumatoid Factor in serum. It is rapid, easy-to-use and easy-to-read with results available within 2 hours. ELI.H.A RF was specially designed to eliminate interferences due to natural anti-sheep agglutinins.


Principle

ELI.H.A RF is based on the Rheumatoid Factor specific haemagglutination properties, used in reactions of the Waaler-Rose type. Sheep red blood cells (Reagent 1) are sensitized by a gamma-globulins fraction of rabbit anti-sheep red blood cells serum. The presence of Rheumatoid Factor in serum samples is revealed by a haemagglutination of the reagent R1: a reddish-brown film can be observed in the well. In the absence of Rheumatoid Factor, patients, these red blood cells deposit, forming a button in well bottom. Non-sensitized red blood cells (reagent R2) are also available in the kit. They ensure the specificity of the reaction by allowing identifying any interference from the natural anti-sheep agglutinins (Forssman heteroantibodies, infectious mononucleosis antibodies…). The reaction is carried out in a U-microplate. Each kit allows 220 tests to be carried out or 20 reactions of 11 dilutions. Results are obtained within 2 hours and are reliable overnight.


Simple Methodology

If an agglutination is observed in well 11 (serum control), then remake a test with a preliminary adsorption of the natural anti-sheep agglutinins (Reagent 3).


Easy-to-Read and Easy-to-Interpret Result

Positive reaction Negative reaction
Presence of haemagglutination. Presence of a cloudy red/brown deposit coating the well. Absence of haemagglutination. Presence of a button at the bottom of the well.

 

Reagents and Material

Quantity Description
1 R1: Vial of 4.4 mL of sensitized red blood cells
1 R2: Vial of 1 mL of non-sensitized red blood cells
1 BUF: Vial of 55 mL of phosphate buffer pH 7.2
1 R3: Vial of 2 mL of adsorbent
1 CONTROL +: Vial of 0.5 mL of titrated positive control
1 CONTROL -: Vial of 0.5 mL of negative control
3 MICROPLATE: Microplate with a U-bottom
2 DROPPER: Special dropper

Material Required but Not Supplied

  • Automatic pipette(s) with a pipetting volume adapted to the volume that will be measured
  • Contaminated waste containers
  • Centrifuge
  • Hemolysis tubes

Stability and Storage

  • The reagents are ready-to-use.
  • All the reagents are stored at 2-8°C. In their original packaging, are stable until the expiry date indicated on the box.
  • Do not freeze.

Performances

Sensitivity Specificity
97.6% 97.4%

 

Manufacturer: ELITech Microbio.
Product(s) intended for healthcare professionals.
Read the instructions on the label and/or instructions for use of the product(s).

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