RF Rheumatoid Factor Rapid Test Kit

Short Description:

The Rheumatoid Factor Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of rheumatoid factor in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis.


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SUMMARY

  Rheumatoid factor (RF) is an autoantibody most relevant in rheumatoid arthritis(RA). It is an antibody against the Fc portion of IgG, which is itself an antibody. RF is often evaluated in patients suspected of having any form of arthritis even though positive results can be due to other causes. It is part of the usual disease criteria of rheumatoid arthritis, and RF may serve as one of several serological markers for autoimmunity unrelated to rheumatoid arthritis. RF can be generated before RA patients exhibit typical clinical symptoms, and has important application value in the early diagnosis, treatment monitoring, and prognosis evaluation of RA High levels of rheumatoid factor (generally above 20IU/ml) occur in rheumatoid arthritis (present in 80%) and Sjögren's syndrome (present in 70%). Rheumatoid Factor(RF) Rapid Test Cassette utilizes RF antibodies to specifically detect the presence of RF in human serum/plasma without the use of an instrument. The Rheumatoid Factor Rapid Test Cassette (Serum/Plasma) is a rapid test that utilizes a combination of rheumatoid factor antibodies coated colored particles for the detection of Rheumatoid Factor in human serum or plasma.

PRINCIPLE

  The Rheumatoid Factor Rapid Test Cassette (Serum/Plasma) is a qualitative membrane- based immunoassay for the detection of Rheumatoid Factor in Serum and Plasma. In this test, human denatured IgG is separately coated on the test line regions of the test cassette. During testing, the extracted specimen reacts with the antigen of rheumatoid factor that are coated onto particles. The mixture migrates up the membrane to react with the human denatured IgG on the membrane and generate one colored line in the test regions. The presence of this colored line of the test regions indicates a positive result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

REAGENTS

The test cassette contains to human denatured IgG conjugated gold colloid particles and human denatured IgG coated on the membrane.

DIRECTIONS FOR USE

Allow test cassette, specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

  1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
  2. Place the cassette on a clean and level surface.

To use a dropper: Hold the dropper vertically, draw the specimen up to the upper end of the nozzle (approximately 10µl), and transfer the specimen into prepared vial containing 1ml of diluents, shake the vial to mix the specimen and the diluents.

  1. Unscrew the cap on the vial and dispense 3 drops of specimen solution into the sample well of the test cassette, and start the timer, see illustration below.
  2. Wait for the colored line(s) to appear. The test result should be read at 10 minutes. Do not interpret the result after 20 minutes.

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