Rheumatoid Factor Test Serum Plasma Lateral Flow Immunochromatographic Assays

Rheumatoid Factor Rapid Test Cassette Lateral Flow Immunochromatographic Assays In Human Serum Or Plasma

Applications:

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.

Description:

Rheumatoid factor (RF) is an autoantibody most relevant in rheumatoid arthritis. 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 arthritis¹.

High levels of rheumatoid factor (generally above 20 IU/ml) occur in rheumatoid arthritis (present in 80%) and Sjögren's syndrome (present in 70%) . Rheumatoid Factor (RF) Rapid Test Kit 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.

How to use?

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

1. Bring the pouch to room temperature before opening. Remove the test cassette from the sealed pouch and use it within one hour.

2. Place the test 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 5μl), and transfer the specimen into prepared vial containing 5ml of diluents, shake the vial to mix the specimen and the diluents.

• To use a micropipette: Pipette and dispense 5µl of specimen into prepared vial containing 5ml of diluents, shake the vial to mix the specimen and the diluents.

  3. Break off the tip of the cap on the vial and dispense 3 drops of specimen solution into the sample well of the test cassette.

  4. Wait for the colored line(s) to appear. The test result should be read at 10 minutes. Do not interpret the result after 15 minutes.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of RF present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Order Information

CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.

CITEST manufactures its IVD products in ISO13485:2016 accredited manufacturing facilities under strict quality assurance systems. Our innovative products are developed using industry-leading design control systems, which ensures consistent product quality and performance.

Our products are used in the clinical market to help people live more healthy lives. When you select CITEST products, you can be assured of high performance and accuracy along with a dedicated customer support team.