CTK Biotech, USA RF Rapid 30 Test

The OnSite RF Rapid Test is a lateral flow immunoassay for the qualitative detection of all subtypes of rheumatoid factor (RF) in human serum, plasma or whole blood at a sensitivity of 8 IU/ml.

• Rapid test to make RF detection simpler and quicker than Latex
• Detects RF levels as low as 8 IU/mL
• Detects all RF isotypes including IgM, IgG, and IgA
• Simple procedure minimizes risk of operator error – no sample preparation required.
• The results are ready in 10 minutes, which increases diagnostic efficiency.
• The least complicated RF test- can be performed in any setting by any health care provider with simple training
• Rapid test format allows room temperature shipping and storage.
• Shelf Life 24 months
• Storage 2-8 °C

TEST PRINCIPLE : The OnSite RF Rapid Test is a lateral flow chromatographic immunoassay. The strip in the test cassette consists of: 1) a burgundy colored conjugate pad containing immunoglobulins conjugated with colloidal gold (Ig conjugates) and a control antibody conjugated with colloidal gold, 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with another immunoglobulin for the detection of rheumatoid factor, and the C line is pre-coated with a control line antibody.  When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. RF, if present in the specimen, will bind to the Ig conjugates. The immunocomplex is then captured on the membrane by the pre-coated immunoglobulin forming a burgundy colored T line, indicating a level of RF greater than or equal to 8 IU/mL. Absence of the T line suggests that the RF level in the specimen is lower than 8 IU/mL.   The test contains an internal control (C line) which should exhibit a burgundy colored line of the immunocomplex of the control antibodies regardless of any color development on the T line. If the C line does not develop, the test result is invalid, and the specimen must be retested with another device.