Intended Use For the qualitative and semi‐ quantitative measurement of Rheumatoid Factor (RF) in human serum. Principle The Rheumatoid Factor (RF) reagent is a suspension of polystyrene latex particles sensitized with specially prepared human IgG. The reagent is based on an immunological reaction between human IgG bound to biologically inert latex particles and rheumatoid factors in the test specimen. When serum containing rheumatoid factors is mixed with the latex reagent, visible agglutination occurs. The RF latex reagent sensitivity has been adjusted to detect a minimum of 8 IU/mL of rheumatoid factors according with the WHO International Standard without previous sample dilution. CONTACT US: TECO DIAGNOSTICS 1268 N. Lakeview Avenue Anaheim, CA 92807 Tel: 714‐463‐1111 Fax: 714‐463‐1169 Test: Rheumatoid Factor Reagent (RF‐100) Number of Tests: 100 tests Format: Liquid Method: Agglutination Reaction Testing Procedure: Manual Storage Temperature: 2‐8°C Sensitivity: >8 IU/mL Qualitative Result: Positive: Any observable agglutination in the reaction mixture Negative: Uniform milky suspension with no agglutination Semi‐Quantitative Result: The titer of the serum is the reciprocal of the highest dilution which exhibits a positive reaction. Limitations of Procedure: Results should be read two (2) minutes after the mixing of the reagent on the slide. Increased levels of RF may be found in some