RA Latex Kit - Rheumatoid Factor Test

The RA Latex Kit is a rapid slide agglutination test for the qualitative and semi-quantitative determination of Rheumatoid Factor (RF) in human serum.

The reagent contains latex particles coated with human gammaglobulin. When mixed with a serum sample containing Rheumatoid Factor antibodies, visible agglutination occurs.

The test can be used as an aid in the assessment of Rheumatoid Factor; however, results should always be interpreted together with the patient's clinical examination and other relevant laboratory findings.

Available in 50-test and 100-test kit configurations.

• Rapid slide latex agglutination method.
• Qualitative and semi-quantitative RF testing.
• Designed for human serum samples.
• Latex particles coated with human gammaglobulin.
• Reagents supplied ready to use.
• Positive and negative controls included.
• Reusable reaction card included.
• Analytical sensitivity stated by the manufacturer as approximately 8-16 IU/mL.
• No prozone effect detected up to 1500 IU/mL.
• Manufacturer reports diagnostic sensitivity of 100%.
• Manufacturer reports diagnostic specificity of 100%.

• Intended for the qualitative and semi-quantitative detection of Rheumatoid Factor (RF) in human serum using a latex slide agglutination method.
• The test is intended to aid laboratory assessment of Rheumatoid Factor and should not be used as the sole basis for diagnosis.

1. Allow all kit components to reach room temperature before testing.
2. Gently shake the latex reagent to disperse the particles.
3. Place 50 µL of undiluted serum onto a circle of the test slide.
4. Add one drop of latex reagent next to the serum sample.
5. Using a stirrer, spread the reagent and serum over the entire reaction area.
6. Gently tilt the test slide backward and forward approximately once every two seconds for 2 minutes.
7. Observe for visible agglutination.
8. Positive and negative controls should be used regularly.
9. After testing, rinse the slide with distilled water and allow it to dry.

• 1 × RA Latex Reagent — sufficient for 50 tests
• 1 × Positive Control — sufficient for 10 tests
• 1 × Negative Control — sufficient for 10 tests
• 50 × Disposable Sample Stirrers
• 1 × Reusable Reaction Card
• 1 × Instructions for Use

• Treat all patient samples and reagents as potentially infectious.
• Wear appropriate protective gloves, eye protection, and laboratory clothing.
• Do not pipette by mouth.
• Use appropriate laboratory biosafety procedures.
• Disposable materials must be disposed of as biohazardous waste or incinerated according to applicable procedures.
• Non-disposable apparatus must be sterilized after use using an appropriate method.
• Spills of potentially infectious material should be absorbed and disinfected appropriately.
• The product contains an aqueous buffer containing salts, including sodium azide as a preservative.
• Do not dilute or modify the supplied reagents.
• Allow reagents and samples to reach 18-30°C before use.
• Do not use reagents after their expiry date.
• Discard reagents if they become contaminated.

• Store all reagents upright at 2-8°C.
• Do not freeze the reagents.
• Do not use reagents after the stated expiry date.
• Discard any reagent if contamination is observed.
• All reagents are supplied ready to use.

• CE Marked