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RHEUMATOID FACTOR (RF) LATEX TEST - RFTEST
The MBDr Rheumatoid Factor Latex Test provides a suspension of polystyrene latex particles which have been coated with heat treated human IgG. The immunoglobulins present in most cases of rheumatoid arthritis bind to the human IgG coating the latex particles. In specimens having abnormally high levels of RF, this binding is evident by rapid agglutination of the latex.
FEATURES
• Fast
• Simple
• easy to use and interpret
• no equipment needed
• no mixing and measuring
• Accurate
• Sensitivity = 15 mlU / ml or greater
• Positive and negative controls are supplied
• Room temperature storage
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PROCEDURES FOR RFTEST |
BENEFITS
• No special equipment is needed
• Results are easy to interpret
• No sample preparation
• Results in 5 minutes |
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Qualitative Test
1. Bring reagents and specimens to room temperature before use. 2. Place one drop (50ul) of RF Positive Control on the first field of reaction slide. Place one drop (50ul) of RF Negative Control on the second fields. The remaining fields are used for test specimens. 3. Using pipet place one drop of each specimen on successive fields. 4. Gently resuspend the RF Latex Reagent and add one drop to each test field. Use stirrers to spread reaction mixture over entire test field. 5. Rotate slide for 3 minutes and read immediately under direct light.
Quantitative Test
1. Bring reagents and specimens to room temperature before use. 2. Using physiological saline, dilute the specimens 1:2, 1:4, 1:8, 1:16, 1:32, or as needed. 3. Place one drop (50ul) of each dilution on successive fields on the reaction slide. 4. Gently resuspended the RF Latex Reagent and add one drop to the reaction slide. Use stirrer to spread reaction mixture over entire test field. 5. Rotate slide for 3 minutes and read immediately under direct light.
INTERPRETATION OF RESULTS
Agglutination within three minutes is a positive result. No agglutination within two minutes is a negative result.
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PERFORMANCE CHARACTERISTICS
Serum and plasma specimens from one hundred and fifty two (152) individuals which have been submitted to clinical laboratories by physicians for RF testing were examined. The MBDr RF Latex Test and another commercial latex kit were used to screen the specimens.
Qualitatively, forty-eight (48) specimens (38.4%) were found positive using both latex kits. Quantitatively, positive RF titers ranged from 20 to 10, 240. There was no more than one titer dilution difference between the two assays in another study, serum and plasma samples from seventy-five (75) apparently healthy individuals were also tested with both assays. All 75 samples from healthy specimens gave negative results with both assays. These data indicate that both the sensitivity and specificity between the two assays were 100%.
In a study on precision, a panel of 10 serum samples with RF titers from 20 to 1280 were tested on 10 consecutive days by the Quantitative Test method (100 determinations). No determinations gave more than a 2-fold difference from the mean titer for a sample. |
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APPLICATION
For detection of Rheumatoid Arthritis. |
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CONTENTS OF THE KIT
1. RF latex reagent : 5ml a suspension of polystyrene latex particles coated with heat-treated human IgG in glycine buffer. 2. RF-Latex Positive Control Serum: 1ml a human serum pool know to have a positive reaction with the MBDr RF Latex Reagent. 3. RF-Latex Negative Control Serum: 1ml a human serum pool know to have a negative reaction with the MBDr RF Latex Reagent. A four reagents contain 0.1% sodium azide as a preservative. 4. Reaction Plate/Slide 1each 5. Disposable Stirrers
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