Description
INTENDED USE:
RF is a reagent for in vitro quantitative determination of Rheumatoid Factor concentration In Human Serum.
Rheumatoid Factors are a group of auto antibodies of immunoglobulin isotypes IgM, IgG, IgA, and IgE. RF Turbilatex reagent measures the concentration of Rheumatoid Factor in human serum.
Salient Features:
- Ready to use and stable reagent until expiration
- Linear upto 200 IU/ml
- Standardized methodology ensuring consistent and reproducible results
- Highly sensitive and specific
- Quick and rapid results
Parameter | Description |
---|---|
Method | Turbilatex |
Number of reagents | Two |
Pack Size available |
|
CLINICAL SIGNIFICANCE:
Rheumatoid factors (RF) are heterogenous group of high molecular weight auto antibodies of immunoglobulin isotypes IgM,IgA,IgG, IgE.They are produced by plasma cells present at sites of tissue injury, and may play a role in regulation of humoral and cellular immunity and protection against evading micro organisms.
Increased Levels : are observed in Rheumatoid Arthritis and Sjogren’s syndrome, scleroderma, dematomyositis Waldenstrom’s disease, sarcoidosis & systemic lupus erythematosus.
PRINCIPLE:
The reagent consists of suspension of latex particles of homogenous size sensitized with anti RF capable of aggregation in presence of RF. This aggregation process produces an increase in the size of latex particles which in turn produces an increase in absorbance of the system.
REAGENTS IN THE PACK / KIT:
REAGENT COMPOSITION:
WORKING REAGENT :
REAGENTS:
Ready to use, Two Reagents system.
SHELF LIFE:
All reagents are supplied ready to use and stableuntil expiration date stated on label when stored inrefrigerator at 2-8°C.
SAMPLE :
Recommended Sample: Fresh sera or stored at2-8°C for no longer than 48 hours.It is necessaryto freeze the sample if the assay is to be carriedout after that notice of period.
CALIBRATION:
Calibration type : Spline (5 points) Prepare the dilutions of calibrators in given belowmanner for calibration.
Assay can be performed with use of separate ● Storage conditions as mentioned on the kit to be adhered.● Do not freeze or expose the reagents to higher temperatureas it may affect the performance of the kit. ● Before the assay bring all the reagents to the room temperature.● Avoid contamination of the reagent during assay process.● Use clean glassware free from dust and debris. ● Reagent to sample ratio as mentioned above must be strictlyadhered, as any changes it affects the factor and result.
CALCULATIONS REFERENCES:
RF concentration = ∆ A (T) / ∆ A(C)*Calibrator concentration
Note: When result is displayed as ** please check calibration table.
- When sample OD is higher than the highest calibrator OD dilute the sample.
- When the sample OD is lower than lowest calibrator OD then result for sample should consider as zero.
1) Anderson, B., Antigens associated withRheumatoid Artritis, in Natelson, S., Pesce,A.J.,Dietz, A.A. eds. Current Topics in Clinical Chemistry, V3:Clinical Immunochemistry. (1979). AA.CC. 176-190.2) Johnson, P.M., Faulk, W.P., (1976). Clin. Immunol.Immunopathol., 6, 414-440 Taborn, J. D., Walker, S. E.,(1979). Lab. Med., 10, 392 – 395. 3) Witherigton, R.H., Teitsson, I., Valdimarsson, H.,Seifert, M.H. (1984).Ann. Rheum. Dis., 42,679-685.
PERFORMANCE CHARACTERISTIC:
- LINEARITY : Reagent is linear up to 200 IU/ml. For Higher values,dilute sample with normal saline & multiply result by dilution factor.
- INTERFERENCES : No Interferences up to Hemoglobin (10 g/L), Triglyceride (50g/L), ASO (IU/ml), Heparin (12 mg/dl), CRP (70 mg/L) was observed. Other drugs and substances may interfere In the tests.
REFERENCE NORMAL VALUE Serum – Up to 20 IU/ml
QUALITY CONTROL:
To ensure adequate quality control, it is recommended that the laboratory should use a normal and abnormal commercial reference control serum. Please note that the quality control material is used to check the function of reagents and the machine together.
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