RF TURBILATEX INTENDED USE: The reagent kit is intended for the” invitro” quantitative determination of Rheumatoid factor in human serum. PROCEDURE: CLINICAL SIGNIFICANCE: Calibration Curve : (Range from 20 to 160 IU/ml) Prepare the following RF calibrator dilutions in normal saline. Multiply the concentration of the RF-calibrator by the corresponding factor stated in table bellow to obtain the RF concentration of each dilution. Rheumatoid factors are a group of antibodies directed to determinants in the Fc portion of the immunoglobulin G molecule. Although rheumatoid factors are found in a number of rheumatoid disorders, such as systemic lupus erythematosus (SLE) and Siogren's syndrome as well as in nonrheumatic conditions, its central role in clinic lies in its utility as an aid in the diagnosis of Rheumatoid Arthritis (RA) .A study of the "American College of Rheumatology" show that the 80.4% of RA patient were RF positive. PRINCIPLE: The RF - Turbilatex is a quantitative turbidimetric test for the measurement of RF in human serum or Plasma.Latex particles coated with human gamma globulin are agglutinated w hen mixed with samples containing RF. The agglutination causes an absorbance change, dependent upon the RF contents of sample that can be quantified by comparison from calibrator of a known RF concentration. CONTENTS: Reagent 1 : Diluent Reagent 2 : Latex Antigen Reagent 3 : RF Calibrator Calibrator dilution 1 Calibrator RF (µl) Normal Saline 100 Factor 0 2 10 90 0.1 3 25 75 0.25 4 50 50 0.5 5 75 25 0.75 6 100 1.0 One point calibration : (Linear range up to 100 IU/ml) Prepare RF calibrator dilution : 30 µl RFcalibrator + 70 µl normal saline. Multiply the RF calibrator concentration by 0.30 to obtain the RF concentration of the diluted calibrator. CALCULATION OF RESULTS: Calibration curve (Note 1) : Calculate the absorbance difference (A2-Ablankreagent) of each point of the calibration curve and plot the value obtained against the RF concentration of each calibrator dilution. Rheumatoid factorconcentration in the sample is calculated by interpolation of its (A2-A blank reagent )in the calibration curve. One Point Calibration MATERIALS REQUIRED BUT NOT PROVIDED: - Clean & Dry Glassware. - Laboratory Glass Pipettes or Micropipettes & Tips. - Bio-Chemistry Analyzer. (A2-A blank reagent Sample ) RF IU/mL. = X Diluted Calibrator concentration (A2-A blank reagent calibrator ) PROCEDURE : SAMPLES: Reagent Blank Calibrator Sample Fresh serum stable for 7 days at 2 -8°C or 3 months at -20° C. Samples with presence of fibrin should be centrifuged before testing. Do not use highly hemolyzed or lipemic samples. Working Reagent 1.0 ml 1.0 ml 1.0 ml PREPARATION OF WORKING REAGENT Working Reagent : Swirl the latex vial gently before use Prepare the necessary amount as follow : 1 ml latex reagent + 9 ml Diluent. RF Calibrator : Reconstitute with 2.0 ml of Distilled water. Mix gently and keep at room temperature for 10 minutes before use. 7 µl - 7 µl - 7 µl Mix and read the absorbance after 2 min of the sample addition. For multipoint calibrator use all the 6 calibrators stated as here above. For single point calibration use diluted calibrator as shown here above NORMAL VALUE: Up to 20 IU/ml Each laboratory should establish its own reference range. STORAGE & STABILITY:. Working Reagent : Stable for 30 days at 2 -8° C RF Calibrator Normal Saline Calibrator * Sample : Stable for 1 month at 2-8°C or 3 months at -20°C. Do not freeze; frozen latex or diluent could change the functionality of the test. GENERAL SYSTEM PARAMETERS: Reaction Type Wavelength : End point / Multi Standard : 650 nm (600-650 nm) Cuvette Temperature Calibrator Concentration Incubation Sample Volume Reagent Volume Zero Setting Blank Light Path Calibrator concentration : 37 C : Dilution Factor x Calibrator Concentration : 2 min. : 7 µl : 1 ml : Deionised Water : Reagent blank : 1 cm. : 153 IU/ml 0 LINEARITY: The reaction is linear up to 160 IU/ml. PAERFORMANCE CHARACTERISTS: 1. Linearity Limit : Up to 160 IU/ml by multi-standard & 100 IU/ml by one point calibration. 2. Detection Limit : Values less than 6 IU/ml give non-reproducible results. 3. Prozone Effect : No prozone effect was detected up to 800 IU/ml. QUALITY CONTROL: It is recommended that each laboratory should prepare their own quality control scheme. LIMITATIONS AND PRECAUTIONS: - Storage conditions mentioned on the kit to be adhered. - Bilirubin (20mg/dl) Haemoglobin (10 g/L), Lipemia (10 g/L)do not terfere. Other substances may interfere. REFERENCES: 1. Frederick Wolfe et al. Arthritis and Rheumatism 1991; 34: 951-960. 2. Robert W Dorner et al. Clinica Chimica Acta 1987; 167: 1-21. 3. Robert H Shmerling et al. The American Journal of Medicine 1991; 91: 528534. IVD CODE NO. PACK SIZE T03 50 ML EC REP UNIONPROJET S.R.L.S. Via Aliprandi 41-20851 Lissone (MB) www.jas-anz.com.au/register ISO 9001:2015 ISO 13485:2003