1x24 / 1x8 / 1 mL 2x24 / 2x8 / 2 mL

RF LEIT WITH CALIBRATOR 11809003 11809004

Intended Use Interferences

This reagent is intended for in vitro quantitative determination of Rheumatoid No interference for
factor in Serum. Haemoglobin up to 500 mg/dL
- Latex enhanced immunoturbidimetry Intra fat up to 5000 mg/dL
- Linear upto 135 IU/mL Bilirubin up to 20 mg/dL
- No sample dilution required
- Ready to use reagents
Materials Provided
RF LEIT Reagent R1,R2 & Calibrator
Clinical Significance
Rheumatoid Factor (RF) is an auto antibody against human IgG commonly seen in
Materials Required but Not Provided
sera of patients with rheumatoid arthritis. The measurement of RF value is useful l Pipettes & Tips
in evaluating the diagnosis, effects of therapy and prognosis of RA, systemic lupus l Test Tubes & racks
erythematosus, Chronic hepatopathy etc.
l Timer
Principle l Incubator
When a sample containing rheumatoid factor is added to denatured human IgG l Analyzer
which has been sensitized to latex particles, antigen-antibody reaction occurs
leading to agglutination. This agglutination leads to an absorbance change which Test Parameters
is measured at (550 to 660nm). The change in absorbance is proportional to
agglutination and the actual concentration is determined by interpolation from a Ful ly Auto Semi Auto
calibration curve prepared from known value calibrators. Analyzer Analyzer
Kit Components Mode of reaction End Point Fixed time
Slope of Reaction Increasing Increasing
Reagent/ Product code Product code Description
Component 11809003 11809004 Wavelength I 660 nm 578
o o
Temperature 37 C 37 C
RF R 1 1 x 24 mL 2 x 24 mL Glycine buffer solution
No.of calibrator 6 6
RF R2 1 x 8 mL 2 x 8 mL Latex suspension coated
Calibrator concentration As on the vial label x As on the vial label x
with denatured human IgG
Dilution factor Dilution factor
Calibrator 1 x 1 mL 1 x 2 mL RF calibrator concentration Linearity 135 IU/mL 135 IU/mL
as mentioned on vial label.
Blank Reagent DI water
Risk & safety Delay 5 sec
Material safety data sheets (MSDS) will be provided on request Interval 120 sec
Reagent Preparation Sample Volume 8 µL 10 µL
The Reagent1, Reagent 2 and calibrator are ready to use. Reagent 1 Volume 210 µL 450 µL
Reagent Storage Reagent 2 Volume 70 µL 150 µL
The sealed reagents are stable up to the expiry date stated on the label, when Cuvette 1 cm light path 1 cm light path
stored at 2 - 80C, protected from light. DO NOT FREEZE
Application parameters for various instrument are available. Please contact
Open Vial Stability customer support department for specific information.
Once opened, the reagent is stable up to four weeks at 2 - 80C if contamination is Calibration
avoided.
Agappe RF Calibrator is recommended for calibration of this assay.
Onboard Calibration Stability
Preparation of Calibration Curve
Calibration is stable for 20 days
Prepare the following calibrator dilutions using normal saline as diluent. Multiply
Reagent Deterioration the concentration of the RF calibrator by the corresponding factor stated in the
table below to obtain the RF concentration of each dilution.
Turbidity or precipitation in any kit component indicates deterioration and the
component must be discarded. Values outside the recommended acceptable range
for the Agappe Protein control may also be an indication of reagent instability Dilution 1 2 3 4 5 6
and associated results are invalid. Sample should be retested using fresh vial of Cali. (µL) - 10 20 50 75 100
reagent.
Saline (µL) 100 70 60 50 25 -
Precaution Dil. factor 0 0.125 0.25 0.5 0.75 1.0
To avoid contamination, use clean laboratory wares. Use clean, dry disposable
pipette tips for dispensing. Close reagent bottles immediately after use. Procedure notes
Avoid direct exposure of reagent to light. Do not blow into the reagent bottles. Laboratory Procedure for Ful ly Auto Analyzer
This reagent is only for IVD use and follow the normal precaution required for Blank Calibrator Sample /control
handling all laboratory reagents.
RF R1 210 µL 210 µL 210 µL
Waste Management Dil.Calibrator - 8 µL -
Reagents must be disposed off in accordance with local regulations. Sample/control - - 8 µL
0
Sample Incubate for 5 minutes at 37 C.
Fresh serum RF R2 70 µL 70 µL 70 µL
Mix and read the absorbance immediately (A1), and after 2 minutes (A2) at 660 nm.

SYMBOLS USED ON THE LABELS

IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT

AGAPPE DIAGNOSTICS LTD.

Agappe Hills, Dist. Ernakulam, Kerala, India-683 562.
Customer Care No. +91 484 3120002 ISO 9001:2008
customercare@agappe.in | www.agappe.com REV. NO.: ADL/IFU/RF/IT/R00 EN ISO 13485:2012
 1x24 / 1x8 / 1 mL 2x24 / 2x8 / 2 mL
RF LEIT WITH CALIBRATOR 11809003 11809004

Laboratory Procedure for Semi Auto Analyzer 2. Comparison

Calibrator Sample /control A comparison study has been performed between Agappe reagent and another
RF R1 450 µL 450 µL internationally available reagent yielded a correlation coefficient of r2=0.995
and a regression equation of y =0.9844x
Dil.Calibrator 10 µL - 3. Precision
Sample/control - 10 µL Intra Run
RF R2 150 µL 150 µL
Control Level 1 Control Level 2
Mix and read the absorbance immediately (A1), and after 2 minutes (A2) at 578 nm. n 20 20
Mean (IU/mL) 20.18 57.51
Calculation
SD 1.29 1.95
Multipoint calibration
CV(%) 6.41 3.39
Calculate the delta abs, plot a standard curve & read the concentration of controls
& samples, by interpolation of curve.
Inter Run
Quality Control Control Level 1 Control Level 2
It is recommended to use Agappe Protein control ( 11614005) to verify the n 20 20
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if control do not recover within Mean (IU/mL) 19.71 57.60
the acceptable range. SD 1.04 1.73
CV(%) 5.29 3.00
Reference Range
It is recommended that each laboratory should establish its own reference values.
Accuracy (IU/mL)
The following value may be used as guide line.
Control Expected Value Measured Value
Serum up to 18 IU/mL
Control Level 1 20.4 ± 4.8 20.85
Results obtained for patient samples are to be correlated with clinical findings of
patient for interpretation and diagnosis. Control Level 2 36.7 ± 6.5 37.41
Performance Agappe Control Level 1 69.88 ± 11.71 70.14
1. Linearity 4. Sensitivity
This reagent is linear up to 135 IU/mL Lower detection Limit is 10 IU/mL
If the concentration is greater than linearity (135 IU/mL), dilute the sample
with normal saline and repeat the assay. Multiply the result with dilution factor Bibliography
Prozone effect: >770 IU/mL 1. Frederick Wolfe et al-Arthritis and Rheumatism 1991 : 34:951-960

SYMBOLS USED ON THE LABELS

IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT

AGAPPE DIAGNOSTICS LTD.

Agappe Hills, Dist. Ernakulam, Kerala, India-683 562.
Customer Care No. +91 484 3120002 ISO 9001:2008
customercare@agappe.in | www.agappe.com REV. NO.: ADL/IFU/RF/IT/R00 EN ISO 13485:2012