RHEUMATOID FACTOR

Cat. No. Pack name Packaging (Content) Automation may explode on percussion. Flush drains with water thoroughly after disposing of fluids con-
5 x 25 ml RF Buffer Application procedures on clinical chemistry analyzers are available upon request. taining sodium azide.
BLT20036 RF 1 x 25 ml RF Reagent 3.Each donor unit used in the preparation of the calibrators and controls was found to be nega-
1 x 1 ml RF Calibrator Manual Procedure tive for the presence of HIV1 and HIV2 antibodies, as well as for the hepatitis B surface antigen
Sample/Control: Ready for use and anti-hepatitis C antibodies, using a method approved by the FDA.
1 x 25 ml RF Buffer
BLT20037 RF 1 x 5 ml RF Reagent Reference curve: generate a reference curve by diluting the calibrator successively 1:2 in saline Also available Calibrators and Controls
1 x 1 ml RF Calibrator 9 g/l. Use saline 9 g/l as zero point.

Test: Mix 50 µl samples, calibrator and control(s) with 900 µl buffer. Read optical density (OD1) Cat. No. Product name Pack name Content
of samples, calibrator and control(s) at 340 nm. Add 180 µl RF Reagent. Mix and incubate
INTENDED USE for 5 minutes at room temperature. Read optical density (OD2) of samples, calibrator and con- BLT20038 RF CALIBRATOR RF CAL 1 x 1 ml
Diagnostic reagent for in vitro quantitative determination of Rheumatoid Factor (RF) in human trol(s) at 340 nm.
serum by turbidimetric immunoassay.(Aggregated human IgG method). BLT20039 RF CONTROL RF CON 1 x 1 ml
Calculate ∆OD’s, plot a calibrator curve and read the concentration of controls and samples.
Diagnostic Implications BLT20034 MULTICONTROL LEVEL 1 MULTICON L1 1 x 1 ml
The diagnosis of rheumatoid arthritis (RA) is based largely on clinical examination, but labora- Reference Values
tory tests (e.g. RF Test) are useful to support the clinical diagnosis and to evaluate the severity 0 - 20 IU/ml (WHO) BLT20035 MULTICONTROL LEVEL 2 MULTICON L2 1 x 1 ml
and course of the disease in the individual patient. This range is given for orientation only. Each laboratory should establish its own reference
RF is a term used to describe a variety of antibodies (in most cases of the IgM type) that will values.
react with modified human IgG (e.g. IgG in circulating immune complexes, IgG adsorbed to References
latex, etc.) and IgG of animal origin. Performances 1. Waaler, e., Acta Path. Microb. Scan., 17 (1940)
RF is highly associated with rheumatoid arthritis, as high as 90 % of patients with RA have RF The performance characteristics for the RF reagents were measured on a clinical chemistry 2. Bandilla, K. I., and Mc Duffie, F. C., Arthritis Rheum., 12, 74 (1969)
titers of more than 20 IU/ml. analyzer (Cobas Mira and Selectra2). 3. Müller, W., The Serology of Rheumatoid Arthritis. Berlin - Göttingen - Heidelberg 97 (1962)

Method Measuring Range: 0 – 500 IU/ml

Measurement of antigen-antibody reaction by the end-point method. Detection Limit: 3 IU/ml
Hook Effect: No risk
Reagents Provided Sensitivity: 0.00027 ABS units/concentration unit
Precision:
Buffer [%CV]
Good’s buffer (pH 7.4). 50 mmol/l.
Sodium azide (0.09 %). Low Medium High

RF reagent Intra-Run 2.68 1.38 1.55

Heat-aggregated human IgG ( <0.5 mg/ml).
Sodium azide (0.09 %). Inter-Run 3.07 1.4 1.78

Calibrator Accuracy:
Dilution of human plasma containing high level of RF with saline. Pooled human serum, [IU/ml)]
liquid and stabilized.
Contains 0.09% sodium azide as preservative. Concentration : see bottle label Control Assigned Measured

Preparation and Stability of Reagents ERBA 111 (94-128) 105

Reagent Preparation Biorad 19.6 (16.6-22.5) 18.0

Liquid reagents, ready for use.
Specificity: Monospecific
Stability and Storage
The reagents are stable until expiry date when kept at 2-8°C. Stability in the instrument is at Interferences: No interference for : Hemoglobin (500 mg/dl), Bilirubin (50 mg/dl),
least 4 weeks if contamination is avoided. Do not freeze. Ascorbic acid (50 mg/dl), Intrafat (3%).
Limitations: None
Reagents required but not supplied USED SYMBOLS
Saline (9 g/l NaCl) Comparison with nephelometry: y = 0.9486x – 0.2587
r = 0.9900 Lot Number In vitro Diagnostics See Instruction for Use
Sample collection
Use fresh serum. If the test can not be carried out on the same day, the serum may be stored at Precautions and warnings Catalougue Number Manufacturer Content
2-8°C for 48 hours. If stored for a longer period, the sample should be frozen. 1.In vitro diagnostic use only.
2.Sodium azide has been reported to form lead or copper azide in laboratory plumbing which Expiry Date Storage Temperature

QUALITY SYSTEM CERTIFIED Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ
12000131 ISO 9001 ISO 13485 e-mail: [email protected], www.erbamannheim.com
12000132

N/78/17/D/INT Date of revision: 4. 12. 2017