RHEUMATOID FACTOR (RF)

Qualitative and semiquantitative determination of rheumatoid factor by agglutination to latex

TEST SUMMARY Area Area Area Area Area Area WASTE DISPOSAL
Reagents
Rheumatoid factors, contained in the serum, produce 1 2 3 4 5 6 Product is intended for professional laboratories. Waste
agglutination of latex particles coated with IgG. products must be handled as per relevant security cards
Physiologic 50 µl 50 µl 50 µl 50 µl 50 µl 50 µl and local regulations.
SAMPLES
Sample 50 µl 50 µl 50 µl 50 µl 50 µl 50 µl
Fresh serum. Stability 7 days at 2-8°C. For longer periods PACKAGING
from from from from from
of time it is recommended to freeze samples at –20°C. 1 2 3 4 5 CODE AK00210 (100 TESTS)
Frozen samples must be totally unfrozen and brought to Latex 1 x 5 ml
room temperature before using. Samples in which Reject 50 µl from last area
turbidity is observed must be cleared by centrifugation Latex 50 µl 50 µl 50 µl 50 µl 50 µl 50 µl
CODE AK00211 (100 TESTS)
before being analysed. Latex 1 x 5 ml
16 32 64 128 256 512 Positive control 1 x 0.5 ml
Titre
REAGENTS UI/ml UI/ml UI/ml UI/ml UI/ml UI/ml Negative control 1 x 0.5 ml
Latex Slide black spot 3
Latex particles coated with IgG; conservative and EXPECTED VALUES Stirrers 50
stabilizer. Approximately 70-80% of patients with a clinical diagnosis
CODE AK00235 (RF Controls)
Positive control of rheumatoid arthritis are seropositive for rheumatoid
Positive control 1 x 0.5 ml
Human base stabilized solution of rheumatoid factors with factor. Positive results were shown for nearly all patients
Negative control 1 x 0.5 ml
a titre that gives a clear agglutination. with variants of rheumatoid arthritis such as Felty’s or
Sjogren’s syndrome. A positive result can be expected in
REFERENCES
Negative control less than 5% of healthy individuals, while in the
Proteic solution not reactive with latex. population aged 60 years and older, 30% may be Koopman W L et al. Arthritis Rheum 1980; 23: 202-208.
seropositive using latex tests for the detection of Van der Sluijs et al. Eur J Clin Chem Biochem 1992; 30:
All reagents contain 0.095% of sodium azide. rheumatoid factor. 301-305.
Borque L et al. Clin Chem 1987; 33 : 704-707.
REAGENTS PREPARATION AND STORAGE CLINICAL SIGNIFICANCE Robert W Dorner et al. Clinica Chimica Acta 1987; 167: 1-
Reagents are ready for the use. 21.
Rheumatoid factors found in the sera of most patients Frederick Wolfe et al. Arthritis and Rheumatism 1991; 34:
The latex suspension must be resuspended with much with rheumatoid arthritis as well as in a variety of other
care. When the suspension becomes homogeneous by 951-960.
diseases, are a group of antibodies most belonging to the
sweet inversion, it is necessary to fill and to empty the Robert H Shmerling et al, The American Journal of
IgM class directed against determinants on the Fc
dosage’s pipette many times. Medicine 1991; 91: 528-534.
fragment of the patients’ IgG immunoglobulin.
Stability: the components of this kit will remain stable until Adalnert F. Schubart et al. The New England journal of
the expiration date stated on the label, when stored at 2- Medicine 1959; 261: 363-368.
NOTE Charles M. Plotz 1956; American Journal of Medicine; 21:
8°C. Do not freeze.
• If reaction’s times are bigger than 2 minutes, they 893-896.
may cause a supervalutation of samples Singer,J.M. et al., Am.J.Med.,21 : 888-892 (1956).
MATERIAL REQUIRED BUT NOT SUPPLIED
concentrations. Waaler, M. et al., Arthrtid Rheum., 4 : 47-57 (1961)
Physiologic solution. • Human sera used in controls have been found Jones, W.L. et al., Amer. J. Clin. Path…, 60 :603-608
COD. AK00210 Slide and disposable stirrers. negative in the reaction with HIV and HBsAg. (1973).
However, they should be handled with care.
PRECAUTIONS • If the results are incompatible with clinical MANUFACTURER
Reagent may contain not reactive and conservative presentation, they have to be evaluated within a total
components. It is opportune to avoid contacts with the clinical study. LTA s.r.l.
skin and do not swallow. Via Milano 15/F
Perform the test according to the general “Good CALIBRATION 20060 Bussero (Milan) ITALY
Laboratory Practice” (GLP) guidelines. Positive and Negative control sera should be always used Tel: ++39 02 95409034
to distinguish an eventual background’s agglutination of Fax: ++39 02 95334185
QUALITATIVE PROCEDURE reactive. e-mail: info@ltaonline.it
Website: http://www.ltaonline.it
Positive Negative TEST PERFORMANCE
Reagents Sample
control control Interferences SYMBOLS
Any interferences are produced with :
Sample 50 µl (1 gt) -- -- Haemoglobin ≤ 1000 mg/dl
Control + -- 50 µl (1 gt) -- Bilirrubin ≤ 20 mg/dl
F Only for IVD use
50 µl (1 gt)
Control -
Latex
--
50 µl (1 gt)
--
50 µl (1 gt) 50 µl (1 gt)
Lipids ≤ 1000 mg/dl C Lot of manufacturing

Lipemic or turbid samples may give false positivity. B Code number

Mix using disposable stirrers and spreading
homogeneously the mixture on the slide, then, shake Sensitivity I Storage temperature interval

slide for 2 minutes by a sweet rotating motion or by a Test gives positive results as from concentrations of 8
Ul/ml.
K Expiration date
stirrer at 100 r.p.m., and observe eventual agglutination
using artificial light. J Warning, read enclosed documents
Not happened phenomenon of prozone in RF
RESULTS INTERPRETATION concentrations studied until 800 UI/ml. L Read the directions

POSITIVE: A clear agglutination within 2 minutes.

Specificity A Biological risk
NEGATIVE: No agglutination within 2 minutes.
A comparison with an available commercial method gave Mod. 01.06 (ver. 3.4 - 05/12/2005)
In case of positivity it is opportune to titre semi
following results on 118 samples compared, giving a
quantitatively the serum.
specificity = 98%.
SEMIQUANTITATIVE PROCEDURE
Prearrange serial dilution of the serum, pipetting in six
+
LTA srl
- TOT.
H
slide areas, 50 µl of physiologic solution and 50 µl of
COMPETITORS

sample in the first area. Using the same pipette (inspiring 48 1

+ 49
and discharging many times) mix carefully contents of 98% 2%
first area and transfer 50 µl in the following area etc. 2 67
- 69
Discharge 50 µl from last area. Dispense latex 3% 97%
suspension, shake, and after 3 minutes observe
agglutination. The titre is given by last clear agglutination. TOT. 50 68 118
Procedure is summarized in the scheme below .