ANTI-n-DNA (LE)

Identification of antibodies anti-n-DNA associated to Lupus Erythematosus systemic (LE) by agglutination to latex

TEST SUMMARY CALIBRATION SYMBOLS

When the latex reagent, which has been coated with Positive and Negative control sera should be always
native Deoxyribonucleic acid (n-DNA), is brought into used to distinguish an eventual background’s
contact with the serum sample, a clear agglutination agglutination of reactive. F Only for IVD use

will be observed if anti-DNA antibodies are present. C Lot of manufacturing

(Positive result). TEST PERFORMANCE
The reagent is designed to agglutinate in the B Code number
SAMPLES presence of levels of anti-nuclear antibodies (ANA) I Storage temperature interval
Serum. commonly found in sistemic Lupus Erythematosus.
Stability at 2-8°C for 2 days. K Expiration date
Sensibility J Warning, read enclosed documents
REAGENTS Test gave positive reactions with 92% of the samples
Latex having titres of ANA ≥ 1/20 by immunofluorescence L Read the directions

Particles of latex covered with Deoxyribonucleic acid; method. A Biological risk

conservative and stabilizer .
No false positive reactions were observed with latex Mod. 01.06 (ver 3.3 - 05/12/2005)
Positive Control reagent in testing performance of samples from
Human base stabilized solution of antibodies anti-n- healthy individuals.

H
DNA with a titre that gives a clear agglutination.
Interferences
Negative Control
Highly lipemic or haemolyzed samples may interfere
Proteic solution doesn’t react with latex.
the agglutination reaction.
All reagents contain 0.095% of sodium azide.
Those patients suffering from a variety of conective
REAGENTS PREPARATION AND STORAGE tissue diseases, may agglutinate the reagent.
Reagents are ready for the use.
The latex suspension must be resuspended with WASTE DISPOSAL
much care. When the suspension becomes Product is intended for professional laboratories.
homogeneous by sweet inversion, it is necessary to Waste products must be handled as per relevant
fill and to empty the dosage’s pipette many times. security cards and local regulations.
The components of this kit will remain stable until the
expiration date stated on the label, when stored at 2- PACKAGING
8°C. Do not freeze. CODE AK00800 (50TESTS)
Latex 1 x 2.5 ml
MATERIAL REQUIRED BUT NOT SUPPLIED Positive Control 1 x 0.25 ml
COD. AK00800 Slide and disposable stirrers. Negative Control 1 x 0.5 ml

PRECAUTION CODE AK00801 (50TESTS)

Reagent may contain not reactive and conservative Latex 1 x 2.5 ml
components. It is opportune to avoid contacts with the Positive Control 1 x 0.25 ml
skin and do not swallow. Negative Control 1 x 0.5 ml
To use normal caution foreseen in a laboratory. Slide black spot 9
Stirrers 25
QUALITATIVE PROCEDURE
REFERENCES
Positive Negative Christian, C.L., Mechez-Bryan, R., and Larson, D.L.,
Reagents Samples (1958). Proc. Soc. Exptl. Biol. Med. 98, 820-823.
Control Control
Friou, G.J., Finch, S.C. Detrae, K.D. (1958). J.
Sample 50 µl (1 gt) -- -- Immunol., 80, 324-329.
Control + -- 50 µl (1 gt) -- Chaomao, J.C., (1976), Ara. J. Med. Tech., 42, 154-
Control - -- -- 50 µl (1 gt) 157.
Latex 50 µl (1 gt) 50 µl (1 gt) 50 µl (1 gt)
MANUFACTURER
Mix using sticks and spreading homogeneously the
mixture on the slide, then, shake slide for 3 minutes LTA s.r.l.
by a sweet rotating motion or by a stirrer at 100 Via Milano 15/F
r.p.m., and observe eventual agglutination using 20060 Bussero (Milan) ITALY
Tel: ++39 02 95409034
artificial light.
Fax: ++39 02 95334185
e-mail: info@ltaonline.it
RESULTS INTERPRETATION Website: http://www.ltaonline.it
POSITIVE: A clear agglutination within 3 minutes.
NEGATIVE: No agglutination within 3 minutes.

NOTE
• If reaction’s times are bigger than 3 minutes, they
can cause a supervalutation of samples
concentrations.
• Human sera used in controls have been found
negative in the reaction with HIV and HBsAg.
However, they should be handled with care.
• If the results are incompatible with clinical
presentation, they have to be evaluated within a
total clinical study.