Anti-DNP is present in high titers in the serum of
majority of SLE patients with active disease but is
present occasionally in remission states. Although
anti-DNP is found exclusively in SLE, only low titers
may be detected in diseases such as chronic hepatitis,
periarteritis nodosa, dermatomyositis, scleroderma and
The Rhelax SLE reagent is a ready-to-use uniform
suspension of polystyrene latex particles coated with
deoxyribonucleoprotein (DNP). Each batch of reagents
undergoes rigorous quality control at various stages of
manufacture for its specificity, sensitivity and performance.
Store the reagent at 2 to 8°C. Do not freeze. The shelf-life
of the reagent is as per the expiry date mentioned on the
Latex particles coated with DNP will agglutinate when
mixed with serum containing anti-DNP. No agglutination
indicates absence of anti-DNP in the serum.
1. In vitro diagnostic reagent for laboratory and
professional use only. Not for medicinal use.
2. All the components derived from human source have
been tested for HBsAg and anti-HIV antibody and
are found to be non-reactive. However, handle the
3. The reagents contain sodium azide 0.1% as preservative.
Avoid contact with skin and mucosa. On disposal,
flush with large quantities of water.
4. The reagent can be damaged due to microbial
contamination or exposure to extreme temperatures.
It is recommended that the performance of the reagent
be verified with the positive and negative controls
5. Shake the latex reagent well before use to disperse
the latex particles uniformly and to improve test
6. Only a clean and dry glass slide must be used. Clean
the slide with distilled water and wipe dry.
Sample Collection and Preparation
No special preparation of the patient is required prior to
sample collection by approved techniques. Use fresh clear
serum samples. In case of delay in testing, store the serum
samples at 2 to 8°C for up to 72 hours. For longer storage,
freeze the serum. However, repeated freezing and thawing
Material Provided with the Kit
Rhelax SLE latex reagent, positive control, negative control.
660 Concise Book of Medical Laboratory Technology: Methods and Interpretations Accessories Pack
Glass slide with six reaction circles, mixing sticks, rubber
teats, sample dispensing pipettes.
Test tube (10 × 75 mm), Pipettes, isotonic saline, stopwatch,
Bring all reagents and samples to room temperature
1. Place one drop of sample to be tested onto one of
the reaction circles of the glass slide using a sample
dispensing pipette provided with the kit.
2. Place one drop of positive and negative control onto
separate reaction circles of the glass slide.
3. Gently shake the latex reagent and add one drop to
each sample and control taken on the slide.
4. Mix with separate mixing sticks, spreading the mixture
uniformly over the entire reaction circle.
5. Immediately start a stopwatch. Rock the slide
gently, back and forth, observing for agglutination
1. Using isotonic saline prepare serial dilutions of the
serum sample 1:2, 1:4, 1:8, 1:16, 1:32.
2. Place each dilution of the serum sample onto separate
reaction circles of the slide.
SEROLOGICAL DIAGNOSIS RHEUMATIC DISORDERS WITH LATEX AGGLUTINATION TESTS RF, CRP, ASL
Spectrum Probable diagnosis Further test indicated
– + – Rheumatic fever Anti-streptolysin titer determination
+ + – Acute rheumatic fever ADNase B, AHy, ANADase
– – + Chronic polyarthritis (CP) Quantitative RF determination
+ – + Inflammation in acute attack Quantitative RF determination
+ – – Acute inflammatory (CP) (early stage) Quantitative RF determination
– – + Lupus erythematosus (LE),
ANA (antinuclear Ab) Anti-ds-DNA
against native double filament
Seronegative chronic polyarthritis
Collagen/MCTD (mixed connective
HLA B 27, Yersinia antibody detection
AMA (antimitochondrial antibody)
+ – – Inflammatory-degenerative
serology (e.g. Rubella infection)
– = Negative, + = Positive, (+) = Weakly positive
3. Add one drop of well-mixed latex reagent to each
dilution of the sample on the slide.
4. Mix with separate mixing sticks, spreading the mixture
uniformly over the entire reaction circle.
5. Immediately start a stopwatch. Rock the slide
gently, back and forth, observing for agglutination
Agglutination is a positive test result and indicates
presence of anti-DNP in the test specimen.
No agglutination is a negative test result and indicates
absence of anti-DNP in the test specimen.
The titer of the serum is the reciprocal of the highest
dilution which gives agglutination.
1. Markedly lipemic, hemolyzed and contaminated
serum samples could produce nonspecific results.
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