RPR-CARBON

RPR-carbon
Slide agglutination

Qualitative determination of plasma reagins 6. Place the slide on a mechanical rotator at 80-100 r.p.m. for 8 min
IVD (Note 1). False positive results could appear if the test is read later
than 8 minutes.
Store at 2 - 8ºC.
Semi-quantitative method
PRINCIPLE OF THE METHOD 1. Make serial two fold dilutions of the sample in 9 g/L saline solution.
The RPR-carbon is a non-treponemal slide agglutination test for the 2. Proceed for each dilution as in the qualitative method.
qualitative and semi-quantitative detection of plasma reagins in human
serum. Carbon particles coated with a lipid complex are agglutinated when READING AND INTERPRETATION
mixed with samples containing reagins of patient affected by sy phillis. Examine macroscopically the presence or absence of visible
agglutination immediately after removing the slide test from the rotator.
CLINICAL SIGNIFICANCE Rotate the slide twice by hand before reading.
Reagins are a group of antibodies against some components of the
damage tissues from patients infected by Treponema pallidum, the Interpretation
agent which causes the syphilis.This microorganism produces some Agglutination Reading Report
damage to the liver and heart, releasing some tissue fragments. Medium or large clumps R Reactive
Immunological patient system reacts producing reagins, antibodies Small clumps W Weakly reactive
against these fragments. No clumping or very slight “roughness” N Non Reactive
The assay is useful to follow the antibiotic therapy answer.
The titer, in the semi-quantitative method, is defined as the highest
REAGENTS dilution showing a positive result.
RPR- Carbon particles coated with a lipid complex, cardiolipin, QUALITY CONTROL
carbon lecithin and cholesterol in phosphate buffer 20 mmol/L. Positive and Negative controls are recommended to monitor the
Preservative. pH, 7,0. performance of procedure, as well as a comparative pattern for a
Control + better result interpretation.
Artificial serum with reagin titer ≥ 1/4.
Red cap All result different from the negative control result, will be considered
Control - as a positive.
Animal serum. Preservative
Blue cap
PERFORMANCE CHARACTERISTICS
PRECAUTIONS 1.Analytical sensitivity: Accurate titer determination of the Reference
Control +: H319- Causes serious eye irritation. Material, under the described assay conditions (see calibration).
Follow the precautionary statements given in MSDS and label of the product. 2.Prozone effect: No prozone effect was detected up to titers ≥1/128.
3.Diagnostic sensitivity: 100 %.
CALIBRATION 4.Diagnostic specificity: 100 %.
The sensitivity is calibrated against the International Reference WHO
(1st Standard Human Syphilitic Serum, ref. 05/132). INTERFERENCES
Bilirubin (20 mg/dL), hemoglobin (10 g/L) and lipids (10 g/L), do not
PREPARATION interfere. Rheumatoid factors (300 IU/mL), interfere. Other substances
RPR-carbon: Homogenize the reagent before use. Place the needle to may interfere5.
the plastic dispenser vial, open the RPR-carbon vial and aspirate the
required amount of reagent. Once the test is finished, return the reagent NOTES
to the original vial and rinse the needle and dispenser with distilled water. 1. During the 8 minutes of reaction time do not expose the slide to a source
of heat or intense light in order to reduce evaporation. Such evaporation
STORAGE AND STABILITY could cause a false agglutination and therefore false positive results.
All the kit components will remain stable until the expiration date printed
on the label, when stored tightly closed at 2-8ºC and contaminations are LIMITATIONS OF THE PROCEDURE
prevented during their use. Do not freeze: frozen reagents could change - RPR carbon test is non-specific for syphilis. All Reactive samples
the functionality of the test. should be retested with treponemic methods such as TPHA and
Mix reagents gently before use. FTA-Abs to confirm the results.
Reagents deterioration: Presence of particles and turbidity. - A Non Reactive result by itself does not exclude a diagnosis of
syphilis. Clinical diagnosis should not be made on findings of a
ADDITIONAL EQUIPMENT single test result, but should integrate both clinical and laboratory
- Mechanical rotator with adjustable speed at 80-100 r.p.m. data.
- Humid store. - False positive results have been reported in diseases such as
- Vortex mixer. infectious mononucleosis, viral pneumonia, toxoplasmosis,
- Pippetes 50 µL. pregnancy and autoimmune diseases.

SAMPLES BIBLIOGRAPHY
Fresh serum or plasma. Stable 7 days at 2-8ºC or 3 months at –20ºC. 1.George P. Schimid. Current Opinion in Infectious Diseases 1994; 7: 34-40
The samples with presence of fibrin should be centrifuged before testing. 2.Sandra A Larsen et al. Clinical Microbiology Reviews 1995; 8 (1): 1-21.
Do not use highly hemolized or lipemic samples. 3.Sandra Larsen et al. A manual of Test for Syphilis American Public
Health Association 1990: 1-192.
PROCEDURE 4.Joseph Earle Moore et al. Gastrointestinal Haemorrhage 1952; 150(5):
Qualitative method 467-473.
1. Allow the reagents and samples to reach room temperature. The 5.Young DS. Effects of drugs on clinical laboratory test, 4th ed. AACC
sensitivity of the test may be reduced at low temperatures. Press, 1995.
2. Place 50 µL of the sample and one drop of each Positive and
PACKAGING
Negative controls into separate circles on the slide test.
3. Homogenize the reagent RPR-carbon before using. Invert the dispenser Ref.: 1200401 150 tests Ref: 1200402 500 tests
vial and press lightly to remove air bubbles. : 3 mL RPR-carbon : 2 x 5 mL RPR-carbon
4. Place the dispenser vial together with the needle in a vertical position : 1 mL Control + : 1 mL Control +
and perpendicular to the slide, and add one drop (20 µL) of reagent : 1 mL Control - : 1 mL Control -
together with each of the samples and controls. : 21 x 8 disposable slides : 63 x 8 disposable slides
5. Mix the drops with a stirrer, spreading them over the entire surface of : Dispensing vial and needle : Dispensing vial and needle
the circle. Use different stirrers for each sample

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