RPR Test Kit

RPR/010* & RPR/012*

*Suffixes indicate change in kit presentation only.
PRINCIPLE MATERIALS AND EQUIPMENT REQUIRED BUT NOT
The RPR (Rapid plasma reagin), test kit is a non-Treponemal test for the PROVIDED.
qualitative and semi-quantitative detection of syphilis using serum Specimen collection container, Serological pipettes (50 & 100μl),
(heated or unheated), or plasma. The RPR test consists of modified timer, rotating table (100rpm), 0.85% physiological saline, glass
VDRL antigen containing carbon particles, which aggregates in the test tubes.
presence of reagin type antibodies in serum or plasma, indicating a
positive result. RECOMMENDATIONS AND CONTROLS
It is recommended that the positive and negative controls are run
CLINICAL SIGNIFICANCE with each batch of test specimens. For the assay to be valid the
The RPR test is “non-treponemal” in that the antibodies detected are not positive control provided should give a strong positive pattern and
specific for T. pallidum, although their presence in patient’s serum or the negative control provided should give a clearly negative result.
plasma is strongly associated with infection by the organism. This test
measures antibody (IgG and IgM) produced in response to lipoidal RECOMMENDED PROCEDURE
material released from damaged host cells as well as to lipoprotein-like A. Qualitative Test
material released from the spirochaetes. These antibodies tend to 1. Draw the sample into the pipstir provided taking care not to
disappear after successful treatment of the infection. transfer and cellular matter.
2. Hold the pipstir vertically above the test card and allow one
WARNINGS AND PRECAUTIONS drop (50µl), of specimen to dispense onto the test card.
For in vitro diagnostic use only. For professional use only. 3. Spread the specimen evenly over the area of the test circle
Health and Safety warnings: using the broad end of the pipstir.
All patient samples and reagents should be treated as potentially 4. Ensure the carbon antigen is shaken and homogenous.
infectious and the user must wear protective gloves, eye protection and 5. Attach the needle to the dispenser and withdraw sufficient
laboratory coats when performing the test. carbon antigen.
Non disposable apparatus must be sterilised after use by an appropriate 6. Dispense a single drop (20µl) of antigen into the centre of the
method. specimen ensuring the dispenser is held vertically.
Disposable apparatus must be treated as biohazardous waste and 7. Rotate card on rotating table for 8 minutes.
autoclaved or incinerated. 8. Read the results macroscopically.
Spillages of potentially infectious material should be absorbed and
disposed of as above. The site of spillage must be sterilised with B. Semi Quantative Test
disinfectant or 70% alcohol. 1. Prepare doubling dilutions of the sample from the undiluted
Do not pipette by mouth. specimen to 1:32 using physiological saline.
If a reagent vial is compromised, discard the contents immediately. 2. Using the pipstirs, place one drop (50µl), of each dilution onto
The product also contains aqueous buffer salts including sodium azide separate test card circles.
as preservative - see material safety data sheet. 3. Using the broad end of the pipster, spread each dilution over
Analytical precautions: the test circle area from weakest to strongest dilution.
Do not modify the test procedure. 4. Continue procedure as from point 4.of the Qualitative test.
All reagents are ready to use do not dilute the reagents in any way.
Reagents and samples to be used at room temperature (18-30ºC). INTERPRETATION OF RESULTS
Shake reagents before use to ensure a homogenous suspension A. Qualitative Test
Avoid cross contamination between different reagents. Positive: Macroscopic agglutination constitutes a positive test
Do not interchange droppers. The disposable pipettes should be result within the accepted limitations of the test procedure,
discarded after a single use. therefore indicating the presence of the antibodies to T.Pallidum.
Discard reagents if they become contaminated or incorrect results are Negative: No macroscopic agglutination constitutes a negative test
obtained with the controls. result within the accepted limitations of the test procedure,
Do not mix reagent of different lots. therefore indicating the absence of the antibodies to T.Pallidum.
B. Semi Quantitative Test
STANDARD KIT COMPONENTS Results can be graded from strong to non-reactive and the titre
RPR/010 RPR/012 expressed as the reciprocal of the last dilution showing a positive
COMPONENT
(100T) (500T) reaction.
RPR Carbon 2ml 10ml Strong Large clumps of carbon particles with a
Positive Control 0.5ml 1ml Reactive (SR) clear background.
Negative Control 0.5ml 1ml Large clumps of carbon particles, more
Reactive (R)
Pipette Stirrers 100 500 dispersed than strong reactive.
Dispenser 1 1 Weak Reactive Small clumps of carbon particles with
Needle 1 1 (WR) light grey background.
Reaction Cards 10 50 Slight clumping of carbon particles,
Instructions For Use 1 1 typically seen as a button of aggregates
Trace Reactive
in the centre of the test circle or
(TR)
dispersed around the edge of the test
SPECIMEN AND SAMPLE PREPARATION
circle.
This kit can be used with plasma or heated serum. Do not use samples
that are haemolysed, turbid or lipaemic. Store at 2-8ºC for up to 7 days A smooth grey pattern or a button of
Non-Reactive
before testing. If longer storage is required, freeze sample at -20ºC or non-aggregated carbon particles in the
(NR)
lower. Ensure frozen samples are thawed before testing. centre of the test circle.

Reactive samples should be recorded as antibody positive and

must be subjected to further tests to determine the presence or
absence of specific anti-Treponemal antibody.
REACTION STABILITY BIBLIOGRAPHY
Read test immediately after rotation. Exercise caution when interpreting 1. McGrew, B.E. et al., Amer. J. Med Tech. , 34, 634 (1968a).
results carried out at temperatures other than that recommended. 2. McGrew, B.E. et al., Amer. J. Clin. Path., 50, 52 (1968b).
3. Norins, L.C. Automation in Clinical Chemistry, 1, 157New
STORAGE AND SHELF LIFE York Mediad (1968).
Store all reagents upright at 2-8ºC. 4. Portnoy, J. et al., U.S. Publ. Health Report, 77, 645 (1962).
DO NOT FREEZE THE REAGENT. 5. Schroeter, A.L. et al.,Adv. In Automated Analysis 1, 256 N.Y.
Do not use reagents after the stated expiry date. Mediad
Discard reagents if they become contaminated. 6. Stevens, R.W. and Stroebel, E., Amer. J. Clin. Path., 53, 32
ALL REAGENTS ARE SUPPLIED READY TO USE (1970).
7. Stout, G.W. et al., J. Conf. Pub. Health Lab. Directors, 26, 7,
LIMITATIONS OF THE METHOD (1968).
1. All reagin tests may give a small proportion of false positive results. 8. Manual Test for Syphilis PHS Publications No 411, (1969).
Diseases such as infectious mononucleosis, leprosy, lupus
erythematous, vaccinia and viral pneumonia can cause such TABLE OF SYMBOLS
reactions. SYMBOL DEFINITION
2. Reactive RPR test specimens should be tested with further
serological tests (i.e. TPHA and FTA-abs), as with any serological Batch Number
procedure, the diagnosis should not be made on a single reactive
result. In-vitro Diagnostics
3. As with other serological tests, the RPR test cannot distinguish
between syphilis and other pathogenic Treponemal infections e.g.
Yaws. Catalogue reference
4. A diagnosis should always be made in conjunction with clinical
findings. Store at
5. False positive/negative results can also occur due to:
• Contamination of test materials
• Improper storage, or test temperatures Expiry date
• Deviation from the Recommended Procedures.
Manufactured by
PERFORMANCE CHARACTERISTICS
The following materials were independently tested to compare the
performance of the RPR reagent with that of a reference reagent from Date of Manufacture
CDC Atlanta and a reagent from another manufacturer.
Read the instructions
Reference plasma panel from CDC Atlanta for use
Positive test panel from a UK hospital ∑
Normal donor plasma Sufficient for
WHO control

All specimens gave 100% concordant qualitative results with all

reagents.

Intra-assay Precision and Accuracy: CV = 0%, accuracy = +/- 0%.

Inter-assay Precision: A standard positive sample tested on eight
occasions showed +/- 1 doubling dilution from the nominal value.

DISCLAIMER
The user is responsible for the performance of the reagent by any
method other than those mentioned in the Recommended Procedures.
Any deviations from the Recommended Procedures should be
validated prior to use.

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