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Syphilis RPR Test B. Semi-quantitative Test
Prepare dilutions of the samples with physiological saline (0.9%) as indi-
Quicktest cated: 1:2, 1:4, 1:8, 1:16, 1:32. Proceed as in the qualitative test.
Package Sizes  Interpretation of Results
[²REF²] 50001 100 Tests Complete Test Kit The last dilution step that contains macroscopic aggregates indicates the
50002 500 Tests Complete Test Kit titer of the sample. If the last dilution gives a positive result the dilution
series should be extended to 1:64, 1:128, 1:256 and 1:512.
50016 500 Tests Reduced accessories
[IVD] Quality Control
[PC] and [NC] should be run with each series of samples and incorporated
Intended Use in reading the results:
SYPHILIS RPR is a non-treponemal flocculation test for the qualitative and
[NC] - homogeneous suspension with no aggregates
quantitative detection of reagin antibodies associated with syphilis in
human serum or plasma. The assay is intended for professional use and [PC] – within 8 min. distinct macroscopical aggregates.
should be used by trained personnel only.
Notes
Principle 1. As with all reagin tests, SYPHILIS RPR TEST may give false positive
The RPR-antigen used in the kit is a modification of VDRL antigen which results. These results can be caused by diseases such as leprosy, lupus
contains microparticulate charcoal to enhance the visual difference erythematosus, infectious mononucleosis, malaria, vaccina and viral
between a positive and negative result. For sera containing anti-reagin pneumonia. All reactive test samples should undergo a further sero-
antibodies flocculation of antigen-charcoal particles is observed. In case of logical test (i.e. TPHA).
non-reactive specimen the specimen-antigen-suspension remains The final diagnosis should be based on a correlation of test results with
homogenous. other clinical findings.
Contents, Reagent Composition 2. Contaminated sera and a longer reaction time may cause false positive
[AGS] 100 or 500 tests RPR Antigen Suspension (white cap) results.
Cardiolipin suspension, containing micro-particulate 3. After each day's testing, the needle should be removed from the dis-
charcoal 0.3 % pensing bottle, rinsed with distilled water and air dried. Recap [AGS] for
[PC] 0.5 or 1.0 ml RPR control serum positive (red cap) storage.
Stabilised liquid control, reactive with RPR antigen (human) 4. [PC] has been tested for HBsAg, HCV and HIV antibodies and was found
[NC] 1.0 ml RPR control serum negative (green cap) to be non-reactive. However, the material should still be regarded and
Stabilised liquid control, non-reactive with RPR antigen handled as potentially hazardous.
[AGS] and [NC] contain 0.095% sodium azide 5. All materials contaminated with patient specimens should be inacti-
vated by validated procedures (autoclaving or chemical treatment) ac-
[PC] contains 0.095% sodium azid and 0.2% Proclin950
cording to applicable regulations.
Material Provided
Performance Characteristics
[²REF²] 50001 50002 50016 Typical performance data can be found in the Verification Report, acces-
Disposable test cards with 10 cells 10 50 10 sible via
Dispensing needle for [AGS] (16 μl) 1 1 1 www.human.de/data/gb/vr/lx-rpr.pdf or
Disposable dispensers for 100 500 0 www.human-de.com/data/vr/lx-rpr.pdf
serum/plasma (50 μl) If the performance data are not accessible via internet, they can be
obtained free of charge from your local distributor.
Stability
[AGS], [PC] and [NC] are stable up to the expiry date when stored at 2...8°C. Safety Notes
Do not freeze [AGS] ! P234 Keep only in original container.
P260 Do not breathe dust/fume/gas/mist/vapours/spray.
Specimen
Plasma, serum (heated or unheated). The samples should be free from P262 Do not get in eyes, on skin, or on clothing.
contamination and non-hemolysed. P281 Use personal protective equipment as required.
Fresh serum samples may be stored for 7 days at 2...8°C or up to 2 years at P303+P361+P353 IF ON SKIN (or hair): Take off immediately all
-20°C. contaminated clothing. Rinse skin with water/shower.
Procedure P305+P351+P338 IF IN EYES: Rinse cautiously with water for several
minutes. Remove contact lenses, if present and easy to do. Continue
A. Qualitative Test rinsing.
Bring [AGS], [PC], [NC] and samples to room temperature. P337+P313 If eye irritation persists: Get medical advice/attention.
[AGS] - mix reagent thoroughly and insert the dispensing needle on the
P401 Store in accordance with local/regional/national/international
dropping attachment. regulations.
The suspension must be totally homogeneous before use. P501 Dispose of contents/container in accordance with local/regional/
Dispense samples/controls onto separate cells of the test card by using national/ international regulations.
the disposable serum dispensers or droppers and spread the fluid over
All materials of human origin have been tested and found non-reactive for
the entire area of the test cells.
HBsAg, HCV- and HIV-antibodies using approved methods. However, all
Sample 1 drop (50 μl) materials of biological origin should be treated as potentially infectious.
[PC] 1 drop
References
[NC] 1 drop
1. Portnoy J. et al., U. S. Publ. Health Report 77, 645 (1962)
[AGS]
2. McGrew B. E. et al., Amer. J. Med. Tech. 34, 634 (1968a)
Hold the bottle vertically. 1 drop
Drop with dispensing needle. each 3. McGrew B. E. et al., Amer. J. Clin. Path. 50, 52 (1968b)
Do not restir. 4. Schroeter A. L. et al., Adv. in Automated Analysis 1, 156, N.Y. Mediad.
Tilt the test card back and forth slowly for 8 minutes or place the card (1970)
on an automated rotator and rotate at 100 r.p.m. for 8 minutes. 5. Stevens R. W., Stroebel E., Amer. J. Clin. Path. 53, 32 (1970)
 Interpretation of Results
Immediately after the 8 minutes rotation read the results macroscopically
in direct light. A reactive result is indicated by large aggregates in the
LX-RPR INF 5000101 GB 04-2019-022 |
centre or the periphery of the test circle. Weak positive results are
indicated by the presence of small aggregates around the edge of the test
circle. A negative (non-reactive) result will display a smooth, even
appearance with no aggregates visible. Samples with positive results
should be retested in the semi-quantitative test.
Human Gesellschaft für Biochemica und Diagnostica mbH
Max-Planck-Ring 21 · 65205 Wiesbaden · Germany
Telefon +49 6122-9988-0 · Telefax +49 6122-9988-100 · e-Mail human@human.de