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Disease/health condition -
Syphilis, Sexually transmitted infections (STIs)
Rapid plasma reagin (RPR) test
Assay format
Charcoal agglutination
Information History
First added in 2019
Changed in 2024
Purpose type
Screening, Monitoring
Purpose
To screen for syphilis and monitor treatment effectiveness.
Specimen types
Serum, Plasma
WHO prequalified or recommended products
N/A
GMDN
51819
Treponema pallidum reagin antibody IVD, kit, agglutination
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen using an agglutination method* . The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024* for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test
EMDN
W0105010399
SYPHILIS REAGENTS OTHER
The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdnWHO supporting publications
World Health Organization. (2023). Laboratory and point-of-care diagnostic testing for sexually transmitted infections, including HIV. World Health Organization. https://iris.who.int/handle/10665/374252
Technical specifications
This tool presents technical specifications for 15 IVD tests for syphilis. To review the one(s) of your interest download the file and go to the “Test menu” tab to make your selection. You will find more details in the “Content” tab of this file.
Related Medical Devices in MeDevIS
The SAGE IVD recommended inclusion in the EDL of serological tests for detection of T. pallidum. The rapid plasma reagin (RPR) test is useful for screening.
Recommended test purpose: for screening for syphilis, and for monitoring treatment effectiveness.
Untreated syphilis in pregnancy is a major cause of death and stillbirths, preterm or low-birth-weight infants, neonatal death and syphilis infections in infants. Use of rapid plasma reagin (RPR) test, venereal disease research laboratory (VDRL) test, Treponema pallidum passive particle agglutination (TPPA) test, and Treponema pallidum haemagglutination (TPHA) test for the detection of T. pallidum is recommended in an evidence-based WHO guideline. A systematic review indicated high sensitivity of the qualitative point-of-care rapid plasma reagin test, and the accuracy of the rapid syphilis test is estimated to be higher. Accuracy is difficult to determine, however, as it depends on the stage of syphilis and the type of test.
Supporting evidence is provided in the WHO guideline, which is based on many systematic reviews. The guideline provides appropriate testing algorithms with rapid plasma reagin (RPR) test, venereal disease research laboratory (VDRL) test, Treponema pallidum passive particle agglutination (TPPA) test, and Treponema pallidum haemagglutination (TPHA) test, which are based on a cost–effectiveness model. Few relevant data were provided on the performance of each test.
World Health Organization. (2019). The selection and use of essential in vitro diagnostics: report of the second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (including the second WHO model list of essential in vitro diagnostics). World Health Organization. https://iris.who.int/handle/10665/329527