In the developing world, laboratory services for sexually transmitted infections (STIs) are either not available, or where limited services are available, patients may not be able to pay for or physically access those services. Despite the existence of national policy for antenatal screening to prevent congenital syphilis and substantial evidence that antenatal screening is cost-effective, implementation of syphilis screening programmes remains unacceptably low because of lack of screening tools that can be used in primary health care settings. The World Health Organization Sexually Transmitted Diseases Diagnostics Initiative (SDI) has developed the ASSURED criteria as a benchmark to decide if tests address disease control needs: Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free and Deliverable to end-users. Rapid syphilis tests that can be used with whole blood approach the ASSURED criteria and can now be deployed in areas where no previous screening has been possible. Although rapid tests for chlamydia and gonorrhoea lack sensitivity, more tests are in development. The way forward for STI diagnostics requires a continuing quest for ASSURED tests, the development of a road map for test introduction, sustainable programmes for quality assurance, and the creation of a robust infrastructure linked to HIV prevention that ensures sustainability of STI control efforts that includes viral STIs.

/pdf/rapid-tests-for-sexually-transmitted-infections-stis-the-way-pdkk85w2u8.pdf

Rapid tests for sexually transmitted infections (STIs) : the way forward

Background Syphilis remains a major public health problem in Europe (both in Eastern Europe since the 1990’s and in

2014 European guideline on the management of syphilis

The mainstay of diagnosis for Treponema pallidum infections is based on nontreponemal and treponemal serologic tests. Many new diagnostic methods for syphilis have been developed, using specific treponemal antigens and novel formats, including rapid point-of-care tests, enzyme immunoassays, and chemiluminescence assays. Although most of these newer tests are not yet cleared for use in the United States by the Food and Drug Administration, their performance and ease of automation have promoted their application for syphilis screening. Both sensitive and specific, new screening tests detect antitreponemal IgM and IgG antibodies by use of wild-type or recombinant T. pallidum antigens. However, these tests cannot distinguish between recent and remote or treated versus untreated infections. In addition, the screening tests require confirmation with nontreponemal tests. This use of treponemal tests for screening and nontreponemal serologic tests as confirmatory tests is a reversal of long-held practice. Clinicians need to understand the science behind these tests to use them properly in syphilis management.

Novel Treponema pallidum Serologic Tests: A Paradigm Shift in Syphilis Screening for the 21st Century

The 2020 edition of the European guideline on the management of syphilis is an update of the 2014 edition. Main modifications and updates include: -The ongoing epidemics of early syphilis in Europe, particularly in men who have sex with men (MSM) -The development of dual treponemal and non-treponemal point-of-care (POC) tests -The progress in non-treponemal test (NTT) automatization -The regular episodic shortage of benzathine penicillin G (BPG) in some European countries -The exclusion of azithromycin as an alternative treatment at any stage of syphilis -The pre-exposure or immediate post-exposure prophylaxis with doxycycline in populations at high risk of acquiring syphilis.

2020 European guideline on the management of syphilis.

Lateral flow immunoassay (LFIA) technology is a paper-based, point-of-care strip biosensor designed to detect a specific analyte in a given sample. This type of assay is now of great interest to researchers for its cost-effectiveness, simplicity, portability and rapidness of detection of analytes, including but not limited to areas such as agriculture, food, biomedicine and pathogen detection. Various nanoparticles (such as metal nanoparticles, carbon-based nanoparticles, quantum dots, lanthanides and up-converting phosphor) functionalized by an antibody to detect an analyte protein or molecular marker present in the surface of an infectious pathogen are used for in LFIAs. Herein, we review the principle of the assay and recent advancements made in terms of the different approaches and designs of the assay towards the detection of infectious agents and diseases.

Recent advances in nanoparticle-based lateral flow immunoassay as a point-of-care diagnostic tool for infectious agents and diseases

Objectives: To evaluate nine rapid syphilis tests at eight geographically diverse laboratory sites for their performance and operational characteristics. Methods: Tests were compared “head to head” using locally assembled panels of 100 archived (50 positive and 50 negative) sera at each site using as reference standards the Treponema pallidum haemagglutination or the T pallidum particle agglutination test. In addition inter-site variation, result stability, test reproducibility and test operational characteristics were assessed. Results: All nine tests gave good performance relative to the reference standard with sensitivities ranging from 84.5–97.7% and specificities from 84.5–98%. Result stability was variable if result reading was delayed past the recommended period. All the tests were found to be easy to use, especially the lateral flow tests. Conclusions: All the tests evaluated have acceptable performance characteristics and could make an impact on the control of syphilis. Tests that can use whole blood and do not require refrigeration were selected for further evaluation in field settings.

/pdf/a-multi-centre-evaluation-of-nine-rapid-point-of-care-51q4nnmyep.pdf

A multi-centre evaluation of nine rapid, point-of-care syphilis tests using archived sera

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A multi-centre evaluation of nine rapid, point-of-care syphilis tests using archived sera