abstract: On February 5th, 2016 an expert meeting on rapid diagnostic tests (RDT) for sexually transmitted infections (STI) was held in Berlin at the Robert-Koch-Institute. The aim of the conference was to update a former evaluation of RDTs for diagnosis of HIV, HBV, HCV, T. pallidum, C. trachomatis and N. gonorrhoeae in low-threshold counseling services for STI that had been published after the previous meeting in 2012. According to the strategy to control HIV, hepatitis B and C and other STI, recently adopted by the German Government, there is a lack of test capabilities and a demand for more testing services as well as improved access to testing. Using RDTs as low-threshold test services in counseling centers or even for testing at home may provide an important option to lower the barrier of testing. Based on performance data evaluated in clinical trials some RDTs for HIV, HCV and syphilis are quite well suited as a point-of-care Test (POCT). In contrast, sufficient diagnostic accuracy for detection of C. trachomatis and N. gonorrhoeae can only be achieved by PCR-based POCTs. In Germany the use of POCTs is subjected to legal stipulations of IfSG and MPG. Of importance, it is not allowed to deliver HIV tests to private persons for home testing (§ 11, MPG). Furthermore, both assessment and communication of infectious diseases are reserved to the physician and must not happen as remote diagnostics (§ 24, IfSG). In addition, like all laboratory tests, RDTs are subject to quality assessment according to guidelines of the German Medical Association.
authors.affiliation: Institut für Medizinische Mikrobiologie, Virologie und Hygiene, Universitätsklinikum Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Deutschland. th.meyer@uke.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Meyer
authors.affiliation: Institut für Medizinische Virologie, Justus-Liebig-Universität Gießen, Gießen, Deutschland.
authors.forename: Christian G
authors.initials: CG
authors.lastname: Schüttler
authors.affiliation: Institut für Medizinische Mikrobiologie, Universitätsklinikum Jena, Jena, Deutschland.
authors.forename: Eberhard
authors.initials: E
authors.lastname: Straube
authors.affiliation: Institut für Virologie, Universitätsklinikum Essen, Universität Duisburg-Essen, Duisburg, Deutschland.
authors.forename: R Stefan
authors.initials: RS
authors.lastname: Roß
authors.affiliation: Institut für Medizinische Virologie, Universitätsklinikum Frankfurt, Frankfurt, Deutschland.
authors.forename: Martin
authors.initials: M
authors.lastname: Stürmer
authors.affiliation: Robert Koch-Institut, Berlin, Deutschland.
authors.forename: Klaus
authors.initials: K
authors.lastname: Jansen
authors.affiliation: Konsiliarlabor für Gonokokken, Vivantes-Klinikum Region Süd, Berlin, Deutschland.
authors.forename: Susanne
authors.initials: S
authors.lastname: Buder
authors.affiliation: Paul-Ehrlich-Institut, Langen, Deutschland.
authors.forename: Sigrid
authors.initials: S
authors.lastname: Nick
authors.affiliation: Labor Krone, Bad Salzufflen, Deutschland.
authors.forename: Hans-Jochen
authors.initials: HJ
authors.lastname: Hagedorn
authors.affiliation: Robert Koch-Institut, Berlin, Deutschland.
authors.forename: Viviane
authors.initials: V
authors.lastname: Bremer
authors.affiliation: Klinik für Dermatologie, Venerologie und Allergologie, Ruhr-Universität Bochum, Bochum, Deutschland.
authors.forename: Norbert H
authors.initials: NH
authors.lastname: Brockmeyer
mesh_terms: D001424:Bacterial Infections / Q000175:diagnosis*; D001432:Bacteriology / Q000592:standards; D019411:Clinical Laboratory Techniques / Q000592:standards*; D019317:Evidence-Based Medicine; D005858:Germany; D006801:Humans; D019095:Point-of-Care Systems / Q000592:standards*; D017410:Practice Guidelines as Topic; D012749:Sexually Transmitted Diseases / Q000175:diagnosis* / Q000821:virology; D015231:Sexually Transmitted Diseases, Bacterial / Q000175:diagnosis* / Q000382:microbiology; D014572:Urology / Q000592:standards; D014773:Virology / Q000592:standards
keywords: lateral flow assay; nucleic acid amplification test; point-of-care; rapid diagnostic test; sexually transmitted infection