[Rapid diagnosis of sexually transmitted infections : Joint statement of DSTIG, RKI, and PEI, as well as the reference centers for HIV, HBV, and HCV and consulting laboratories for Chlamydia, gonococci, and Treponema pallidum].

[Rapid diagnosis of sexually transmitted infections : Joint statement of DSTIG, RKI, and PEI, as well as the reference centers for HIV, HBV, and HCV and consulting laboratories for Chlamydia, gonococci, and Treponema pallidum]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2020 Sep 15;: Authors: Meyer T, Eberle J, Roß RS, Schüttler CG, Baier M, Buder S, Kohl PK, Münstermann D, Hagedorn HJ, Nick S, Jansen K, Bremer V, Mau M, Brockmeyer NH Abstract In February 2019, the fourth expert meeting on rapid diagnostic tests (RDTs) for sexually transmitted infections (STI) was held at the Robert Koch Institute (RKI) in Berlin. Novel technical developments and new aspects of RDT applications were discussed by representatives from the German STI Society (DSTIG); RKI; the Paul Ehrlich Institute; national reference centers for HIV, HBV, and HCV; and reference laboratories for Chlamydia, gonococci, and Treponema pallidum.As a result of this meeting, we present a revision of the joint statement on STI diagnostics with RDTs from 2017. The Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices became effective in May 2017 and includes more stringent regulatory requirements for RDTs, mainly concerning conformity of manufacturing processes and performance characteristics of class D in vitro diagnostics (detection of HIV, HBV, HCV, and T. pallidum). Some RDTs for HIV, HCV, and...
Source: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz - Category: International Medicine & Public Health Authors: Tags: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz Source Type: research