[Accreditation of a multiplex real time PCR assay for detection and semi-quantitative determination of pathogens responsible of sexually-transmitted infections].

Preliminary evaluation of qualitative and semi-quantitative clinical laboratory measurements is a prerequisite for the accreditation of clinical laboratories, according to the French committee of accreditation guidelines following the European reference standard EN ISO 15189. Numerous papers have been published regarding biochemistry, hematology or immunology. However, data are still lacking for molecular biology. We report our experience and present the performance characteristics of Allplex™ STI Essential real time PCR assay for the detection of seven pathogens, among which some are systematically responsible of sexually-transmitted infections. Moreover, a semi-quantitative determination of Ureaplasma urealyticum, Ureaplasma parvum and Mycoplasma hominis is proposed thanks to a calibration.