ABSTRACT
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.
Subject(s)
Accreditation , Microbiological Techniques , Multiplex Polymerase Chain Reaction , Real-Time Polymerase Chain Reaction , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/microbiology , Automation, Laboratory/instrumentation , Automation, Laboratory/methods , Automation, Laboratory/standards , Calibration , DNA, Bacterial/analysis , DNA, Bacterial/genetics , DNA, Bacterial/isolation & purification , Humans , Microbiological Techniques/instrumentation , Microbiological Techniques/methods , Microbiological Techniques/standards , Multiplex Polymerase Chain Reaction/instrumentation , Multiplex Polymerase Chain Reaction/methods , Multiplex Polymerase Chain Reaction/standards , Mycoplasma hominis/genetics , Mycoplasma hominis/isolation & purification , Real-Time Polymerase Chain Reaction/instrumentation , Real-Time Polymerase Chain Reaction/methods , Real-Time Polymerase Chain Reaction/standards , Reproducibility of Results , Ureaplasma/genetics , Ureaplasma/isolation & purification , Ureaplasma urealyticum/genetics , Ureaplasma urealyticum/isolation & purificationABSTRACT
Preliminary evaluation of 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 and immunology. However, data are lacking for automated complete blood count accreditation. We report here our experience at Hôpital européen Georges Pompidou hematology laboratory and present the performance characteristics of two mirrored LH750 Beckman-Coulter analysers, including precision, accuracy and uncertainty of measurement.
