title: Working towards accreditation by the International Standards Organization 15189 Standard: how to validate an in-house developed method an example of lead determination in whole blood by electrothermal atomic absorption spectrometry.
abstract: Laboratories working towards accreditation by the International Standards Organization (ISO) 15189 standard are required to demonstrate the validity of their analytical methods. The different guidelines set by various accreditation organizations make it difficult to provide objective evidence that an in-house method is fit for the intended purpose. Besides, the required performance characteristics tests and acceptance criteria are not always detailed. The laboratory must choose the most suitable validation protocol and set the acceptance criteria. Therefore, we propose a validation protocol to evaluate the performance of an in-house method. As an example, we validated the process for the detection and quantification of lead in whole blood by electrothermal absorption spectrometry. The fundamental parameters tested were, selectivity, calibration model, precision, accuracy (and uncertainty of measurement), contamination, stability of the sample, reference interval, and analytical interference. We have developed a protocol that has been applied successfully to quantify lead in whole blood by electrothermal atomic absorption spectrometry (ETAAS). In particular, our method is selective, linear, accurate, and precise, making it suitable for use in routine diagnostics.
authors.affiliation: Laboratory of Biochemistry, Percy Military Hospital, Clamart, France.
authors.forename: Carine
authors.initials: C
authors.lastname: Garcia Hejl
authors.affiliation: Laboratory of Biochemistry, Val de Grâce Military Hospital, Paris, France.
authors.forename: Jose Manuel
authors.initials: JM
authors.lastname: Ramirez
authors.affiliation: Laboratory of Biochemistry, Percy Military Hospital, Clamart, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Vest
authors.affiliation: Laboratory of Biochemistry, Percy Military Hospital, Clamart, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Chianea
authors.affiliation: Laboratory of Biochemistry, Val de Grâce Military Hospital, Paris, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Renard
mesh_terms: D000068:Accreditation; D006801:Humans; D007753:Laboratories / Q000592:standards; D007854:Lead / Q000097:blood* / Q000592:standards; D012015:Reference Standards; D013054:Spectrophotometry, Atomic / Q000592:standards; D054928:Validation Studies as Topic
chemical_list: D007854:Lead
keywords: Atomic absorption spectrophotometry; Lead; Validation