ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation.
Clin Chem Lab Med
; 61(4): 608-626, 2023 03 28.
Article
em En
| MEDLINE
| ID: mdl-36716120
Palavras-chave
AB, accrediting body; BRCA1/2, breast cancer genes 1 and 2; CA, competent authority; CAPA, corrective and preventive actions; CDx, companion diagnostics; CGP, comprehensive genomic profile; CRGA, clinically relevant genomic alterations; EEA, European economic area; EFLM, European Federation of Clinical Chemistry and Laboratory Medicine; EMA, European Medicines Agency; EU, European Union; European Regulation 2017/746 on In-Vitro-Diagnostic Devices; FMEA, failure-mode effects analysis; GA, genomic alterations; GDPR, General Data Protection Regulation; HI, health institution; HRD, homologous recombination deficiency; HRR, homologous recombination repair; ISO 15189:2012; ISO, International Organization for Standardization; IVDD, In-Vitro Diagnostic Device Directive; IVDR, In-Vitro Diagnostic Device Regulation; LDT, laboratory-developed test; MDCG, Medical Device Coordination Group; MSI, micro satellite instability; MU, measurement uncertainty; NB, notified body; NGS, next generation sequencing; NTRK, neurotrophic tyrosine receptor kinase; PARPi, poly (ADP-ribose) polymerase inhibitors; PRRC, person responsible for regulatory compliance; PT, proficiency testing; RUO, research use only; RiliBÄk, Richtlinie der Bundesärztekammer zur Qualitätssicherung Laboratoriums medizinischer Untersuchungen; SOP, standard operating procedure; TMB, tumor mutational burden; UDI, unique device identifier; VAF, variant allele frequency; iQC, internal quality control; laboratory-developed tests for in-house use; method validation
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Kit de Reagentes para Diagnóstico
/
Serviços de Laboratório Clínico
Tipo de estudo:
Diagnostic_studies
/
Prognostic_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article