A pilot study of on-site evaluation as external quality assessment for ISO 15189 accreditation of laboratories performing next-generation sequencing oncology tests.

ABSTRACT:

Background

As next-generation sequencing (NGS) oncology tests vary by platform, application, and target of genes, specific methods for external quality assessment (EQA) have not been universally applied. Hence, we have attempted to implement on-site evaluation as EQA in the accreditation program under ISO 15189 for laboratories that perform NGS oncology tests.

Methods

A total of 10 laboratories that performed NGS oncology tests were enrolled. Two types of EQA samples were prepared (Acrometrix Oncology Hotspot Control DNA and OncoSpan gDNA DNA samples), and the variant allele frequency of targeted genes was assigned. The samples were subjected to NGS oncology tests in participant laboratories according to their routine protocols. Based on the result reports, auditors visited

SUBMITTER: Ravzanaadii M 

PROVIDER: S-EPMC10388225 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature