ArticleJournal of clinical laboratory analysis2023
A pilot study of on-site evaluation as external quality assessment for ISO 15189 accreditation of laboratories performing next-generation sequencing oncology tests.
Article in Journal of clinical laboratory analysis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The trial behind it
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Who cites it
2 citing papers in PubMed, 2 citations in OpenAlex.
- Comparative Evaluation of Sequencing Technologies for Detecting Antimicrobial Resistance in Bloodstream Infections.Antibiotics (Basel, Switzerland) · 2025Review
- A pilot study of on-site evaluation as external quality assessment for ISO 15189 accreditation of laboratories performing next-generation sequencing oncology tests.Journal of clinical laboratory analysis · 2023Article
Corrections and comments
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Authors and funding
5 authors at 1 institution in 2 countries.
Funding
Abstract
backgroundAs 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.
methodsA 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 the participant laboratories to perform on-site evaluations and provided feedback regarding possible laboratory process improvement.
resultsThe participant laboratories identified the targeted variants in the Acrometrix Oncology Hotspot Control DNA and OncoSpan gDNA samples with a success rate of 31-100% and 9.5-100%, respectively, compared with reference information, depending on their sequencing systems, and reported a few lower-variant allele frequencies. Six of the eight evaluated laboratories failed to report at least three pathogenic variants due to errors in wet-lab and/or dry-lab processes. Based on the feedback reports and self-assessment, auditors and laboratory staff discussed potential improvements to processes during on-site evaluations for laboratory accreditations.
conclusionsOn-site evaluation as EQA for NGS oncology tests in the laboratory accreditation program under ISO 15189 was successfully implemented and proved applicable to a broad spectrum of NGS tests.
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