ArticleVirchows Archiv : an international journal of pathology2021
Status quo of ALK testing in lung cancer: results of an EQA scheme based on in-situ hybridization, immunohistochemistry, and RNA/DNA sequencing.
Article in Virchows Archiv : an international journal of pathology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed, 9 citations in OpenAlex.
- Current Biomarkers in Non-Small Cell Lung Cancer-The Molecular Pathologist's Perspective.Diagnostics (Basel, Switzerland) · 2025Review
- Establishment of potential reference measurement procedure and reference materials for EML4-ALK fusion variants measurement.Scientific reports · 2024Article
- Proficiency testing of PIK3CA mutations in HR+/HER2-breast cancer on liquid biopsy and tissue.Virchows Archiv : an international journal of pathology · 2023Article
- Automated Lung Cancer Segmentation in Tissue Micro Array Analysis Histopathological Images Using a Prototype of Computer-Assisted Diagnosis.Journal of personalized medicine · 2023Article
- Identification and therapeutic evaluation of ALK rearrangements in non-small-cell lung cancer.The journal of pathology. Clinical research · 2022Article
- The Significance of External Quality Assessment Schemes for Molecular Testing in Clinical Laboratories.Cancers · 2022Review
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Authors and funding
22 authors at 8 institutions in 2 countries.
Funding
Abstract
With this external quality assessment (EQA) scheme, we aim to investigate the diagnostic performance of the currently available methods for the detection of ALK alterations in non-small cell lung cancer on a national scale, namely, in situ hybridization (ISH), immunohistochemistry (IHC), and RNA/DNA sequencing (NGS). The EQA scheme cohort consisted of ten specimens, including four ALK positive and six ALK negative samples, which were thoroughly pretested using IHC, ISH, and RNA/DNA NGS. Unstained tumor sections were provided to the 57 participants, and the results were retrieved via an online questionnaire. ISH was used by 29, IHC by 38, and RNA/DNA sequencing by 19 participants. Twenty-eight institutions (97%) passed the ring trial using ISH, 33 (87%) by using IHC, and 18 (95%) by using NGS. The highest sensitivity and interrater agreement (Fleiss ' kappa) was observed for RNA/DNA sequencing (99%, 0.975), followed by ISH (94%, 0.898) and IHC (92%, 0.888). However, the proportion of samples that were not evaluable due to bad tissue quality was also higher for RNA/DNA sequencing (4%) compared with ISH (0.7%) and IHC (0.5%). While all three methods produced reliable results between the different institutions, the highest sensitivity and concordance were observed for RNA/DNA sequencing. These findings encourage the broad implementation of this method in routine diagnostic, although the application might be limited by technical capacity, economical restrictions, and tissue quality of formalin-fixed samples.
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