Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Bonstingl, L; Skofler, C; Ulz, C; Zinnegger, M; Sallinger, K; Schönberger, J; Schuch, K; Pankratz, K; Borrás-Cherrier, A; Somodi, V; Abuja, PM; Oberauner-Wappis, L; Moser, T; Heitzer, E; Bauernhofer, T; Kroneis, T; El-Heliebi, A.
Clinical Application of ISO and CEN/TS Standards for Liquid Biopsies-Information Everybody Wants but Nobody Wants to Pay For.
Clin Chem. 2024; 70(9): 1140-1150.
Doi: 10.1093/clinchem/hvae079
Web of Science
PubMed
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- Leading authors Med Uni Graz
- Bonstingl Lilli
- El-Heliebi Amin
- Skofler Christina
- Co-authors Med Uni Graz
- Abuja Peter Michael
- Bauernhofer Thomas
- Heitzer Ellen
- Kroneis Thomas
- Moser Tina
- Oberauner-Wappis Lisa
- Pankratz Karin Brigitte
- Sallinger Katja
- Schönberger Julia Maria
- Schuch Katharina
- Ulz Christine Maria
- Zinnegger Margret
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- Abstract:
- BACKGROUND: Liquid biopsies are emerging as valuable clinical biomarkers for cancer monitoring. Although International Organization for Standards (ISO) and Technical Specifications from the European Committee for Standardization (CEN/TS) standardized workflows exist, their implementation in clinical practice is underdeveloped. We aimed to assess the applicability of ISO and CEN/TS standards in a real-world clinical setting, with a particular focus on evaluating the impact of preanalytical parameters and hemolysis on liquid biopsy analysis. METHODS: We evaluated 659 peripheral blood samples from advanced prostate cancer patients against ISO and CEN/TS standards and documented all essential criteria, including tube draw order, filling level, temperature, and time tracking from blood draw to storage. We assessed hemolysis and its effect on circulating tumor DNA (ctDNA) and circulating tumor cell (CTC) analysis. RESULTS: Our results demonstrated a high compliance rate, with 96.2% (634/659) of samples meeting essential ISO and CEN/TS criteria. We did not observe a significant impact on ctDNA or CTC detection rates between hemolytic and nonhemolytic samples. Hemolysis was identified in 12.9% (40/311) of plasma samples from our advanced prostate cancer cohort, and within the draw order of 5 blood collection tubes, hemolysis did not significantly increase from tube 1 to 5. In total, 83.8% (552/659) of blood collection tubes had high fill levels above 80% of nominal filling level. CONCLUSIONS: Our study demonstrates the feasibility and benefits of adhering to ISO and CEN/TS standards in a clinical liquid biopsy study. The standards revealed that hemolysis occurred frequently but did not impair downstream ctDNA and CTC analysis in our cohort of advanced prostate cancer patients.
- Find related publications in this database (using NLM MeSH Indexing)
- Humans - administration & dosage
- Liquid Biopsy - standards
- Male - administration & dosage
- Prostatic Neoplasms - pathology
- Neoplastic Cells, Circulating - pathology
- Circulating Tumor DNA - blood
- Hemolysis - administration & dosage
- Biomarkers, Tumor - blood