Analytical validation of a novel multi-target blood-based test to detect hepatocellular carcinoma
| Autor: | Patrick Joseph, Theran A Myers, David K. Edwards, Andrea M Johnson, Jennifer J Laffin, Janelle J. Bruinsma, Jeanne M Dudek |
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| Rok vydání: | 2021 |
| Předmět: |
Oncology
medicine.medical_specialty Carcinoma Hepatocellular Concordance Population Pathology and Forensic Medicine Internal medicine Genetics Carcinoma Biomarkers Tumor Medicine Blood test Humans Liquid biopsy education Molecular Biology Reproducibility education.field_of_study Hematologic Tests medicine.diagnostic_test business.industry Liver Neoplasms Nuclear Proteins Reproducibility of Results medicine.disease Galactosyltransferases Hepatocellular carcinoma Molecular Medicine Biomarker (medicine) alpha-Fetoproteins business Biomarkers |
| Zdroj: | Expert review of molecular diagnostics. 21(11) |
| ISSN: | 1744-8352 |
| Popis: | Introduction Surveillance is essential to diagnose and more effectively treat hepatocellular carcinoma (HCC) in at-risk patients. However, the performance of currently recommended surveillance strategies is suboptimal, particularly for early-stage detection, and patient adherence remains low. Here, we establish the analytical performance of a novel liquid biopsy test to evaluate the presence of HCC. Methods The multi-target HCC blood test (mt-HBT) integrates results from three DNA methylation markers (HOXA1, TSPYL5, and B3GALT6), the protein biomarker α-fetoprotein (AFP), and patient sex. The methylation markers are quantified from cell-free DNA extracted from plasma, and AFP is measured from serum. We conducted analytical validation studies on the mt-HBT, including analytical sensitivity, linearity, cross-contamination, interference, analytical accuracy, and precision. Results The mt-HBT performance met all pre-specified analytical performance criteria. The test demonstrated high reproducibility, with ≥97% concordance relative to the expected results for six categories of surrogate samples across the test's dynamic range. Of 17 candidate interfering substances, none caused significant interference to biomarker quantitation, and no occurrences of sample-to-sample cross-contamination were observed. Conclusion These data demonstrate that the mt-HBT can produce consistent, reliable results for patients in the intended-use population, for whom surveillance is recommended. |
| Databáze: | OpenAIRE |
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