Analytical performance validation of a coronary heart disease risk assessment multi-analyte proteomic test
| Autor: | Swathi Vijayakumar, Lilian Tee, Ivana Burazor, Cynthia French, Michael Beggs, Niamh Nolan, Douglas S Harrington, Evangelos Hytopoulos, William H Biggs |
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| Rok vydání: | 2012 |
| Předmět: |
Proteomics
Oncology medicine.medical_specialty Pathology Bilirubin Biomedical Engineering Coronary Disease Risk Assessment Sensitivity and Specificity Specimen Handling chemistry.chemical_compound Internal medicine medicine Humans Myocardial infarction Multi analyte Immunoassay Reproducibility medicine.diagnostic_test business.industry Biochemistry (medical) Reproducibility of Results Blood Proteins General Medicine medicine.disease Coronary heart disease chemistry Molecular Medicine Biomarker (medicine) business Risk assessment Biomarkers |
| Zdroj: | Expert Opinion on Medical Diagnostics. 7:127-136 |
| ISSN: | 1753-0067 1753-0059 |
| Popis: | Coronary heart disease (CHD) remains prevalent despite efforts to improve CHD risk assessment. The authors developed a multi-analyte immunoassay-based CHD risk assessment (CHDRA) algorithm, clinically validated in a multicenter study, to improve CHDRA in intermediate risk individuals.Clinical laboratory validation of the CHDRA biomarker assays' analytical performance.Multiplexed immunoassay panels developed for the seven CHDRA assays were evaluated with donor sera in a clinical laboratory. Specificity, sensitivity, interfering substances and reproducibility of the CHDRA assays, along with the effects of pre-analytical specimen processing, were evaluated.Analytical measurements of the CHDRA panel proteins (CTACK, Eotaxin, Fas Ligand, HGF, IL-16, MCP-3 and sFas) exhibited acceptable accuracy (80 - 120%), cross-reactivity (1%), interference (30% at high concentrations of bilirubin, lipids, hemoglobin and HAMA), sensitivity and reproducibility (20% CV across multiple runs, operators and instruments). Recoveries from donor sera subjected to typical clinical laboratory pre-analytical conditions were within 80 - 120%. The pre-analytical variables did not substantively impact the CHDRA scores.The CHDRA panel analytical validation in a clinical laboratory meets or exceeds the specifications established during the clinical utility studies. Risk score reproducibility across multiple test scenarios suggests the assays are not susceptible to clinical laboratory pre-analytical and analytical variation. |
| Databáze: | OpenAIRE |
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