| Autor: |
Nolan, Niamh, Tee, Lilian, Vijayakumar, Swathi, Burazor, Ivana, Hytopoulos, Evangelos, Biggs, William H, Beggs, Michael, French, Cynthia, Harrington, Douglas S |
| Zdroj: |
Expert Opinion on Medical Diagnostics; March 2013, Vol. 7 Issue: 2 p127-136, 10p |
| Abstrakt: |
Background: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.Objective:Clinical laboratory validation of the CHDRA biomarker assays' analytical performance.Methods: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.Results: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.Conclusions: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: |
Supplemental Index |
| Externí odkaz: |
|
