Assay Performance of a Label-Free, Solution-Phase CYFRA 21-1 Determination

Autor: Amanda K. Kussrow, Michael N. Kammer, Pierre P. Massion, Rebekah Webster, Darryl J. Bornhop
Rok vydání: 2022
Předmět:
Zdroj: ACS Omega. 7:31916-31923
ISSN: 2470-1343
DOI: 10.1021/acsomega.2c02763
Popis: CYFRA 21.1, a cytokeratin fragment of epithelial origin, has long been a valuable blood-based biomarker. As with most biomarkers, the clinical diagnostic value of CYFRA 21.1 is dependent on the quantitative performance of the assay. Looking toward translation, it is shown here that a free-solution assay (FSA) coupled with a compensated interferometric reader (CIR) can be used to provide excellent analytical performance in quantifying CYFRA 21.1 in patient serum samples. This report focuses on the analytical performance of the high-sensitivity (hs)-CYFRA 21.1 assay in the context of quantifying the biomarker in two indeterminate pulmonary nodule (IPN) patient cohorts totaling 179 patients. Each of the ten assay calibrations consisted of 6 concentrations, each run as 7 replicates (e.g., 10 × 6 × 7 data points) and were performed on two different instruments by two different operators. Coefficients of variation (CVs) for the hs-CYFRA 21.1 analytical figures of merit, limit of quantification (LOQ) of ca. 60 pg/mL
Databáze: OpenAIRE