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

[Image: see text] 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...

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Autores principales: Kussrow, Amanda K., Kammer, Michael N., Massion, Pierre P., Webster, Rebekah, Bornhop, Darryl J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Chemical Society 2022
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9476196/
https://www.ncbi.nlm.nih.gov/pubmed/36120008
http://dx.doi.org/10.1021/acsomega.2c02763
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author Kussrow, Amanda K.
Kammer, Michael N.
Massion, Pierre P.
Webster, Rebekah
Bornhop, Darryl J.
author_facet Kussrow, Amanda K.
Kammer, Michael N.
Massion, Pierre P.
Webster, Rebekah
Bornhop, Darryl J.
author_sort Kussrow, Amanda K.
collection PubMed
description [Image: see text] 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, B(max), initial slope, probe–target binding affinity, and reproducibility of quantifying an unknown were found to range from 2.5 to 8.3%. Our results demonstrate the excellent performance of our FSA-CIR hs-CYFRA 21-1 assay and a proof of concept for potentially redefining the performance characteristics of this existing important candidate biomarker.
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spelling pubmed-94761962022-09-16 Assay Performance of a Label-Free, Solution-Phase CYFRA 21-1 Determination Kussrow, Amanda K. Kammer, Michael N. Massion, Pierre P. Webster, Rebekah Bornhop, Darryl J. ACS Omega [Image: see text] 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, B(max), initial slope, probe–target binding affinity, and reproducibility of quantifying an unknown were found to range from 2.5 to 8.3%. Our results demonstrate the excellent performance of our FSA-CIR hs-CYFRA 21-1 assay and a proof of concept for potentially redefining the performance characteristics of this existing important candidate biomarker. American Chemical Society 2022-08-29 /pmc/articles/PMC9476196/ /pubmed/36120008 http://dx.doi.org/10.1021/acsomega.2c02763 Text en © 2022 The Authors. Published by American Chemical Society https://creativecommons.org/licenses/by-nc-nd/4.0/Permits non-commercial access and re-use, provided that author attribution and integrity are maintained; but does not permit creation of adaptations or other derivative works (https://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Kussrow, Amanda K.
Kammer, Michael N.
Massion, Pierre P.
Webster, Rebekah
Bornhop, Darryl J.
Assay Performance of a Label-Free, Solution-Phase CYFRA 21-1 Determination
title Assay Performance of a Label-Free, Solution-Phase CYFRA 21-1 Determination
title_full Assay Performance of a Label-Free, Solution-Phase CYFRA 21-1 Determination
title_fullStr Assay Performance of a Label-Free, Solution-Phase CYFRA 21-1 Determination
title_full_unstemmed Assay Performance of a Label-Free, Solution-Phase CYFRA 21-1 Determination
title_short Assay Performance of a Label-Free, Solution-Phase CYFRA 21-1 Determination
title_sort assay performance of a label-free, solution-phase cyfra 21-1 determination
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9476196/
https://www.ncbi.nlm.nih.gov/pubmed/36120008
http://dx.doi.org/10.1021/acsomega.2c02763
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