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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...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Chemical Society
2022
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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. |
format | Online Article Text |
id | pubmed-9476196 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | American Chemical Society |
record_format | MEDLINE/PubMed |
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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