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

Amanda K Kussrow1, Michael N Kammer2, Pierre P Massion2

  • 1Department of Chemistry and The Vanderbilt Institute for Chemical Biology, Vanderbilt University, Nashville, Tennessee 37235, United States.

ACS Omega
|September 19, 2022
PubMed
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This summary is machine-generated.

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A new high-sensitivity assay for CYFRA 21.1 (cytokeratin 21.1 fragment) demonstrates excellent analytical performance. This free-solution assay (FSA) with a compensated interferometric reader (CIR) accurately quantifies this biomarker in patient samples.

Area of Science:

  • Biomarker Discovery and Validation
  • Analytical Chemistry
  • Clinical Diagnostics

Background:

  • CYFRA 21.1, a cytokeratin fragment, is a valuable blood-based biomarker for epithelial origin.
  • The clinical utility of CYFRA 21.1 relies heavily on precise quantitative assay performance.

Purpose of the Study:

  • To evaluate the analytical performance of a novel high-sensitivity CYFRA 21.1 assay.
  • To demonstrate the efficacy of a free-solution assay (FSA) coupled with a compensated interferometric reader (CIR) for biomarker quantification.

Main Methods:

  • Assessed the high-sensitivity CYFRA 21.1 (hs-CYFRA 21.1) assay in 179 indeterminate pulmonary nodule (IPN) patients.
  • Utilized ten assay calibrations with multiple replicates across different instruments and operators.
  • Determined analytical figures of merit including limit of quantification (LOQ) and reproducibility.

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Main Results:

  • Achieved an LOQ of approximately 60 pg/mL for hs-CYFRA 21.1.
  • Reported coefficients of variation (CVs) ranging from 2.5% to 8.3% for key analytical parameters.
  • Demonstrated excellent reproducibility in quantifying unknown samples.

Conclusions:

  • The FSA-CIR hs-CYFRA 21.1 assay exhibits excellent analytical performance.
  • This study provides a proof of concept for potentially enhancing the performance characteristics of CYFRA 21.1 as a biomarker.