Fig 1: SCC-Ag profile analysis. a Profiles of SCC-Ag values for the 32 patients with all five time points. Each curve represents the SCC-Ag profile for one patient. b GAM analysis of the effect of lymph node metastasis on the SCC-Ag profile. The black arrow points to the start of adjuvant treatment, while the red arrow indicates the end of adjuvant treatment. SCC-Ag intercept p < 0.001, SCC-Ag trend p = 0.62. c GAM analysis of the effect of postoperative adjuvant treatment on the SCC-Ag profile. The black arrow indicates the start of adjuvant treatment, and the red arrow indicates the end of adjuvant treatment. SCC-Ag intercept p = 0.01, SCC-Ag trend p = 0.005
Fig 2: Passing–Bablok regression analysis of the SCC-Ag concentration of 352 samples obtained with the Architect and the Simoa SCC-Ag assay. Scatter diagram with regression line (blue line) and 95% confidence bands (light blue) for the regression line. Pearson correlation coefficient (R) of 0.979 (p < 0.001). Passing–Bablok regression line equation: y = 0.89x − 0.01 (intercept 95% confidence interval (CI): − 0.05 to 0.03; slope 95% CI: 0.85 to 0.95
Fig 3: Simoa SCC-Ag median values and range at each time point (day 0, day 4, weeks 2–4, months 2–4, months 5–7)
Fig 4: Simoa SCC-Ag assay calibration curve and validation. a Typical Simoa SCC-Ag assay calibration curve. Recombinant human SCC-Ag was serially diluted, and the calibrator range was 0.049 to 50 ng/mL with a recovery of all back-calculated concentrations between 80 and 120%. The fitting model for the calibration curve was a weighted four-parameter logistics (1/Y2). AEB: Average enzyme per bead (measured signal). b Validation results and acceptance criteria
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