Assay Performance and Quantification Limits in Perioperative Serum Cytokine Measurement After Total Hip Arthroplasty: A Secondary Laboratory Analysis
4 affiliations
- 1Doctoral School, “Carol Davila” University of Medicine and Pharmacy, 050474 Bucharest, Romania
- 2Faculty of Medicine, “Carol Davila” University of Medicine and Pharmacy, 050474 Bucharest, Romania
- 3Infectious Diseases Department–Hemorrhagic Fevers, National Institute for Infectious Diseases “Prof. Dr. Matei Balș”, 021105 Bucharest, Romania
- 4Immunology Laboratory, National Institute for Infectious Diseases “Prof. Dr. Matei Balș”, 021105 Bucharest, Romania
Abstract
Background: Commercial cytokine assays may not span the concentrations encountered in perioperative serum. We examined the extent to which reconstructed enzyme-linked immunosorbent assay data from a total hip arthroplasty cohort could support temporal biological interpretation when most IL-6 and IL-10 results were below the validated quantification range. Methods: This post hoc secondary laboratory analysis used serum collected preoperatively and at 6, 24, and 48 h later from 44 of 52 participants in a single-centre three-arm trial. Five cytokines were measured by sandwich ELISA. Optical-density (OD) values were reconstructed from scanned reports and triangulated across three transcriptions. OD trajectories were summarised with within-patient rank tests as exploratory assay-signal observations. Five omnibus tests were Holm-adjusted across analytes. Detectability was analysed as a paired binary outcome using Cochran’s Q and exact McNemar comparisons with Holm correction. Clinical characteristics, acute-phase markers, and missing-data structure were evaluated in the assayed subcohort. Results: The assayed subcohort included all 18 no-block participants and 26 of 34 block recipients; the 8 non-assayed participants were late-enrolled block recipients. IL-6 OD varied over time (Friedman raw p = 2.6 × 10−11; Holm-adjusted p = 1.3 × 10−10), but 154/176 readings (87.5%) were below the LLOQ. IL-6 detectability was 0/44, 9/44, 7/44, and 6/44 at the four timepoints (Cochran Q = 12.27, p = 0.0065); only the preoperative-to-6 h McNemar comparison remained significant after correction (adjusted p = 0.023). TNF-alpha, IL-1alpha, and IL-10 OD also varied in exploratory analyses, whereas IL-1beta was inconclusive. CRP rose from a median 0.20 mg/dL preoperatively to 7.70 mg/dL at 24 h and 14.55 mg/dL at 48 h in the same 44 participants. Conclusions: The data document an assay-range and data-recovery problem more securely than they establish cytokine kinetics. The reconstructed OD changed systematically after surgery, especially for IL-6, but measurements below the validated range cannot establish concentration ordering, cross-cytokine dominance, or counter-regulation. Because re-assaying was not possible, all biological interpretations are presented as tentative and non-transferable. The reproducible findings are the extent of censoring, the limits of the available assay records, and the need to match the assay range to expected perioperative concentrations before clinical sampling.
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BibTeX
@article{anastasescu2026assay,
title = {{Assay Performance and Quantification Limits in Perioperative Serum Cytokine Measurement After Total Hip Arthroplasty: A Secondary Laboratory Analysis}},
author = {Arabela-Codruța Cocea (Anastasescu) and Dan-Cristian Munteanu and Mădălina Popa and Cristian Ioan Stoica},
journal = {Journal of Clinical Medicine},
year = {2026},
month = oct,
doi = {10.3390/jcm15207829},
url = {https://www.mdpi.com/2077-0383/15/20/7829},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Assay Performance and Quantification Limits in Perioperative Serum Cytokine Measurement After Total Hip Arthroplasty: A Secondary Laboratory Analysis
AU - Arabela-Codruța Cocea (Anastasescu)
AU - Dan-Cristian Munteanu
AU - Mădălina Popa
AU - Cristian Ioan Stoica
PY - 2026
DA - 2026/10/10
JO - Journal of Clinical Medicine
DO - 10.3390/jcm15207829
UR - https://www.mdpi.com/2077-0383/15/20/7829
AB - Background: Commercial cytokine assays may not span the concentrations encountered in perioperative serum. We examined the extent to which reconstructed enzyme-linked immunosorbent assay data from a total hip arthroplasty cohort could support temporal biological interpretation when most IL-6 and IL-10 results were below the validated quantification range. Methods: This post hoc secondary laboratory analysis used serum collected preoperatively and at 6, 24, and 48 h later from 44 of 52 participants in a single-centre three-arm trial. Five cytokines were measured by sandwich ELISA. Optical-density (OD) values were reconstructed from scanned reports and triangulated across three transcriptions. OD trajectories were summarised with within-patient rank tests as exploratory assay-signal observations. Five omnibus tests were Holm-adjusted across analytes. Detectability was analysed as a paired binary outcome using Cochran’s Q and exact McNemar comparisons with Holm correction. Clinical characteristics, acute-phase markers, and missing-data structure were evaluated in the assayed subcohort. Results: The assayed subcohort included all 18 no-block participants and 26 of 34 block recipients; the 8 non-assayed participants were late-enrolled block recipients. IL-6 OD varied over time (Friedman raw p = 2.6 × 10−11; Holm-adjusted p = 1.3 × 10−10), but 154/176 readings (87.5%) were below the LLOQ. IL-6 detectability was 0/44, 9/44, 7/44, and 6/44 at the four timepoints (Cochran Q = 12.27, p = 0.0065); only the preoperative-to-6 h McNemar comparison remained significant after correction (adjusted p = 0.023). TNF-alpha, IL-1alpha, and IL-10 OD also varied in exploratory analyses, whereas IL-1beta was inconclusive. CRP rose from a median 0.20 mg/dL preoperatively to 7.70 mg/dL at 24 h and 14.55 mg/dL at 48 h in the same 44 participants. Conclusions: The data document an assay-range and data-recovery problem more securely than they establish cytokine kinetics. The reconstructed OD changed systematically after surgery, especially for IL-6, but measurements below the validated range cannot establish concentration ordering, cross-cytokine dominance, or counter-regulation. Because re-assaying was not possible, all biological interpretations are presented as tentative and non-transferable. The reproducible findings are the extent of censoring, the limits of the available assay records, and the need to match the assay range to expected perioperative concentrations before clinical sampling.
SN - 2077-0383
ER -