Abstract
Objectives
Few studies have reported on delta checks for tumour markers, even though these markers are often evaluated serially. Therefore, this study aimed to establish a practical delta check limit in different clinical settings for five tumour markers: alpha-fetoprotein, cancer antigen 19-9, cancer antigen 125, carcinoembryonic antigen, and prostate-specific antigen.
Methods
Pairs of patients’ results (current and previous) for five tumour markers between 2020 and 2021 were retrospectively collected from three university hospitals. The data were classified into three subgroups, namely: health check-up recipient (subgroup H), outpatient (subgroup O), and inpatient (subgroup I) clinics. The check limits of delta percent change (DPC), absolute DPC (absDPC), and reference change value (RCV) for each test were determined using the development set (the first 18 months, n=179,929) and then validated and simulated by applying the validation set (the last 6 months, n=66,332).
Results
The check limits of DPC and absDPC for most tests varied significantly among the subgroups. Likewise, the proportions of samples requiring further evaluation, calculated by excluding samples with both current and previous results within the reference intervals, were 0.2–2.9% (lower limit of DPC), 0.2–2.7% (upper limit of DPC), 0.3–5.6% (absDPC), and 0.8–35.3% (RCV99.9%). Furthermore, high negative predictive values >0.99 were observed in all subgroups in the in silico simulation.
Conclusions
Using real-world data, we found that DPC was the most appropriate delta-check method for tumour markers. Moreover, Delta-check limits for tumour markers should be applied based on clinical settings.
Funding source: The Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea.
Award Identifier / Grant number: 2023IP0003-1
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Research funding: This study was supported by a grant (2023IP0003-1) from the Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Informed consent was waived due to the retrospective nature of this study.
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Ethical approval: This research involving human subjects complied with all relevant national regulations, institutional policies and is in accordance with the tenets of the Helsinki Declaration (as revised in 2013), and has been was approved by our Institutional Review Board (2210-023-120, HPIRB 2022-09-017, ISPAIK 2022-09-031).
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2022-1098).
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