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Practical delta check limits for tumour markers in different clinical settings

  • Shinae Yu ORCID logo , Kyung-Hwa Shin ORCID logo , Sunghwan Shin ORCID logo , Hyeyoung Lee ORCID logo , Soo Jin Yoo ORCID logo , Kyung Ran Jun ORCID logo , Hangsik Shin ORCID logo and Sollip Kim ORCID logo EMAIL logo
Published/Copyright: March 31, 2023
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 61 Issue 10

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.

Keywords: alpha-fetoprotein; carcinoembryonic antigen; delta check; prostate-specific antigen; reference change values; tumour marker
Corresponding author: Sollip Kim, MD, PhD, Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea, Phone: 82-2-3010-4553, Fax: +82-2-2045-3081, E-mail:
Shinae Yu and Kyung-Hwa Shin contributed equally to this work.

Funding source: The Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea.

Award Identifier / Grant number: 2023IP0003-1

  1. Research funding: This study was supported by a grant (2023IP0003-1) from the Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was waived due to the retrospective nature of this study.

  5. 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).

Received: 2022-10-31
Accepted: 2023-03-19
Published Online: 2023-03-31
Published in Print: 2023-09-26

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2022-1098
Keywords for this article
alpha-fetoprotein; carcinoembryonic antigen; delta check; prostate-specific antigen; reference change values; tumour marker

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Laboratory Medicine: from just testing to saving lives
  4. Reviews
  5. Serum biomarkers of remodeling in severe asthma with fixed airway obstruction and the potential role of KL-6
  6. Safety monitoring of drug-induced muscle injury and rhabdomyolysis: a biomarker-guided approach for clinical practice and drug trials
  7. Mini Review
  8. Concise review on the combined use of immunocapture, mass spectrometry and liquid chromatography for clinical applications
  9. Opinion Paper
  10. Recommendation for the design of stability studies on clinical specimens
  11. General Clinical Chemistry and Laboratory Medicine
  12. Assessment of WHO 07/202 reference material and human serum pools for commutability and for the potential to reduce variability among soluble transferrin receptor assays
  13. veRification: an R Shiny application for laboratory method verification and validation
  14. Impact of storage temperature and time before analysis on electrolytes (Na+, K+, Ca2+), lactate, glucose, blood gases (pH, pO2, pCO2), tHb, O2Hb, COHb and MetHb results
  15. The stability of blood gases and CO-oximetry under slushed ice and room temperature conditions
  16. Elevated levels of renal function tests conferred increased risks of developing various pregnancy complications and adverse perinatal outcomes: insights from a population-based cohort study
  17. Poor comparability of plasma renin activity measurement in determining patient samples: the status quo and recommendations for harmonization
  18. Salivary cortisol and cortisone in diagnosis of Cushing’s syndrome – a comparison of six different analytical methods
  19. Improved diagnostics of purine and pyrimidine metabolism disorders using LC-MS/MS and its clinical application
  20. Analytical evaluation of a GAD65 antibodies chemiluminescence immunoassay for CSF in neurological syndromes
  21. Reference Values and Biological Variations
  22. Evaluation of low-density lipoprotein cholesterol equations by cross-platform assessment of accuracy-based EQA data against SI-traceable reference value
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  30. Validation of non-invasive point of care blood content analysis using the TensorTip™ MTX device: a method comparison study
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