ArticleJournal of clinical laboratory analysis2026
Establishment of Reference Interval for CA72-4 in Healthy Adults in Shenzhen, China.
Article in Journal of clinical laboratory analysis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThis study aimed to establish a reference interval (RI) for the tumor marker carbohydrate antigen 72-4 (CA72-4) in healthy adults in Shenzhen, China, and to validate its applicability.
methodsSerum CA72-4 results from 2614 adults undergoing routine check-ups were analyzed per CLSI EP28-A3c. High outliers were removed with Tukey's 1.5 × IQR rule. Distribution normality was tested by Shapiro-Wilk, and the need for partitioning by sex or age was assessed with the Harris-Boyd Z-test. The RI was derived non-parametrically from the 2.5th and 97.5th percentiles; a 90% confidence interval (CI) for the upper limit was obtained by 2000-bootstrap resampling. Performance was evaluated in an independent set of 206 adults (Apr 2025) by the exceedance rate (< 5% acceptable).
resultsCA72-4 values were markedly right-skewed. After excluding 258 outliers (9.9%), 2356 results remained. No significant sex- or age-related differences were found (Z < 3); thus, a combined RI was adopted. The 2.5th percentile was 0.54 U/mL (90% CI, 0.52-0.55) and the 97.5th percentile 8.5 U/mL (90% CI, 8.29-8.90). The oldest subgroup (61-85 year) showed a modest increase, but it did not affect the overall RI. In validation, 4.85% (10/206) exceeded 8.5 U/mL, meeting the preset criterion.
conclusionsAn upper reference limit of 8.5 U/mL for CA72-4 in Shenzhen healthy adults-higher than the manufacturer's value-reduces false positives in health screening. Slight age-related increases suggest cautious interpretation in the elderly. This study provides an important reference for region-specific tumor marker intervals in Shenzhen and similar populations.
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