PMID- 36789402 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230217 IS - 2398-8835 (Electronic) IS - 2398-8835 (Linking) VI - 6 IP - 2 DP - 2023 Feb TI - Establishment and validation of reference intervals for tumor markers (AFP, CEA, CA19-9, CA15-3, CA125, PSA, HE4, Cyfra 21-1, and ProGRP) in primary care centers in Korea: A cross-sectional retrospective study. PG - e1107 LID - 10.1002/hsr2.1107 [doi] LID - e1107 AB - BACKGROUND AND AIMS: The reference interval (RI) for a tumor marker may vary between populations, detection systems, and the methods used to obtain their values. The aims of this study were to establish age- and sex-specific RIs for the following nine common tumor markers and to validate the established RIs in Korean adults: alpha fetoprotein (AFP), carcinoembryonic antigen (CEA), cancer antigen (CA) 19-9, CA15-3, CA125, Human epididymis protein 4 (HE4), total prostate specific antigen, cytokeratin fragment (Cyfra) 21-1, and progastrin-releasing peptide (ProGRP). METHODS: This cross-sectional study consecutively selected 214,159 individuals (aged 18-98 years) who underwent health checkups at 16 health-promotion centers in 13 Korean cities. Finally, 62,752 examinees were used to establish the RIs after removing outliers. RIs were established using an indirect method according to the CLSI EP28-A3C guideline. The established RIs were validated by calculating the proportion of individuals outside each RI. RESULTS: Sex-related differences were observed for AFP, CEA, CA19-9, Cyfra 21-1, and ProGRP (p < 0.05): AFP, CEA and Cyfra 21-1 were higher in males, and CA19-9 and proGRP were higher in females. Most of the tumor markers except CA15-3 and CA125 increased with age: CA125 decreased at >/=50 years of age (p < 0.05), while CA15-3 did not vary with age. Less than 5% of subjects were outside all RIs (the 2.5th and 97.5th percentiles) established in the present study. Meanwhile, less than 3% of the healthy reference subjects fell outside the current and manufacturers' RIs of all tumor markers except Cyfra 21-1. CONCLUSION: This study has determined age- and sex-specific RIs for nine common tumor markers in the healthy Korean population, which could be useful for clinicians making clinical decisions and assessments. CI - (c) 2023 The Authors. Health Science Reports published by Wiley Periodicals LLC. FAU - Nah, Eun-Hee AU - Nah EH AUID- ORCID: 0000-0003-0637-4364 AD - Health Promotion Research Institute Korea Association of Health Promotion Seoul Korea. FAU - Cho, Seon AU - Cho S AD - Health Promotion Research Institute Korea Association of Health Promotion Seoul Korea. FAU - Park, Hyeran AU - Park H AD - Health Promotion Research Institute Korea Association of Health Promotion Seoul Korea. FAU - Kim, Suyoung AU - Kim S AD - Health Promotion Research Institute Korea Association of Health Promotion Seoul Korea. FAU - Kwon, Eunjoo AU - Kwon E AD - Health Promotion Research Institute Korea Association of Health Promotion Seoul Korea. FAU - Cho, Han-Ik AU - Cho HI AD - MEDIcheck LAB Korea Association of Health Promotion Seoul Korea. LA - eng PT - Journal Article DEP - 20230211 PL - United States TA - Health Sci Rep JT - Health science reports JID - 101728855 PMC - PMC9919475 OTO - NOTNLM OT - age-specific reference interval OT - reference interval OT - tumor marker OT - validation COIS- This authors declare no conflict of interest. EDAT- 2023/02/16 06:00 MHDA- 2023/02/16 06:01 PMCR- 2023/02/11 CRDT- 2023/02/15 02:13 PHST- 2022/10/10 00:00 [received] PHST- 2023/01/09 00:00 [revised] PHST- 2023/01/30 00:00 [accepted] PHST- 2023/02/15 02:13 [entrez] PHST- 2023/02/16 06:00 [pubmed] PHST- 2023/02/16 06:01 [medline] PHST- 2023/02/11 00:00 [pmc-release] AID - HSR21107 [pii] AID - 10.1002/hsr2.1107 [doi] PST - epublish SO - Health Sci Rep. 2023 Feb 11;6(2):e1107. doi: 10.1002/hsr2.1107. eCollection 2023 Feb.