CLSI Guided Reference Interval Limits for Cancer Biomarkers for Adults and Geriatrics

Abstract

Reference interval limits for cancer biomarkers in geriatrics are rare because priority is given to the development of reference interval limits for those in the age range of 18–60 years, which are normally used for clinical trials study. The aim of this study was therefore to develop gender and age-specific reference interval limits for cancer markers CA19-9, CEA, CA 15-3, CA 125, and PSA for adults and geriatrics in Taita-Taveta County, Kenya, using the CLSI CA28-A3 guideline. This prospective cross-sectional study involved 244 healthy referents, including 124 females and 120 males of ages 50–95, between May 2015 and December 2017 at the Department of Clinical Chemistry of Moi Subcounty Hospital, Voi, Kenya. Serum CA 19-9, CEA, CA 15-3, CA 125, and PSA of the 244 referents were measured using a well-calibrated, quality controlled Clinical Chemistry AutoAnalyzer. Gender differences in the measured values of the biomarkers were assessed using the Mann-Whitney U test, while age differences were assessed using the Kruskal-Wallis H test followed by the Mann-Whitney U test with an adjusted significant ρ-value of less than 0.0167. Reference interval limits for the measured cancer biomarkers were expressed in terms of medians and ranged between 2.5 and 97.5 percentiles. The established 95% reference interval limits were: 0-58 U/mL males and 0-42.8 U/mL females for CA 19–9, 0–7 ng/mL for CEA, 0-56.9 U/mL for CA 15–3, 0–25 ng/mL for CA 125, and 0–6.8 ng/mL for PSA. Gender-related biomarker values were developed for CA 19-9 adults and geriatrics (60–70 years), CEA for geriatrics (60–70 years), and CA 15-3 for adults. Age-related biomarker values were developed for CA 19–9 males and not for females. In conclusion, gender-related 95% reference interval limits were developed for CA 19-9, CEA, CA 15-3, CA 125, and PSA, and age-related 95% reference interval limits were established for CA 19-9. CA 19-9 decreased from adulthood to the early elderly and increased in the more elderly population. These developed reference interval limits for these biomarkers, which differed from those reported in previous literature, could be adopted for use in Taita-Taveta County, Kenya, for better medical care. Doi: 10.28991/SciMedJ-2022-04-02-04 Full Text: PDF