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

Geriatric Cancer Markers Reference Intervals Taita Taveta Kenya.

Authors

  • Richard M. Gitimu
    richard.gitimu@ttu.ac.ke
    1) Department of Biochemistry, Microbiology and Biotechnology, Kenyatta University, P.O Box 43844-00100, Nairobi, Kenya. 2) Department of Laboratory Medicine, Taita Taveta University, P.O Box 635-80300 Voi,, Kenya https://orcid.org/0000-0001-7443-896X
  • Stanley K. Waithaka Department of Medical laboratory Sciences, Mount Kenya University, P.O Box 342-01000 Thika,, Kenya
  • Joseph K. Gikunju Department of Medical Laboratory Sciences, Jomo Kenyatta University of Agriculture and Technology, P.O Box 62000-00100 Nairobi,, Kenya
  • Eliud N. M. Njagi Department of Biochemistry, Microbiology and Biotechnology, Kenyatta University, P.O Box 43844-00100, Nairobi,, Kenya
Vol. 4 No. 2 (2022): June
Research Articles

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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 1860 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 5095, 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 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 199, 07 ng/mL for CEA, 0-56.9 U/mL for CA 153, 025 ng/mL for CA 125, and 06.8 ng/mL for PSA. Gender-related biomarker values were developed for CA 19-9 adults and geriatrics (6070 years), CEA for geriatrics (6070 years), and CA 15-3 for adults. Age-related biomarker values were developed for CA 199 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

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