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KMID : 1100720230430010082
Annals of Laboratory Medicine
2023 Volume.43 No. 1 p.82 ~ p.85
Establishment of Reference Intervals of Cytokeratin 19 Fragment Antigen 21-1 in Korean Adults
Yoon Su-Mi

Lim Yong-Kwan
Kim Hye-Ryoun
Lee Mi-Kyung
Kweon Oh-Joo
Abstract
Cytokeratin 19 fragment antigen 21-1 (CYFRA 21-1) is useful for predicting and monitoring non-small cell lung cancer prognosis. We established reference intervals (RIs) of CYFRA 21-1 in Korean adults, including those older than 60 years. Data of 4,098 apparently healthy subjects (age range, 20?87 years) were analyzed after excluding those with a history of malignancy, high tumor marker concentrations (except CYFRA 21-1), and/or abnormal findings on a chest computed tomography scan through medical chart review. After removing two outliers, RIs of CYFRA 21-1 were determined using data of 4,096 subjects based on the non-parametric method (2.5th and 97.5th percentiles) according to CLSI guidelines EP28-A3c. The subjects were divided into two and four groups according to sex and age (20?40, 41?50, 51?60, and >60 years), respectively, and the median CYFRA 21-1 concentration was compared between the groups. The RI of CYFRA 21-1 was 0.66?3.84 ng/mL, applicable to both men and women. Regardless of sex, the CYFRA 21-1 concentration increased with age, suggesting that age-dependent RIs of CYFRA 21-1 should be applied. Rather than using a single RI provided by the manufacturer, the RI of CYFRA 21-1 should be continually verified and established in each clinical laboratory.
KEYWORD
CYFRA 21-1, Reference interval, Age, Sex, Korean, Adult
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