Ann Lab Med.  2023 Jan;43(1):82-85. 10.3343/alm.2023.43.1.82.

Establishment of Reference Intervals of Cytokeratin 19 Fragment Antigen 21-1 in Korean Adults

• Yoon S
• Lim YK
• Kim HR
• Lee MK
• Kweon OJ

• KMID: 2551606
• DOI: http://doi.org/10.3343/alm.2023.43.1.82

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

Figure

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  Fig. 1 Distribution of CYFRA 21-1 concentration in all subjects (N=4,096).

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  Fig. 2 Distribution of CYFRA 21-1 concentration according to age (N=4,096). The median CYFRA 21-1 concentration indicates significant differences between groups, determined using the Kruskal–Wallis test (P<0.01).

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