한국인에서 Soluble ST2의 참고치 설정
Establishing Reference Intervals for Soluble ST2 Assay in a Korean Population
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배경: Soluble ST2 (sST2)는 새로운 심장 표지자이다. 기존 연구들에서, 심부전 예후를 판정하는 임상적 기준치로 35 ng/mL가 사용되었다. 이 연구의 목표는 한국인에서 sST2의 참고 범위를 설정하고, 임상적 기준치의 진단적 적용을 평가하는 것이다. 방법: 2014년 3월부터 5월까지, 총 255명의 건강인(남성 128명과 여성 127명)의 혈청 잔여 검체로 Presage ST2 ELISA assay (Critical Diagnostics, USA)를 사용하여 sST2을 측정하였다. CLSI EP28-A3c 가이드라인에 따라 비모수적 퍼센타일 방법을 사용하여 sST2의 참고 범위를 설정하였다. 결과: 혈청 sST2 농도의 중앙값(사분범위)은 총 대상자, 남성, 그리고 여성에서 각각 23.8 (19.0-28.7) ng/mL, 26.6 (21.0-30.9) ng/mL, 21.9 (17.3-26.5) ng/mL였다. 혈청 sST2 농도는 남성이 여성보다 유의하게 높았다(P<0.0001). 혈청 sST2의 97.5 퍼센타일 상한참고치는 총 대상자, 남성, 그리고 여성에서 각각 43.8 ng/mL, 49.6 ng/mL, 35.4 ng/mL 였다. 성별에 따른 상한참고치는 기존 연구들의 결과와 유사하였다. 결론: 성별에 따라 혈청 sST2의 농도 분포가 다르므로, 성별 특이적인 참고 범위를 사용할 필요가 있다. 건강인에서 심부전의 임상적 기준치인 35 ng/mL을 적용하는 것은, 특히 남성에서 위양성 결과를 보일 수 있으므로 유의해야 한다.
Abstract
Background: Soluble ST2 (sST2) has emerged as a biomarker of heart failure. Previous studies indicated 35 ng/mL of sST2 as the clinically prognostic cut-off value. This study aims to establish reference intervals in a Korean population using an sST2 assay and to evaluate the applicability of the cut-off value. Methods: From March to May 2014, sST2 levels were assayed in serum samples of 255 cardio-healthy Koreans (128 men and 127 women) using the Presage ST2 ELISA kit (Critical Diagnostics, USA). The reference interval for sST2 was defined using the nonparametric percentile method according to the CLSI EP28-A3c guideline. Results: The median sST2 concentrations were 23.8 ng/mL (interquartile range (IQR), 19.0-28.7), 26.6 ng/mL (IQR, 21.0-30.9), and 21.9 ng/mL (IQR, 17.3-26.5) for the entire cohort, men, and women, respectively. sST2 levels were significantly higher in men than in women (P<0.0001). The 97.5th percentile upper reference limits for sST2 were 43.8 ng/mL, 49.6 ng/mL, and 35.4 ng/mL for the cohort, men, and women, respectively. Gender-specific upper reference limits were similar to limits reported by other studies. Conclusions: We suggest that gender-specific reference intervals should be used for the Korean population, as application of a single cut-off value of 35 ng/mL may be overcautious of the possibility of false positivity, especially in men.
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