부갑상선호르몬 측정을 위한 두 가지 2세대 검사법의 비교
Comparison Between Two Different Second-Generation Parathyroid Hormone Assays
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배경: 부갑상선호르몬(parathyroid hormone, PTH)의 측정은 일/이차성 부갑상선 항진증 및 저하증의 진단 및 치료 방향의 결정에 중요하다. PTH는 혈액 내에 다양한 분자의 형태로 존재하므로, 측정 방법에 따라 농도값에 상당한 차이가 있는 것으로 알려져 있다. 본 연구에서는 두 가지 서로 다른 방법의 2세대 PTH 검사를 비교 평가해 보았다. 방법: 두 검사법의 비교평가를 위해 PTH가 의뢰된 잔여 검체 56개를 이용하였다. 각 검체를 기존의 면역방사계수측정법(ELSA-PTH; Cisbio assays, France)과 새로 도입한 자동화 화학발광면역측정법(Alinity i Intact PTH; Abbott, USA)으로 검사를 시행한 후 상관성을 분석하였다. Alinity i Intact PTH 검사법의 분석능 검증을 위해 정밀도, 직선성, 참고범위 및 정량한계 검증이 수행되었다. 결과: ELSA-PTH와 Alinity i Intact PTH의 중앙값은 각각 69.0 pg/mL과 101.9 pg/mL였고 Alinity i Intact PTH의 측정값이 유의하게 높았다(P<0.0001). Pearson 상관계수는 0.959였고, 두 검사법의 결과값 차이의 평균은 78.57 pg/mL였다. Alinity i Intact PTH 분석능 평가로 3가지 농도에서 구한 변이계수는 반복정밀도 1.9%, 2.4%, 1.8%와 검사실내정밀도 2.0%, 2.7%, 2.7%였다. 평가된 3–3,000 pg/mL 범위에서 직선성을 확인하였으며 제조사가 제시한 참고범위 15–68.3 pg/mL와 정량한계 3 pg/mL를 검증하였다. 결론: ELSA-PTH와 Alinity i Intact PTH의 측정값은 높은 상관관계를 보였고, Alinity i Intact PTH 검사는 검사실 도입에 적합한 분석능을 보였다.
Abstract
Background: Accurate measurement of parathyroid hormone (PTH) levels is crucial for the diagnosis and treatment of hyperparathyroidism and hypoparathyroidism. Given the existence of various PTH forms in the bloodstream, it is well-known that there are variations in PTH levels depending on the measurement method. This study aimed to evaluate two different second-generation PTH assays. Methods: A total of 56 residual samples originally requested for PTH testing were utilized for comparing the two methods. Each sample was subjected to analysis using an immunoradiometric assay (ELSA-PTH; Cisbio Bioassays, France) and a chemiluminescence microparticle immunoassay (Alinity i Intact PTH; Abbott, USA). Precision and linearity were analyzed, and reference interval and limit of quantitation (LoQ) were verified to investigate the performance of the Alinity i Intact PTH assay. Results: The median PTH values of ELSA-PTH and Alinity i Intact PTH were 69.0 pg/mL and 101.9 pg/mL, respectively, with significantly higher PTH values for Alinity i Intact PTH (P<0.0001). The Pearson correlation coefficient was 0.959, and the average difference between the two tests was 78.57 pg/mL. For Alinity i Intact PTH, the coefficient of variation obtained at three concentrations was 1.9%, 2.4%, 1.8% for repeatability, and 2.0%, 2.7%, 2.7% for within-laboratory precision. Linearity was observed in the range of 3–3,000 pg/mL. The reference interval and LoQ reported by the manufacturer were verified. Conclusions: The PTH results of the ELSA-PTH and Alinity i Intact PTH assays showed a strong correlation, and the Alinity i Intact PTH assay demonstrated acceptable analytical performance.
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