Abstract：
OBJECTIVE: To establish reference intervals (RIs) for PTX-3 and to validate the performance of these RIs in a population including healthy volunteers and Takayasu\'s arteritis (TAK) patients.
METHODS: Plasma PTX-3 levels were determined in 166 healthy volunteers and 63 TAK patients. RIs were established in healthy volunteers according to guidelines from the Clinical and Laboratory Standards Institute (CLSI, C28-A3). Global assessment was used to quantitatively diagnose active/non-active TAK patients. Screening and monitoring performances were validated by identifying active TAK patients from the whole population or diagnosed TAK patients.
RESULTS: The PTX-3 RI was calculated to be 0.87-2.78 ng/mL. For screening purposes, 1.55 ng/mL had a high sensitivity of 90.32 % and the RI upper limit (2.78 ng/mL) had a high specificity of 97.94 %. For monitoring purposes, the sensitivity/specificity of the cut-off value (1.55 ng/mL) and RI median were 90.32 %/90.63 % and 80.85 %/90.63 %, respectively. These screening and monitoring performances of PTX-3 were superior to those of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR).
CONCLUSIONS: The distribution of serum PTX-3 levels was stable and uniform across the population. The screening and monitoring performances of the cut-off value and RI-derived values of PTX-3 were higher than CRP and ESR.
METHODS: Plasma PTX-3 levels were determined in 166 healthy volunteers and 63 TAK patients. RIs were established in healthy volunteers according to guidelines from the Clinical and Laboratory Standards Institute (CLSI, C28-A3). Global assessment was used to quantitatively diagnose active/non-active TAK patients. Screening and monitoring performances were validated by identifying active TAK patients from the whole population or diagnosed TAK patients.
RESULTS: The PTX-3 RI was calculated to be 0.87-2.78 ng/mL. For screening purposes, 1.55 ng/mL had a high sensitivity of 90.32 % and the RI upper limit (2.78 ng/mL) had a high specificity of 97.94 %. For monitoring purposes, the sensitivity/specificity of the cut-off value (1.55 ng/mL) and RI median were 90.32 %/90.63 % and 80.85 %/90.63 %, respectively. These screening and monitoring performances of PTX-3 were superior to those of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR).
CONCLUSIONS: The distribution of serum PTX-3 levels was stable and uniform across the population. The screening and monitoring performances of the cut-off value and RI-derived values of PTX-3 were higher than CRP and ESR.
摘要：
目的：建立PTX-3的参考区间（RI），并验证这些RI在健康志愿者和Takayasu动脉炎（TAK）患者人群中的表现。
方法：测定166名健康志愿者和63名TAK患者的血浆PTX-3水平。根据临床和实验室标准研究所（CLSI，C28-A3)。全局评估用于定量诊断活动性/非活动性TAK患者。通过从整个人群或诊断的TAK患者中识别活跃的TAK患者来验证筛查和监测性能。
结果:计算的PTX-3RI为0.87-2.78ng/mL。出于筛选目的，1.55ng/mL的灵敏度为90.32％，RI上限（2.78ng/mL）的特异性为97.94％。出于监测目的，截断值(1.55ng/mL)和RI中位数的敏感性/特异性分别为90.32%/90.63%和80.85%/90.63%,分别。PTX-3的筛查和监测性能优于C反应蛋白（CRP）和红细胞沉降率（ESR）。
结论：人群中血清PTX-3水平的分布稳定均匀。PTX-3的截断值和RI衍生值的筛选和监测性能高于CRP和ESR。
方法：测定166名健康志愿者和63名TAK患者的血浆PTX-3水平。根据临床和实验室标准研究所（CLSI，C28-A3)。全局评估用于定量诊断活动性/非活动性TAK患者。通过从整个人群或诊断的TAK患者中识别活跃的TAK患者来验证筛查和监测性能。
结果:计算的PTX-3RI为0.87-2.78ng/mL。出于筛选目的，1.55ng/mL的灵敏度为90.32％，RI上限（2.78ng/mL）的特异性为97.94％。出于监测目的，截断值(1.55ng/mL)和RI中位数的敏感性/特异性分别为90.32%/90.63%和80.85%/90.63%,分别。PTX-3的筛查和监测性能优于C反应蛋白（CRP）和红细胞沉降率（ESR）。
结论：人群中血清PTX-3水平的分布稳定均匀。PTX-3的截断值和RI衍生值的筛选和监测性能高于CRP和ESR。
