基于磁微粒化学发光法的肝纤四项检测限与功能灵敏度研究

Research on magnetism particulate immuno chemistry luminescence method for limit of detection and functional sensitivity of four items of liver fibrosis

目的评价磁微粒化学发光法检测肝纤维化血清学标志物(透明质酸、层粘连蛋白、Ⅲ型前胶原N端肽、Ⅳ型胶原)的空白限、检出限和功能灵敏度。方法参照美国临床和实验室标准化协会(Clinical and Laboratory Standards Institute,CLSI)文件,利用空白样品及系列梯度稀释样品在Auto Lumo A2000全自动化学发光测定系统上进行检测,确定该方法配套试剂的空白限、检出限及功能灵敏度。结果透明质酸的空白限为7.59 ng/mL,检出限为16.17 ng/mL,20%变异系数(coefficient of variation,CV)功能灵敏度为18.72 ng/mL;层粘连蛋白的空白限为1.38 ng/mL,检出限为3.53 ng/mL,20%CV功能灵敏度为4.16 ng/mL;Ⅲ型前胶原N端肽的空白限为0.89 ng/mL,检出限为2.40 ng/mL,20%CV功能灵敏度为2.48 ng/mL;Ⅳ型胶原的空白限为2.42 ng/mL,检出限为6.49 ng/mL,20%CV功能灵敏度为9.21 ng/mL。结论 Auto Lumo A2000全自动化学发光测定仪肝纤四项的空白限、检出限和功能灵敏度的建立为临床诊断和治疗提供了更有价值的信息。

Objective To evaluate the limit of blank（LoB）, limit of detection（LeD） and functional sensitivity（F.S） of serum items for liver fibrosis[hyaluronic acid（HA）, laminin（LN）, procollagen type HI N- terminal Propeptide（PIIINP）, collagen type IV（CIV）] by magnetism particulate immune chemistry luminescence method. Methods The LoB, LeD and F.S were confirmed by using the blank samples and series gradient dilution samples on AutoLumo A2000 in accordance with the files of clinical and laboratory standards institute （CLSI）. Results The LoB of HA, LN, PIIINP, and CIV were 7.59 ng/mL, 1.38 ng/mL, 0.89 ng/mL and 2.42 ng/mL, respectively. The LeD of HA, LN, PII1NP, and CIV were 16.17 ng/mL, 3.53 ng/mL, 2.40 ng/mL and 6.49 ng/mL, respectively. The 20% CV F.S of HA, LN, PIIINP, and CIV were 18.72 ng/mL, 4.16 ng/mL, 2.48 ng/mL and 9.21 ng/mL, respectively. Conclusion More valuable informations for clinical diagnosis and treatment were provided by cofirming the LoB, LeD and F.S of the four liver fibrosis serum items on AutoLumo A2000.