基于磁微粒化學(xué)發(fā)光法的肝纖四項(xiàng)檢測限與功能靈敏度研究

王新靈　李忠信　關(guān)　學(xué)　渠　海

基于磁微粒化學(xué)發(fā)光法的肝纖四項(xiàng)檢測限與功能靈敏度研究

王新靈1李忠信2★關(guān)學(xué)2渠海2

［摘要］目的評價磁微粒化學(xué)發(fā)光法檢測肝纖維化血清學(xué)標(biāo)志物（透明質(zhì)酸、層粘連蛋白、Ⅲ型前膠原N端肽、Ⅳ型膠原）的空白限、檢出限和功能靈敏度。方法參照美國臨床和實(shí)驗(yàn)室標(biāo)準(zhǔn)化協(xié)會（Clinical and Laboratory Standards Institute，CLSI）文件，利用空白樣品及系列梯度稀釋樣品在AutoLumo A2000全自動化學(xué)發(fā)光測定系統(tǒng)上進(jìn)行檢測，確定該方法配套試劑的空白限、檢出限及功能靈敏度。結(jié)果透明質(zhì)酸的空白限為7．59 ng／mL，檢出限為16．17 ng／mL，20%變異系數(shù)（coefficient of variation，CV）功能靈敏度為18．72 ng／mL；層粘連蛋白的空白限為1．38 ng／mL，檢出限為3．53 ng／mL，20%CV功能靈敏度為4．16 ng／mL；Ⅲ型前膠原N端肽的空白限為0．89 ng／mL，檢出限為2．40 ng／mL，20%CV功能靈敏度為2．48 ng／mL；Ⅳ型膠原的空白限為2．42 ng／mL，檢出限為6．49 ng／mL，20%CV功能靈敏度為9．21 ng／mL。結(jié)論AutoLumo A2000全自動化學(xué)發(fā)光測定儀肝纖四項(xiàng)的空白限、檢出限和功能靈敏度的建立為臨床診斷和治療提供了更有價值的信息。

［關(guān)鍵詞］血清學(xué)；肝纖維化；磁微粒化學(xué)發(fā)光法；空白限；檢出限；功能靈敏度

作者單位：1．河南中醫(yī)學(xué)院藥學(xué)院，河南，鄭州450046 2．鄭州安圖生物工程股份有限公司，河南，鄭州450016

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

WANG Xinling1, LI Zhongxin2★, GUAN Xue2, QU Hai2
(1. School of Pharmacy, Henan University of Traditional Chinese Medicine, Zhengzhou, Henan, China, 450046; 2. Zhengzhou Autobio Biological Engineering Co.Ltd, Zhengzhou, Henan,China, 450016)

[ABSTRACT] Objective To evaluate the limit of blank(LoB), limit of detection(LoD) and functional sensitivity(F.S) of serum items for liver fibrosis[hyaluronic acid(HA), laminin(LN), procollagen type III N-terminal Propeptide(PIIINP), collagen type IV(CIV)] by magnetism particulate immuno chemistry luminescence method.MethodsThe LoB, LoD 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 LoD of HA, LN, PIIINP, 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, LoD and F.S of the four liver fibrosis serum items on AutoLumo A2000.

[KEY WORDS]Serology; Liver fibrosis; Magnetism particulate immuno chemistry luminescence method; Limit of blank (LoB); Limit of detection (LoD); Functional sensitivity (F.S)

肝纖維化是緊隨肝細(xì)胞破壞之后的自身修復(fù)過程，是慢性肝病發(fā)展為肝硬化的必經(jīng)之路，其實(shí)質(zhì)是細(xì)胞外基質(zhì)合成與降解失衡，導(dǎo)致細(xì)胞外基質(zhì)尤其是膠原在肝內(nèi)的過度增加和沉積［1-2］。肝纖維化血清學(xué)四項(xiàng)指標(biāo)是目前最為常用的檢測肝纖維化的血清學(xué)指標(biāo)，包括透明質(zhì)酸（hyaluronic acid，HA）、層粘連蛋白（laminin，LN）、Ⅲ型前膠原N端肽（procollagen typeⅢN-terminal propeptide，PIIINP）和Ⅳ型膠原（collagen type IV，CIV）。……