机构：[1]Clinical laboratory, NanFang Hospital, Southern Medical University, China[2]Clinical laboratory,Guangdong Provincial People's Hospital, China广东省人民医院[3]Guangdong Traditional Chinese Medicine Hospital clinical laboratory, China广东省中医院[4]The First People's Hospital of Foshan clinical laboratory, China[5]The Second Affiliated Hospital of Guangzhou Medical University clinical laboratory, China[6]The Third Affiliated Hospital, Sun Yat-Sen University clinical laboratory, China中山大学附属第三医院[7]The Third Affiliated Hospital of Southern Medical University Rheumatology Laboratory, China[8]Guangzhou Kingmed Diagnostics clinical laboratory immunology group, China[9]Guangzhou Kangrun Biotech Co.,Ltd, China[10]Huayin Medical Laboratory Center Co., Ltd, China
Introduction: ndirect immunofluorescence assay (IFA) using HEp-2 as substrate plays a consolidate role for the detection and measurement of ANA, which is currently considered as the reference method for detection. Manual operation is still very common in China, therefore, the need of standardization and automation for ANA-IFA detecting has been highlighted. Objective: The current multi-center study is aimed to evaluate if HELIOS (AESKU Diagnostics, Wendelsheim, Germany) contributes to comparability of ANA screening results among different labs,and establish application specification of HELIOS for standardization of ANA detection. Methods: ANA detection by manual IFA method and HELIOS on 230 clinical serum samples in eight laboratories. The performance to discriminate positive/negative screening results, endpoint titer estimation and pattern recognition were evaluated in HELIOS and manual visual. Results: The positive coincident rate for ANA detection by manual IFA ranges from 87.7% to 97.8%, the negative coincidence rate ranges from 68.8% to 100%, the correctly estimated titer evaluation were 80 to 171 cases, the correct pattern in 146 to 161 cases, respectively. The positive coincident rate of HELIOS for ANA detection ranges from 91.2% to 97.7%, the negative coincidence rate ranges from 96.5% to 100%, the correctly estimated titer evaluation were 145 to 157 cases, the correct pattern in 123 to 140 cases, respectively. Conclusion: HELIOS could provide accurate diagnostic results, this include not only positive/negative results, but also endpoint titer, common patterns. The application of this system can help to promote standardization of ANA detection.
第一作者机构：[1]Clinical laboratory, NanFang Hospital, Southern Medical University, China
共同第一作者：
通讯作者：
通讯机构：[1]Clinical laboratory, NanFang Hospital, Southern Medical University, China[10]Huayin Medical Laboratory Center Co., Ltd, China[*1]Guangzhou Kangrun Biotech Co.,Ltd, China
推荐引用方式(GB/T 7714)：
Li Xin,Pan Jie,Zhou Hui,et al.A multi-centre study for standardization of antinuclear antibody indirect immunofluorescence screening with automated system[J].JOURNAL OF IMMUNOLOGICAL METHODS.2020,477:doi:10.1016/j.jim.2019.112701.
APA：
Li, Xin,Pan, Jie,Zhou, Hui,He, Min,Li, WeiXuan...&Hou, Tieying.(2020).A multi-centre study for standardization of antinuclear antibody indirect immunofluorescence screening with automated system.JOURNAL OF IMMUNOLOGICAL METHODS,477,
MLA：
Li, Xin,et al."A multi-centre study for standardization of antinuclear antibody indirect immunofluorescence screening with automated system".JOURNAL OF IMMUNOLOGICAL METHODS 477.(2020)
