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A multi-centre study for standardization of antinuclear antibody indirect immunofluorescence screening with automated system.
Journal of Immunological Methods ( IF 1.6 ) Pub Date : 2019-11-06 , DOI: 10.1016/j.jim.2019.112701 Xin Li 1 , Jie Pan 1 , Hui Zhou 2 , Min He 3 , WeiXuan Li 4 , ZhanZe Chen 4 , WeiLiang Dai 4 , Fang Wang 5 , QiuJing Wei 6 , XiaoBin Lao 7 , Ling Zhang 8 , Ling Li 8 , Honghai Hu 9 , Min Li 9 , Yurong Qiu 10 , Tieying Hou 2
Journal of Immunological Methods ( IF 1.6 ) Pub Date : 2019-11-06 , DOI: 10.1016/j.jim.2019.112701 Xin Li 1 , Jie Pan 1 , Hui Zhou 2 , Min He 3 , WeiXuan Li 4 , ZhanZe Chen 4 , WeiLiang Dai 4 , Fang Wang 5 , QiuJing Wei 6 , XiaoBin Lao 7 , Ling Zhang 8 , Ling Li 8 , Honghai Hu 9 , Min Li 9 , Yurong Qiu 10 , Tieying Hou 2
Affiliation
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.
更新日期：2019-11-01
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