间接免疫荧光法检测抗核抗体室内质控品制备和性能验证  

Preparation and performance verification of internal quality control materials of antinuclear antibodies detected by indirect immunofluorescence assay

作　　者：高雪丹 苏真珍[1] 黄卓春[1] 胡静[1] 王丽[1] 杨滨[1] GAO Xue-dan;SU Zhen-zhen;HUANG Zhuo-chun;HU Jing;WANG Li;YANG Bin(Department of Laboratory Medicine,West China Hospital of Sichuan University,Chengdu 610041,China)

机构地区：[1]四川大学华西医院实验医学科,成都610041

出　　处：《中华临床免疫和变态反应杂志》2021年第4期364-369,共6页Chinese Journal of Allergy & Clinical Immunology

基　　金：国家自然科学基金(81772258);四川省科技厅科技支撑项目(2019YFS0310)。

摘　　要：目的建立抗核抗体(antinuclear antibody,ANA)室内质控品自制和性能验证规范化程序,以有效监测实验室间接免疫荧光法检测ANA的质量,保证其检测一致性和准确性。方法收集ANA高滴度强荧光(滴度1∶3200~1∶10000)单一荧光核型(均质型)临床血清样本,将其与混合阴性ANA血清按1∶30比例混合制备成1∶100~1∶320滴度的弱阳性质控品,收集阴性血清作为阴性质控品。将质控品灭活后采用间接免疫荧光法检测并以人工判读和荧光判读仪判读(荧光强度值),同时进行均匀性和稳定性验证,并用自制质控品进行仪器重复性和一致性性能验证。结果自制弱阳性和阴性ANA质控均有较好的均匀性和稳定性,其荧光强度值变异系数基本在10%以内,以自制质控品验证仪器也具有较好的重复性和一致性。结论采用荧光强度值可基本实现定量监测ANA质控品的检测结果,且本实验室自制ANA质控品有良好的性能,可满足临床需求并可为其他实验室制备和验证质控品提供参考。Objective To establish a standardized procedure for the preparation in home and performance verification of internal quality control materials for the detection of antinuclear antibody(ANA),so as to effectively monitor the quality of ANA detected by indirect immunofluorescence assay in the laboratory and ensure the consistency and accuracy of the detection.Methods A clinical serum sample with a single fluorescence model(homogeneous)of a high titer(1∶3200~1∶10000)was collected and mixed with a mixed negative ANA serum at a ratio of 1∶30 to prepare a weak positive quality control with the titer of 1∶100~1∶320.The negative serum was collected as a negative quality control materials.The control materials were detected by indirect immunofluorescence after inactivating of the virus,and the uniformity and stability were verified by manual interpretation and fluorescence interpretation instrument(fluorescence intensity value)simultaneously,and the repeatability and consistency of the instrument were verified by homemade quality control.Results Both the homemade weak positive and negative ANA quality control materials had satisfying uniformity and stability,and the variation coefficient of fluorescence intensity value was basically within 10%.The homemade control materials verifed that the instrument also had good repeatability and consistency.Conclusions The fluorescence intensity value can basically achieve quantitative monitoring of the detection results of ANA quality control materials.Moreover,the homemade ANA control materials in our laboratory have satisfying perfor-mance,which can meet the clinical requirements and provide reference for other laboratories to prepare and verify the internal quality control materials.

关 键 词：抗核抗体 间接免疫荧光法 室内质控品 荧光强度值 

分 类 号：R44[医药卫生—诊断学]