Rohwäder Edda, Locke Michael, Fraune Johanna, Fechner Kai
Institute of Experimental Immunology, Euroimmun AG, Seekamp 31, 23560 Lübeck, Germany.
Expert Rev Mol Diagn. 2015 Apr;15(4):451-62. doi: 10.1586/14737159.2015.993612. Epub 2014 Dec 20.
Indirect immunofluorescence assay is the recommended gold standard to test for antinuclear antibodies (ANA), which are important biomarkers for systemic rheumatic autoimmune diseases. It is internationally accepted that indirect immunofluorescence assay ANA screening is most sensitive on human epithelial (HEp-2) cells. The cells present a multitude of antigens that display distinguishable localization patterns in interphase and mitotic cells in indirect immunofluorescence analysis. Here, we present the IFA 40: HEp-20-10 test kit (Euroimmun AG, Lübeck, Germany), which is cleared for sale on the US market by the FDA. The test has been designed for qualitative and semiquantitative screening of ANA in human sera. It uses the commonly applied 1:40 cutoff dilution and the enhanced HEp-20-10 cell line for more efficient pattern recognition and has been validated in various studies and by method comparison. The IFA 40: HEp-20-10 test fulfills the essential criteria for reliable application in autoimmune diagnostics.
间接免疫荧光法是检测抗核抗体（ANA）的推荐金标准，抗核抗体是系统性风湿性自身免疫疾病的重要生物标志物。国际上公认，间接免疫荧光法进行ANA筛查时，对人上皮（HEp-2）细胞最为敏感。在间接免疫荧光分析中，这些细胞呈现出多种抗原，在间期细胞和有丝分裂细胞中表现出可区分的定位模式。在此，我们介绍IFA 40: HEp-20-10检测试剂盒（德国吕贝克欧蒙医学诊断有限公司），该试剂盒已获美国食品药品监督管理局批准在美国市场销售。该检测方法旨在对人血清中的ANA进行定性和半定量筛查。它采用常用的1:40截断稀释度，并使用增强型HEp-20-10细胞系以实现更有效的模式识别，且已在各种研究及方法比较中得到验证。IFA 40: HEp-20-10检测符合自身免疫诊断可靠应用的基本标准。
