Chandratilleke Dinusha, Silvestrini Roger, Culican Sue, Campbell David, Byth-Wilson Karen, Swaminathan Sanjay, Lin Ming-Wei
Department of Immunopathology, ICPMR, Westmead Hospital, Westmead, NSW, Australia; Faculty of Medicine, University of Sydney, Sydney, NSW, Australia.
Department of Immunopathology, ICPMR, Westmead Hospital, Westmead, NSW, Australia.
Pathology. 2016 Aug;48(5):491-7. doi: 10.1016/j.pathol.2016.04.004. Epub 2016 Jun 14.
Extractable nuclear antigen (ENA) antibody testing is often requested in patients with suspected connective tissue diseases. Most laboratories in Australia use a two step process involving a high sensitivity screening assay followed by a high specificity confirmation test. Multiplexing technology with Addressable Laser Bead Immunoassay (e.g., FIDIS) offers simultaneous detection of multiple antibody specificities, allowing a single step screening and confirmation. We compared our current diagnostic laboratory testing algorithm [Organtec ELISA screen / Euroimmun line immunoassay (LIA) confirmation] and the FIDIS Connective Profile. A total of 529 samples (443 consecutive+86 known autoantibody positivity) were run through both algorithms, and 479 samples (90.5%) were concordant. The same autoantibody profile was detected in 100 samples (18.9%) and 379 were concordant negative samples (71.6%). The 50 discordant samples (9.5%) were subdivided into 'likely FIDIS or current method correct' or 'unresolved' based on ancillary data. 'Unresolved' samples (n = 25) were subclassified into 'potentially' versus 'potentially not' clinically significant based on the change to clinical interpretation. Only nine samples (1.7%) were deemed to be 'potentially clinically significant'. Overall, we found that the FIDIS Connective Profile ENA kit is non-inferior to the current ELISA screen/LIA characterisation. Reagent and capital costs may be limiting factors in using the FIDIS, but potential benefits include a single step analysis and simultaneous detection of dsDNA antibodies.
对于疑似结缔组织病的患者，通常会要求进行可提取核抗原（ENA）抗体检测。澳大利亚的大多数实验室采用两步法，即先进行高灵敏度筛查试验，然后进行高特异性确认试验。采用可寻址激光珠免疫分析的多重技术（如FIDIS）可同时检测多种抗体特异性，实现一步筛查和确认。我们比较了我们目前的诊断实验室检测算法[Organtec ELISA筛查/Euroimmun线性免疫分析（LIA）确认]和FIDIS结缔组织谱检测。总共529个样本（443个连续样本+86个已知自身抗体阳性样本）通过两种算法进行检测，479个样本（90.5%）结果一致。在100个样本（18.9%）中检测到相同的自身抗体谱，379个样本（71.6%）为一致阴性样本。根据辅助数据，将50个不一致的样本（9.5%）分为“可能FIDIS或当前方法正确”或“未解决”。根据对临床解释的改变，将“未解决”的样本（n = 25）进一步分为“可能具有”或“可能不具有”临床意义。只有9个样本（1.7%）被认为“可能具有临床意义”。总体而言，我们发现FIDIS结缔组织谱ENA试剂盒不劣于目前的ELISA筛查/LIA鉴定方法。试剂和设备成本可能是使用FIDIS的限制因素，但潜在的好处包括一步分析和同时检测双链DNA抗体。
