Feng Yanfei, Ke Xue, Ma Rongshui, Chen Ying, Hu Gengxi, Liu Feizhou
Research Center, Shanghai HealthDigit, Co., Ltd., Shanghai 200233, Peoples Republic of China.
Clin Chem. 2004 Feb;50(2):416-22. doi: 10.1373/clinchem.2003.023994. Epub 2003 Dec 11.
Clinical needs often dictate testing for several autoantibodies in a single patient with evidence of autoimmune disease. We developed a microarray containing 15 autoantigens for the detection of autoantibodies in rheumatoid autoimmune diseases.
We synthesized recombinant centromere protein B, cytokeratin 19, SSA 52-kDa antigen, SSA 60-kDa antigen, SSB antigen, and Jo-1 antigen and prepared anti-nuclear antibody antigens. Cyclic citrullinated peptide, histone, goat IgG for detection of rheumatoid factor, double-stranded DNA, and single-stranded DNA were purchased, as were recombinant small nuclear ribonucleoprotein U1, topoisomerase I, and Smith antigen (Sm). All 15 antigens were of human origin except calf thymus Sm. Proteins were printed on polystyrene. The arrays were incubated with serum samples and then with horseradish peroxidase-conjugated secondary antibodies and chemiluminescent substrates, and light signals were captured by a charge-coupled device camera-based chip reader. Antibodies were quantified by use of calibration curves. Positive samples were confirmed by commercially available methods.
The detection limit of the microarray system was 20 pg of IgG printed on the polystyrene support. More than 85% of the confirmed positive sera were detected as positive with the microarray system based on cutoff values established with the microarray system. The imprecision (CV) of the microarrays was <15% for all 15 autoantibody assays, with the exception of single-stranded DNA (18% and 23%) within and between batches. Characteristic autoantibody patterns were seen in patients with clinical diagnoses of rheumatoid arthritis (n = 83), systemic lupus erythematosus (n = 71), systemic sclerosis (n = 36), polymyositis (n = 38), and Sjogren syndrome (n = 20).
This microarray system provides results similar to those by conventional methods. Assessment of the diagnostic accuracy of the system remains to be done.
临床需求常常要求对有自身免疫性疾病证据的单个患者检测多种自身抗体。我们开发了一种包含15种自身抗原的微阵列,用于检测类风湿性自身免疫疾病中的自身抗体。
我们合成了重组着丝粒蛋白B、细胞角蛋白19、SSA 52-kDa抗原、SSA 60-kDa抗原、SSB抗原和Jo-1抗原,并制备了抗核抗体抗原。购买了环瓜氨酸肽、组蛋白、用于检测类风湿因子的山羊IgG、双链DNA和单链DNA,以及重组小核核糖核蛋白U1、拓扑异构酶I和史密斯抗原(Sm)。除小牛胸腺Sm外,所有15种抗原均为人源。将蛋白质印在聚苯乙烯上。将微阵列与血清样本孵育,然后与辣根过氧化物酶偶联的二抗和化学发光底物孵育,通过基于电荷耦合器件相机的芯片读取器捕获光信号。通过使用校准曲线对抗体进行定量。阳性样本通过市售方法进行确认。
微阵列系统的检测限为印在聚苯乙烯支持物上的20 pg IgG。基于微阵列系统确定的临界值,超过85%经确认的阳性血清在微阵列系统中被检测为阳性。除批次内和批次间的单链DNA(分别为18%和23%)外,所有15种自身抗体检测的微阵列不精密度(CV)均<15%。在临床诊断为类风湿性关节炎(n = 83)、系统性红斑狼疮(n = 71)、系统性硬化症(n = 36)、多发性肌炎(n = 38)和干燥综合征(n = 20)的患者中观察到了特征性的自身抗体模式。
该微阵列系统提供的结果与传统方法相似。该系统的诊断准确性评估仍有待进行。