酶联免疫吸附试验检测人血清抗双链DNA抗体在系统性红斑狼疮诊断中的性能评估

目的对人血清抗双链DNA(dsDNA)抗体的酶联免疫吸附检测试剂盒Anti-dsDNA-NcX ELISA行实验室检测性能评估及在系统性红斑狼疮(SLE)诊断中的应用评价。方法对Anti-dsDNA-NcX ELISA试剂盒进行实验性能评价;并用间接免疫荧光法(IIF)和酶联免疫吸附法(ELISA)两种方法共三种试剂盒,同时检测健康体检正常者30例、非系统性红斑狼疮自身免疫病患者27例及SLE患者92例血清抗dsDNA抗体。以SLE的临床诊断为金标准,评价Anti-dsDNA-NcX ELISA试剂盒用于SLE的诊断性能。结果 Anti-dsDNA-NcX ELISA试剂盒达到了各项实验室检测性能指标,试剂盒的最低检测限为2.7 U/m l,线性相关系数为0.998,批内精密度变异系数(CV)<6%,批间精密度CV<10%,溶血、脂血、黄疸对检测结果没有干扰,与类风湿性关节炎、干燥综合征等非SLE自身免疫病患者血清间不存在交叉反应。健康体检正常者血清抗dsDNA抗体水平P97.5为67.0 U/m。l92例狼疮性肾炎患者,两种ELISA试剂的阳性率(60.9%)均高于IIF(20.6%),差异有统计学意义(P...

Clinical Performance of Enzyme Linked Immunosorbent Assay Detecting Serum Antibodies Against Double-stranded DNA in Diagnosis of Systemic Lupus Erythematosus

Objective To estimate the clinical performance of enzyme linked immunosorbent assay(ELISA) kits(Anti-dsDNA-NcX ELISA) detecting serum antibodies against double-stranded DNA(dsDNA) in the diagnosis of Systemic lupus erythematosus(SLE).Methods A performance evaluation was carried out on Anti-dsDNA-NcX ELISA kits.Indirect immunofluorescence(IIF) and ELISA(a total of 3 kits) were used to detect serum anti-dsDNA antibodies in 30 healthy subjects,27 non-SLE patients with autoimmune disease and 92 SLE patients.Tak...