摘要
目的评价以HEp-2细胞为底物的间接免疫荧光法(IFA)和包被多种纯化核抗原的酶联免疫吸附试验(ELISA)检测抗核抗体(ANA)的特点及其在系统性红斑狼疮(SLE)诊断中的应用价值。方法同时采用IFA法和ELISA法检测血清ANA共409例,其中SLE 226例和健康对照183名,将两种方法检测结果的敏感度、特异度、准确度、阳性预测值、阴性预测值、阳性似然比、阴性似然比、结果符合率、判断一致性κ值及秩相关系数进行比较分析；通过ROC曲线比较两种方法的准确度；结果不一致标本进行可提取性核抗原抗体谱(ENA)检测分析；同时将IFA法检测不同荧光模型样本分别与ELISA结果进行相关分析。结果SLE患者组IFA法和ELISA法检测ANA的敏感度分别为91．15%和92．04%,特异度分别为96．17%和92．90%,准确度分别为93．40%和92．42%,阳性预测值分别为96．71%和94．12%％,阴性预测值分别为89．80%和90．43%．两种方法比较差异均无统计学意义(P＞0．05),ROC曲线对两种方法准确度分析差异无统计学意义(P=0．409)；两方法检测结果符合率为91．20%,秩相关系数R=0．823,判断一致性κ=0．825：在36例两种方法检测结果不一致标本中,14例IFA(+)ELISA(一),其中1例IFA法滴度达1：1000的高尔基体型．其余为临界值左右的核仁型和斑点型,而在22例IFA(一)ELISA(+)患者中,其中有11例ELISA法吸光度(A)2．67～30．5；将此36例血清标本进行ENA抗体谱检测,14例IFA(+)ELISA(一)患者ENA阳性率为14．29%,而22例IFA(一)ELISA(+)患者ENA阳性率高达68．18%,两者比较差异有统计学意义(P＜0．01)。IFA法检测的不同荧光模型的阳性标本中,斑点型滴度与ELISA法A值相关性较差R=0．083,均质型相关性最好。R=0．595。结论IFA作为ANA检测的推荐方法具有直观、可分型等特点,且能提供与自身免疫性疾病相关的核型信息,但需要荧光显微镜及较丰富判断经验的技术人员；而
Objective To compare and evaluate the usefulness of diagnostic tests of IFA with HEp-2 cell substrate and ELISA coated with purified nuclear antigens for ANA in SLE. Methods Sera derived from 226 SLE cases and 183 healthy controls were tested for ANA and all parameters were compared such as sensitivity, specificity, accuracy, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, result consistency, rank correlation coefficient and kappa of ANA detected by IFA and ELISA. Accuracy was evaluated by ROC for two methods. All 36 samples with different results from two methods were detected for ENA. The correlation of titer to A ratio of different patterns as studied. Results The sensitivity of IFA and ELISA was 91.15% and 92.04% respectively for SLE patients, specificity was 96.17% and 92.90%, accuracy was 93.40% and 92.42%, positive predictive value was 96.71% and 94.12%, negative predictive value was 89.80% and 90.43%, no significant difference was found, between the two methods （P〉 0.05）. No significant difference was found in accuracy of both methods by ROC （P=0.409）. Good agreement was found between two methods with rank correlation coefficient （R=0.823） and kappa （K=0.825）. All of 36 samples with different ANA results from two methods were detected for ENA. In 14 cases with IFA positive and ELISA negative, the titer of one case was up to 1 ： 1000 and the pattern was Golgi by IFA, the titers of the rest were about cutoff level and the pattern were granular and nucleolus mostly. In 22 cases with IFA negative and ELISA positive, 11 cases of them had the A ratio ranged from 2.67-30.5. Positive rate of ENA was 14.29% in 14 cases with IFA positive and ELISA negative, 68.18% in 22 cases with IFA negative and ELISA positive and the difference was significant （P〈0.01）. Poor correlation of titer to A ratio for granular pattern samples （R=0.083）, but good correlation for homogeneous pattern was found （R=0.595）. Conclusion IFA as the reco
出处
《中华风湿病学杂志》
CAS
CSCD
2006年第10期610-614,共5页
Chinese Journal of Rheumatology
关键词
抗体
抗核
酶联免疫吸附测定
间接免疫荧光法
Antibodies, antinuclear, Enzyme-linked immunosorbent assay
Indirect immunofluorescenceassay
