Enzyme-Linked Immunosorbent Assay Screening Then Indirect Immunofluorescence Confirmation of Antinuclear Antibodies A Statistical Analysis
Enzyme-Linked Immunosorbent Assay Screening Then Indirect Immunofluorescence Confirmation of Antinuclear Antibodies A Statistical Analysis
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DOI：
10.1309/ajcp6r8eelgodayw
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发表时间：
2011-05-01
影响因子：
3.5
通讯作者：
Hill, Harry R.
中科院分区：
文献类型：
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作者：
Copple, Susan S.;Sawitzke, Allen D.;Hill, Harry R.
本研究的目的是通过酶联免疫吸附试验（ELISA）分析抗核抗体（ANA）筛查，然后进行间接荧光抗体（IFA）检测，以确认和表征抗体的模式和滴度。我们评价了224例临床定义的血清样本中的4种ANA ELISA和1种HEp-2 IFA底物，其中30例来自系统性红斑狼疮（SLE）病例，94例来自类风湿性关节炎病例，100例来自健康供体，495例提交用于常规ANA检测的血清样本和12例由疾病控制和预防中心分发的参考血清样本。IFA检测由2名执业医师独立判读，ELISA检测SLE血清的敏感性为90%~ 97%，IFA检测的敏感性为80%。ELISA的特异性为36%至94%，而IFA的特异性为99%。总体而言，ANA检测的ELISA表现出更好的灵敏度和良好的特异性，表明ELISA是IFA检测的更经济有效的替代方案，用于ANA的初始筛查。ANA ELISA阳性的样本应进行HEp-2检测，以确定滴度和模式。
The purpose of this study was to analyze antinuclear antibody (ANA) screening by enzyme-linked immunosorbent assay (ELISA) followed by indirect fluorescent antibody (IFA) testing to confirm and characterize the pattern and titer of the antibody. We evaluated 4 ANA ELISAs and 1 HEp-2 IFA substrate in 224 clinically defined serum samples consisting of 30 from systemic lupus erythematosus (SLE) cases, 94 from rheumatoid arthritis cases, and 100 from healthy donors plus 495 serum samples submitted for routine ANA testing and 12 reference serum samples distributed by the Centers for Disease Control and Prevention. IFA tests were read independently by 2 certified medical technologists.ELISA sensitivities ranged from 90% to 97% compared with 80% by IFA in the SLE serum samples. The ELISAs had specificities of 36% to 94%, whereas the IFA had 99% specificity.Overall, ELISAs for ANA assays demonstrated better sensitivity and good specificity, suggesting ELISA is a more cost-effective alternative to IFA testing for initial ANA screening. Samples positive by ANA ELISA should be tested on HEp-2 to determine the titer and pattern.