Evaluation and validation of an enzyme-linked immunosorbent assay and an immunochromatographic test for serological diagnosis of severe acute respiratory syndrome
Evaluation and validation of an enzyme-linked immunosorbent assay and an immunochromatographic test for serological diagnosis of severe acute respiratory syndrome
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DOI：
10.1128/cdli.11.4.699-703.2004
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发表时间：
2004-07-01
期刊：
影响因子：
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通讯作者：
Wong, CJ
中科院分区：
文献类型：
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作者：
Guan, M;Chan, KH;Wong, CJ
对新开发的SARS特异性酶联免疫吸附试验（ELISA）进行了进一步验证，以确定临界值并评估其对临床样本的诊断性能。同时，还评价了免疫层析试验。共收集了227份SARS患者的临床血清标本，以及385份健康献血员的血清标本。通过使用免疫荧光（IF）测试作为“金标准”，ELISA和免疫层析测试不仅能够从恢复期后期样本（从临床症状发作起>21天）中检测到SARS的免疫球蛋白G抗体（如先前所建立的），而且还能够从急性期早期样本（从发作起1至10天）中检测到SARS的免疫球蛋白G抗体。使用0.25的光密度（OD）作为其截止值的ELISA产生最佳灵敏度，同时保持高特异性。在患者出现临床症状后1 ~ 10天、11 ~ 20天、21 ~ 30天和30天以上的4组样本中，SARS特异性抗体的检出率分别为58%、70%、75%和95%。同样，免疫层析检测分别在四组中的55%、68%、81%和79%中检测到SARS特异性抗体。ELISA和快速检测的总体特异性分别为99.5%和97.7%。ELISA OD值与IF滴度呈中度正相关（r = 0.6915; P < 0.001），但ELISA法和快速法的检出率与IF滴度一致。
A newly developed severe acute respiratory syndrome (SARS)-specific enzyme-linked immunosorbent assay (ELISA) was further validated to confirm cutoff values and evaluate its diagnostic performance with clinical samples. In parallel, an immunochromatographic test was also evaluated. A total of 227 clinical serum specimens collected from SARS patients were used in the study, together with 385 samples from healthy donors. By use of an immunofluorescent (IF) test as the "gold standard," both the ELISA and the immunochromatographic test were able to detect immunoglobulin G antibodies to SARS not only from late-convalescent-stage samples (>21 days from the onset of clinical symptoms), as previously established, but also from early-acute-phase samples (1 to 10 days from onset). The ELISA, using an optical density (OD) of 0.25 as its cutoff value, produced the best sensitivity while maintaining high specificity. It detected SARS-specific antibodies in 58, 70, 75, and 95%, respectively, of the four groups of samples collected from patients 1 to 10 days, 11 to 20 days, 21 to 30 days, and more than 30 days after the onset of clinical symptoms. Similarly, the immuno chromatographic test detected SARS-specific antibodies in 55, 68, 81, and 79% of the four groups, respectively. The overall specificities for the ELISA and the rapid test were 99.5 and 97.7%, respectively. Although the positive correlation observed between the ELISA OD values and the IF titers was moderate (r = 0.6915; P < 0.001), the detection rates of both the ELISA and the rapid test were found well in agreement with the IF titers.