Evaluation of four commercially available rapid serologic tests for diagnosis of leptospirosis
Evaluation of four commercially available rapid serologic tests for diagnosis of leptospirosis
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DOI：
10.1128/jcm.41.2.803-809.2003
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发表时间：
2003-02-01
影响因子：
9.4
通讯作者：
Weyant, RS
中科院分区：
文献类型：
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作者：
Bajani, MD;Ashford, DA;Weyant, RS
对四种用于钩端螺旋体病血清学诊断的快速检测方法进行了评估，并将每种方法的性能与现行标准显微镜凝集试验（MAT）的性能进行了比较。这四项快速检测是微孔板免疫球蛋白 M (IgM) 酶联免疫吸附测定 (ELISA)、间接血凝测定 (IRA)、IgM 试纸测定 (LDS) 和 IgM 斑点 ELISA 试纸测试 (DST)。对来自四个不同地理位置的 133 例钩端螺旋体病病例的 276 份血清以及来自正常个体或患有其他传染病或自身免疫性疾病的个体的 642 份血清进行了测试。急性期血清（n = 148）是在症状出现后 14 天（中位数 = 6.0）以内收集的，恢复期血清（n = 128）是在症状出现后 15 天（中位数 = 29.1）大于或等于 15 天时收集的。采用传统方法（二乘二列联表），LDS法、DST法、ELISA法、IRA法对钩端螺旋体病病例检出灵敏度分别为93.2%、92.5%、86.5%、79.0%。 DST 的特异性为 98.8%，ELISA 和 MAT 的特异性为 97%，IRA 的特异性为 95.8%，LDS 的特异性为 89.6%。通过包含所有快速检测和临床病例定义的潜在类别分析 (LCA) 模型，DST 的敏感性为 95.5%，LDS 的敏感性为 94.5%，ELISA 的敏感性为 89.9%，IRA 的敏感性为 81.1%。传统方法估计的敏感性和特异性与 LCA 估计值非常接近。然而，LCA 允许估计 MAT 的灵敏度 (98.2%)，而传统方法不允许这样做。对于急性期血清，LDS 的敏感性为 52.7%，DST 的敏感性为 50.0%，MAT 和 ELISA 的敏感性为 48.7%，IRA 的敏感性为 38.5%。恢复期血清的灵敏度通过 MAT 测定为 93.8%，通过 DST 测定为 84.4%，通过 LDS 测定为 83.6%，通过 ELISA 测定为 75.0%，通过 IHA 测定为 67.2%。每个检测均与 MAT 具有良好的总体相关性，其中与 DST 的一致性最高（kappa 值，0.85；95% 置信区间 [CI]，0.8 至 0.90）。 ELISA 和 DST 之间的相关性最好（kappa 值，0.86；95% CI，0.81 至 0.91）。在 Epstein-Barr 病毒、人类免疫缺陷病毒和牙周病患者以及健康志愿者的血清中，假阳性 LDS 结果很常见（大于或等于 20%）。 DST 和 ELISA 的易用性以及极高的灵敏度和特异性使其成为诊断测试的良好选择。
Four rapid tests for the serologic diagnosis of leptospirosis were evaluated, and the performance of each was compared with that of the current standard, the microscopic agglutination test (MAT). The four rapid tests were a microplate immunoglobulin M (IgM)-enzyme-linked immunosorbent assay (ELISA), an indirect hemagglutination assay (IRA), an IgM dipstick assay (LDS), and an IgM dot-ELISA dipstick test (DST). A panel of 276 sera from 133 cases of leptospirosis from four different geographic locations was tested as well as 642 sera from normal individuals or individuals with other infectious or autoimmune diseases. Acute-phase sera from cases (n = 148) were collected less than or equal to14 days (median = 6.0) after the onset of symptoms, and convalescent-phase sera (n = 128) were collected greater than or equal to15 days after onset (median = 29.1). By a traditional method (two-by-two contingency table), the sensitivities for detection of leptospirosis cases were 93.2% by LDS, 92.5% by DST, 86.5% by ELISA, and 79.0% by IRA. Specificity was 98.8% by DST, 97% by ELISA and MAT, 95.8% by IRA, and 89.6% by LDS. With a latent class analysis (LCA) model that included all the rapid tests and the clinical case definition, sensitivity was 95.5% by DST, 94.5% by LDS, 89.9% by ELISA, and 81.1% by IRA. The sensitivity and specificity estimated by the traditional methods were quite close to the LCA estimates. However, LCA allowed estimation of the sensitivity of the MAT (98.2%), which traditional methods do not allow. For acute-phase sera, sensitivity was 52.7% by LDS, 50.0% by DST, 48.7% by MAT and ELISA, and 38.5% by IRA. The sensitivity for convalescent-phase sera was 93.8% by MAT, 84.4% by DST, 83.6% by LDS, 75.0% by ELISA, and 67.2% by IHA. A good overall correlation with the MAT was obtained for each of the assays, with the highest concordance being with the DST (kappa value, 0.85; 95% confidence interval [CI], 0.8 to 0.90). The best correlation was between ELISA and DST (kappa value, 0.86; 95% CI, 0.81 to 0.91). False-positive LDS results were frequent (greater than or equal to20%) in sera from individuals with Epstein-Barr virus, human immunodeficiency virus, and periodontal disease and from healthy volunteers. The ease of use and significantly high sensitivity and specificity of DST and ELISA make these good choices for diagnostic testing.