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首页> 外文期刊>Journal of Clinical Microbiology >Evaluation of Four Commercially Available Rapid Serologic Tests for Diagnosis of Leptospirosis
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Evaluation of Four Commercially Available Rapid Serologic Tests for Diagnosis of Leptospirosis

机译：四种可用于钩端螺旋体病诊断的市售快速血清学检测方法的评估

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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 (IHA), 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 ≤14 days (median = 6.0) after the onset of symptoms, and convalescent-phase sera (n = 128) were collected ≥15 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 IHA. Specificity was 98.8% by DST, 97% by ELISA and MAT, 95.8% by IHA, 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 IHA. 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 IHA. 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 (≥20%) 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.
机译：评估了四项针对钩端螺旋体病血清学诊断的快速测试，并将每项测试的性能与当前标准显微镜凝集测试（MAT）进行了比较。四个快速测试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（IHA），IgM量油尺测定（LDS）和IgM点ELISA量油尺测试（DST）。测试了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性或自身免疫性疾病的个体的642份血清。在症状发作后≤14天（中位数= 6.0）收集病例（ n = 148）的急性期血清，恢复期血清（ n = 128） ）在发病后≥15天收集（中位数= 29.1）。用传统方法（两列两列列式表），钩端螺旋体检出的灵敏度通过LDS检测为93.2％，通过DST检测为92.5％，通过ELISA检测为86.5％，通过IHA检测为79.0％。 DST的特异性为98.8％，ELISA和MAT的特异性为97％，IHA的特异性为95.8％，LDS的特异性为89.6％。使用包含所有快速测试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％，IHA的敏感性为81.1％。传统方法估计的敏感性和特异性与LCA估计非常接近。但是，LCA允许估计MAT的灵敏度（98.2％），这是传统方法所不允许的。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％，IHA的敏感性为38.5％。康复期血清的MAT灵敏度为93.8％，DST为84.4％，LDS为83.6％，ELISA为75.0％，IHA为67.2％。每种测定均与MAT具有良好的总体相关性，与DST的一致性最高（kappa值为0.85; 95％置信区间[CI]为0.8至0.90）。 ELISA和DST之间的相关性最好（kappa值为0.86; 95％CI为0.81至0.91）。患有爱泼斯坦-巴尔病毒，人免疫缺陷病毒和牙周疾病的个体以及健康志愿者的血清中，假阳性LDS结果频繁（≥20％）。 DST和ELISA的易用性以及极高的灵敏度和特异性使它们成为诊断测试的良好选择。

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