Department of Medical Parasitology and Mycology, Tehran University of Medical Sciences, School of Public Health, Tehran, Iran.
Center for Research of Endemic Parasites of Iran (CREPI), Tehran University of Medical Sciences, Tehran, Iran.
BMC Infect Dis. 2020 Dec 11;20(1):946. doi: 10.1186/s12879-020-05558-7.
Direct agglutination test (DAT) as a simple, accurate and reliable method, has been widely used for serodiagnosis of visceral leishmaniasis (VL) during the last three decades. The present study is a systematic review and meta-analysis to evaluate the diagnostic accuracy of DAT for serodiagnosis of human VL.
Electronic databases, including MEDLINE (via PubMed), SCOPUS, Web of Science, SID and Mag Iran (two Persian scientific search engines) were searched from December 2004 to April 2019. We determined the pooled sensitivity and specificity rates of DAT for the diagnosis of human VL, calculated positive and negative likelihood ratios (LR+ and LR-), and constructed summary receiver operating characteristic (ROC) curves parameters across the eligible studies.
Of the 2928 records identified in the mentioned electronic databases and after examining reference lists of articles, 24 articles met inclusion criteria and were enrolled in the systematic review and out of them 20 records qualified for meta-analysis. The pooled sensitivity and specificity rates of DAT was 96% [95% CI, 92-98] and 95% [CI95% 86-99], respectively. The likelihood ratio of a positive test (LR+) was found to be 21 [CI95%, 6.6-66.5] and the likelihood ratio of a negative test (LR-) was found to be 0.04 [(CI95%, 0.02-0.08]. The combined estimate of the diagnostic odds ratio for DAT was high [467 (CI95%, 114-1912]). We found that the summary receiver operating characteristic curve (SROC) is positioned near the upper left corner of the curve and the area under curve (AUC) was 0.98 (95% CI, 0.97 to 0.99).
Referring to our analysis, we determined that DAT can be considered as a valuable tool for the serodiagnosis of human VL with high sensitivity and specificity. As DAT is a simple, accurate and efficient serological test, it can be recommended for serodiagnosis of human VL particularly in endemic areas.
直接凝集试验（DAT）作为一种简单、准确、可靠的方法，在过去三十年中被广泛用于内脏利什曼病（VL）的血清学诊断。本研究是一项系统评价和荟萃分析，旨在评估 DAT 对人类 VL 血清学诊断的准确性。
从 2004 年 12 月至 2019 年 4 月，我们检索了电子数据库，包括 MEDLINE（通过 PubMed）、SCOPUS、Web of Science、SID 和 Mag Iran（两个波斯科学搜索引擎）。我们确定了 DAT 对人类 VL 诊断的合并敏感性和特异性率，计算了阳性和阴性似然比（LR+和 LR-），并绘制了符合纳入标准的研究的综合受试者工作特征（ROC）曲线参数。
在所提到的电子数据库中，我们从 2928 条记录中确定了 24 篇文章符合纳入标准，并对文章的参考文献进行了检查，其中 20 篇记录符合荟萃分析的纳入标准。DAT 的合并敏感性和特异性率分别为 96%[95%置信区间，92-98%]和 95%[95%置信区间，86-99%]。阳性试验的似然比（LR+）为 21[95%置信区间，6.6-66.5]，阴性试验的似然比（LR-）为 0.04[95%置信区间，0.02-0.08]。DAT 的诊断比值比的综合估计值较高[467（95%置信区间，114-1912）]。我们发现，综合受试者工作特征曲线（SROC）位于曲线的左上角附近，曲线下面积（AUC）为 0.98（95%置信区间，0.97-0.99）。
根据我们的分析，我们确定 DAT 可以被认为是一种用于人类 VL 血清学诊断的有价值的工具，具有较高的敏感性和特异性。由于 DAT 是一种简单、准确、高效的血清学检测方法，因此可以推荐用于人类 VL 的血清学诊断，特别是在流行地区。
