Pappa Styliani A, Kontou Panagiota I, Bagos Pantelis G, Braliou Georgia G
Department of Computer Science and Biomedical Informatics, University of Thessaly, 2-4, Papasiopoulou Str., 35131 Lamia, Greece.
Pathogens. 2021 Feb 27;10(3):269. doi: 10.3390/pathogens10030269.
Leishmaniasis is a neglected tropical disease affecting humans and domesticated animals with high mortality in endemic countries. The pleiotropy of symptoms and the complicated gold-standard methods make the need for non-invasive, highly sensitive diagnostic tests imperative. Individual studies on molecular-based diagnosis in urine show high discrepancy; thus, a data-evidenced comparison of various techniques is necessary. We performed a systematic review and meta-analysis using the bivariate method of diagnostic methods to pool sensitivities and specificities. We investigated the impact of DNA-extraction method, PCR type, amplified locus, host species, leishmaniasis form, and geographical region. The pooled sensitivity was 69.2%. Tests performed with the kit-based DNA extraction method and qPCR outweighed in sensitivity the phenol-chloroform-based and PCR methods, while their combination showed a sensitivity of 79.3%. Amplified locus, human or canine as host and cutaneous or visceral leishmaniasis revealed similar sensitivities. Tests in European and Middle Eastern countries performed better than tests in other regions (sensitivity 81.7% vs. 43.7%). A combination of kit-based DNA extraction and qPCR could be a safer choice for molecular diagnosis for infection in urine samples in European-Middle Eastern countries. For the rest of the world, more studies are needed to better characterize the endemic parasite species.
利什曼病是一种被忽视的热带疾病，在流行国家会影响人类和家畜，死亡率很高。症状的多效性以及复杂的金标准方法使得非侵入性、高灵敏度诊断测试成为当务之急。关于尿液中基于分子的诊断的个别研究显示差异很大；因此，有必要对各种技术进行数据证据比较。我们使用诊断方法的双变量方法进行了系统评价和荟萃分析，以汇总敏感性和特异性。我们研究了DNA提取方法、PCR类型、扩增位点、宿主物种、利什曼病形式和地理区域的影响。汇总敏感性为69.2%。基于试剂盒的DNA提取方法和定量PCR进行的测试在敏感性上超过了基于酚-氯仿的方法和普通PCR方法，而它们的组合显示敏感性为79.3%。扩增位点、作为宿主的人类或犬类以及皮肤或内脏利什曼病显示出相似的敏感性。在欧洲和中东国家进行的测试比其他地区的测试表现更好（敏感性81.7%对43.7%）。基于试剂盒的DNA提取和定量PCR的组合可能是欧洲-中东国家尿液样本中感染分子诊断的更安全选择。对于世界其他地区，需要更多研究来更好地表征地方性寄生虫物种。
