Unitat de Farmacologia Veterinària and LeishLAB-Servei d'Anàlisi de Fàrmacs, Departament de Farmacologia, de Terapèutica i de Toxicologia, Universitat Autònoma de Barcelona, Bellaterra (Barcelona), Spain.
Am J Trop Med Hyg. 2010 Feb;82(2):251-6. doi: 10.4269/ajtmh.2010.09-0366.
There is no gold standard for diagnosing leishmaniases. Our aim was to assess the operative validity of tests used in detecting Leishmania infection using samples from experimental infections, a reliable equivalent to the classic definition of gold standard. Without statistical differences, the highest sensitivity was achieved by protein A (ProtA), immunoglobulin (Ig)G2, indirect fluorescenece antibody test (IFAT), lymphocyte proliferation assay, quantitative real-time polymerase chain reaction of bone marrow (qPCR-BM), qPCR-Blood, and IgG; and the highest specificity by IgG1, IgM, IgA, qPCR-Blood, IgG, IgG2, and qPCR-BM. Maximum positive predictive value was obtained simultaneously by IgG2, qPCR-Blood, and IgG; and maximum negative predictive value by qPCR-BM. Best positive and negative likelihood ratios were obtained by IgG2. The test having the greatest, statistically significant, area under the receiver operating characteristics curve was IgG2 enzyme-linked immunosorbent assay (ELISA). Thus, according to the gold standard used, IFAT and qPCR are far from fulfilling the requirements to be considered gold standards, and the test showing the highest potential to detect Leishmania infection is Leishmania-specific ELISA IgG2.
尚无用于诊断利什曼病的金标准。我们的目的是使用来自实验感染的样本评估检测利什曼原虫感染的检测方法的手术有效性，这是对经典金标准定义的可靠等效方法。没有统计学差异时，蛋白 A（ProtA）、免疫球蛋白（Ig）G2、间接荧光抗体试验（IFAT）、淋巴细胞增殖试验、骨髓实时定量聚合酶链反应（qPCR-BM）、qPCR-血液和 IgG 的灵敏度最高；IgG1、IgM、IgA、qPCR-血液、IgG、IgG2 和 qPCR-BM 的特异性最高。IgG2、qPCR-血液和 IgG 同时获得最高的阳性预测值；qPCR-BM 获得最高的阴性预测值。IgG2 的阳性和阴性似然比最佳。在接受者操作特征曲线下面积最大且具有统计学意义的检测方法是 IgG2 酶联免疫吸附试验（ELISA）。因此，根据使用的金标准，IFAT 和 qPCR 远未达到被认为是金标准的要求，而最有潜力检测利什曼原虫感染的检测方法是利什曼原虫特异性 IgG2 ELISA。
