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Abstract：
The current study developed and evaluated the performance of a urine-based enzyme-linked immunosorbent assay (ELISA) for the screening of Schistosoma japonicum infection in a human cohort (n = 412) recruited from endemic areas, Northern Samar, the Philippines. The diagnostic performance of the urine ELISA assay was further compared with the Kato-Katz (KK) technique, serum-based ELISA assays, point-of-care circulating cathodic antigen (POC-CCA) urine cassette test, and droplet digital (dd)PCR assays performed on feces, serum, urine, and saliva samples, which were designated as F_ddPCR, SR_ddPCR, U_ddPCR, and SL_ddPCR, respectively. When urine samples concentrated 16× were assessed, the SjSAP4 + Sj23-LHD-ELISA (U) showed sensitivity/specificity values of 47.2/93.8% for the detection of S. japonicum infection in KK-positive individuals (n = 108). The prevalence of S. japonicum infection in the total cohort determined by the urine ELISA assay was 48.8%, which was lower than that obtained with the F_ddPCR (74.5%, p < 0.001), SR_ddPCR (67.2%, p < 0.001), and SjSAP4 + Sj23-LHD-ELISA (S) (66.0%, p < 0.001), but higher than that determined by the Sj23-LHD-ELISA (S) (24.5%, p < 0.001), POC-CCA assay (12.4%, p < 0.001), and SL_ddPCR (25.5%, p < 0.001). Using the other diagnostic tests as a reference, the urine ELISA assay showed a sensitivity between 47.2 and 56.9%, a specificity between 50.7 and 55.2%, and an accuracy between 49.3 and 53.4%. The concentrated urine SjSAP4 + Sj23-LHD-ELISA developed in the current study was more sensitive than both the KK test and POC-CCA assay, and showed a comparable level of diagnostic accuracy to that of the U_ddPCR. However, its diagnostic performance was less robust than that of the F_ddPCR, SR_ddPCR, and SjSAP4 + Sj23-LHD-ELISA (S) assays. Although they are convenient and involve a highly acceptable non-invasive procedure for clinical sample collection, the insufficient sensitivity of the three urine-based assays (the urine ELISA assay, the U_ddPCR test, and the POC-CCA assay) will limit their value for the routine screening of schistosomiasis japonica in the post mass drug administration (MDA) era, where low-intensity infections are predominant in many endemic areas.
摘要：
当前的研究开发并评估了基于尿液的酶联免疫吸附测定（ELISA）的性能，以筛查从流行地区招募的人类队列（n=412）中的日本血吸虫感染，北萨马尔,菲律宾。尿液ELISA测定的诊断性能进一步与Kato-Katz（KK）技术进行比较，基于血清的ELISA测定，即时循环阴极抗原（POC-CCA）尿盒测试，以及对粪便进行液滴数字（dd）PCR分析，血清,尿液,还有唾液样本,被指定为F_ddPCR，SR_ddPCR,U_ddPCR,和SL_ddPCR，分别。当尿液样本浓缩16倍进行评估时，SjSAP4+Sj23-LHD-ELISA(U)在KK阳性个体(n=108)中检测日本血吸虫感染的敏感性/特异性值为47.2/93.8%.通过尿液ELISA测定法确定的总队列中日本血吸虫感染的患病率为48.8％，低于F_ddPCR获得的(74.5%，p<0.001)，SR_ddPCR(67.2%，p<0.001)，和SjSAP4+Sj23-LHD-ELISA（S）（66.0％，p<0.001)，但高于Sj23-LHD-ELISA（S）（24.5%，p<0.001)，POC-CCA测定(12.4%，p<0.001)，和SL_ddPCR(25.5%，p<0.001)。使用其他诊断测试作为参考，尿液ELISA检测显示灵敏度在47.2和56.9％之间，特异性在50.7%至55.2%之间，准确率在49.3%到53.4%之间。本研究中开发的浓缩尿液SjSAP4Sj23-LHD-ELISA比KK测试和POC-CCA测定更敏感，并显示出与U_ddPCR相当的诊断准确性水平。然而,其诊断性能不如F_ddPCR，SR_ddPCR,和SjSAP4+Sj23-LHD-ELISA(S)测定。尽管它们很方便，并且涉及高度可接受的非侵入性临床样本收集程序，三种基于尿液的检测方法(尿液ELISA检测，U_ddPCR测试，和POC-CCA测定）将限制它们在大规模用药（MDA）时代常规筛查日本血吸虫病的价值，在许多流行地区，低强度感染占主导地位。
