Department of Adult Nursing, Faculty of Nursing, Khon Kaen University, Khon Kaen, Thailand.
Cholangiocarcinoma Research Institute, Khon Kaen University, Khon Kaen, Thailand.
Infect Dis Poverty. 2023 Nov 21;12(1):102. doi: 10.1186/s40249-023-01162-4.
Screening for opisthorchiasis, a parasitic worm infection affecting many millions of people in Southeast Asia, has traditionally relied on faecal egg examination such as the formalin-ethyl acetate concentration technique (FECT) and Kato-Katz method. Although the urinary enzyme-linked immunosorbent assay (ELISA) has been used more recently, we developed a urinary antigen-based rapid diagnostic test (RDT) to simplify diagnosis and as a point-of-care testing (POCT) and field applications for surveillance and control of opisthorchiasis.
A urinary Opisthorchis viverrini (OV)-RDT was developed using immunochromatographic methodology with a specific monoclonal antibody against OV. The diagnostic performance of the urinary OV-RDT was compared to that of quantitative faecal FECT and urinary antigen ELISA (n = 493). Cross-reactivities of urinary OV-RDT with other helminthiases coexisted with O. viverrini were determined (n = 96). A field trial in the application of urinary OV-RDT was compared with urinary antigen ELISA at baseline screening and assessment of drug treatment outcomes in opisthorchiasis (n = 1629). The McNemar chi-square, Kruskal-Wallis and Cohen's kappa coefficient (κ-value) tests were used for statistical analyses.
Urinary OV-RDT had sensitivity of 94.2% and specificity of 93.2%, compared to faecal FECT. Urinary OV-RDT had high diagnostic agreement (Kappa = 0.842-0.874, P < 0.001) and quantitative correlation with urinary antigen ELISA (Kruskal-Wallis tests = 316.2, P < 0.0001) and faecal FECT (Kruskal-Wallis tests = 362.3, P < 0.0001). The positive rates by OV-RDT, ELISA and FECT were 48.9%, 52.5% and 49.3%, respectively. Cross-reactions of urinary OV-RDT with other helminthiases were few (2%). Field trials of urinary OV-RDT yielded comparable prevalence of O. viverrini between urinary OV-RDT (53.2%) and urinary antigen ELISA (54.0%). OV screening showed high diagnostic agreement (kappa > 0.8, P < 0.0001) between urinary OV-RDT and urinary antigen ELISA. The cure rates of opisthorchiasis at 1 month post-praziquantel treatment determined by urinary OV-RDT (86.6%) and urinary antigen ELISA (80.5%) were similar (P > 0.05).
The urinary OV-RDT test has high potential as a new tool for screening and evaluating treatment outcomes in opisthorchiasis. The ease of sample collection and simplicity of urinary OV-RDT may facilitate mass screening, control and elimination of opisthorchiasis, thereby contributing to a reduction in the disease burden in Southeast Asia.
在东南亚，数以百万计的人感染了寄生虫性蠕虫病——华支睾吸虫病，传统的筛查方法一直依赖粪便虫卵检查，如甲醛-乙醚浓缩技术（FECT）和加藤厚涂片法。尽管最近已经使用了尿液酶联免疫吸附试验（ELISA），但我们开发了一种基于尿液抗原的快速诊断检测（RDT），以简化诊断，并作为一种即时检测（POCT）和现场应用，用于监测和控制华支睾吸虫病。
采用免疫层析法，用针对华支睾吸虫的特异性单克隆抗体，开发了一种尿液华支睾吸虫（OV）-RDT。比较了尿液 OV-RDT 与定量粪便 FECT 和尿液抗原 ELISA 的诊断性能（n=493）。用尿液 OV-RDT 检测了与华支睾吸虫并存的其他几种寄生虫病的交叉反应性（n=96）。在华支睾吸虫病的基线筛查和药物治疗效果评估中，比较了现场应用尿液 OV-RDT 与尿液抗原 ELISA（n=1629）。统计分析采用 McNemar 卡方检验、Kruskal-Wallis 检验和 Cohen's kappa 系数（κ 值）。
与粪便 FECT 相比，尿液 OV-RDT 的灵敏度为 94.2%，特异性为 93.2%。尿液 OV-RDT 具有较高的诊断一致性（Kappa=0.842-0.874，P<0.001），与尿液抗原 ELISA（Kruskal-Wallis 检验=316.2，P<0.0001）和粪便 FECT（Kruskal-Wallis 检验=362.3，P<0.0001）具有高度定量相关性。OV-RDT、ELISA 和 FECT 的阳性率分别为 48.9%、52.5%和 49.3%。尿液 OV-RDT 与其他寄生虫病的交叉反应较少（2%）。尿液 OV-RDT 的现场试验结果显示，华支睾吸虫的流行率与尿液 OV-RDT（53.2%）和尿液抗原 ELISA（54.0%）相当。OV 筛查显示，尿液 OV-RDT 和尿液抗原 ELISA 之间的诊断一致性很高（kappa>0.8，P<0.0001）。在吡喹酮治疗 1 个月后，尿液 OV-RDT（86.6%）和尿液抗原 ELISA（80.5%）的华支睾吸虫病治愈率相似（P>0.05）。
尿液 OV-RDT 检测具有很大的潜力，可作为筛查和评估华支睾吸虫病治疗效果的新工具。尿液样本采集的简便性和尿液 OV-RDT 的简单性可能有助于大规模筛查、控制和消除华支睾吸虫病，从而有助于减轻东南亚地区的疾病负担。
