Accuracy of a new rapid diagnostic test for urinary antigen detection and assessment of drug treatment in opisthorchiasis  

作　　者：Chanika Worasith Jiraporn Sithithaworn Phattharaphon Wongphutorn Chutima Homwong Kanoknan Khongsukwiwat Anchalee Techasen Kulthida Y.Kopolrat Watcharin Loilome Nisana Namwat Bandit Thinkamrop Chaiwat Tawarungruang Attapol Titapun Thewarach Laha Ross H.Andrews Simon D.Taylor‑Robinson Paiboon Sithithaworn 

机构地区：[1]Department of Adult Nursing,Faculty of Nursing,Khon Kaen University,Khon Kaen,Thailand [2]Cholangiocarcinoma Research Institute,Khon Kaen University,Khon Kaen,Thailand [3]Faculty of Associated Medical Sciences,Khon Kaen University,Khon Kaen,Thailand [4]Biomedical Science Program,Graduate School,Khon Kaen University,Khon Kaen,Thailand [5]Faculty of Public Health,Kasetsart University Chalermphrakiat Sakon Nakhon Province Campus,Sakon Nakhon,Thailand [6]Department of Systems Biosciences and Computational Medicine,Faculty of Medicine,Khon Kaen University,Khon Kaen,Thailand [7]Khon Kaen University Phenome Centre,Khon Kaen University,Khon Kaen,Thailand [8]Department of Epidemiology and Biostatistics,Faculty of Public Health,Khon Kaen University,Khon Kaen,Thailand [9]Department of Surgery,Faculty of Medicine,Khon Kaen University,Khon Kaen,Thailand [10]Depart‑ment of Parasitology,Faculty of Medicine,Khon Kaen University,Khon Kaen,Thailand [11]Faculty of Medicine,St Mary’s Campus,Imperial College London,London,UK [12]Division of Digestive Health,Department of Surgery and Can‑cer,Imperial College London,London,UK

出　　处：《Infectious Diseases of Poverty》2023年第6期79-90,共12页贫困所致传染病（英文）

基　　金：supported by the Cholangiocarcinoma Research Institute,Khon Kaen University,Thailand.This project is funded by the National Science Research Council of Thailand(NRCT)the Post-Doctoral Training Program from Khon Kaen University,Thailand(PD2565-02-01);supported by the Thailand Centre of Excellence for Life Sciences(TCELS);SDT-R was funded by the Wellcome Trust ISSF grant at Imperial College London.

摘　　要：Background 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.Methods A urinaryOpisthorchis 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 withO.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.Results 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 ofO.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

关 键 词：Liver fluke Opisthorchis viverrini Urinary antigen detection Urinary Opisthorchis viverrini rapid diagnosis test Enzyme-linked immunosorbent assay Quantitative formalin-ethyl acetate concentration technique 

分 类 号：R532.15[医药卫生—内科学]