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

• Published in: Infectious diseases of poverty Vol. 12; no. 1; pp. 102 - 12
• Main Authors: Worasith, Chanika, Sithithaworn, Jiraporn, Wongphutorn, Phattharaphon, Homwong, Chutima, Khongsukwiwat, Kanoknan, Techasen, Anchalee, Kopolrat, Kulthida Y., Loilome, Watcharin, Namwat, Nisana, Thinkamrop, Bandit, Tawarungruang, Chaiwat, Titapun, Attapol, Laha, Thewarach, Andrews, Ross H., Taylor-Robinson, Simon D., Sithithaworn, Paiboon
• Format: Journal Article
• Language: English
• Published: London BioMed Central 21.11.2023; BioMed Central Ltd; BMC
• Subjects: Acetates; Analysis; Animals; Antigen-antibody reactions; Antigens; Clinical outcomes; Diagnostic tests; Eggs; Enzyme-linked immunosorbent assay; Enzymes; Esters; Fluke infections; Formaldehyde; Health aspects; Humans; Immunization; Infections; Infectious Diseases; Laboratory animals; Liver fluke; Medical diagnosis; Medical screening; Medicine; Medicine & Public Health; Methods; Monoclonal antibodies; Opisthorchiasis - diagnosis; Opisthorchiasis - drug therapy; Opisthorchiasis - epidemiology; Opisthorchis; Opisthorchis viverrini; Performance evaluation; Polyethylene glycol; Praziquantel - therapeutic use; Public Health; Quantitative analysis; Quantitative formalin-ethyl acetate concentration technique; Rapid Diagnostic Tests; Research Article; Sensitivity and Specificity; Statistical analysis; Thailand - epidemiology; Tropical diseases; Tropical Medicine; Urinary antigen detection; Urinary Opisthorchis viverrini rapid diagnosis test; Urine; Thailand; Southeast Asia; St Louis Missouri; United States > US; Quantitative formalin-ethyl acetate concentration technique; Urinary antigen detection; Urinary; Enzyme-linked immunosorbent assay; Liver fluke; rapid diagnosis test; Urinary Opisthorchis viverrini rapid diagnosis test; Opisthorchis viverrini
• ISSN: 2049-9957; 2095-5162; 2049-9957
• DOI: 10.1186/s40249-023-01162-4

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 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. 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 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). Conclusions 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. Graphical Abstract