Infectious Diseases of Poverty (Nov 2023)

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

  • 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

DOI
https://doi.org/10.1186/s40249-023-01162-4
Journal volume & issue
Vol. 12, no. 1
pp. 1 – 12

Abstract

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Abstract 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 0.8, 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

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