Article Text
Abstract
Background Although the Alere Filariasis Test Strip (FTS) is recommended for surveillance and monitoring of Wuchereria bancrofti infection, the performance characteristics of this tool in post-treatment settings have not been established. To determine the accuracy of the FTS in effectively monitoring treatment of bancroftian infection, we investigated the sensitivity of the test in detecting different subgroups of asymptomatic adult worm-infected individuals at pre-treatment and post-treatment and the specificity of the test in detecting treatment success following therapy.
Methods Plasma samples obtained from the same cohort of individuals (n = 143) with known adult worm and microfilariae (Mf) burdens at pre-treatment and 24 months post-treatment were used. The sensitivity of the FTS was assessed for the detection of microfilaremic and amicrofilaremic subgroups of adult worm-infected individuals at both time points. The post-treatment specificity of the test was assessed in those who cleared both adult worm and Mf burdens 24 months following doxycycline treatment. Seventy-one samples from W. bancrofti-uninfected individuals living in the same endemic areas were also analyzed.
Results The FTS showed significantly greater sensitivity for the detection of microfilaremic adult worm-infected individuals (pre-treatment = 100%; 24 months post-treatment = 95.8%) than amicrofilaremic adult worm-infected individuals (pre-treatment = 65.8%; 24 months post-treatment = 52.2%). The FTS’s specificity for successfully treated individuals at 24 months post-treatment was 73.0% (CI = 62.58–81.90), which was significantly less than the specificity of the test for uninfected individuals (95.8%, CI = 88.14–99.12).
Conclusion From our results, the FTS does not satisfy the WHO’s minimum diagnostic requirements of 85% sensitivity and 98.8% specificity for identifying amicrofilaremic adult worm-infected individuals and successfully treated individuals at 24 months post-treatment, respectively. Our study highlights the need for high-quality diagnostic tools to provide a more precise endpoint infection threshold and accelerate the achievement of the global elimination target for 2030.