Target product profiles for new diagnostics to inform strongyloidiasis control programs.

Area of Science:

• Medical Diagnostics
• Parasitology
• Public Health

Background:

• The World Health Organization emphasizes the need for new diagnostics to support strongyloidiasis deworming programs.
• Target Product Profiles (TPPs) are crucial for guiding research and development (R&D) of new diagnostics.
• Currently, diagnostic TPPs are lacking for strongyloidiasis, unlike other soil-transmitted helminthiases.

Purpose of the Study:

• To establish minimal requirements for new strongyloidiasis diagnostics by investigating potential Target Product Profiles (TPPs).
• To assess the impact of diagnostic performance, cost, and throughput on program decision-making and survey costs.
• To compare the cost-efficiency of different diagnostic platforms and survey designs for strongyloidiasis control.

Main Methods:

• Utilized a simulation framework to evaluate the effect of imperfect diagnostics on program costs and decisions.
• Investigated requirements for diagnostic performance, cost per test, and sample throughput for future assays.
• Compared survey costs of potential assays (antibody-detecting assays, lateral flow assay (LFA), Ab-ELISA) against the reference Baermann method.
• Determined cost-efficient school-based survey designs for Bordier Ab-ELISA and a prototype NIE-LFA.

Main Results:

• Assay specificity is more critical than sensitivity for R&D in diagnostic methods for control programs.
• Diagnostic performance requirements became less stringent with larger sample sizes and higher acceptance of incorrect decision-making.
• Lateral flow assays (LFAs) demonstrated lower survey costs compared to the Baermann method.
• The prototype NIE-LFA facilitated the most cost-efficient survey designs among the evaluated assays.

Conclusions:

• Future R&D should prioritize the development of point-of-care assays with high specificity for strongyloidiasis.
• The prototype NIE-LFA presents a cost-effective alternative to the Baermann method, supporting strongyloidiasis control programs.