Onchocerciasis TestPlus (OT+) Review of the evidence package submited to the WHO Expert Review Panel for Diagnostic. Meeting of the TAG Onchocerciasis Subgroup 27 August 2026

Overview

This report records the advice of the Onchocerciasis Subgroup of the WHO Diagnostic Technical Advisory Group (DTAG) to WHO, based on the developer’s presentation of its evidence package. It is not the report of the WHO Expert Review Panel for Diagnostics (ERPD). The ERPD assessment of the OT+ dossier is a separate process, conducted in parallel by independent reviewers, and its outcome is not known at the time of writing. Nothing in this report anticipates or replaces the ERPD decision, and this report does not constitute WHO guidance or a WHO position on the product.

The OV DTAG subgroup met on 27 August 2026 to review the Onchocerciasis Test Plus (OT+), a lateral-flow rapid diagnostic test developed by Drugs & Diagnostics for Tropical Diseases (DDTD) that detects IgG4 antibodies to three Onchocerca volvulus antigens across two test lines. The developer submitted a dossier to the WHO Expert Review Panel for Diagnostics (ERPD) in late July 2026, claiming a single intended use: onchocerciasis elimination mapping (OEM), as a research-use-only (RUO) test on capillary whole blood and dried blood spots (DBS).