Diagnostic tests for Nipah virus: A landscape analysis

Introduction: Nipah virus (NiV) is an emerging human pathogen with a high case fatality rate. The World Health Organization research and development roadmap for NiV published in 2019 highlighted a lack of validated and regulated Nipah virus (NiV) diagnostic tests, particularly those that can be used at the point of care (POC). This analysis assessed the current landscape of NiV diagnostics, including commercial tests and tests in development, to determine whether these gaps remain.

Methods: Commercial tests for NiV diagnosis were identified through searches of diagnostic databases and news platforms, targeted internet queries, and email exchanges with manufacturers. Non-commercial tests were identified through a literature search. Molecular tests, immunoassays and supportive protocols such as field-appropriate sample inactivation were included.

Results: We identified 43 commercial NiV tests. Only six tests had national regulatory approval. Three molecular tests were designed for near POC and one lateral flow assay for true POC testing. Twenty-eight publications were identified by the literature search, of which 23 described test development and/or validation, three were independent evaluations or external quality assurance studies, and two were NiV inactivation protocols. Nine publications reported novel POC prototype development, of which seven were molecular assays, one an antigen test, and one a ribozyme biosensor. Clinical performance data on these prototypes were limited.

Conclusions: Few commercial tests for NiV are available, especially POC tests suitable for use in remote settings where the virus is endemic. To address this gap, further evaluation and validation of tests in development with POC potential is required.