Diagnostic tests for Nipah virus: A landscape analysis

Area of Science:

• Virology
• Infectious Diseases
• Diagnostic Development

Background:

• Nipah virus (NiV) is an emerging pathogen with high fatality.
• The WHO identified a critical need for validated point-of-care (POC) NiV diagnostic tests.
• Existing diagnostic gaps for NiV remain a significant concern.

Purpose of the Study:

• To assess the current landscape of Nipah virus (NiV) diagnostics.
• To identify available commercial NiV tests and those in development.
• To determine if the diagnostic gaps highlighted by the WHO persist.

Main Methods:

• Searched diagnostic databases, news platforms, and manufacturer communications for commercial NiV tests.
• Conducted a literature search for non-commercial NiV tests, including molecular assays and immunoassays.
• Included supportive protocols like field-appropriate sample inactivation.

Main Results:

• Identified 43 commercial NiV tests, with only six holding national regulatory approval.
• Found limited point-of-care (POC) options: three near-POC molecular tests and one true POC lateral flow assay.
• Literature search revealed 23 test development/validation studies and nine novel POC prototype developments with limited performance data.

Conclusions:

• Few commercial Nipah virus (NiV) diagnostic tests are available, particularly for POC use in remote, endemic areas.
• Significant need exists for validated and regulated NiV diagnostic solutions.
• Further evaluation and validation of NiV tests with POC potential are required to bridge the existing gap.