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Multiplexed Isothermal Amplification Based Diagnostic Platform to Detect Zika, Chikungunya, and Dengue 1

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Diagnostic tests for Nipah virus: A landscape analysis.

Laura Mazzola¹, Hanesh Chi Fru¹, Dounia Cherkaoui¹

¹FIND, Geneva, Switzerland.

Diagnostic Microbiology and Infectious Disease

|September 13, 2025

Summary

Limited Nipah virus (NiV) diagnostic tests are available, especially for point-of-care (POC) use in endemic regions. Further validation of developing NiV diagnostic tests is crucial to address this gap.

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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.