Evidence map›Paper›PMID 41910272›Full record

ArticleJournal of clinical microbiology2026

Development of a broad-lineage Lassa virus rapid diagnostic test informed by the WHO REASSURED framework.

Hwachul Shin, Minji Lee, Myung-Min Choi, Jin-Won Kim, Hwajung Yi, Shannon Whitmer, Leanna Sayyad, Joel Montgomery, John Klena, Yoon-Seok Chung

Abstract readEvaluation Study
In one paragraph

Article in Journal of clinical microbiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Hwachul Shin *Division of High-risk Pathogen, Korea Disease Control and Prevention Agency (KDCA), Cheongju, Republic of Korea.ORCID 0000-0002-2479-973X
Minji Lee *Division of High-risk Pathogen, Korea Disease Control and Prevention Agency (KDCA), Cheongju, Republic of Korea.ORCID 0000-0003-4356-0051
Myung-Min ChoiDivision of Laboratory Diagnosis and Analysis, Gyeongnam Regional Center for Disease Control and Prevention, Busan, Republic of Korea.ORCID 0000-0002-7242-297X
Jin-Won KimDivision of High-risk Pathogen, Korea Disease Control and Prevention Agency (KDCA), Cheongju, Republic of Korea.
Hwajung YiDivision of High-risk Pathogen, Korea Disease Control and Prevention Agency (KDCA), Cheongju, Republic of Korea.ORCID 0000-0001-9381-0616
Shannon WhitmerViral Special Pathogens Branch, US Centers for Disease Control and Prevention Research Centers, Atlanta, Georgia, USA.ORCID 0000-0002-0819-6736
Leanna SayyadViral Special Pathogens Branch, US Centers for Disease Control and Prevention Research Centers, Atlanta, Georgia, USA.ORCID 0000-0003-4487-9080
Joel MontgomeryViral Special Pathogens Branch, US Centers for Disease Control and Prevention Research Centers, Atlanta, Georgia, USA.ORCID 0000-0003-0523-4431
John KlenaViral Special Pathogens Branch, US Centers for Disease Control and Prevention Research Centers, Atlanta, Georgia, USA.ORCID 0000-0001-9933-6193
Yoon-Seok ChungDivision of High-risk Pathogen, Korea Disease Control and Prevention Agency (KDCA), Cheongju, Republic of Korea.ORCID 0000-0003-4562-5533

Funding

Korea Disease Control and Prevention Agency 6331--301-210-13
6 · The paper itself

Abstract

Lassa fever is a high-risk viral disease endemic to West Africa for which rapid and reliable diagnosis is essential for outbreak control. Here, we describe the development of a lateral flow-based rapid diagnostic test (RDT) targeting the Lassa virus nucleoprotein using newly generated monoclonal antibody pairs. The analytical performance of the assay was evaluated using human serum and plasma specimens as well as inactivated Lassa virus strains and compared with a commercially available antigen test. The final RDT (Pair 2; 1P-44-7/9B-28) demonstrated high analytical sensitivity and 100% specificity across 60 human samples and detected multiple genetically diverse Lassa virus strains, with lineage-dependent differences in analytical sensitivity. In direct analytical comparisons using recombinant antigen, the assay was approximately 64-fold more sensitive than the ReLASV Pan-Lassa Antigen Rapid Test. The RDT provides a rapid visual readout, remains stable at ambient temperatures, and is suitable for decentralized testing workflows, features aligned with key aspects of the World Health Organization (WHO) REASSURED framework. These results indicate that the developed RDT offers a robust and broadly reactive platform for Lassa virus antigen detection and has potential utility for surveillance and outbreak response in resource-limited settings.IMPORTANCELassa fever remains a significant public health concern in West Africa, where diagnostic capacity is often limited in endemic regions. This study describes the development of a broad-lineage Lassa virus rapid diagnostic test informed by the World Health Organization (WHO) REASSURED framework. The assay demonstrates high analytical sensitivity and broad lineage coverage in a field-deployable format, supporting its potential utility for early case detection and decentralized surveillance in endemic settings.

Indexed as

Lassa FeverLassa virusRapid Diagnostic TestsAfrica, WesternAntibodies, MonoclonalAntibodies, ViralAntigens, ViralHumansNucleoproteinsSensitivity and SpecificityWorld Health OrganizationAntibodies, MonoclonalAntibodies, ViralAntigens, ViralNucleoproteinsantibodyantigenLassa virusrapid diagnostic testREASSURED

Identifiers

PMID41910272
PMCPMC13170227

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.