Evidence map›Paper›PMID 40035587›Full record

ArticleMicrobiology spectrum2025

The development and validation of a microneutralization assay for the detection and quantification of anti-yellow fever virus antibodies in human serum.

Katherine Fries, Ping Luo, Rebekah Baldwin, Raechel Goldberg, Ivan Ordonez, Lingyi Zheng, James Huleatt, Louis Devlin

Abstract readValidation Study
In one paragraph

Article in Microbiology spectrum, 2025. 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

8 authors.

Katherine FriesGlobal Clinical Immunology, Sanofi, Swiftwater, Pennsylvania, USA.ORCID 0009-0006-9060-2938
Ping LuoGlobal Clinical Immunology, Sanofi, Swiftwater, Pennsylvania, USA.
Rebekah BaldwinGlobal Clinical Immunology, Sanofi, Swiftwater, Pennsylvania, USA.
Raechel GoldbergGlobal Clinical Immunology, Sanofi, Swiftwater, Pennsylvania, USA.
Ivan OrdonezTranslational and Early Development Biostatistics, Sanofi, Orlando, Florida, USA.
Lingyi ZhengTranslational and Early Development Biostatistics, Sanofi, Swiftwater, Pennsylvania, USA.
James HuleattGlobal Clinical Immunology, Sanofi, Swiftwater, Pennsylvania, USA.
Louis DevlinGlobal Clinical Immunology, Sanofi, Swiftwater, Pennsylvania, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The plaque reduction neutralization test (PRNT) has been used widely for the detection and quantitation of yellow fever (YF) virus-neutralizing antibodies in human serum; however, it is labor-intensive and challenging to adapt to high-throughput clinical testing needed for vaccine licensure. Here, we describe the development and validation of a new Vero cell-based YF microneutralization (MN) assay, with immunostaining readout, for the detection and quantification of YF virus-neutralizing antibodies in human serum. Comparison of neutralizing antibody titers measured with the YF MN assay versus the historical YF PRNT, based on a 50% reduction in plaque counts (PRNT IMPORTANCE: With increased globalization and shifting climate patterns, yellow fever (YF) is re-emerging as a global threat. At present, vaccination remains the most effective prevention strategy. This study describes the development and validation of a new YF microneutralization (MN) assay for the detection and quantification of YF virus-neutralizing antibodies in human serum that offers increased throughput compared with the current standard assay. Overall, the YF MN assay demonstrated acceptable intra-assay precision (repeatability), intermediate precision, dilutional accuracy, linearity, and specificity and is suitable for the detection of YF virus-neutralizing antibodies. Further, the Center for Biologics Evaluation and Research (CBER) supports the use of the YF MN assay in the licensure of candidate YF vaccines.

Indexed as

Antibodies, NeutralizingAntibodies, ViralNeutralization TestsYellow FeverYellow fever virusAnimalsChlorocebus aethiopsHumansReproducibility of ResultsSensitivity and SpecificityVero CellsAntibodies, NeutralizingAntibodies, Viralassay developmentassay validationmicroneutralization assayneutralizing antibodiesorthoflavivirusyellow fever virus

Identifiers

PMID40035587
PMCPMC11960057

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Registered trials

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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.