Evidence map›Paper›PMID 41436454›Full record

ArticleNPJ vaccines2025

Evaluation of high-throughput sequencing for replacing the conventional adventitious virus detection assays used for biologics.

Pei-Ju Chin, Jen-Hui Tsou, Alison Armstrong, Noémie Deneyer, Valeria Zanda, Sophie Ayama-Canden, Anne-Sophie Colinet, Sandra M Fuentes, Nikolay Korokhov, Christophe Lambert and 8 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in NPJ vaccines, 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. Article
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

18 authors.

Pei-Ju Chin *Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Jen-Hui Tsou *Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Alison Armstrong *Millipore Sigma, Rockville, MD, USA.
Noémie Deneyer *GSK, Wavre, Wavre, Belgium.
Valeria Zanda *EMD Serono RBM S.p.A. Istituto di Ricerche Biomediche A. Marxer, Via Ribes 1 10010 Colleretto Giacosa, Italy, an affiliate of Merck KGaA, Darmstadt, Germany.
Sophie Ayama-CandenAkkodis Belgium c/o GSK, Evere, 1140, Belgium.
Anne-Sophie ColinetGSK, Rixensart, Rixensart, Belgium.
Sandra M FuentesDivision of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Nikolay KorokhovMillipore Sigma, Rockville, MD, USA.
Christophe LambertGSK, Rixensart, Rixensart, Belgium.
Alfonso LavorgnaMillipore Sigma, Rockville, MD, USA.
Manuel NollAkkodis Belgium c/o GSK, Evere, 1140, Belgium.
Simone OlgiatiEMD Serono RBM S.p.A. Istituto di Ricerche Biomediche A. Marxer, Via Ribes 1 10010 Colleretto Giacosa, Italy, an affiliate of Merck KGaA, Darmstadt, Germany.
Michel ProtzGSK, Rixensart, Rixensart, Belgium.
Shahjahan ShaidGSK Marburg, Marburg, Germany.
Afshin SohrabiMillipore Sigma, Rockville, MD, USA.
Mary WhitemanMillipore Sigma, Rockville, MD, USA.
Arifa S KhanDivision of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. arifa.khan@fda.hhs.gov.

Funding

National Institute for Innovation in Manufacturing Biopharmaceuticals/Gates Foundation OPP1204996
6 · The paper itself

Abstract

High-throughput sequencing (HTS) can detect known and novel adventitious viruses in biological materials that might be missed by the conventional in vitro and in vivo assays. We compared HTS with the conventional assays using the same sample preparation of CHO cell harvest spiked with human respiratory syncytial virus (RSV) and mammalian orthoreovirus (Reo1). The viruses were selected with the expectation that one would produce a positive result in each test. The study results indicated both RSV and Reo1 were detected by HTS and in vitro assays, albeit with inter-assay and intra-lab differences in sensitivity of virus detection, and only Reo1 was detected by the in vivo assays. The results support using HTS to replace the in vivo assays. Additionally, based on capabilities of HTS for non-targeted virus detection, it may supplement or replace the in vitro assays. The study further highlighted that the analytical sensitivity of HTS can be improved.

Identifiers

PMID41436454
PMCPMC12847995

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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.