Evidence map›Paper›PMID 40155393›Full record

ArticleNPJ vaccines2025

Virus detection by short read high throughput sequencing in a high virus low cellular background.

Pei-Ju Chin, Christophe Lambert, Pascale Beurdelay, Robert L Charlebois, Anne-Sophie Colinet, Marc Eloit, Shanaz Gilchrist, Maria Gilleece, Matthew Hess, Andreas Leimbach and 5 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. 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

15 authors.

Pei-Ju Chin *Office of Vaccines Research and Review, Center for Biologics Evaluation and Review, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.
Christophe Lambert *GSK, Rue de l'Institut 89, Rixensart, Belgium.
Pascale BeurdelayPathoQuest, 11 rue Watt, Paris, France.
Robert L CharleboisSanofi, 1755 Steeles Avenue West, Toronto, ON, Canada.
Anne-Sophie ColinetGSK, Rue de l'Institut 89, Rixensart, Belgium.
Marc EloitPathoQuest, 11 rue Watt, Paris, France.
Shanaz GilchristSanofi, 1755 Steeles Avenue West, Toronto, ON, Canada.
Maria GilleeceBiogen 5000 Davis Drive, Durham, NC, USA.
Matthew HessBiogen 5000 Davis Drive, Durham, NC, USA.
Andreas LeimbachEurofins Genomics Europe Pharma and Diagnostics Products & Services Sanger/PCR GmbH, Konstanz, Germany.
Tom J B de ManMilliporeSigma, Rockville, MD, USA.
Olivier VandeputteGSK, Rue de l'Institut 89, Rixensart, Belgium.
Dawid WalasMilliporeSigma, Rockville, MD, USA.
Weihong WangEurofins Lancaster Laboratories, Inc, Lancaster, PA, USA.
Arifa S KhanOffice of Vaccines Research and Review, Center for Biologics Evaluation and Review, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA. arifa.khan@fda.hhs.gov.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The safety of all biological products includes demonstrating the absence of adventitious viruses by testing various types of samples at different stages of the manufacturing process. Seven laboratories evaluated short-read high-throughput sequencing (HTS) for sensitivity and breadth of adventitious virus detection using viruses with distinct physicochemical and genome properties. These five viruses are currently designated as CBER NGS Virus Reagents and include: Epstein-Barr virus (EBV; or human herpes virus 4), feline leukemia virus (FeLV), respiratory syncytial virus (RSV), mammalian orthoreovirus type 1 (Reo1), and porcine circovirus type 1 (PCV1). To evaluate adventitious virus detection in a biological material with a high production virus titer and low cellular background, the 5 viruses were mixed and different copies of the viral genomes spiked into 1 - 5 × 10

Identifiers

PMID40155393
PMCPMC11953420

What OpenQuestion holds

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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.