Evidence map›Paper›PMID 26709640›Full record

ArticleVaccine2016

Development of a candidate reference material for adventitious virus detection in vaccine and biologicals manufacturing by deep sequencing.

Edward T Mee, Mark D Preston, Philip D Minor, Silke Schepelmann, CS533 Study Participants

Abstract read
In one paragraph

Article in Vaccine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing 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

21 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. High-throughput Sequencing in Vaccine Research.Journal of veterinary research · 2021
    Article
  5. Implementation of next-generation sequencing for virus identification in veterinary diagnostic laboratories.Journal of veterinary diagnostic investigation : official publication of the American Association of Veterinary Laboratory Diagnosticians, Inc · 2021
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
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  12. Article
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  15. Article
  16. Viral Surveillance in Serum Samples From Patients With Acute Liver Failure By Metagenomic Next-Generation Sequencing.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017
    Article
  17. Article
  18. Article
  19. Generic Amplicon Deep Sequencing to DetermineFrontiers in microbiology · 2017
    Article
  20. 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

5 authors.

Edward T MeeDivision of Virology, National Institute for Biological Standards and Control, Medicines and Healthcare Products Regulatory Agency, South Mimms, Hertfordshire EN6 3QG, United Kingdom. Electronic address: edward.mee@nibsc.org.
Mark D PrestonDivision of Technology, Development and Infrastructure, National Institute for Biological Standards and Control, Medicines and Healthcare Products Regulatory Agency, South Mimms, Hertfordshire EN6 3QG, United Kingdom.
Philip D MinorDivision of Virology, National Institute for Biological Standards and Control, Medicines and Healthcare Products Regulatory Agency, South Mimms, Hertfordshire EN6 3QG, United Kingdom.
Silke SchepelmannDivision of Virology, National Institute for Biological Standards and Control, Medicines and Healthcare Products Regulatory Agency, South Mimms, Hertfordshire EN6 3QG, United Kingdom.
CS533 Study Participants

Funding

Metagenomic detection of emerging viruses in the blood supplyR01HL105770 · NHLBI · VITALANT · PI DELWART, ERIC L · 2011 to 2015
$2.4M
NHLBI NIH HHS R01 HL105770NHLBI NIH HHS R01-HL-105770
6 · The paper itself

Abstract

backgroundUnbiased deep sequencing offers the potential for improved adventitious virus screening in vaccines and biotherapeutics. Successful implementation of such assays will require appropriate control materials to confirm assay performance and sensitivity.

methodsA common reference material containing 25 target viruses was produced and 16 laboratories were invited to process it using their preferred adventitious virus detection assay.

resultsFifteen laboratories returned results, obtained using a wide range of wet-lab and informatics methods. Six of 25 target viruses were detected by all laboratories, with the remaining viruses detected by 4-14 laboratories. Six non-target viruses were detected by three or more laboratories.

conclusionThe study demonstrated that a wide range of methods are currently used for adventitious virus detection screening in biological products by deep sequencing and that they can yield significantly different results. This underscores the need for common reference materials to ensure satisfactory assay performance and enable comparisons between laboratories.

Indexed as

Biological ProductsDrug ContaminationHigh-Throughput Nucleotide SequencingLaboratoriesReference StandardsVaccinesVirusesBiological ProductsVaccinesAdventitious virusCollaborative studyDeep sequencingReference materialVaccine

Identifiers

PMID26709640
PMCPMC4823300

What OpenQuestion holds

Textmetadata
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.