Evidence map›Paper›PMID 22000165›Full record

ReviewBiologicals : journal of the International Association of Biological Standardization2011

Evaluation of the human host range of bovine and porcine viruses that may contaminate bovine serum and porcine trypsin used in the manufacture of biological products.

Carol Marcus-Sekura, James C Richardson, Rebecca K Harston, Nandini Sane, Rebecca L Sheets

Open access · greenAbstract readReview
In one paragraph

Review in Biologicals : journal of the International Association of Biological Standardization, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
4.7field-weighted citation impact, top 6% of its field
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

16 citing papers in PubMed, 55 citations in OpenAlex.

  1. Review
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  9. Review
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  11. Review
  12. Virome of US bovine calf serum.Biologicals : journal of the International Association of Biological Standardization · 2017
    Article
  13. Review
  14. Article
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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 at 3 institutions in 1 country.

Carol Marcus-SekuraBiotechnology Assessment Services Inc., 7413 Ottenbrook Terrace, Rockville, MD 20855, USA. crsek@aol.com
James C Richardson
Rebecca K Harston
Nandini Sane
Rebecca L Sheets
BioScience Laboratories (United States) · USNational Institute of Allergy and Infectious Diseases · USOffice of Technology Transfer · US

Funding

Intramural NIH HHS Z99 AI999999NIAID NIH HHS N01 AI040045
6 · The paper itself

Abstract

Current U.S. requirements for testing cell substrates used in production of human biological products for contamination with bovine and porcine viruses are U.S. Department of Agriculture (USDA) 9CFR tests for bovine serum or porcine trypsin. 9CFR requires testing of bovine serum for seven specific viruses in six families (immunofluorescence) and at least 2 additional families non-specifically (cytopathicity and hemadsorption). 9CFR testing of porcine trypsin is for porcine parvovirus. Recent contaminations suggest these tests may not be sufficient. Assay sensitivity was not the issue for these contaminations that were caused by viruses/virus families not represented in the 9CFR screen. A detailed literature search was undertaken to determine which viruses that infect cattle or swine or bovine or porcine cells in culture also have human host range [ability to infect humans or human cells in culture] and to predict their detection by the currently used 9CFR procedures. There are more viruses of potential risk to biological products manufactured using bovine or porcine raw materials than are likely to be detected by 9CFR testing procedures; even within families, not all members would necessarily be detected. Testing gaps and alternative methodologies should be evaluated to continue to ensure safe, high quality human biologicals.

Indexed as

AnimalsBiological ProductsCattleDrug ContaminationHost SpecificityHumansSerumSwineTrypsinVirusesVirus Physiological PhenomenaBiological ProductsTrypsin

Identifiers

PMID22000165
PMCPMC3206158
OpenAlexW2054109157

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.