Evidence map›Paper›PMID 27974397›Full record

ArticleClinical and vaccine immunology : CVI2017

Assignment of Opsonic Values to Pneumococcal Reference Serum 007sp for Use in Opsonophagocytic Assays for 13 Serotypes.

R L Burton, J Antonello, D Cooper, D Goldblatt, K H Kim, B D Plikaytis, L Roalfe, D Wauters, F Williams, G L Xie and 2 more

Open access · diamondAbstract read
In one paragraph

Article in Clinical and vaccine immunology : CVI, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
3.3field-weighted citation impact, top 8% 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

19 citing papers in PubMed, 29 citations in OpenAlex.

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  10. Sugar-Coated Killer: Serotype 3 Pneumococcal Disease.Frontiers in cellular and infection microbiology · 2020
    Review
  11. Article
  12. Using only a subset of pneumococcal serotypes is reliable for the diagnosis of specific antibody deficiency in children: A proof-of-concept study.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2019
    Article
  13. Article
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  15. Measuring immune responses to pneumococcal vaccines.Journal of immunological methods · 2018
    Review
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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

12 authors at 7 institutions in 5 countries.

R L BurtonDepartment of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
J AntonelloDepartment of Biometrics Research, Merck & Co., Inc., West Point, Pennsylvania, USA.
D CooperPfizer Vaccine Research, Pfizer, Pearl River, New York, USA.
D GoldblattUCL Institute of Child Health, London, United Kingdom.
K H KimDepartment of Pediatrics and Center for Vaccine Evaluation and Study, Ewha Womans University School of Medicine, Seoul, South Korea.
B D PlikaytisBioStat Consulting, LLC, Atlanta, Georgia, USA.
L RoalfeUCL Institute of Child Health, London, United Kingdom.
D WautersGSK Vaccines, Rixensart, Belgium.
F WilliamsFDA/CBER, Silver Spring, Maryland, USA.
G L XieLanzhou Institute of Biological Products, Lanzhou, China.
M H NahmDepartment of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA mnahm@uabmc.edu Mustafa.Akkoyunlu@fda.hhs.gov.
M AkkoyunluFDA/CBER, Silver Spring, Maryland, USA mnahm@uabmc.edu Mustafa.Akkoyunlu@fda.hhs.gov.
University College London · GBUniversity of Alabama at Birmingham · USBiostatistical Consulting (United States) · USEwha Womans University · KRGlaxoSmithKline (Belgium) · BELanzhou Institute of Husbandry and Pharmaceutical Sciences · CNPfizer (United States) · US

Funding

NIAID NIH HHS HHSN272201200005C
6 · The paper itself

Abstract

Opsonophagocytic assays (OPAs) are routinely used for assessing the immunogenicity of pneumococcal vaccines, with OPA data often being utilized for licensure of new vaccine formulations. However, no reference serum for pneumococcal OPAs is available, making evaluation of data among different laboratories difficult. This international collaboration was initiated to (i) assign consensus opsonic indexes (OIs) to FDA pneumococcal reference serum lot 007sp (here referred to as 007sp) and a panel of serum samples used for calibration of the OPA and (ii) determine if the normalization of the OPA results obtained with test samples to those obtained with 007sp decreases the variability in OPA results among laboratories. To meet these goals, six participating laboratories tested a panel of serum samples in five runs for 13 serotypes. For each serum sample, consensus OIs were obtained using a mixed-effects analysis of variance model. For the calibration serum samples, normalized consensus values were also determined on the basis of the results obtained with 007sp. For each serotype, the overall reduction in interlaboratory variability was calculated by comparing the coefficients of variation of the unadjusted and the normalized values. Normalization of the results substantially reduced the interlaboratory variability, ranging from a 15% reduction in variability for serotype 9V to a 64% reduction for serotype 7F. Normalization also increased the proportion of data within 2-fold of the consensus value from approximately 70% (average for all serotypes) to >90%. On the basis of the data obtained in this study, pneumococcal reference standard lot 007sp will likely be a useful reagent for the normalization of pneumococcal OPA results from different laboratories. The data also support the use of the 16 FDA serum samples used for calibration of the OPA as part of the initial evaluation of new assays or periodic assessment of established assays.

Indexed as

PhagocytesAntibodies, BacterialCalibrationImmunoassayOpsonin ProteinsPneumococcal VaccinesReference StandardsReproducibility of ResultsSerogroupStreptococcus pneumoniaeAntibodies, BacterialOpsonin ProteinsPneumococcal Vaccines007spOPAopsonicpneumococcusstandardization

Identifiers

PMID27974397
PMCPMC5299120
OpenAlexW2571306756

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.