Evidence map›Paper›PMID 22675155›Full record

ArticleClinical and vaccine immunology : CVI2012

Validation of an immunodiagnostic assay for detection of 13 Streptococcus pneumoniae serotype-specific polysaccharides in human urine.

Michael W Pride, Susanne M Huijts, Kangjian Wu, Victor Souza, Sherry Passador, Chunyan Tinder, Esther Song, Arik Elfassy, Lisa McNeil, Ronald Menton and 6 more

Registry-linked trialAbstract readValidation Study
In one paragraph

Article in Clinical and vaccine immunology : CVI, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03322670 (Description of Pneumococcal Community-acquired Pneumonia in General Practice in France), which is not on this map. Cited by 69 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 3 pooled it
–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.

NCT03322670 completednot on this mapstarted 2017, after this paper: background citation

Description of Pneumococcal Community-acquired Pneumonia in General Practice in France

TypeobservationalSponsorCNGE ConseilRan2017 to 2020Enrolled412ConditionsCommunity-acquired PneumoniaArmsSigns of CAP and a positive chest X-Ray, Patients directly hospitalized, Control patients, Patients with partial participation, Signs of CAP and a negative chest X-Ray
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. The impact of 13-valent pneumococcal conjugate vaccination on virus-associated community-acquired pneumonia in elderly: Exploratory analysis of the CAPiTA trial.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2018
    Trial
  5. Article
  6. Article
  7. Observational
  8. Article
  9. Article
  10. Article
  11. The microbiological characteristics and diagnosis ofHuman vaccines & immunotherapeutics · 2025
    Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Observational
  19. Open forum infectious diseases · 2025
    Article
  20. Article

9 more citing papers are in PubMed but not listed here.

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

16 authors.

Michael W PrideVaccine Research East and Early Development, Pfizer Research, Pearl River, New York, New York, USA. michael.pride@pfizer.com
Susanne M Huijts
Kangjian Wu
Victor Souza
Sherry Passador
Chunyan Tinder
Esther Song
Arik Elfassy
Lisa McNeil
Ronald Menton
Roger French
Janice Callahan
Chris Webber
William C Gruber
Marc J M Bonten
Kathrin U Jansen

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To improve the clinical diagnosis of pneumococcal infection in bacteremic and nonbacteremic community-acquired pneumonia (CAP), a Luminex technology-based multiplex urinary antigen detection (UAD) diagnostic assay was developed and validated. The UAD assay can simultaneously detect 13 different serotypes of Streptococcus pneumoniae by capturing serotype-specific S. pneumoniae polysaccharides (PnPSs) secreted in human urine. Assay specificity is achieved by capturing the polysaccharides with serotype-specific monoclonal antibodies (MAbs) on spectrally unique microspheres. Positivity for each serotype was based on positivity cutoff values calculated from a standard curve run on each assay plate together with positive- and negative-control urine samples. The assay is highly specific, since significant signals are detected only when each PnPS was paired with its homologous MAb-coated microspheres. Validation experiments demonstrated excellent accuracy and precision. The UAD assay and corresponding positivity cutoff values were clinically validated by assessing 776 urine specimens obtained from patients with X-ray-confirmed CAP. The UAD assay demonstrated 97% sensitivity and 100% specificity using samples obtained from patients with bacteremic, blood culture-positive CAP. Importantly, the UAD assay identified Streptococcus pneumoniae (13 serotypes) in a proportion of individuals with nonbacteremic CAP, a patient population for which the pneumococcal etiology of CAP was previously difficult to assess. Therefore, the UAD assay provides a specific, noninvasive, sensitive, and reproducible tool to support vaccine efficacy as well as epidemiological evaluation of pneumococcal disease, including CAP, in adults.

Indexed as

AgedAnimalsAntibodies, BacterialAntibodies, MonoclonalAntigens, BacterialClinical Laboratory TechniquesFemaleHumansImmunoassayMaleMiceMice, Inbred BALB CMicrospheresMiddle AgedPneumococcal InfectionsPolysaccharides, BacterialAntibodies, BacterialAntibodies, MonoclonalAntigens, BacterialPolysaccharides, Bacterial

Identifiers

PMID22675155
PMCPMC3416073

What OpenQuestion holds

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Read underepoch 390

Registered trials

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.