ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020
Qualification and Clinical Validation of an Immunodiagnostic Assay for Detecting 11 Additional Streptococcus pneumoniae Serotype-specific Polysaccharides in Human Urine.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 1 of them a synthesis that pooled it.
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37 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.
- Serotype distribution of invasive and non-invasive pneumococcal disease in adults ≥65 years of age following the introduction of 10- and 13-valent pneumococcal conjugate vaccines in infant national immunization programs: a systematic literature review.Frontiers in public health · 2025Pooled it
- A randomized phase 1/2 study of the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in healthy adults 50 through 85 years of age.Human vaccines & immunotherapeutics · 2021Trial
- Pneumococcal serotype distribution and diagnostic yield of serotype-specific urinary antigen detection in adults with CAP in Switzerland, 2016-2021: a prospective cohort study.BMC infectious diseases · 2026Article
- Pneumococcal pneumonia in adults - re-emergence of vaccine serotypes: a prospective multicenter cohort study in Germany, 2020-2023.Pneumonia (Nathan Qld.) · 2026Article
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- Factors associated with severe pneumonia in adults hospitalised with community-acquired pneumonia in Mongolia.BMC public health · 2026Article
- Pneumococcal community-acquired pneumonia in hospitalized adults in México 2018-2021: serotype distribution and clinical characteristics.Frontiers in public health · 2026Article
- Pneumococcal carriage and disease in adults hospitalised with community-acquired pneumonia in Mongolia: prospective pneumonia surveillance program (2019-2022).Pneumonia (Nathan Qld.) · 2025Article
- Rationale and design of the Pneumococcal Pneumonia Epidemiology, Urine Serotyping and Mental Outcomes (PNEUMO) study Europe.ERJ open research · 2025Article
- Clinical characteristics of Mycoplasma pneumoniae compared to Streptococcus pneumoniae in hospitalized adults with community-acquired pneumonia- a prospective study.BMC infectious diseases · 2025Article
- Urinary pneumococcal serotype detection among children with and without community-acquired pneumonia.BMC infectious diseases · 2025Article
- All-Cause and Pneumococcal Community-Acquired Pneumonia Hospitalizations Among Adults in Tennessee and Georgia.JAMA network open · 2025Article
- Alterations in the prevalence and serotypes of Streptococcus pneumoniae in elderly patients with community-acquired pneumonia: a meta-analysis and systematic review.Pneumonia (Nathan Qld.) · 2025Review
- Description and characterization of pneumococcal community acquired pneumonia (CAP) among radiologically confirmed CAP in outpatients.NPJ primary care respiratory medicine · 2025Observational
- Article
- Combined multiplex panel test results are a poor estimate of disease prevalence without adjustment for test error.PLoS computational biology · 2024Article
- Multicountry Review of Streptococcus pneumoniae Serotype Distribution Among Adults With Community-Acquired Pneumonia.The Journal of infectious diseases · 2024Article
- Contact with young children is a major risk factor for pneumococcal colonization in older adults.FEMS microbes · 2024Article
- Qualification of a 21-valent pneumococcal urine antigen detection assay and development of clinical positivity cutoffs.Bioanalysis · 2024Article
- Nanofluidic qPCR unable to detect and serotype Streptococcus pneumoniae in urine samples of hospitalized South African patients with community-acquired pneumonia.Scientific reports · 2023Article
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Authors and funding
18 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIdentifying Streptococcus pneumoniae serotypes by urinary antigen detection (UAD) assay is the most sensitive way to evaluate the epidemiology of nonbacteremic community-acquired pneumonia (CAP). We first described a UAD assay to detect the S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, covered by the licensed 13-valent S. pneumoniae conjugate vaccine. To assess the substantial remaining pneumococcal disease burden after introduction of several pneumococcal vaccines, a UAD-2 assay was developed to detect 11 additional serotypes (2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20, 22F, and 33F) in individuals with radiographically confirmed CAP.
methodsThe specificity of the UAD-2 assay was achieved by capturing pneumococcal polysaccharides with serotype-specific monoclonal antibodies, using Luminex technology. Assay qualification was used to assess accuracy, precision, and sample linearity. Serotype positivity was based on cutoffs determined by nonparametric statistical evaluation of urine samples from individuals without pneumococcal disease. The sensitivity and specificity of the positivity cutoffs were assessed in a clinical validation, using urine samples obtained from a large study that measured the proportion of radiographically confirmed CAP caused by S. pneumoniae serotypes in hospitalized US adults.
resultsThe UAD-2 assay was shown to be specific and reproducible. Clinical validation demonstrated assay sensitivity and specificity of 92.2% and 95.9% against a reference standard of bacteremic pneumonia. In addition, the UAD-2 assay identified a S. pneumoniae serotype in 3.72% of nonbacteremic CAP cases obtained from hospitalized US adults. When combined with bacteremic CAP cases, the proportion of pneumonias with a UAD-2 serotype was 4.33%.
conclusionsThe qualified/clinically validated UAD-2 method has applicability in understanding the epidemiology of nonbacteremic S. pneumoniae CAP and for assessing the efficacy of future pneumococcal conjugate vaccines that are under development.
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