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Title: The PneuCarriage Project: A Multi-Centre Comparative Study to Identify the Best Serotyping Methods for Examining Pneumococcal Carriage in Vaccine Evaluation Studies
Authors: Catherine Satzke
Eileen M. Dunne
Barbara D. Porter
Keith P. Klugman
E. Kim Mulholland
Jorge E. Vidal
Fuminori Sakai
Janet E. Strachan
Deborah C. Hay Burgess
Douglas Holtzman
K. Boelsen
Maha Habib
Jayne Manning
Belinda D. Ortika
Casey L. Pell
Jenna A. Smyth
Martin Antonio
Keith P. Klugman
Katherine L. O’Brien
Roy M. Robins-Browne
J. Anthony Scott
Samir K. Saha
Fiona M. Russell
Andrew R. Greenhill
Deborah Lehmann
Peter V. Adrian
Shabir A. Madhi
Lorry G. Rubin
Atqia Rizvi
Jason Hinds
Katherine A. Gould
Fanrong Kong
Shahin Oftadeh
Gwendolyn L. Gilbert
Lu Feng
Boyang Cao
Gláucia Paranhos-Baccalà
Jean Noel Telles
Mélina Messaoudi
Ray Borrow
Elaine Stanford
Robert George
Carmen Sheppard
Silvio D. Brugger
Kathrin Mühlemann
Markus Hilty
Ismar A. Rivera-Olivero
Jacobus H. de Waard
Bambos M. Charalambous
Marcus H. Leung
Chiara Azzari
Maria Moriondo
Francesco Nieddu
Peter W.M. Hermans
Christa E. van der Gaast-de Jongh
Paul Turner
David J. Ecker
Rangarajan Sampath
Royal Children's Hospital, Melbourne
University of Melbourne
Rollins School of Public Health
London School of Hygiene & Tropical Medicine
Bill and Melinda Gates Foundation
Kimataifa Diagnostics & Devices Consulting
Takeda Vaccines
Murdoch Children's Research Institute
Vaccinology Theme
Johns Hopkins Bloomberg School of Public Health
Kenya Medical Research Institute
Dhaka Shishu Hospital
Papua New Guinea Institute of Medical Research
Federation University Australia
Telethon Kids Institute
University of Witwatersrand
Children's Medical Center
University of London
Westmead Hospital
The University of Sydney
Nankai University
Public Health England
Statens Serum Institut
University of Bern
The Forsyth Institute
Harvard School of Dental Medicine
UniversitatsSpital Bern
Universidad Central de Venezuela
City University of Hong Kong
Universita degli Studi di Firenze
Radboud University Nijmegen Medical Centre
Mahidol University
Angkor Hospital for Children
University of Oxford
Keywords: Medicine
Issue Date: 1-Nov-2015
Citation: PLoS Medicine. Vol.12, No.11 (2015)
Abstract: © 2015 Satzke et al. Background: The pneumococcus is a diverse pathogen whose primary niche is the nasopharynx. Over 90 different serotypes exist, and nasopharyngeal carriage of multiple serotypes is common. Understanding pneumococcal carriage is essential for evaluating the impact of pneumococcal vaccines. Traditional serotyping methods are cumbersome and insufficient for detecting multiple serotype carriage, and there are few data comparing the new methods that have been developed over the past decade. We established the PneuCarriage project, a large, international multi-centre study dedicated to the identification of the best pneumococcal serotyping methods for carriage studies. Methods and Findings: Reference sample sets were distributed to 15 research groups for blinded testing. Twenty pneumococcal serotyping methods were used to test 81 laboratory-prepared (spiked) samples. The five top-performing methods were used to test 260 nasopharyngeal (field) samples collected from children in six high-burden countries. Sensitivity and positive predictive value (PPV) were determined for the test methods and the reference method (traditional serotyping of >100 colonies from each sample). For the alternate serotyping methods, the overall sensitivity ranged from 1% to 99% (reference method 98%), and PPV from 8% to 100% (reference method 100%), when testing the spiked samples. Fifteen methods had ≥70% sensitivity to detect the dominant (major) serotype, whilst only eight methods had ≥70% sensitivity to detect minor serotypes. For the field samples, the overall sensitivity ranged from 74.2% to 95.8% (reference method 93.8%), and PPV from 82.2% to 96.4% (reference method 99.6%). The microarray had the highest sensitivity (95.8%) and high PPV (93.7%). The major limitation of this study is that not all of the available alternative serotyping methods were included. Conclusions: Most methods were able to detect the dominant serotype in a sample, but many performed poorly in detecting the minor serotype populations. Microarray with a culture amplification step was the top-performing method. Results from this comprehensive evaluation will inform future vaccine evaluation and impact studies, particularly in low-income settings, where pneumococcal disease burden remains high.
ISSN: 15491676
Appears in Collections:Scopus 2011-2015

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