The PneuCarriage Project: A Multi-Centre Comparative Study to Identify the Best Serotyping Methods for Examining Pneumococcal Carriage in Vaccine Evaluation Studies.

摘要: Background The pneumococcus is a diverse pathogen whose primary niche the nasopharynx. Over 90 different serotypes exist, and nasopharyngeal carriage of multiple common. Understanding pneumococcal essential for evaluating impact vaccines. Traditional serotyping methods are cumbersome insufficient detecting serotype carriage, there few data comparing new that have been developed over past decade. We established PneuCarriage project, large, international multi-centre study dedicated to identification best studies. Methods Findings Reference sample sets were distributed 15 research groups blinded testing. Twenty used test 81 laboratory-prepared (spiked) samples. The five top-performing 260 (field) samples collected from children in six high-burden countries. Sensitivity positive predictive value (PPV) determined reference method (traditional >100 colonies each sample). For alternate methods, overall sensitivity ranged 1% 99% (reference 98%), PPV 8% 100% 100%), when testing spiked Fifteen had ≥70% detect dominant (major) serotype, whilst only eight minor serotypes. For field samples, 74.2% 95.8% 93.8%), 82.2% 96.4% 99.6%). microarray highest (95.8%) high (93.7%). major limitation this not all available alternative included. Conclusions Most able sample, but many performed poorly populations. Microarray with culture amplification step was method. Results comprehensive evaluation will inform future vaccine studies, particularly low-income settings, where disease burden remains high.