Bioanalysis · 2024
Qualification of a 21-valent pneumococcal urine antigen detection assay and development of clinical positivity cutoffs.
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Choudhury Arpita, Zhang Yuhua, Ma Junshui, Li Ruonan, Chamcha Radha, Akgul Ali, Stachura Nina, Follmer Thy, Newhard Will, Jackson Gunnar, Herbert Jessica, Nguyen Caspar, Pham Huy, Nasrin Shamima, McCabe Kelsi, Rajam Gowrisankar, Johnson Kelly D, Rouphael Nadine, Cruz Sergio Yahir, Verch Thorsten
Аннотация
Aim: Serotype-specific assays detecting pneumococcal polysaccharides in bodily fluids are needed to understand the pneumococcal serotype distribution in non-bacteremic pneumonia.Methods: We developed a urine antigen detection assay and using urine samples from adult outpatients without pneumonia developed positivity cutoffs for both a previously published 15-valent and the new 21-valent assay. Clinical sensitivity was confirmed with samples from patients with invasive pneumococcal disease.Results: Total assay precision ranged from 7.6 to 17.8% coefficient of variation while accuracy ranged between 80 and 150% recovery, except for three serotypes where recoveries ranged from 32 to 60%. Clinical sensitivity was 86.4% and specificity was 96.5% across all 30 serotypes.Conclusion: The assay could potentially assess serotype-distribution in non-infected and infected participants with pneumococcal disease.