Development of an extended specificity multiplex immunoassay for detection of Streptococcus pneumoniae serotype-specific antigen in urine using human monoclonal antibodies.

We report that the assay is capable of detecting all the targeted serotypes and the CWP at 0.1ng/ml with some serotypes detected as low as 0.3 pg/ml. The analytical serotype specificity was determined as 98.4% using a panel of polysaccharide negative urine specimens spiked with non-pneumococcal bacterial antigens. We also report clinical sensitivities of 96.2% and specificities of 89.9% established using a panel of urine specimens from patients diagnosed with community acquired pneumonia or pneumococcal disease. This assay can be extended for testing other clinical samples and has the potential to greatly improve serotype-specific surveillance in the many cases of pneumococcal disease from which a culture is never obtained. PMID: 28978509 [PubMed - as supplied by publisher]
Source: Clinical and Vaccine Immunology - Category: Allergy & Immunology Authors: Tags: Clin Vaccine Immunol Source Type: research