For release of parenteral drug products, bacterial endotoxin testing is one of a panel of necessary tests. In order to ensure the validity of such tests, various controls are performed, including demonstration of compendial method suitability or method qualification. In addition to compendial suitability testing, quality control (QC) sample hold-time studies are requested by authorities like the Food and Drug Administration (FDA) as described in "Guidance for Industry: Pyrogen and Endotoxins Testing.
View Article and Find Full Text PDFSixty-two invasive non-typhoidal Salmonella (NTS) isolates from children aged 2-29 months in rural Gambia were examined for serovar prevalence and antimicrobial susceptibility, and characterized using multilocus sequence typing (MLST) of seven genes, aroC, dnaN, hemD, hisD, purE, sucA and thrA. Salmonella enterica serovar Enteritidis was the most common serovar (80.6 %), followed by S.
View Article and Find Full Text PDFProtection against pneumococcal disease is thought to be mediated primarily by antibodies that are opsonic [Musher DM, Chapman AJ, Goree A, Jonsson S, Briles D, Baughn RE. Natural and vaccine-related immunity to Streptococcus pneumoniae. J Infect Dis 1986;154(2):245-56].
View Article and Find Full Text PDFThe purpose of this study was to develop a simple and non-labour-intensive molecular method to identify the phase 1 H antigens of Salmonella. The variable region of the flagellin gene, fliC, from 96 Salmonella strains representing 51 different phase 1 H antigens was sequenced in one direction. Unique sequences were found for 45 of the 51 different antigens.
View Article and Find Full Text PDFSeveral countries still permit strains of Salmonella enterica serotype Enteritidis, a leading cause of gastrointestinal illness in humans, to be used in rat baits. To assess the human health risk associated with such rat bait, we first reviewed historic data on health hazards associated with Ratin, a rodenticide that was used in Europe until the early 1960s. Ratin caused outbreaks of human illness, including several deaths.
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