RESUMEN
Listeria monocytogenes is a foodborne pathogen associated with severe diseases in humans and animals. The genotypic analysis of 17 L. monocytogenes isolates recovered from humans in India during 2006-2009 using multiplex serotyping PCR allowing serovar predictions, conventional serology and by pulsed field gel electrophoresis (PFGE) is presented. The isolates were recovered from patients exhibiting various clinical conditions. A multiplex-PCR based serotyping assay revealed 88·24% (15/17) of the strains belonging to the serovar group 4b, 4d, 4e and 11·76% (2/17) to the serovar group 1/2b, 3b. Conventional serology indicated that 13 (76·47%) L. monocytogenes isolates to be of serotype 4b, 2 (11·76%) serotype 4d, and 2 (11·76%) serotype 1/2b. Ten ApaI and nine AscI pulsotypes were recognized among the 17 human isolates. PFGE analysis allowed discrimination among isolates of the same serotype and among isolates from the same sampling areas or those isolated from different areas. Thus, PFGE together with multiplex-PCR serotyping allows rapid discrimination of L. monocytogenes strains. In addition, the predominance of L. monocytogenes serotype 4b is of concern, as this serotype has been most frequently associated with human listeriosis outbreaks.
Asunto(s)
Brotes de Enfermedades , Electroforesis en Gel de Campo Pulsado , Microbiología Ambiental , Contaminación de Alimentos , Listeria monocytogenes/genética , Listeriosis/epidemiología , ADN Bacteriano/aislamiento & purificación , Femenino , Microbiología de Alimentos , Genotipo , Humanos , India/epidemiología , Listeria monocytogenes/clasificación , Listeria monocytogenes/aislamiento & purificación , Listeriosis/microbiología , Masculino , Reacción en Cadena de la Polimerasa , Reproducibilidad de los Resultados , SerotipificaciónRESUMEN
BACKGROUND: As there is little Indian data about severity, frequency and types of research related injuries, costs involved and policies regarding compensation, this study was conducted to review the present Indian scenario. METHODS: The study was carried out in three parts; a questionnaire-based survey, in-depth interviews, and a review of informed consent and insurance documents of projects submitted to three ethics committees. RESULTS: 47% of investigators were either unaware of, or had not understood, the legal requirements and depended on sponsors to manage these issues, whereas 74% of ethics committee members were aware of the requirements. Although 40% of investigators, 30% of ethics committee members and all sponsors had policies to manage compensation issues, these were mainly to provide immediate free medical care or reimbursement of expenses incurred for the acute management of an adverse event. Compensation for loss of time/wages, death, physical disability or long term incapacitation was not included. A review of informed consent and insurance documents showed that compensation issues were inadequately discussed, with only insurance certificates submitted to ethics committees. CONCLUSION: In India, there are no uniform policies and investigators are largely unaware of their responsibilities. Therefore, there is an urgent need to draft national guidelines regarding compensation for research injuries of research participants and highlight the responsibilities of each stakeholder. Potential research injuries should be categorised based on risk assessment, severity and seriousness of the injury. Further, it would be necessary to have arbitration committees to determine the extent of compensation. Training and awareness workshops for those involved in clinical research, including research participants, is also needed.
Asunto(s)
Investigación Biomédica/organización & administración , Ensayos Clínicos como Asunto , Compensación y Reparación , Comités de Ética/organización & administración , Regulación Gubernamental , Investigadores , Accidentes de Trabajo/economía , Accidentes de Trabajo/legislación & jurisprudencia , Investigación Biomédica/normas , Ensayos Clínicos como Asunto/economía , Comités de Ética/normas , Humanos , India , Consentimiento Informado/ética , Encuestas y CuestionariosRESUMEN
A study of 100 neonates with clinical suspicion of septicemia, admitted in neonatal intensive care unit of SCSM General Hospital, Solapur was carried out to assess the utility of various indices of sepsis screen. Bacterial and hematological profile of these neonataes was studied. Parameters of sepsis screen such as leukocyte count, band form to neutrophil ratio, neutrophils with toxic granulations, micro ESR and test for C-reactive protein were analysed to know their sensitivity and specificity.