Common Standard Operating Procedure Research Articles

Comparison of Cefotaxime-Resistant Escherichia coli and sul1 and intI1 by qPCR for Monitoring of Antibiotic Resistance of Wastewater, Surface Water, and Recycled Water.

Awareness of the need for surveillance of antimicrobial resistance (AMR) in water environments is growing, but there is uncertainty regarding appropriate monitoring targets. Adapting culture-based fecal indicator monitoring to include antibiotics in the media provides a potentially low-tech and accessible option, while quantitative polymerase chain reaction (qPCR) targeting key genes of interest provides a broad, quantitative measure across the microbial community. The purpose of this study was to compare findings obtained from the culture of cefotaxime-resistant (cefR) Escherichia coli with two qPCR methods for quantification of antibiotic resistance genes across wastewater, recycled water, and surface waters. The culture method was a modification of US EPA Method 1603 for E. coli, in which cefotaxime is included in the medium to capture cefR strains, while qPCR methods quantified sul1 and intI1. A common standard operating procedure for each target was applied to samples collected by six water utilities across the United States and processed by two laboratories. The methods performed consistently, and all three measures reflected the same overarching trends across water types. The qPCR detection of sul1 yielded the widest dynamic range of measurement as an AMR indicator (7-log versus 3.5-log for cefR E. coli), while intI1 was the most frequently detected target (99% versus 96.5% and 50.8% for sul1 and cefR E. coli, respectively). All methods produced comparable measurements between labs (p < 0.05, Kruskal-Wallis). Further study is needed to consider how relevant each measure is to capturing hot spots for the evolution and dissemination of AMR in the environment and as indicators of AMR-associated human health risk.

Prevalence and resistance pattern of uropathogens from community settings of different regions: an experience from India.

IntroductionUrinary tract infection (UTI) is one of the most common infections in clinical practice worldwide in both healthcare and community settings causing significant morbidity and mortality. It is one of the major conditions at the community level treated empirically and regarded as a potential cause of emergence of antimicrobial resistance (AMR). Limited information is available regarding community-acquired UTI (CA-UTI) from India.MethodologyThis is a first of its kind, multicentric-cross-sectional study at the community level targeting patients attending the out-patient department (OPD) of the community health centre (CHC) from four geographical regions (North, South, West and East) of India. The study had been designed to determine the epidemiology, antibiogram profile and identification of extended-spectrum beta-lactamase (ESBL) producer and carbapenem resistant (CR) uropathogens. Samples were collected prospectively from UTI suspected patients coming at CHC and processed at the tertiary healthcare centres using a common standard operating procedure. Clinical history of all the patients exhibiting significant bacteriuria was collected and data was analysed.ResultOverall, 250 out of a total of 2459 (10.1 %) urine samples were positive for bacteria with significant bacteriuria (adult: paediatrics, 6.7 : 1). Females were predominantly affected (male: female, 1 : 2.9). History of recent episode of UTI was observed as the commonest risk factor followed by diabetes mellitus. Altogether, 86 % of total cases were caused by Escherichia coli (68 %) and Klebsiella pneumoniae (17.6 %) together. Among the commonly used oral antibiotics for the Gram-negative bacilli (GNB), the highest resistance was observed against beta-lactams, first- and second-generation cephalosporins, fluoroquinolones and co-trimoxazole. Overall, the prevalence of ESBL producer and CR isolates were 44.8, and 4.3 %, respectively. However, the ESBL production, CR and nitrofurantoin resistance among the uropathogenic E. coli (UPEC) isolates was 52.8, 5.1 and 14 %, respectively. No resistance was found against fosfomycin among the UPEC isolates.ConclusionThe current study highlights the increasing incidence of AMR among uropathogens at the community-settings of India. A significant percentage of ESBL producers among the isolated UPEC and K. pneumoniae were observed. The currently available evidence supports the clinical recommendation of fosfomycin and nitrofurantoin for empiric therapy in CA-UTI in India.

Uveal Melanoma – Standardised Procedure in Diagnosis, Therapy and Surveillance

Abstract Background Uveal melanoma is a rare intraocular tumour, for which there is currently no national evidence-based guideline in Germany. The aim of this project was to provide a common standard operating procedure (SOP) for the diagnosis, treatment and follow-up care of uveal melanoma, within the network of German leading oncology centres funded by German Cancer Aid. The SOP was created as part of a moderated consensus process. Results and Conclusion In a multistage process, a common SOP was developed for the diagnosis, therapy and follow-up of uveal melanoma, as based on current knowledge of the subject.

Interfacing a biosurveillance portal and an international network of institutional analysts to detect biological threats.

The Early Alerting and Reporting (EAR) project, launched in 2008, is aimed at improving global early alerting and risk assessment and evaluating the feasibility and opportunity of integrating the analysis of biological, chemical, radionuclear (CBRN), and pandemic influenza threats. At a time when no international collaborations existed in the field of event-based surveillance, EAR's innovative approach involved both epidemic intelligence experts and internet-based biosurveillance system providers in the framework of an international collaboration called the Global Health Security Initiative, which involved the ministries of health of the G7 countries and Mexico, the World Health Organization, and the European Commission. The EAR project pooled data from 7 major internet-based biosurveillance systems onto a common portal that was progressively optimized for biological threat detection under the guidance of epidemic intelligence experts from public health institutions in Canada, the European Centre for Disease Prevention and Control, France, Germany, Italy, Japan, the United Kingdom, and the United States. The group became the first end users of the EAR portal, constituting a network of analysts working with a common standard operating procedure and risk assessment tools on a rotation basis to constantly screen and assess public information on the web for events that could suggest an intentional release of biological agents. Following the first 2-year pilot phase, the EAR project was tested in its capacity to monitor biological threats, proving that its working model was feasible and demonstrating the high commitment of the countries and international institutions involved. During the testing period, analysts using the EAR platform did not miss intentional events of a biological nature and did not issue false alarms. Through the findings of this initial assessment, this article provides insights into how the field of epidemic intelligence can advance through an international network and, more specifically, how it was further developed in the EAR project.

A Strategic Plan for the Second Phase (2013–2015) of the Korea Biobank Project

The Korea Biobank Project (KBP) was led by the Ministry of Health and Welfare to establish a network between the National Biobank of Korea and biobanks run by university-affiliated general hospitals (regional biobanks). The Ministry of Health and Welfare started the project to enhance medical and health technology by collecting, managing, and providing researchers with high-quality human bioresources. The National Biobank of Korea, under the leadership of the Ministry of Health and Welfare, collects specimens through various cohorts and regional biobanks within university hospitals gather specimens from patients. The project began in 2008, and the first phase ended in 2012, which meant that there needed to be a plan for the second phase that begins in 2013. Consequently, professionals from within and outside the project were gathered to develop a plan for the second phase. Under the leadership of the planning committee, six working groups were formed to formulate a practical plan. By conducting two workshops with experts in the six working groups and the planning committee and three forums in 2011 and 2012, they have developed a strategic plan for the second phase of the KBP. This document presents a brief report of the second phase of the project based on a discussion with them.During the first phase of the project (2008–2012), a network was set up between the National Biobank of Korea and 17 biobanks at university-affiliated hospitals in an effort to unify informatics and governance among the participating biobanks. The biobanks within the network manage data on their biospecimens with a unified Biobank Information Management System. Continuous efforts are being made to develop a common standard operating procedure for resource collection, management, distribution, and personal information security, and currently, management of these data is carried out in a somewhat unified manner. In addition, the KBP has trained and educated professionals to work within the biobanks, and has also carried out various publicity promotions to the public and researchers. During the first phase, biospecimens from more than 300,000 participants through various cohorts and biospecimens from more than 200,000 patients from hospitals were collected, which were distributed to approximately 600 research projects.The planning committee for the second phase evaluated that the first phase of the KBP was successful. However, the first phase of the project was meant to allow autonomy to the individual biobanks. The biobanks were able to choose the kind of specimens they were going to collect and the amount of specimen they would set as a goal, as well as being allowed to choose their own methods to manage their biobanks (autonomy). Therefore, some biobanks collected resources that were easy to collect and the resources needed by researchers were not strategically collected. In addition, there was also a low distribution rate to researchers outside of hospitals, who do not have as much access to specimens and cases as those in hospitals. There were also many cases in which researchers were not aware of the KBP, and the distribution processes were not set up to be convenient to the demands of researchers.Accordingly, the second phase of the KBP will be focused on increasing the integration and cooperation between the biobanks within the network. The KBP plans to set goals for the strategic collection of the needed human bioresources. Although the main principle of the first phase was to establish infrastructure and resource collection, the key objective of the second phase is the efficient utilization of gathered resources. In order to fully utilize the gathered resources in an efficient way, distribution systems and policies must be improved. Vitalization of distribution, securing of high-value resource and related clinical and laboratory information, international standardization of resource management systems, and establishment of a virtuous cycle between research and development (R&D) and biobanks are the four main strategies. Based on these strategies, 12 related objectives have been set and are planned to be executed.

Performance Metrics for Liquid Chromatography-Tandem Mass Spectrometry Systems in Proteomics Analyses

A major unmet need in LC-MS/MS-based proteomics analyses is a set of tools for quantitative assessment of system performance and evaluation of technical variability. Here we describe 46 system performance metrics for monitoring chromatographic performance, electrospray source stability, MS1 and MS2 signals, dynamic sampling of ions for MS/MS, and peptide identification. Applied to data sets from replicate LC-MS/MS analyses, these metrics displayed consistent, reasonable responses to controlled perturbations. The metrics typically displayed variations less than 10% and thus can reveal even subtle differences in performance of system components. Analyses of data from interlaboratory studies conducted under a common standard operating procedure identified outlier data and provided clues to specific causes. Moreover, interlaboratory variation reflected by the metrics indicates which system components vary the most between laboratories. Application of these metrics enables rational, quantitative quality assessment for proteomics and other LC-MS/MS analytical applications.

SHORT COMMUNICATION: THE EFFECT OF TANNIN SOLUTION IN PERFORMING SUCCESFULL EGG MICROINJECTION ON AFRICAN CATFISH (Clarias gariepinus)

In order to successfully perform a gene transfer activity using microinjection, an individual egg is needed. The common standard operating procedure to collect the individual egg is by applying chemical solution to remove the sticky layer covering the egg surface. Among several available solutions, tannin is one of alternative substances that can be used in performing egg microinjection on African catfish. In this study, the effect of different dosages of tannin solution to remove the sticky layer of eggs was observed. The study was conducted at the Laboratory of Fish Breeding and Genetics, Bogor Agricultural University. Prior to microinjection, the eggs were treated with different dosages of tannin solution right after fertilization. There were four different levels of dosage used as the treatments i.e.: 0.3, 0.5, 0.7, and 0.9 ppm. After the treatments, each individual egg was injected using DNA pmâactin-hrGFP plasmid with a concentration of 20 μg/mL. The results showed that the dosage of 0.5 ppm of tannin was the most effective treatment compared to the other dosages. This dosage produced 71.4% hatching rate and 57.1% transgenic embryos respectively.

Satisfaction survey in general hospital personnel involved in blood transfusion: implementation of the ISO 9001: 2000 standard

As part of its policy of constant quality improvement, Établissement français du sang (EFS) des pays de la Loire (Pays de la Loire Regional Blood Transfusion Centre) carried out a satisfaction survey among the hospital personnel involved in prescribing and using immunohaematological tests and labile blood products (LBP). The polling tool selected by agreement between the Saint Nazaire’s hospital management and Quality Assurance (QA) Department was a questionnaire that permitted item rating and free commentary. It addressed the personnel’s perception of the quality of erythrocyte immunohaematological (EIH) testing and of the products administered, as well as their perception of the quality of communications with the local EFS. The questionnaire was sent to 26 physicians and 32 senior nurses in 15 hospital departments. The reply rate was 60% and expressed an 85% overall satisfaction level. Dissatisfaction causes were more specifically analysed, the main one involving LBP distribution in emergency situations. A joint undertaking by the EFS and the hospital led to the implementation of corrective measures, including the writing and implementation of a common standard operating procedure for emergency transfusion management. The results obtained demonstrated the feasibility of this type of survey and the interest, to a blood transfusion centre and the hospital personnel involved in transfusion, of assessing their very own perception of service quality.

Enquête de satisfaction des acteurs impliqués dans la transfusion dans un centre hospitalier général : une application de la norme ISO 9001 : 2000

As part of its policy of constant quality improvement, Etablissement Français du Sang (EFS) des Pays de la Loire (Pays de la Loire Regional blood transfusion institution) carried out a satisfaction survey among the hospital personnel involved in prescribing and using immuno-hematological tests and labile blood products. The polling tool selected by agreement between the hospital management and quality assurance department was a questionnaire that permitted item rating and free commentary. It addressed the personnel’s perception of the quality of erythrocyte immuno-hematological (EIH) testing and of the products administered, as well as their perception of the quality of communications with the local EFS. The questionnaire was sent to 26 physicians and 32 senior nurses in 15 hospital departments. The reply rate was 60% and expressed a 85% overall satisfaction level. Dissatisfaction causes were more specifically analysed, the main one involving labile blood product distribution in emergency situations. A joint undertaking by the EFS and the hospital led to the implementation of corrective measures, including the writing and implementation of a common standard operating procedure for emergency transfusion management. The results obtained demonstrated the feasibility of this type of survey and the interest, to a blood transfusion centre and the hospital personnel involved in transfusion, of assessing their very own perception of service quality.

Interlaboratory validation of the In Vitro eye irritation tests for cosmetic ingredients (7) evaluation of cytotoxicity test by CornePack ®

The cytotoxicity test of neutral red (NR) uptake in normal rabbit corneal epithelial cells (CornePack ®) was validated as an alternative method to the Draize rabbit eye irritation test (Draize test). We tested 38 cosmetic ingredients as well as isotonic sodium chloride solution in three phases of the validation study. The test procedures were controlled among participating laboratories under a common standard operating procedure (SOP). The concentration of test substances that showed a 50% reduction in NR uptake relative compared with controls (median NR uptake concentration: NR 50, μg/ml) was determined and compared with in vivo Draize scores. Six laboratories participated in the first phase of the validation study, seven in the second, and five in the third. The average interlaboratory coefficient of variation (CV) was 32.9%. The correlation and rank correlation coefficients between the maximal average Draize total scores (MAS) and NR 50 were −0.583 and 0.587, respectively. When the anionic detergents were excluded from analysis, the correlation coefficient increased to −0.738. When the cut-off point for positive and negative irritation was set at MAS of 15 and the predictability of this method was assessed by liner regression line, six substances (two acids, two alkanolamines and two alcohols) were false negative. Through this project, it appeared that CornePack, supplied in kit form with frozen secondary cultured cell in serum-free medium, could provide an effective, highly sensitive and simple preliminary screen for determining the cytotoxicity of substances. These results suggested that CornePack might have the potential to predict the MAS if definite criteria can be established for the compounds to be applicable. However, it is important to understand the nature of CornePack responses since its NR 50 profile was quite different from other cytotoxicity assays.

Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (8) Evaluation of cytotoxicity tests on SIRC cells

Two common assays, the neutral red uptake assay (SIRC–NRU) and the crystal violet staining assay (SIRC–CVS), were evaluated as alternatives to the Draize eye irritation test (Draize test).The cytotoxicity of thirty-eight cosmetic ingredients as well as a physiological saline solution was determined on SIRC cells at five to seven laboratories. SIRC–NRU and SIRC–CVS were performed according to the common standard operating procedure (SOP). The 50% effective concentration (EC 50) was determined for each ingredient. The EC 50 of SIRC–CVS was similar to that of SIRC–NRU, showing a strong correlation (r=0.995). The coefficient of variation (CV) of EC 50 which represents the interlaboratory reproducibility of SIRC–NRU was 32.1%, whereas that of SIRC–CVS was 32.8%. The logarithmically transformed EC 50 values showed a strong correlation with the maximal average Draize total score (MAS) (SIRC–NRU: r=−0.816 (n=30), SIRC–CVS: r=−0.805 (n=29)). Both methods could be applied to water-insoluble substances and dyes. However, strong acids, alkanolamines and alcohols had a tendency to deviate from the linear regression lines which were obtained from the in vivo and in vitro data for both methods in the present study. These results suggest that cytotoxicological testing on SIRC cells may provide an alternative method to the Draize test for cosmetic ingredients.

Validation of Speciated Nonmethane Hydrocarbon Compound Data Collected During the 1992 Atlanta Intensive as Part of the Southern Oxidants Study (SOS)

Abstract Volatile hydrocarbons play an important role in the photochemical formation of tropospheric ozone, especially in urban atmospheres. In order to assess the significance and relative impact of biogenic and anthropogenic hydrocarbon emissions as precursors of ozone formation, a program to monitor a suite of 56 common nonmethane hydrocarbons (NMHCs), the 1992 Atlanta Intensive, was implemented as part of the Southern Oxidants Study (SOS). During the last decade, Atlanta has averaged approximately 12 days of ozone nonattainment per year, typically occurring in summer during periods of air stagnation. Under current EPA guidelines, this classifies the Atlanta metropolitan area as having a serious ozone nonattainment problem. This study constituted a significant example of an intensive data collection effort for NMHCs. Three independent laboratory groups using a common standard operating procedure were involved in the analysis of both time integrated (hourly) and discrete canister samples collected over ...