Clinical trials of new culture media for staphylococcus isolation

2021 ◽  
Vol 66 (2) ◽  
pp. 115-121
Author(s):  
O. V. Polosenko ◽  
A. P. Shepelin ◽  
N. I. Azhermacheva ◽  
I. V. Abaev
Keyword(s):  
Growth Rate ◽  
Clinical Trials ◽  
Culture Media ◽  
Clinical Samples ◽  
Biological Parameters ◽  
Nutrient Media ◽  
Testing Laboratory ◽  
Statistical Reliability ◽  
And Control

A comparative analysis of the quality of the developed nutrient media, Baird-Parker dry agar base and Vogel-Johnson dry agar Base and foreign analogues, was done based on results of clinical trials. The tested media were qualified by the main biological parameters, such as sensitivity, growth rate, and differentiating and inhibiting properties. The evaluation of statistical reliability of the results of trials of clinical samples was evaluated taking into account the number of parallel studies and the number of matches of the results of studies conducted by different performers. 116 clinical samples of received by a laboratory of the testing laboratory center for research from hospital no.164 over the period of clinical trials were analyzed. 46 cultures of potential pathogens were isolated when culturing on test and control media: S. aureus -35; S. epidermidis-6; S. saprophyticus - 5. Lecithinase activity on the medium “Baird-Parker dry agar Base” and mannitol fermentation on the medium “Vogel-Johnson dry agar Base” in the preliminary phenotypic test allow the isolation and differentiation of clinical isolates of S. aureus from S. epidermidis, and S. saprophyticus.

scholarly journals National control laboratory independent lot testing of COVID-19 vaccines: the UK experience

npj Vaccines ◽  
2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Nicola J. Rose ◽  
Paul Stickings ◽  
Silke Schepelmann ◽  
Marc J. A. Bailey ◽  
Chris Burns
Keyword(s):  
Clinical Trials ◽  
Vaccine Development ◽  
Regulatory Approval ◽  
Safety Measures ◽  
Discovery Research ◽  
Innovative Products ◽  
The Uk ◽  
Vaccine Availability ◽  
And Control

AbstractThe past 18 months have seen an unprecedented approach to vaccine development in the global effort against the COVID-19 pandemic. The process from discovery research, through clinical trials and regulatory approval often takes more than 10 years. However, the critical need to expedite vaccine availability in the pandemic has meant that new approaches to development, manufacturing, and regulation have been required: this has necessitated many stages of product development, clinical trials, and manufacturing to be undertaken in parallel at a global level. Through the development of these innovative products, the world has the best chance of finding individual, or combinations of, vaccines that will provide adequate protection for the world’s population. Despite the huge scientific and regulatory achievements and significant investment to accelerate vaccine availability, it is essential that safety measures are not compromised. Here we focus on the post regulatory approval testing by independent laboratories that provides an additional assurance of the safety and quality of a product, with an emphasis on the UK experience through the National Institute for Biological Standards and Control (NIBSC), an expert centre of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

scholarly journals Commutability of reference and control materials: an essential factor for assuring the quality of measurements in Laboratory Medicine

2019 ◽  
Vol 57 (7) ◽  
pp. 967-973 ◽  
Author(s):  
Federica Braga ◽  
Mauro Panteghini
Keyword(s):  
External Quality Assessment ◽  
Prediction Interval ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Clinical Samples ◽  
Essential Factor ◽  
Common Reference ◽  
And Control ◽  
Selection Of

Abstract Traceability to a common reference ensures equivalence of results obtained by different assays. Traceability is achieved by an unbroken sequence of calibrations, using reference materials (RMs) that must be commutable. Using non-commutable RMs for calibration will introduce a bias in the calibrated method producing incorrect results for clinical samples (CS). Commutability was defined in 1973 as “the ability of an enzyme material to show inter-assay activity changes comparable to those of the same enzyme in human serum” and later extended as a characteristic of all RMs. However, the concept is still poorly understood and appreciated. Commutability assessment has been covered in CLSI guidelines and requires: (a) selection of 20 CS spanning the relevant concentration range; (b) analysis of both RM and CS with the pair of procedures; (c) data elaboration using regression analysis and calculation if RM fall within the 95% prediction interval defined by CS. This approach has been criticized and to improve it The International Federation of Clinical Chemistry and Laboratory Medicine established a working group that recently finalized recommendations. Commutability is also a requirement for the applicability of external quality assessment (EQA) results in the evaluation of the performance of participating laboratories in terms of standardization of their measurements. Unfortunately, EQA materials are usually not validated for commutability.

Comparative evaluation of nutrient media of Escherichia coli isolating for using in veterinary laboratories

Bacteriology ◽  
2020 ◽  
Vol 5 (2) ◽  
pp. 24-32
Author(s):  
Yu.A. Skomorina ◽  
◽  
A.A. Kremleva ◽  
L.Sh. Akhmetova ◽  
T.V. Podolskaya ◽  
...  
Keyword(s):  
Escherichia Coli ◽  
Key Words ◽  
Comparative Studies ◽  
Comparative Evaluation ◽  
Culture Media ◽  
Biological Properties ◽  
Nutrient Media ◽  
High Productivity ◽  
New Generation

The article is focus on comparative studies of modern differential diagnostic nutrient media for effective cultivation and identification of Escherichia coli. The assessment of the quality of media by biological properties was carried out in accordance with their purpose. Special attention is paid to the new generation of differential diagnostic nutrient media. It was found that the tested media have high productivity and inhibitory properties. New culture media of inland producers are not inferior in terms of the characteristics declared by the manufacturers. In case of methods validation the veterinarian laboratory will be able to use new nutrient media. Key words: nutrient media, Escherichia, productivity, selectivity and specificity

scholarly journals LAJU PERTUMBUHAN IKAN NILA (Oreocromis niloticus) YANG DIPELIHARA DENGAN MENGGUNAKAN SISTEM BIOFLOK DI KABUPATEN SUMBA TIMUR

Marinade ◽  
2021 ◽  
Vol 4 (01) ◽  
pp. 10-15
Author(s):  
Ridwan Meldi Nite ◽  
Nurbety Tarigan
Keyword(s):  
Growth Rate ◽  
Specific Growth ◽  
Heterotrophic Bacteria ◽  
Culture Media ◽  
Inorganic Nitrogen ◽  
Fish Growth ◽  
Passing Rate ◽  
Biofloc Technology ◽  
The Cost

Biofloc technology is a fish culture technology based on the principle of assimilation of inorganic nitrogen (ammonia, nitrite and nitrate) by the microbial community (heterotrophic bacteria) in culture media which can then be used by the cultivated organism as a food source. The use of probiotics in aquaculture is used to control microbes in the water, in the digestive tract of the host, improve the quality of the aquatic environment through the process of biodegradation. Biofloc technology is expected to minimize the cost of feed most spent during tilapia cultivation. The purpose of this activity is to evaluate the growth of tilapia (Oreocromis niloticus) using the biofloc system. The method used is an experimental method. All parameters measured were analyzed descriptively. The results of the growth rate of tilapia maintained for 32 days using the biofloc system are a life-passing rate of 100%, and a specific growth rate of 5.23% with a body weight of 35 grams and a body length of 9.6 cm. Based on this, the biofloc system can provide a maximum fish growth rate.

scholarly journals Outcome of multifaceted interventions for improving the quality of antenatal care in Nigerian referral hospitals

2020 ◽  
Vol 17 (1) ◽  
Author(s):  
Friday Ebhodaghe Okonofua ◽  
Lorretta Favour Chizomam Ntoimo ◽  
Bola Ekezue ◽  
Victor Ohenhen ◽  
Kingsley Agholor ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Antenatal Care ◽  
Trial Registration ◽  
Central Hospital ◽  
Referral Hospitals ◽  
Registration Number ◽  
Multifaceted Interventions ◽  
Clinical Trials Registry ◽  
And Control

Abstract Background The study was designed as quasi-experimental research to investigate the effectiveness of multifaceted interventions for improving the quality of antenatal care in referral hospitals in Nigeria. Two referral hospitals (the Central Hospital in Benin City, South-South Nigeria, and the General Hospital in Minna) served as intervention sites, while two hospitals in comparable locations, (the Central Hospital Warri and the Suleja Hospital Abuja) were the control hospitals. Methods Intervention activities consisted of the introduction of a strategic plan with the shared vision of reducing maternal mortality by 50% in 1 year in the hospitals; staff training and re-training; the establishment of an automated appointment system; composite health education involving couples and providers; advocacy with policymakers; and the implementation of maternal death reviews and surveillance. These activities were implemented in the intervention hospitals over 21 months (October 2017 to June 2019). Exit interviews of pregnant women at intervention and control sites by trained interviewers were used to assess the quality of antenatal care after their visit, A total of 777 women were interviewed (427 in the intervention sites and 350 in the control sites). Data were analyzed with univariate and multivariate Poisson and logistic regression to determine the extent to which health providers in the clinics completed the 18 signal functions identified in the WHO assessment tool. Results The regression analyses showed the interventions were effective in improving six quality indicators (QIs) for counseling and information sharing. The difference between intervention and control sites on these QIs was significant at < 0.05. On the contrary, the interventions were less effective for maternal and fetal measurements; and disease testing and management QIs. Conclusion The positive effects of the interventions are likely due to the effectiveness of the training and health education components. The lack of intervention impact observed for maternal and fetal measurements may be due to the high workload of care staff and inadequate clinic supplies, which we did not address. We conclude that interventions that address the quality of antenatal care in low-resource settings should focus on improving all elements of care, including adequate staffing and mobilization of material resources. Trial registration This study was registered in the ISRCTN on August 14th, 2020. Trial Registration Number. SRCTN17985403. Retrospective registration. The reason for the retrospective registration is the current non-recognition of the Nigeria Clinical Trials Registry (NCTR); which is currently not an ICMJE or WHO ICTRP approved registry. (This study was registered in the Nigeria Clinical Trials Registry on April 14th, 2016. Trial Registration Number NCTR No: 91540209).

In-laboratory quality control of nutrients for automatic bacteriology analyzer YUNON®Labstar 50

2021 ◽  
Vol 66 (2) ◽  
pp. 110-114
Author(s):  
Lyubov Grigorievna Boronina ◽  
E. V. Samatova ◽  
M. P. Kukushkina ◽  
S. A. Panova ◽  
S. S. Ustyugova
Keyword(s):  
Haemophilus Influenzae ◽  
Streptococcus Pyogenes ◽  
Nutrient Medium ◽  
Culture Media ◽  
Enterobacter Cloacae ◽  
Biological Properties ◽  
Nutrient Media ◽  
Biological Technology ◽  
Reference Strains

The quality of culture media for blood culture was checked: nutrient medium for children with an antibiotic neutralizer for the cultivation of aerobes, nutrient medium with an antibiotic neutralizer for the cultivation of anaerobes, a nutrient medium with an antibiotic neutralizer for the cultivation of aerobes, nutrient medium for the cultivation of aerobes UNONA® used in the automatic bacteriological analyzer JUNONA ®Labstar 50 (SCENKER Biological Technology Co., Ltd. China). Used tenfold dilutions from 18-24 hour cultures of reference strains: ATCC 13124 Clostridium perfringens; ATCC 25285 Bacteroides fragilis; NCTC 194I8 Haemophilus influenzae; ATCC 49619 Streptococcus pneumoniae; ATCC 16615 Streptococcus pyogenes; ATCC 27853 Pseudomonas aeruginosa; ATCC 25923 Staphylococcus aureus; ATCC 25922 Escherichia coli; BKPGU-401/-885-653 Candida albicans; ATCC13813 Streptococcus agalactiae; No. 186 Enterobacter cloacae; ATCC 29212 Enterococcus faecalis; clinical isolates: Acinetobacter lwofii, Enterobacter cloacae, Candida tropicalis. All investigated reference strains were isolated on nutrient media in accordance with their biological properties when inoculated with 50 CFU / ml less than 72 hours later, as stated by the manufacturer. The study has shown that growth factors must be used to test the quality of the culture media with Haemophilus influenzae bacteria and this must be reflected in the manufacturer’s instructions.

Comparative analysis of nutrient media for determination of the biochemical properties of Enterobacteria

Bacteriology ◽  
2020 ◽  
Vol 5 (1) ◽  
pp. 41-47
Author(s):  
O.V. Polosenko ◽  
◽  
A.P. Shepelin ◽  
Keyword(s):  
Culture Media ◽  
Biological Properties ◽  
Biochemical Properties ◽  
Comparative Assessment ◽  
Nutrient Media ◽  
Important Condition ◽  
Phenotypic Properties ◽  
Primary Isolation

The stage of identification of microorganisms is one of the most important and time-consuming stages of conducting bacteriological studies. On nutrient media with primary isolation by a combination of biochemical characteristics, several genera of enterobacteria can be detected simultaneously. Therefore, an important condition for the effectiveness of bacteriological studies to isolate representatives of the Enterobacteriaceae family is an adequate selection and quality of culture media. This allows you to determine the phenotypic properties of the grown cultures of microorganisms and correctly identify them. A comparative assessment of the biological properties of a number of modern nutrient media was carried out to determine the cultural-morphological and biochemical properties of enterobacteria. Key words: nutrient media, enterobacteria, phenotypic features, biochemical properties, differentiating properties, selectivity

scholarly journals Breathalyser-Based eHealth Data Suggest That Self-Reporting of Abstinence Is a Poor Outcome Measure for Alcohol Use Disorder Clinical Trials

2020 ◽  
Vol 55 (3) ◽  
pp. 237-245 ◽  
Author(s):  
Markku D Hämäläinen ◽  
Andreas Zetterström ◽  
Maria Winkvist ◽  
Marcus Söderquist ◽  
Patrik Öhagen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Alcohol Use ◽  
Alcohol Use Disorder ◽  
Outcome Measure ◽  
Heavy Drinking ◽  
Control Group ◽  
Significant Difference ◽  
And Control ◽  
Positive Effect

Abstract Aims To evaluate the efficacy and monitoring capabilities of a breathalyser-based eHealth system for patients with alcohol use disorder (AUD) and to investigate the quality and validity of timeline follow-back (TLFB) as outcome measure in clinical trials and treatment. Methods Patients (n = 115) were recruited to clinical trials from a 12-step aftercare programme (12S-ABS) and from hospital care with abstinence (HC-ABS) or controlled drinking (HC-CDR) as goal and randomly divided into an eHealth and a control group. The effect of the eHealth system was analysed with TLFB-derived primary outcomes—change in number of abstinent days (AbsDay) and heavy drinking days (HDDs) compared to baseline—and phosphatidyl ethanol (PEth) measurements. Validity and quality of TLFB were evaluated by comparison with breath alcohol content (BrAC) and eHealth digital biomarkers (DBs): Addiction Monitoring Index (AMI) and Maximum Time Between Tests (MTBT). TLFB reports were compared to eHealth data regarding reported abstinence. Results The primary outcome (TLFB) showed no significant difference between eHealth and control groups, but PEth did show a significant difference especially at months 2 and 3. Self-reported daily abstinence suffered from severe quality issues: of the 28-day TLFB reports showing full abstinence eHealth data falsified 34% (BrAC measurements), 39% (MTBT), 54% (AMI) and 68% (BrAC/MTBT/AMI). 12S-ABS and HC-ABS patients showed severe under-reporting. Conclusions No effect of the eHealth system was measured with TLFB, but a small positive effect was measured with PEth. The eHealth system revealed severe quality problems with TLFB, especially regarding abstinence—should measurement-based eHealth data replace TLFB as outcome measure for AUD?

Resistance Monitor and Control for Vacuum Evaporation of Metals and Carbon

1976 ◽  
Vol 34 ◽  
pp. 572-573
Author(s):  
Russell L. Steere ◽  
Eric F. Erbe ◽  
J. Michael Moseley
Keyword(s):  
Electronic Device ◽  
Point Sources ◽  
High Contrast ◽  
Variable Resistor ◽  
Quality Of Results ◽  
Low Contrast ◽  
Evaporation Source ◽  
And Control ◽  
At Will

We have designed and built an electronic device which compares the resistance of a defined area of vacuum evaporated material with a variable resistor. When the two resistances are matched, the device automatically disconnects the primary side of the substrate transformer and stops further evaporation.This approach to controlled evaporation in conjunction with the modified guns and evaporation source permits reliably reproducible multiple Pt shadow films from a single Pt wrapped carbon point source. The reproducibility from consecutive C point sources is also reliable. Furthermore, the device we have developed permits us to select a predetermined resistance so that low contrast high-resolution shadows, heavy high contrast shadows, or any grade in between can be selected at will. The reproducibility and quality of results are demonstrated in Figures 1-4 which represent evaporations at various settings of the variable resistor.

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