DNA Microarray Technology as a Tool for Regulatory Risk Assessment

2011 ◽  
Vol 39 (5) ◽  
pp. 427-428
2017 ◽  
Vol 68 (11) ◽  
pp. 2546-2550
Author(s):  
Monica Licker ◽  
Andrei Anghel ◽  
Roxana Moldovan ◽  
Elena Hogea ◽  
Delia Muntean ◽  
...  

Antimicrobial resistance (AMR) represents a real burden for the modern medicine. One of the most frecvently isolated hospital acquired (HA) pathogens wordlwide, is Methicillin resistant Staphylococcus aureus (MRSA). Recently not only HA, but also community-acquired MRSA (CA-MRSA) infections have been reported. A prospective study was performed between February 2009 and October 2010, with the aim to investigate bacterial resistance of CA-MRSA and HA-MRSA. DNA microarray technology has been used for the detection of 4 AMR genes for the studied MRSA strains. A number of 218 HA- S.aureus strains have been isolated, from which 89 (40. 82%) were MRSA. In the community, 1.553 S.aureus strains were isolated, out of which, 356 (22. 92%) were MRSA. From these, a number of 17 HA and 12 CA �MRSA strains have been analyzed by DNA microarray technology. From 100% phenotypically described HA- MRSA, we identified mecA gene in 10 strains (58. 83%). Other 6 strains (35. 29%) have been erm(A) positive and 4 (23. 53%) - tet(O) positive. 83. 33% (10 strains) from the CA strains had mecA gene, only one (8. 33%) was erm(A) positive and 4 (33. 33%) were erm(C) positive. DNA microarray is a method allowing the concomitant scan of multiple genes and can be done within a few hours. That type of rapid and reliable methods for antimicrobial sensitivity tests are important to start an appropriate therapy.


CNS Spectrums ◽  
2009 ◽  
Vol 14 (1) ◽  
pp. 19-35 ◽  
Author(s):  
Jose de Leon ◽  
Margaret T. Susce ◽  
Maria Johnson ◽  
Mike Hardin ◽  
Lorraine Maw ◽  
...  

ABSTRACTIntroduction: An important technological advance in genetic testing is the DNA microarray, which allows for the simultaneous testing of thousands of DNA sequences. The AmpliChip CYP450 Test employs this microarray technology for cytochrome P450 (CYP) 2D6 and CYP2C19 genotyping. Isoenzymes encoded by these genes are responsible for the metabolism of many widely prescribed drugs. The objectives of this study were to identify CYP2D6 and CYP2C19 alleles and phenotypes in a psychiatric patient population in Kentucky, and to describe practical issues associated with DNA microarray technology.Methods: A total of 4,532 psychiatric patients were recruited from three state hospitals in Kentucky. Whole blood, buccal swabs, or saliva samples were genotyped with the AmpliChip CYP450 Test to derive a predicted phenotype.Results: In this cohort, the overall prevalence of CYP2D6 poor metabolizers was 7.6% (95% CI 7%, 8.3%), 8.2% in the Caucasians (95% CI 7.4%, 9.1%) and 1.8% in the African Americans (95% CI 0.9%, 3.5%). The overall prevalence of CYP2D6 ultrarapid metabolizers was 1.5% (95% CI 1.2%, 1.9%), 1.5% in the Caucasians (95% CI 1.1%, 1.9%) and 2.0% in the African Americans (95% CI 1.1%, 3.7%). The overall prevalence of CYP2C19 poor metabolizers was 2.0% (95% CI 1.8%, 2.7%), 2.2% in Caucasians (95% CI 1.6%, 2.5%) and 4.0% in African Americans (95% CI 2.6%, 6.1%).Conclusion: We also propose a numeric system for expression of CYP2D6 and CYP2C19 enzyme activity to aid clinicians in determining treatment strategy for patients receiving therapeutics that are metabolized by the CYP2D6 or CYP2C19 gene products.


2021 ◽  
Author(s):  
John W Green ◽  
Manousos Foudoulakis ◽  
Timothy Fredricks ◽  
Tiffany Carro ◽  
Jonathan Maul ◽  
...  

Abstract Avian reproduction studies for regulatory risk assessment are undergoing review by regulatory authorities, often leading to requests for statistical re-analysis of older studies using newer methods, sometimes with older study data that do not support these newer methods. We propose detailed statistical protocols with updated statistical methodology for use with both new and older studies and recommend improvements in experimental study design to set-up future studies for robust statistical analyses. There is increased regulatory and industry attention to the potential use of benchmark dose (BMD) methodology to derive the point of departure in avian reproduction studies, to be used as the endpoint in regulatory risk assessment. We present benefits and limitations of this BMD approach for older studies being re-evaluated and for new studies designed for with BMD analysis anticipated. Model averaging is recommended as preferable to model selection for BMD analysis. Even for a new study following the modified experimental design analyses with BMD methodology will only be possible for a restricted set of response variables. The judicious use of historical control data, identification of outlier data points, increased use of distributions more consistent with the nature of the data collected as opposed to forcing normality-based methods, and trend-based hypothesis tests are shown to be effective for many studies, but limitations on their applicability are also recognized and explained. Updated statistical methodologies are illustrated with case studies conducted under existing regulatory guidelines that have been submitted for product registrations. Through the adoption of improved avian reproduction study design elements combined with the suggested revised statistical methodologies the conduct, analyses, and utility of avian reproduction studies for avian risk assessments can be improved.


2004 ◽  
Vol 169 (8) ◽  
pp. 654-659 ◽  
Author(s):  
Sorin Draghici ◽  
Dechang Chen ◽  
Jaques Reifman

2016 ◽  
Vol 10 (1) ◽  
pp. 176-182 ◽  
Author(s):  
Reza Ranjbar ◽  
Payam Behzadi ◽  
Caterina Mammina

Background:Francisella tularensis(F. tularensis) is the etiological microorganism for tularemia. There are different forms of tularemia such as respiratory tularemia. Respiratory tularemia is the most severe form of tularemia with a high rate of mortality; if not treated. Therefore, traditional microbiological tools and Polymerase Chain Reaction (PCR) are not useful for a rapid, reliable, accurate, sensitive and specific diagnosis. But, DNA microarray technology does. DNA microarray technology needs to appropriate microarray probe designing.Objective:The main goal of this original article was to design suitable long oligo microarray probes for detection and identification ofF. tularensis.Method:For performing this research, the complete genomes ofF. tularensissubsp.tularensisFSC198,F. tularensissubsp.holarcticaLVS,F. tularensissubsp.mediasiatica,F. tularensissubsp.novicida(F. novicidaU112), andF. philomiragiasubsp.philomiragiaATCC 25017 were studiedviaNCBI BLAST tool, GView and PanSeq Servers and finally the microarray probes were produced and processedviaAlleleID 7.7 software and Oligoanalyzer tool, respectively.Results:In thisin silicoinvestigation, a number of long oligo microarray probes were designed for detecting and identifyingF. tularensis. Among these probes, 15 probes were recognized as the best candidates for microarray chip designing.Conclusion:Calibrated microarray probes reduce the biasis of DNA microarray technology as an advanced, rapid, accurate and cost-effective molecular diagnostic tool with high specificity and sensitivity. Professional microarray probe designing provides us with much more facility and flexibility regarding preparation of a microarray diagnostic chip.


Data ◽  
2019 ◽  
Vol 4 (3) ◽  
pp. 98 ◽  
Author(s):  
Kathleen A Lewis ◽  
John Tzilivakis

Pollination services are vital for agriculture, food security and biodiversity. Although many insect species provide pollination services, honeybees are thought to be the major provider of this service to agriculture. However, the importance of wild bees in this respect should not be overlooked. Whilst regulatory risk assessment processes have, for a long time, included that for pollinators, using honeybees (Apis mellifera) as a protective surrogate, there are concerns that this approach may not be sufficiently adequate particularly because of global declines in pollinating insects. Consequently, risk assessments are now being expanded to include wild bee species such as bumblebees (Bombus spp.) and solitary bees (Osmia spp.). However, toxicity data for these species is scarce and are absent from the main pesticide reference resources. The aim of the study described here was to collate data relating to the acute toxicity of pesticides to wild bee species (both topical and dietary exposure) from published regulatory documents and peer reviewed literature, and to incorporate this into one of the main online resources for pesticide risk assessment data: The Pesticide Properties Database, thus ensuring that the data is maintained and continuously kept up to date. The outcome of this study is a dataset collated from 316 regulatory and peer reviewed articles that contains 178 records covering 120 different pesticides and their variants which includes 142 records for bumblebees and a further 115 records for other wild bee species.


Author(s):  
Krishnamurthy Natarajan ◽  
Matthew J. Marton ◽  
Alan G. Hinnebusch

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