Routine Microbiological Tests for Studies
Microbiology can provide tests for research studies or for a CTIMP (Clinical Trial of Investigational Medical Product). CTIMP studies that look at the safety or efficacy of a medicine/foodstuff/placebo in humans, as defined by the Medicines for Human Use (Clinical Trials) Regulations 2004. They are subject to approval and monitoring by the MHRA (Medicines and Healthcare Regulatory agency).
Most routine microbiology tests can be viewed at Tests and Tubes and can be requested for your study by filling in this form (hyperlink to form).
If you require further information or wish to discuss your requirements, please contact
Ian Cocking, Service Manager
Tel: 0113 3926777
Healthcare Associated Infections (HCAI) research group.
Who we are
The Healthcare Associated Infections (HCAI) Research Group is a bench to bed-side, multi-organisation group, with staff from LTHT, University of Leeds and Public Health England and led by Prof Mark Wilcox. We have an international reputation, notably in Clostridium difficile research, and have expanded into other HCAI research areas. By bringing together scientists, bioinformations, medics and nurses from the University, LTHT and PHE to partner with funding bodies and industry, we have been able to create a broad portfolio of successful studies with a wide reach. We have a significant track record of working with industrial/commercial partners as well as funding bodies.
We are therefore ideally placed to look at the full spectrum of research, from innovative ‘blue skies’ approaches, service development, clinical research and public health outcomes, with each aspect informing the others. We have an extensive portfolio of research studies from laboratory based investigations to clinical studies including NIHR portfolio project/studies, clinical trials, laboratory evaluations and large scale (European-wide) epidemiology and surveillance studies
Epidemiology and surveillance studies
We have several research projects, particularly around C. difficile epidemiology, resistance and prevalence. Please see our UoL Research Project pages for current studies http://medhealth.leeds.ac.uk/info/2931/research_projects
Diagnostic Assay studies
We have access to a number of assay platforms (Dynex DS2 ®, Cepheid GeneXpert ®, BioMerieux Biofire ®) and significant expertise in performing diagnostic assay evaluations and comparisons. Please see our UoL Diagnostic Assay Studies page for current studies
In vitro gut models
We have significant experience in the development and validation of clinically reflective gut models in which to study C. difficile and carbapenemase producing organisms.
In partnership with the pharmaceutical/biotherapeutics industries this has been part of the development and evaluation pathway of a number of antimicrobials/therapeutics.
We have extensive experience in antimicrobial susceptibility testing, particularly of C. difficile and have been involved in the evaluation of novel antimicrobial compounds during the pre-clinical phase and beyond. Please see our uoL Susceptibility testing page http://medhealth.leeds.ac.uk/info/2933/collaboration/2178/susceptibility_testing
Leeds has operated as the PHE UK C. difficile laboratory as part of the C. difficileRibotyping Network (CDRN) (led by Prof. Wilcox) since 2013. As such, the HCAI research group is well placed with extensive access to C. difficilestrains from across the UK. In addition, we hold a large collection of isolates from across Europe.
Whole Genome Sequencing
We have a major collaborative research programme the infection research team in Oxford. This includes the Health Innovation Challenge Fund (HICF) and Healthcare Protection Research Unit (HPRU), exploring the potential of next generation sequencing to transform the diagnosis of infection.
We have provided bioinformatic analysis of the gut microbiome as part of a number of research studies and CTIMPs. We are pleased to discuss any collaborative opportunities or bespoke research projects. Please contact us.
Centralised testing for studies and CTIMPs
We are able to provide central laboratory testing services for clinical trials and studies in C. difficile and other pathogens, drawing on a breadth of knowledge and experience from UoL, LTHT and PHE members of HCIA research staff. We are also able to provide microbiome analysis and data management, transfer and curating, to your requirements. Our staff undergo regular training in good clinical practice (GCP), good clinical laboratory practice (GCLP), good record keeping and information governance. We have clear and controlled policies for any CTIMP work we undertake, reviewed by a formal HCAI governance group and working within LTHT and UoL guidelines.
Our recent CTIMP work can be found here
Equipment and Facilities
Our Containment Level 2 research laboratories house the following pieces of equipment, available for use in testing.
- Class 2 biosafety hood
- -200C and -800C freezers*
- Aerobic and anaerobic incubators (370C)*
- Centrifuges (refrigerated and non-refrigerated)
- Trial-dedicated pipettes
- Media Preparation Facilities
- Autoclave facilities
- DNA extraction and PCR facilities
- Qiagen CLC genomics workbench
- Microbiome analysis pipeline
*Our major pieces of equipment are also electronically monitored on the Tutela system, providing accurate, controlled records.
To discuss requirements as part of central lab testing for Clinical Trials, please contact us
Healthcare Associated Infection Research Group
Old Medical School
Leeds General Infirmary
0113 392 6125