DRU Cymru Central Laboratory · 2019-05-22 · DRU Cymru Laboratory Originally based in Cardiff in...
Transcript of DRU Cymru Central Laboratory · 2019-05-22 · DRU Cymru Laboratory Originally based in Cardiff in...
DRU Cymru Central Laboratory
Dr Gareth Dunseath, Manager – Accredited Central Laboratory
DRU Cymru Central Laboratory
DRU Cymru Laboratory
Originally based in Cardiff in Llandough Hospital then UHW before relocating to Swansea University in 2010
Currently housed in the Grove Building, Swansea University, Singleton Campus since mid-2017
DRU Cymru Central Laboratory
The Lab team- who are we?
Lab Director Prof Steve Luzio
Lab Manager Dr Gareth Dunseath
Quality Facilitator Dr Charlotte Jones
Lab Project Manager Dominic Bright
Molecular Biology Dr Sarah Prior / Dr Rachel Churm
DRU Cymru Central Laboratory
Our aim
to provide a high quality service specialising in tests relevant to diabetes and endocrinology research. In addition tothis analysis service, we are able to support the development and testing (including validation) of new devices.
What we can provide:
• Setup advice
• Provision of sample collection kits with sample labels
• Sample collection / Lab manuals
• Sample transport arrangement (ambient / chilled / frozen)
• Sample analysis using a variety of methods
• Customised results reporting
• Sample storage at -20 / -80°C in freezers linked to temperature loggers and alarms
• Biobanking
DRU Cymru Central Laboratory
Good Clinical and Laboratory Practice (GCLP) Accreditation
• Demonstrates that the DRU Cymru Lab complies with Good Clinical andLaboratory Practice (a quality system for laboratories analysing samples fromClinical Trials) and operates to a standard that maintains patient confidentialityand ensures their rights while also demonstrating the reliability, quality andintegrity of the data that we produce.
• GCLP Accreditation first achieved in 2007 following a 2 day external audit
• Successfully re-accredited in 2008/9 2011, 2012, 2014, 2016 and early 2019
DRU Cymru Central Laboratory
What does GCLP cover?
• Samples
• Equipment
• Analysis
• Quality control
• Results reporting
• Project management
• Staff training
• Audits
• Logistics
• Contracts/agreements
DRU Cymru Central Laboratory
Facilities- Technology available
• Clinical Chemistry analyser • Fully automated• Semi automated
• HPLC Laboratory HbA1c analyser
• Glucose/lactate analyser (‘Gold Standard’ method)
• Automated ELISA workstations
• ELISA photometric plate reader
• Chemiluminescence plate reader
• Point of Care Analysers (PoCT)• Hba1c• Urinalysis
• Fridges/Freezers (-20 and -80°C)
• 24/7 external temperature monitoring with alarms (via text /email)• Sample tracking and barcoding software
DRU Cymru Central Laboratory
Facilities- Technology available
• Sample tracking/logging software with barcoding
• Exact location and details of individual samples recorded- allows us to comply with HTA regulations
DRU Cymru Central Laboratory
Facilities- Technology available
External temperature monitoring
Results constantly uploaded to a websiteallowing a ‘live’ view of the temperatures
DRU Cymru Central Laboratory
Facilities- Technology available
External temperature monitoring
When things go wrong:
When temperatures are outsidepre-set limits, text and email alertsare sent to all lab users
DRU Cymru Central Laboratory
Lab manuals
Customised lab manuals with instructions/details for study teams (including e.g. sample collection details, storage, sample shipping, stock ordering etc.)
DRU Cymru Central Laboratory
Results reporting
• Customised to suit the needs of the client:
• Single, signed results sheets through to large spreadsheets
• All results are verified by a second lab member before submission
Participant
ID
Visit
number
Sample
timepoint
Glucose Insulin C-
peptide
Cortisol NEFA D-
Hydroxybutyrate
mmol/L pmol/L pmol/L ng/ml mmol/l mmol/l
DRU Cymru Central Laboratory
Who do we work with?
Collaborations with / support to:
• Universities
• NHS
• Pharmaceutical companies
• Diagnostics and Device manufacturers
• Other SMEs
DRU Cymru Central Laboratory
Study support
Currently we are providing laboratory support to around 15 diverse studies, both in set-up and ongoing:
• 2 large multicentre studies in T1DM (UK wide)
• 1 study with 2 study sites (Cardiff/Sweden)
• Nutritional study (Sri Lanka)
• Technology development/validation study with Welsh SME
• 2 studies leading to PhD
• Biomarker study in Gestational Diabetes Mellitus
• Development of a novel treatment for managing T2DM using faecal microbiota transplantation
• Cardiovascular health in prison population
DRU Cymru Central Laboratory
Studies supported – Clinical Trials
Closed Loop from Onset in type 1 Diabetes - ‘CLOuD’
Assessing the effect of closed loop insulin delivery from onset of T1DM in youth on residual beta-cell function versus standard insulin therapy
• NIHR EME funded study
• Multicentre study aiming to recruit approximately 100 participants
• Newly diagnosed with T1DM and aged less than 18
• Each participant in study for 2 years (plus 1 year extension)
• DRU Cymru Lab providing sample collection equipment (tubes, labels, lab manuals etc)
• Organising periodic frozen sample collection from sites using courier service
• Analysing HbA1c (every 3 months) and C-peptide and glucose from MMTT (every 6 months)
• So far analysis on over 1200 glucose and C-peptide samples and almost 500 HbA1c samples
DRU Cymru Central Laboratory
Studies supported – Clinical Trials
USTEKID study
Phase II multi-centre, double-blind, randomised trial of Ustekinumab in adolescents with new-onset type 1 diabetesto determine the efficacy of Ustekinumab for preserving Mixed Meal Tolerance Test (MMTT) stimulated 2-hour insulin C-peptide area under the curve (AUC) at week 52 as compared to placebo.
• NIHR EME funded study
• Multicentre study aiming to recruit approximately 72 participants
• Newly diagnosed with T1DM and aged less than 18
• Dosed within first 100 days of diagnosis
• DRU Cymru Lab measuring eligibility screening samples for beta-cell autoantibodies and MMTT C-peptide levels
• Batch analysing additional autoantibody samples, HbA1c, MMTT samples and dried blood spot C-peptide levels
• As of 2nd May, 6 participants randomised
DRU Cymru Central Laboratory
Studies supported – Device Trials
Study of the Accuracy of the SmartSensor telemed (SSt) Oral Glucose Tolerance Test (OGTT) Device
Single use, disposable OGTT device, offering the potential for an OGTT to be performed at home / community setting
• All instructions provided
• Device has 2 glucose dehydrogenase strips (0 hour and 2 hour)
• User activated buttons
• Procedure driven by internal clock/timer with audible and visible prompts
• Results not displayed but stored on a detachable data record
Long term relationship with manufacturer, have worked on several previous version of the device
DRU Cymru Central Laboratory
Study of the Accuracy of the SmartSensor telemed (SSt) Oral Glucose Tolerance Test (OGTT) Device
to determine the accuracy of the SSt OGTT Device in comparison to two laboratory reference methods using blood samples obtained during an OGTT
• 100 participants (with and without glucose intolerance)
• Attended Joint Clinical Research Facility (JCRF) having fasted overnight
• At time 0, a fingerprick blood sample was taken and applied to the 0 hour glucose strip
• A corresponding venous glucose sample taken for reference laboratory glucose measurement (2 analysers)
• A 75 gram glucose drink was consumed
• Process repeated after 2 hours
• Data record removed, scanned and results uploaded to a database
• Results and diagnosis compared to reference laboratory
DRU Cymru Central Laboratory
Published in Diabetic Medicine April 2019
Results
• Easy to use with 98% success rate
• Excellent agreement between device and reference laboratory analyser
glucose concentrations
• Excellent agreement between device and reference laboratory diagnosis
Glucose
intolerant by:
Device
N Sensitivity Specificity
FPG
(≥6.1mmol/l)
98 1.000 0.988
2 hour PG
(≥7.8mmol/l)
96 0.900 0.987
DRU Cymru Central Laboratory
Studies supported – Device Trials
Glucose meter studies to International Organisation for Standardisation (ISO) guidelines
When used properly glucose monitoring may allow the user to take action to control the amount of glucose present in the blood
DRU Cymru Central Laboratory
Glucose meter studies to ISO guidelines
e.g. • Menarini• GlucoRx• Agamatrix• Mendor
Why is this needed?
New ISO guidelines (ISO15197) have been introduced to establish acceptable performance
95% of individual glucose meter results should fall within ± 15% of the ‘gold standard’ measurement procedure at glucose concentrations ≥5.55 mmol/L
and/or 95% with ± 0.83 mmol/L of the ‘gold standard’ measurement procedure at glucose concentration <5.55 mmol/L
DRU Cymru Central Laboratory
To determine the system accuracy of blood glucose meters in comparison to the laboratory reference method
What is done for the study?
1. Approximately 100 volunteers recruited to allow glucose concentrations to cover a wide concentration range
2. Fingerprick performed using a lancet
3. Capillary blood collected into a capillary collection tube
• Centrifuge
• Measure glucose on reference laboratory analyser
4. Multiple measurements made on study glucose meters
5. Repeat step 3
6. Accept results if the 2 reference laboratory glucose results are within 0.22mmol/L (at glucose concentrations
<5.55mmol/L) or within 4% (glucose concentrations ≥5.55mmol/L)
7. Data assessed by ‘bias’ and in ‘error grids’
DRU Cymru Central Laboratory
Example results
DRU Cymru Central Laboratory
Alternative sampling techniques
Finding ways to increase the convenience and comfort of collecting samples from patients and study participants, especially when samples are required at multiple visits over an extended period of time
• Typically many tests require a venous blood sample
• Require trained staff for sample collection
• Participant needs to attend a clinical site for each sample collection
Currently DRU Cymru Lab are investigating alternative methods of sample collection for some of our more common biological markers, including different sample types (e.g. capillary blood and urine) and also ‘microsampling’ methods, where very small ‘fingerprick’ capillary blood samples are collected onto specialised collection devices.
• Can these samples be collected easily by participants from home?
• Can these samples be sent to DRU Cymru Lab through the postal system without any stability issues?
• What new markers can be measured from samples collected in this way?
DRU Cymru Central Laboratory
Alternative sampling techniques
‘Fingerprick’ capillary blood
• Dried Blood spots (DBS)
• Volumetric Absorptive Microsampling (VAMS™) - Mitra®
DRU Cymru Central Laboratory
Contact details:
Diabetes Research Unit Cymru Laboratory Ground floor, Grove buildingSwansea UniversitySingleton ParkSwanseaSA2 8PP
www.diabeteswales.org.uk/en/lab
DRU Cymru Central Laboratory