October 1 2016 Executive summary 162000 stored samples have been identified 28000 are stored in Liberia 58000 in Guinea 33000 in Sierra Leone and 42000 stored outside ID: 731763
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Slide1
Biobanking of Ebola samples
October 1,
2016Slide2
Executive summary
~162,000
stored samples
have been identified.
~
28,000
are stored in Liberia,
~58,000 in Guinea, ~33,000 in Sierra Leone and ~42,000 stored outside the affected countriesThere are ~15,000 positive examples identified to dateThere are ~5,500 survivor samples identified to dateToday, survivor samples originate largely from survivor programs and studies. In the future additional survivor samples could be identified as samples from routine care are linked to other data sources (death registries, ETU records, etc.)There are ~55,000 stored research samples identified to date. ~85% of research samples reside inside affected countriesThere are urgent needs around short-term sample preservationShort-term sample preservation is tenuous. Nearly all facilities lack a backup freezer. No labs have equipment failure emergency plans (no dry ice, no backup lab). Inconsistent fuel supply can also threaten sample preservationWHO has identified key action items in five areas, includingEnsuring current laboratories have back-up systems (deep freezers, etc.) to preserve samplesSupporting conversations on which samples need preservation for future researchConvening donors and country leaders to determine biobank locations and fundingEnsuring high quality inventory management will be in place at biobanksSetting the ethical foundation for biobank samples deployed in future research Experience during the Ebola epidemic points to key lessons for laboratory capacity that can be applied to future outbreaksLaboratory coordination committees should be formed to agree on diagnostic approaches, assist in validation of new equipment, and increase communication across labsLaboratory human resources must be strengthened. Technicians must be rapidly trained in diagnostic methods and safe handling of samples. Additional individuals need to be educated in microbiology, virology, and the related sciences to build this cadre long-termAfter an epidemic, countries need maintenance plans for “inherited” equipment from global partners, so that donor investments in equipment are not lostThere must be plans to restore laboratory operations for other diseases after an epidemic strikes
EXECUTIVE SUMMARY
SEPT 1, 2016Slide3
Contents
Project objectives and rationale
Summary
of
findings
Key
action items
L
essons
for future epidemicsSlide4
The objectives of the WHO project were to
support
sample
preservation and inform future research strategy
Primary objective
PROJECT OBJECTIVES AND RATIONALE
Areas of impact
Objectives
Guide immediate sample preservation measures
Create a comprehensive repository of all samples stored in country to estimate and plan short-term storage measures in addition to long-term biobank strategy
A
Provide inputs into
future research
strategy discussions
Understand quantity, type, and basic characteristics of samples (e.g. results) to enable any future discussions on research priorities for the samples
BSlide5
To achieve the two objectives, WHO collected
the
following Ebola samples information
PROJECT OBJECTIVES AND RATIONALE
Information desired and rationale
Guide immediate sample preser-vation measures
Research strategy
Information being collected
Virulence of
samples
Marker of “hot samples” (e.g. positive
test for Ebola)
Quantity of biological samples to estimate storage capacity
Number of total biological samples in each lab
Samples with antibodies for vaccine research
Earmark “survivor” samples and “hot samples”
Samples with virus for vaccine/medical research
Earmark of “hot samples”
Patient samples receiving different treatments and/or vaccination for possible future meta-analyses
Designate samples obtained in routine screening and care (Ebola treatment units, community screening etc.) versus research studies (e.g. vaccine trial, therapeutic trial, or observational study)
A
BSlide6
Contents
Project objectives and rationale
Summary of
findings
Key
action items
L
essons
for future epidemicsSlide7
Number of samples
c
The
vast majority
(~75%)
of samples
remain in the country where they were originally collected
Slightly more than half (~55%) of all samples were collected in research and clinical trials1 There are approximately 162,000 stored Ebola samples identified
Total
161,771
Sent out of Sierra Leone
10,271
3
Remain
in Sierra Leone
33,395
2
5,593
58,407
Sent out
of Guinea
29,497
Remain in Guinea
Sent out
of Liberia
2,680
840
Remain in Liberia
27,521
1 55
% includes only samples identified as collected either from research/clinical trials or routine screening and care. It does not include the “Unknown” category of samples
2
Sierra Leone samples were not designated as collected in research/clinical trials versus routine screening and care
3
There are other labs in Sierra Leone that sent samples out of the county, but the number of samples were not
specified
SUMMARY OF FINDINGS
SEPT 1,
2016
Unknown
2
Samples collected
in research and
clinical trials
Samples collected in routine screening and
care (from Ebola treatment units, other
health facilities, community screening, etc.)
Current physical location of sample
Country where sample originally collected
Sierra Leone
Guinea
LiberiaSlide8
Number of samples
c
1 Percentages only include samples where positive, negative, or survivor designation is known. “Unknown” category is not included in these
percentages
There are other labs in Sierra Leone that sent samples out of county, but the number of samples were not
specified
The vast majority of stored samples
tested negative for EVD
27,521
920
161,771
3,539
Sent out of Liberia
Sent out of Guinea
2,680
29,497
Remain in
Guinea
58,407
5,095
Remain
in Liberia
993
9,603
3
1,470
Total
Remain
in Sierra Leone
22,007
6,360
99,211
5,510
33,395
10,271
2
Sent out
of Sierra Leone
SUMMARY OF FINDINGS
Tested negative for Ebola
Tested positive for Ebola
Samples from Ebola survivors
Unknown
SEPT 1,
2016
~15,000 samples tested positive for Ebola (~13% of all stored samples
1
)
~5,500 stored samples are identified coming from Ebola survivors (~5% of all samples
1
)
Current physical location of sample
Country where sample originally collected
Sierra Leone
Guinea
LiberiaSlide9
Contents
Project objectives and rationale
Summary
of
findings
Key action items
L
essons for future epidemicsSlide10
Key action items for WHO and country stakeholders
Long-term
Research
ethics
Time frame
Key area
Short-term
Short-term back-up for high risk labs
1
Biobank
structure
3
Inventory
management
4
Rationalize
samples to store
2
Objective of WHO actions
Targeted support to preserve the highest priority samples at current labs before full
biobank
creation
Develop a sustainable plan for bio-banking samples:
Decide degree of storage consolidation desired
Select location(s) for storage
Identify and install needed infrastructure and equipment
Establish common protocols across
biobank
(s) to access samples for future research
Determine where samples should be inventoried (at current facilities or after transport to
biobank
)
Prioritize key samples to store in the
biobank
(s)
Ensure consent for samples obtained in routine care
Understand current consent for research samples and broaden consent where appropriate
5
KEY ACTION ITEMSSlide11
Contents
Project objectives and rationale
Summary
of
findings
Key
action items
L
essons
for future epidemicsSlide12
The Ebola epidemic reveals key laboratory lessons for
future outbreaks (1/3)
LESSONS FOR FUTURE EPIDEMICS
Lab coordination during the outbreak
Samples sent out of country
Material transfer agreements (MTAs)
should facilitate a clear understanding of the number and types of samples leaving the country
Researchers should report in near-real time the number and types of samples being sent, to improve visibility for country leadershipThe use and fate of samples (e.g. stored indefinitely or eventually destroyed) should be clearly definedResearchers should clearly define opportunities for mutual benefit, includingWhere appropriate, leaving some samples in-country for capacity buildingTraining of local workers
Countries should have a
laboratory coordination committee
During the epidemic, laboratory directors meet in person once weekly
Committee agrees on common diagnostic approachesMembers quickly elevate challenges, e.g. request assistance validating results of new laboratory equipment
Standard operating procedures are developed and sharedSlide13
The Ebola epidemic reveals key laboratory lessons
for future outbreaks (2/3)
LESSONS FOR FUTURE EPIDEMICS
Equipment
mainte-nance
Countries should enact
centralized maintenance programs
for equipmentA list of maintained equipment models and manufacturers should be establishedSimplified supply chains of spare parts can thus be maintainedEquipment technicians should train in maintenance and calibration of supported models, and be centrally deployed when neededCountries can require or request that external partners purchase preferred equipment modelsHuman resources
Skilled
laboratory human resources
are a critical gapDuring an epidemic, training programs should be rapidly deployed to all laboratories, with refresher training and regular follow-up assessmentWorker personal protective equipment should be provided; laboratory workers should be educated on its use
Field-workers should receive intensive training and auditing of how they label and secure samplesOver the long term, more workers should be educated in the laboratory sciencesSlide14
The Ebola epidemic reveals key laboratory lessons
for future outbreaks (3/3)
Affected countries need plans to
resume (and ideally maintain) normal laboratory capacity
during outbreaks
Reference
labs need active communication plans (through lab coordination committees or direct visits to country laboratories) to increase sample referrals
After epidemics, laboratories need to redirect human resources back to routine diagnostic testsReagents for routine tests, which often expired during the epidemic, need to be reordered Restoring operations after the epidemicLESSONS FOR FUTURE EPIDEMICSEthics and consentAfter the epidemic, a process for ensuring a strong ethical basis for the use of biobank samples should be pursued. This includes Creating / strengthening country ethics boards to align on consent processes for future research proposals
Deciding whether to pursue consent proactively for all samples collected during the epidemic. Options for proactively pursuing consent areFor samples obtained in routine care, eitherLocate all individuals who provided samples to obtain direct consent, orPublicize intent to deploy samples for
biobank research. Open period of public discussion / comment
For research samples, document current research consent. Approach IRBs / subjects where consent amendment could be considered