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Biobanking of Ebola samples

October 1, 2016
EXECUTIVE SUMMARY
Executive summary SEPT 1, 2016

~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 countries
There are ~15,000 positive examples identified to date
There are ~5,500 survivor samples identified to date
Today, 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 countries
There are urgent needs around short-term sample preservation
Short-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 preservation

WHO has identified key action items in five areas, including


Ensuring current laboratories have back-up systems (deep freezers, etc.) to preserve samples
Supporting conversations on which samples need preservation for future research
Convening donors and country leaders to determine biobank locations and funding
Ensuring high quality inventory management will be in place at biobanks
Setting 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 outbreaks
Laboratory coordination committees should be formed to agree on diagnostic approaches, assist in validation of new
equipment, and increase communication across labs
Laboratory 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-term
After an epidemic, countries need maintenance plans for inherited equipment from global partners, so that donor
investments in equipment are not lost
There must be plans to restore laboratory operations for other diseases after an epidemic strikes

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Contents

Project objectives and rationale


Summary of findings
Key action items
Lessons for future epidemics
PROJECT OBJECTIVES AND RATIONALE
The objectives of the WHO project were to support sample
preservation and inform future research strategy
Primary objective

Areas of impact Objectives


Create a comprehensive repository of all samples
stored in country to estimate and plan short-term
Guide
storage measures in addition to long-term
immediate
biobank strategy
A sample
preservation
measures

Understand quantity, type, and basic


characteristics of samples (e.g. results) to enable
Provide any future discussions on research priorities for
inputs into the samples
B future
research
strategy
discussions

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PROJECT OBJECTIVES AND RATIONALE
To achieve the two objectives, WHO collected the
following Ebola samples information
Information desired and
rationale Information being collected
Quantity of biological samples to Number of total biological samples in
Guide estimate storage capacity each lab
immediate
sample
A
preser-
vation Virulence of samples Marker of hot samples (e.g. positive
measures test for Ebola)

Samples with virus for Earmark of hot samples


vaccine/medical research

Samples with antibodies for Earmark survivor samples and hot


vaccine research samples
B Research
strategy
Patient samples receiving Designate samples obtained in routine
different treatments and/or screening and care (Ebola treatment
vaccination for possible future units, community screening etc.) versus
meta-analyses research studies (e.g. vaccine trial,
therapeutic trial, or observational study)

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Contents

Project objectives and rationale


Summary of findings
Key action items
Lessons for future epidemics
SUMMARY OF FINDINGS
There are approximately 162,000 stored Ebola samples identified SEPT 1, 2016

Number of samples Samples collected in routine screening and Samples collected Unknown2
care (from Ebola treatment units, other in research and
health facilities, community screening, etc.) clinical trials

10,2713 161,771
33,3952 10,271

46,280
33,395
29,497 The vast
5,593 majority
6,904 (~75%) of
58,407 17,000 samples
54,772 remain in the
22,240 country where
they were
originally
c
36,167
collected
27,521 2,680
840 60,719 Slightly more
1,840 than half
16,660
(~55%) of all
10,861
samples were
Current physical Remain Sent out Remain Sent out Remain Sent out of Total collected in
location of in Liberia of Liberia in Guinea of Guinea in Sierra Sierra Leone research and
Leone
sample clinical trials1

Country where
sample originally Liberia Guinea Sierra Leone
collected

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

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SUMMARY OF FINDINGS
The vast majority of stored samples tested negative for EVD SEPT 1, 2016

Number of samples Samples from Ebola survivors Tested positive for Ebola Tested negative for Ebola Unknown

10,2712 161,771
33,395 10,271 5,510
5,028 15,116
6,360
29,497 22,007
5,095 ~15,000
samples
24,317 tested positive
58,407
2,575 3,539
99,211 for Ebola
(~13% of all
stored
52,293 samples1)
c ~5,500 stored
27,521 2,680 samples are
1,119 1,470 920 993 identified
767 41,934
15,329 coming from
9,6033 Ebola
Remain Sent out Remain Sent out Remain Sent out Total survivors
Current physical
in Liberia of Liberia in Guinea of Guinea in Sierra of Sierra (~5% of all
location of
Leone Leone samples1)
sample

Country where
sample originally Liberia Guinea Sierra Leone
collected

1 Percentages only include samples where positive, negative, or survivor designation is known. Unknown category is not included in these percentages
2 There are other labs in Sierra Leone that sent samples out of county, but the number of samples were not specified

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Contents

Project objectives and rationale


Summary of findings
Key action items
Lessons for future epidemics
KEY ACTION ITEMS
Key action items for WHO and country stakeholders

Time frame Key area Objective of WHO actions


1 Short-term back- Targeted support to preserve the highest priority
up for high risk samples at current labs before full biobank creation
Short-term
labs

2 Rationalize Prioritize key samples to store in the biobank(s)


samples to store
3 Biobank structure 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
4 Inventory Establish common protocols across biobank(s) to
Long-term
management access samples for future research
Determine where samples should be inventoried (at
current facilities or after transport to biobank)
5 Research ethics Ensure consent for samples obtained in routine care
Understand current consent for research samples and
broaden consent where appropriate

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Contents

Project objectives and rationale


Summary of findings
Key action items
Lessons for future epidemics
LESSONS FOR FUTURE EPIDEMICS
The Ebola epidemic reveals key laboratory lessons for
future outbreaks (1/3)
Countries should have a laboratory coordination committee
Lab During the epidemic, laboratory directors meet in person once weekly
coordination Committee agrees on common diagnostic approaches
during the Members quickly elevate challenges, e.g. request assistance validating
outbreak results of new laboratory equipment
Standard operating procedures are developed and shared
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 leadership
The use and fate of samples (e.g. stored indefinitely or eventually
destroyed) should be clearly defined
Samples Researchers should clearly define opportunities for mutual benefit,
sent out of
including
country
Where appropriate, leaving some samples in-country for capacity building
Training of local workers

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LESSONS FOR FUTURE EPIDEMICS
The Ebola epidemic reveals key laboratory lessons
for future outbreaks (2/3)
Countries should enact centralized maintenance programs for equipment
A list of maintained equipment models and manufacturers should be
established
Equipment
Simplified supply chains of spare parts can thus be maintained
mainte-
Equipment technicians should train in maintenance and calibration of
nance
supported models, and be centrally deployed when needed
Countries can require or request that external partners purchase preferred
equipment models

Skilled laboratory human resources are a critical gap


During an epidemic, training programs should be rapidly deployed to all
laboratories, with refresher training and regular follow-up assessment
Worker 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
Human
label and secure samples
resources
Over the long term, more workers should be educated in the laboratory
sciences

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LESSONS FOR FUTURE EPIDEMICS
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
Restoring
Reference labs need active communication plans (through lab coordination
committees or direct visits to country laboratories) to increase sample
operations
referrals
after the
epidemic After epidemics, laboratories need to redirect human resources back to
routine diagnostic tests
Reagents for routine tests, which often expired during the epidemic, need to
be reordered
After 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
Ethics and during the epidemic. Options for proactively pursuing consent are
consent For samples obtained in routine care, either
- Locate all individuals who provided samples to obtain direct consent, or
- Publicize 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

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