COVID-19

To test or not to test?

Considerations for COVID-19
testing strategies

Sara Barada
Partner - Health Industries
PwC Middle East

April 5, 2020
Purpose & Introduction
This document presents the different diagnostic testing strategies in response to COVID-19 around the globe while shedding
light on the importance of diagnostic testing and the different factors surrounding it and recommending practical measures to
address it moving forward. It is intended for anyone interested in learning about testing strategies, and what these mean, as
well as any individuals involved in response efforts such as government officials and provider organisations, as well as the
general public.
Diagnostic Testing is a critical measure in fighting against the COVID-19 global
pandemic and responding to the current crisis. To date, there are two main
types of diagnostic tests and the WHO has set guidelines for testing eligibility.
However, strategies have varied across countries, ranging from early and
aggressive to delayed and limited which could be due to various constraints
varying from one country to another.

This is the first step in the chain reaction of preparedness and response. There
are valuable lessons learned from the global cases addressed in this report for
regional and global governments and entities involved in response to consider
for developing and refreshing their diagnostic strategy.

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Diagnostic Testing is a critical measure in
The
fighting
pandemic
COVID-19 outbreak
against the COVID-19 has
global The current situation - COVID-19 in numbers
been declared a pandemic by
and responding to the current
crisis.
the World Health Figures as of 14/04/20 11:30am
Organization,
According causing
to WHO, diagnostic huge
testing is critical
to track COVID-19, understand epidemiology, 1,921,369 457,549 14,939,783 185
impact
inform caseon people’s
management and lives,
suppress Confirmed Cases Recovered Tested Countries
families and communities.
transmission.
Confirmed Cases per Country
Together with social distancing diagnostic
Testing
testing is remains
consideredatocritical
be a keymeasure
factor in in 1. United States 582,468
‘flattening the curve’.
fighting against the global pandemic
2. Spain 170,099
and responding
We continue to see to
an the current
increase in thecrisis
number
of cases testing positive every day, with the U.S 3. Italy 159,516
becoming theto
According epicenter
the WHO,of thediagnostic
pandemic.
Meanwhile China and other Asian countries are
testing is critical to track the virus,
showing positive results in containing the virus.
4. France 137,877
understand epidemiology, inform
5. Germany 130,072
case management
Unfortunately, reported and suppress
figures are
underestimated
transmission. as they do not cover the entire
population that could be infected but yet to be 6. United Kingdom 89,571
tested.
Together with social distancing 7. China 83,302
Testing strategies
diagnostic varyisacross
testing countriesto
considered in be
timing, scope, scale, execution and overall 8. Iran 73,303
a key factor in ‘flattening the curve’
outcomes.
9. Turkey 61,041
The U.S has become the epicenter of
the pandemic 10. Belgium 30,589

Source: John Hopkins Coronavirus Research Center, April 14, 2020 https://coronavirus.jhu.edu/map.html Test Tracker, Foundation for Innovative New
PwC Diagnostics (FIND) April 14, 2020,https://www.finddx.org/covid-19/test-tracker/,
 There are two main testing protocols to identify active
infections and exposure to COVID-19
Antigen tests check whether you have the disease. PCR testing remains the gold standard of testing and is used by labs around the Antibody tests identify who had contracted the disease
world to test for COVID-19. The WHO had urged countries from the onset of the pandemic to begin mobilising research to create rapid and developed immunity. They are critical for ongoing
point of care tests for use at community level. There has been progress in private companies developing point of care tests with faster surveillance and determining who gets to go back to
turnaround including a test developed by Abbott that promises results in 15 minutes and has recently been approved by the US FDA. work, focusing on the next phase of the response.

Antigen Test Antibody Test

Identifies active COVID-19 infections Identifies exposure to COVID-19
Is the virus in your system? Has the virus been in your system?

Polymerase Chain Reaction Isothermal Nucleic Acid Amplification, Antibody/Antigen binding, conducted
Method
(PCR), conducted at the lab conducted at point of care at home

Throat or Nasal Swab collected Throat or Nasal Swab collected

Sample Collection Finger-prick, collected at home
at point of care at point of care

4-6 hours; Approximately 20 minutes to produce

Turnaround Time Approximately 15 minutes
Full cycle takes 24-48 hours +/- result

• Example test by Abbott

Development • WHO gold standard • Led by private companies
Laboratories in the US
Stage • Multiple diagnostic tests • Already deployed in China and
• It obtained EUA from FDA on
developed/approved globally plans to deploy in the UK
March 27th, 2020
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 COVID-19 diagnostic tests go through a cycle of development, approvals and
deployment with challenges along each part of the value chain
Test Development WHO published guidelines
The virus was sequenced
and published in China on diagnostic testing
Genetic PCR WHO development based on the
German method
Sequencing Testing Kit Guidelines
The genetic sequence was Over 200 commercial tests
used to develop the first have been developed
testing kit in Germany by globally
TIB Molbiol

Countries such as South Korea and
Singapore allocated for rapid
approval and deployment of tests.
Meanwhile in other countries more
rigid regulations slowed down the
availability and scalability of these
tests.
Moreover, every related specialized
material or equipment required adds
a potential bottleneck to the
manufacturing and supply chain
processes.
Regulatory Approval – Application process, requirements, and
turnaround time differ within each country
The production process requires highly-specialized materials
including specialized swabs, PPE, reagents and laboratory hardware
National Public Health authorities respectively oversee distribution
of testing kits to authorised labs
At the beginning of the crisis WHO dispatched 250,000 test kits to
159 laboratories globally
Test Deployment
Upon sample collection, diagnostic work is conducted in a Biosafety
Level 2 laboratory. Complex research work requires a high
containment, BSL3 laboratory

While the diagnostic testing life cycle continues to face challenges, it is important to note that the response has been much faster in comparison to previous
outbreaks such as the SARS outbreak 2002 – 2003, where the timeline to identify and establish assays was almost 6 months.
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 International guidelines recommend who should be tested for COVID-19,
including prioritisation measures
WHO has issued and regularly updates
guidelines on testing eligibility.
The latest update from WHO provides
recommendations for priority testing
measures to rationalise who should get
tested in cases of insufficient capacity or
widespread community transmission.
Similar guidelines have been issued by
public health agencies across the world,
all of which focus on symptomatic
patients.
While priority testing recommendations
shift the focus to high risk individuals
including health workers and symptomatic
patients in closed settings such as nursing
homes, worker camps and refugee camps
which are relevant to our region.
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“We have a simple message for all countries: test, test, test.”
– Dr. Tedros Adhanom Ghebreyesus, WHO Director General (16th March 2020)
Priority groups for testing are defined as per the case definition of each health agency with WHO guidelines widely adopted:
20th March 2020 20th March 2020 8th March 2020 2nd Feb 2020
A. Acute respiratory illness & travel Applicable only to
history visitors from China
B. Acute respiratory illness & contact
Regulation Laboratory Testing
C. Severe acute respiratory illness &
unknown diagnosis
In a scenario of community transmission and insufficient testing capacity priority testing measures have been implemented:
• High-risk individuals As per WHO Guidelines 1. Inpatients & healthcare Introduced mass testing early
workers in community transmission
• Symptomatic health workers
2. High-risk individuals
• Symptomatic cases in a
closed setting (nursing home, 3. As per capacity
hospital)
There continues to be a variation
across countries setting or
implementing testing strategies,
especially as the disease spreads
To date, 14,939,783 COVID-19 Tests have
more rapidly and testing systems
and supply chains become
been performed around the world
overwhelmed. COVID-19 data correct as of April 14:
For example, South Korea continued
Total tests performed and tests performed per million people
with mass testing aggressively even
after community transmission
started.

When community transmission

started, the UK tightened their testing
policies to patients with severe
symptoms and frontline NHS staff
who are showing symptoms along
their families, while countries such as
Sweden changed strategies halfway,
starting with a high number of tests
then refocusing efforts on mitigation
rather than containment.

Leading in tests per million, you will

see Bahrain and the UAE from the
region, South Korea and Singapore
topping charts in Asia, and Italy
leading the list for Europe.

For the US, while the total numbers

of tests is the highest, the number
per population remains small and
there is a significant variation across
Source: Test Tracker, Foundation for Innovative New Diagnostics (FIND) April 14th 2020,https://www.finddx.org/covid-19/test-tracker/,
states with New York leading the way
in testing. The list of countries is not exhaustive, certain countries were selected for purposes of illustration and relevance. There was no reported data on Kuwait or Oman. To date,
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Iceland leads in total number of tests performed per million but was not included so as to not skew the representation. The data represents the figures reported to the source
up to April 5th and as such may not reflect the actual number of tests performed or tests performed per million up to that date.
Countries’ testing strategies fall on a
spectrum from limited and delayed to
COVID-19 testing strategies varied around the globe as
aggressive and early action on testing.
While each of the countries has had its
countries rush to scale up diagnostic capacity
own experience, there are some
commonalities from opposite sides of
the spectrum:
United States 8,523 Singapore 12,424 United Arab Emirates 59,969
The countries on the right side of the
spectrum have taken measures to improve
their testing capacity and notably took Limited and Delayed Aggressive and Early
these measures early on, focusing their
Tests per million, as of April 14, 2020
efforts on testing and tracing This included:
laxing regulatory approvals, involving the United Kingdom 5,416 Germany 15,730 South Korea 10,118
private sector labs and increasing testing Illustrative examples
channels such as drive throughs such as in
Korea and the UAE, turning primary care
clinics to testing centers for example in
● Secured supply of testing kits early on
Singapore. ● Set own guidelines for testing suspected cases
● Implemented hotline for testing appointments
● Appointed designated Regional Public Health labs
● Designated national reference centre for diagnostics
● Taking time to test new testing approach before roll out
Meanwhile, countries on the left side of the
spectrum with lower numbers of tests per
population may have faced supply chain
shortages, delays in decision-making and ● Decided to develop their own tests ● Mass testing and tracing strategy including drive through
taking action, rigid regulatory approval ● Response fluctuating between federal and state level ● Expedited diagnostic test to bypass regulatory approval
● Shifted testing from solely public health labs to include other ● Created large network of Public and Private labs
processes, and tighter testing protocols
and criteria. These countries are now trying
to approach testing more aggressively,
however the spread of the disease due to ● Set guidelines to test mildly symptomatic cases ● Expedited regulatory approval for testing kits
delayed action makes it difficult to catch up. ● Set up National coronavirus diagnostic working group ● Enforced contact tracing and prioritised testing
Germany, however, has been expanding ● Decentralised testing to state level ● Turned primary healthcare clinics to test centres
the scope of testing to cover mild
symptomatic patients.
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Source: Test Tracker, Foundation for Innovative New Diagnostics (FIND) April 5, 2020,https://www.finddx.org/covid-19/test-tracker/,
 There are a number of interrelated constraints that
account for variation in diagnostic testing strategies
Testing capacity Economic impact
Challenges with availability of sufficient testing kits and The cost of testing and the size of the investment required
required equipment significantly impedes the speed and to roll it out widely puts a strain on government budgets.
scalability of testing. This in addition to supply chain More confirmed cases also impact on business continuity
bottlenecks and required regulatory approvals is causing resulting in further economic challenges, especially in the
production difficulties and considerably limiting testing early stages of the outbreak when its transmission
capacity. mechanisms and gravity are not fully understood.

Political influence Compliance & safety

Weighing public health policy against economic and Diagnostic Testing and Social Distancing policies may
social considerations has a large impact on the speed conflict at times such as in testing locales which may lack
and outcome of measures. These challenges are effective and safe crowd management measures. This
especially visible in countries with complex governance, combined with limited awareness can impact the general
regulatory, and political frameworks. public’s compliance.

Policy lag

With rapidly changing events, how fast the pandemic is growing and its unpredictable
nature, policy and action lag behind with lack of immediate and sufficient evidence on
the impact of measures. This often renders strategies under-informed and quickly
outdated. It also makes it difficult to evaluate strategies and quickly shift gears to
alternative strategies when need be.

The variation in the diagnostic testing approach across the countries is driven by a number of constraints, the impact of which varies from one country to another.
Further complexity arises from their interdependency – a delay in the mitigation of one constraint immediately affects the others.
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 Diagnostic testing is the first step in a chain reaction that impacts
on preparedness and response strategies and outcomes

Decision-making Control Incidence Healthcare capacity Patient outcomes

Testing provides
policy-makers,
governments, and
health authorities with
the needed data on
the number of cases
to enable
evidence-based,
data-driven, and
timely decisions.
Early detection
confirmed by
diagnostic testing
allows for earlier case
isolation, contact
tracing, social
distancing, and other
measures which
prevent the further
spread of the virus.
With more prevention
and control measures
in effect, the
transmission of the
virus acurbed
significantly, and the
total number of new
cases begins to
decline.
Lower incidence
translates into lower
hospitalisation. This
relieves the strain on
healthcare systems at
the level of diagnosis,
treatment, and
supporting infra and
equipment.
Early diagnosis allows
for early treatment. A
less stressed healthcare
system can better
allocate resources to
manage advanced cases
with comorbidities
requiring critical care,
thus expected better
outcomes.

It is crucial to have an effective diagnostic testing strategy early on because it is the first step in the chain reaction which prompts and informs overall preparedness and response.
Testing confirms the size of the problem and helps forecast its impact.; it informs an evidence based data driven response.

Observations on the global COVID-19 response have already correlated early and extensive testing measures to better patient outcomes. It is likely that there will more scientific
studies coming out about the correlation between testing strategy and patient outcomes
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There are some immediate lessons learned and key
considerations to refresh the testing strategy
A diagnostic testing strategy must be aligned with the strategic preparedness and
response strategy to help flatten the curve Features of the testing strategy
1 Plan for the worst… Act… Refresh
Be proactive, plan for the worst, act quickly and keep refreshing your strategies as you measure their impact. Dynamic & Pro-active
Make sure your strategy is dynamic and flexible to deal with the ever changing nature of this pandemic, so be
prepared to change course and let the public know why you have done that.

2 Listen to the science...(when possible) balance Economy and Public Health

Keep your strategies evidence-based, listen to science and support the scientific community and keep finding
ways to balance economic and public health considerations
Evidence-Based

3 Increase testing capacity... Involve the private sector

Involve the private sector more and get them to collaborate with you to help you increase your capacity and
be better prepared for what’s coming next. Measurable

4 Reduce regulatory & supply chain roadblocks… Speed is king

Work to ease regulatory and supply chain roadblocks and act quickly.
Engaging & Collaborative
5 Implement safely and responsibly

Implement your strategy safely with clear responsibility and accountability…and make sure you align the
testing strategy with social distancing and other research and policy efforts
Success is defined by how well all parties worked together with a common vision: National and local agencies,
global health agencies, public and private labs, the education and scientific communities, suppliers and
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manufactures, businesses, healthcare providers, public and healthcare professionals and the general public
References (1/3)
1. John Hopkins Coronavirus Research Center, April 5, 2020
https://coronavirus.jhu.edu/map.html
2. Test Tracker, Foundation for Innovative New Diagnostics (FIND) April 5, 2020
https://www.finddx.org/covid-19/test-tracker
3. Laboratory testing for coronavirus disease (COVID-19) in suspected human cases , WHO, March 19, 2020
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/laboratory-guidance
4. Coronavirus tests: researchers chase new diagnostics to fight the pandemic, Nature, March 23, 2020
https://www.nature.com/articles/d41586-020-00827-6
5. Fast, portable tests come online to curb coronavirus pandemic, Nature, March 23, 2020
https://www.nature.com/articles/d41587-020-00010-2
6. Laboratory testing for coronavirus disease (COVID-19) in suspected human cases , WHO, March 19, 2020
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/laboratory-guidance
7. Coronavirus tests: researchers chase new diagnostics to fight the pandemic, Nature, March 23, 2020
https://www.nature.com/articles/d41586-020-00827-6
8. Fast, portable tests come online to curb coronavirus pandemic, Nature, March 23, 2020
https://www.nature.com/articles/d41587-020-00010-2
9. Abbott Launches 5-Minute Virus Test for Use Almost Anywhere, Bloomberg March 28, 2020
https://www.bloomberg.com/news/articles/2020-03-27/abbott-launches-5-minute-covid-19-test-for-use-almost-anywhere
10. How Roche’s new coronavirus test sped its way to FDA authorization, Fortune, March 24, 2020
https://fortune.com/2020/03/13/coronavirus-test-roche-covid-19/
11. Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19), CDC, March 24, 2020
https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html
12. Global Surveillance for human infection with coronavirus disease (COVID-19), WHO, March 20, 2020
https://www.who.int/publications-detail/global-surveillance-for-human-infection-with-novel-coronavirus-(2019-ncov)
13. Critical preparedness, readiness and response actions for COVID-19, March 22, 2020
https://www.who.int/publications-detail/critical-preparedness-readiness-and-response-actions-for-covid-19
14. NHS to roll out testing for frontline staff and care workers, Financial Times, March 28, 2020
https://www.ft.com/content/34ca2b32-4fc2-4d3c-b250-23d1ba47ebe7
15. COVID-19: investigation and initial clinical management of possible cases, PHE, March 27, 2020
https://www.gov.uk/government/publications/wuhan-novel-coronavirus-initial-investigation-of-possible-cases/investigation-and-initial-clinical-management-of-possible-cases-of-wuha
n-novel-coronavirus-wn-cov-infection#interim-definition-possible-cases
16. Case definition and European surveillance for COVID-19, ECDC, March 20, 2020
https://www.ecdc.europa.eu/en/case-definition-and-european-surveillance-human-infection-novel-coronavirus-2019-ncov
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References (2/3)
17. The case definition of 2019 novel coronavirus will be expanded, KCDC, February 2, 2020
https://www.cdc.go.kr/board/board.es?mid=a30402000000&bid=0030&act=view&list_no=365875&tag=&nPage=1
18. WHO Director-General's opening remarks at the media briefing on COVID-19, WHO, 16 March 2020
https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---16-march-2020
19. The World Health Organization has called on countries to ‘test, test, test’ for coronavirus - this is why, WEF, March 17, 2020
https://www.weforum.org/agenda/2020/03/coronavirus-covid-19-testing-disease/
20. How many tests for COVID-19 are being performed around the world?, Our World in Data, March 20, 2020
https://ourworldindata.org/covid-testing
21. Laboratory testing strategy recommendations for COVID-19 – Interim guidance, WHO, March 22, 2020
https://apps.who.int/iris/bitstream/handle/10665/331509/WHO-COVID-19-lab_testing-2020.1-eng.pdf 20.
22. South Korea learned its successful Covid-19 strategy from a previous coronavirus outbreak: MERS, Bulletin of the Atomic Scientists, March 20, 2020
https://thebulletin.org/2020/03/south-korea-learned-its-successful-covid-19-strategy-from-a-previous-coronavirus-outbreak-mers/
23. Can’t Get Tested? Maybe You’re in the Wrong Country, New York Times,, March 20, 2020
https://www.nytimes.com/2020/03/20/world/europe/coronavirus-testing-world-countries-cities-states.html
24. Coronavirus in South Korea: How 'trace, test and treat' may be saving lives, BBC News, March 12, 2020
https://www.bbc.com/news/world-asia-51836898
25. Korean Government’s Response System, KCDC, February 25, 2020
http://ncov.mohw.go.kr/en/baroView.do?brdId=11&brdGubun=111&dataGubun=&ncvContSeq=&contSeq=&board_id=&gubun=
26. Coronavirus: What are new antibody tests bought by government and when will they be available?, Independent, March 20 , 2020
https://www.independent.co.uk/news/health/coronavirus-tests-antibody-uk-nhs-boris-johnson-sharon-peacock-a9426471.html
27. COVID-19: how to arrange laboratory testing, PHE, March 28, 2020
https://www.gov.uk/government/publications/wuhan-novel-coronavirus-guidance-for-clinical-diagnostic-laboratories/wuhan-novel-coronavirus-who-to-call-to-request-laboratory-testin
g#capability
28. COVID-19: investigation and initial clinical management of possible cases, PHE, March 27, 2020
https://www.gov.uk/government/publications/wuhan-novel-coronavirus-initial-investigation-of-possible-cases/investigation-and-initial-clinical-management-of-possible-cases-of-wuha
n-novel-coronavirus-wn-cov-infection#interim-definition-possible-cases
29. Germany's low coronavirus mortality rate intrigues experts, The Guardian, March 22, 2020
https://www.theguardian.com/world/2020/mar/22/germany-low-coronavirus-mortality-rate-puzzles-experts
30. Why is Covid-19 death rate so low in Germany?, CNN, March 25, 2020
https://edition.cnn.com/2020/03/24/opinions/germany-low-death-rate-for-coronavirus-sepkowitz/index.html

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References (3/3)
31. Coronavirus in Germany: Health care system under pressure, DW, March 6, 2020
https://www.dw.com/en/coronavirus-in-germany-health-care-system-under-pressure/a-52663510
32. Coronavirus: UAE to introduce 20-minute tests to tackle cases faster, The National, March 29, 2020
https://www.thenational.ae/uae/science/coronavirus-uae-to-introduce-20-minute-tests-to-tackle-cases-faster-1.997891
33. What Singapore can teach the U.S. about responding to Covid-19, STAT, March 23, 2020
https://www.statnews.com/2020/03/23/singapore-teach-united-states-about-covid-19-response/
34. HSA Expedites Approval of COVID-19 Diagnostic Tests in Singapore via Provisional Authorisation, HSA, March 28, 2020
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-tests-in-singapore-via-provisional-authorisation
35. Sufficient capacity in healthcare system amid COVID-19 outbreak, but Singapore cannot be complacent, CNA, March 25, 2020
https://www.channelnewsasia.com/news/singapore/sufficient-capacity-healthcare-system-covid-19-outbreak-12574414 21.
36. CORONAVIRUS TESTING SHOULDN’T BE THIS COMPLICATED, March 17, 2020
https://www.theverge.com/2020/3/17/21184015/coronavirus-testing-pcr-diagnostic-point-of-care-cdc-techonology
37. The 25 most concerning lines from Donald Trump's CDC visit, CNN Politics, March 9 2020
https://edition.cnn.com/2020/03/09/politics/trump-cdc-coronavirus/index.html,
38. Why Widespread Coronavirus Testing Isn’t Coming Anytime Soon, The New Yorker, March 24, 2020
https://www.newyorker.com/news/news-desk/why-widespread-coronavirus-testing-isnt-coming-anytime-soon
39. Coronavirus: Boris Johnson delivers first daily update, March 16, 2020
https://www.bbc.com/news/uk-51901818

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Our team is here to support and advise you….
Authors of this document are part of our PwC Middle East Health Industries team and are readily available to
address your concerns. In light of the ongoing challenges of the COVID-19 virus, we will use virtual,
teleconference and other collaborative tools in lieu of face-to-face interactions and support remotely for as long
as this is appropriate.

Hamish Clark Sara Barada

Health Industries Leader Partner, Health Industries
PwC Middle East PwC Middle East
sara.barada@pwc.com
hamish.clark@pwc.com

Sandra Joy Atweh Clare Roche

Manager, Health Industries Senior Consultant, Health Industries
PwC Middle East PwC Middle East

sandra.joy.atweh@pwc.com clare.roche@pwc.com

For more information on our Healthcare services, please click here: PwC Middle East Healthcare

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Thank you

pwc.com

This content is for general information purposes only, and should not be used as a substitute for consultation with professional advisors. The figures and views presented in the point of view
were believed to be true at the time of writing (13 April 2020) and these are subject to change given the rapidly emerging research, studies and evidence on a global and regional level. For
more information regarding COVID-19 please refer to https://www.pwc.com/m1/en/publications/covid-19.html

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