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COVID-19
To test or not to test?Considerations for COVID-19 testing strategies
April 5, 2020
Sara Barada Partner - Health IndustriesPwC Middle East
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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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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.
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The current situation - COVID-19 in numbers The COVID-19 outbreak has been declared a pandemic by the World Health Organization, causing huge impact on people’s lives, families and communities.
Testing remains a critical measure in fighting against the global pandemic and responding to the current crisis
According to the WHO, diagnostic testing is critical to track the virus, understand epidemiology, inform case management and suppress transmission.
Together with social distancing diagnostic testing is considered to be a key factor in ‘flattening the curve’
The U.S has become the epicenter of the pandemic
1,921,369Confirmed Cases
457,549Recovered
14,939,783Tested
185Countries
1. United States
3. Italy
6. United Kingdom
2. Spain
4. France
7. China
5. Germany
8. Iran
10. Belgium
9. Turkey
Figures as of 14/04/20 11:30am
Confirmed Cases per Country
582,468
170,099
137,877
130,072
159,516
89,571
83,302
73,303
61,041
30,589
Source: John Hopkins Coronavirus Research Center, April 14, 2020 https://coronavirus.jhu.edu/map.html Test Tracker, Foundation for Innovative New Diagnostics (FIND) April 14, 2020,https://www.finddx.org/covid-19/test-tracker/,
Diagnostic Testing is a critical measure in fighting against the COVID-19 global pandemic and responding to the current crisis.
According to WHO, diagnostic testing is critical to track COVID-19, understand epidemiology, inform case management and suppress transmission.
Together with social distancing diagnostic testing is considered to be a key factor in ‘flattening the curve’.
We continue to see an increase in the number of cases testing positive every day, with the U.S becoming the epicenter of the pandemic. Meanwhile China and other Asian countries are showing positive results in containing the virus.
Unfortunately, reported figures are underestimated as they do not cover the entire population that could be infected but yet to be tested.
Testing strategies vary across countries in timing, scope, scale, execution and overall outcomes.
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There are two main testing protocols to identify active infections and exposure to COVID-19
Antigen Test Antibody Test
Sample Collection
Method
Turnaround Time
Development Stage
Isothermal Nucleic Acid Amplification, conducted at point of care
Polymerase Chain Reaction (PCR), conducted at the lab
Throat or Nasal Swab collected at point of care
Throat or Nasal Swab collected at point of care
4-6 hours; Full cycle takes 24-48 hours Approximately 15 minutes
Has the virus been in your system?
• WHO gold standard• Multiple diagnostic tests
developed/approved globally
• Example test by Abbott Laboratories in the US
• It obtained EUA from FDA on March 27th, 2020
Antibody/Antigen binding, conducted at home
Finger-prick, collected at home
Approximately 20 minutes to produce +/- result
• Led by private companies• Already deployed in China and
plans to deploy in the UK
Identifies active COVID-19 infections Is the virus in your system?
Identifies exposure to COVID-19
Antibody tests identify who had contracted the disease and developed immunity. They are critical for ongoing surveillance and determining who gets to go back to work, focusing on the next phase of the response.
Antigen tests check whether you have the disease. PCR testing remains the gold standard of testing and is used by labs around the world to test for COVID-19. The WHO had urged countries from the onset of the pandemic to begin mobilising research to create rapid point of care tests for use at community level. There has been progress in private companies developing point of care tests with faster turnaround including a test developed by Abbott that promises results in 15 minutes and has recently been approved by the US FDA.
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PCR Testing Kit
WHO Guidelines
Regulatory Approval – Application process, requirements, and turnaround time differ within each country
Genetic Sequencing
Test Deployment
Test DevelopmentThe virus was sequenced and published in China
The genetic sequence was used to develop the first testing kit in Germany by TIB Molbiol
WHO published guidelines on diagnostic testing development based on the German method
Over 200 commercial tests have been developed globally
COVID-19 diagnostic tests go through a cycle of development, approvals and deployment with challenges along each part of the value chain
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 labsAt the beginning of the crisis WHO dispatched 250,000 test kits to 159 laboratories globally
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.
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.
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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.
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.
Regulation Laboratory Testing
20th March 202020th March 2020
A. Acute respiratory illness & travel history
B. Acute respiratory illness & contact
C. Severe acute respiratory illness & unknown diagnosis
8th March 2020 2nd Feb 2020
In a scenario of community transmission and insufficient testing capacity priority testing measures have been implemented:
• High-risk individuals
• Symptomatic health workers
• Symptomatic cases in a closed setting (nursing home, hospital)
As per WHO Guidelines 1. Inpatients & healthcare workers
Introduced mass testing early in community transmission
2. High-risk individuals
3. As per capacity
Priority groups for testing are defined as per the case definition of each health agency with WHO guidelines widely adopted:
Applicable only to visitors from China
“We have a simple message for all countries: test, test, test.” – Dr. Tedros Adhanom Ghebreyesus, WHO Director General (16th March 2020)
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To date, 14,939,783 COVID-19 Tests have been performed around the world
COVID-19 data correct as of April 14:Total tests performed and tests performed per million people
Source: Test Tracker, Foundation for Innovative New Diagnostics (FIND) April 14th 2020,https://www.finddx.org/covid-19/test-tracker/,
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, 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.
There continues to be a variation across countries setting or implementing testing strategies, especially as the disease spreads more rapidly and testing systems and supply chains become overwhelmed.
For example, South Korea continued 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 states with New York leading the way in testing.
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● Mass testing and tracing strategy including drive through● Expedited diagnostic test to bypass regulatory approval ● Created large network of Public and Private labs
● Expedited regulatory approval for testing kits● Enforced contact tracing and prioritised testing● Turned primary healthcare clinics to test centres
● Secured supply of testing kits early on● Implemented hotline for testing appointments● Designated national reference centre for diagnostics
● Set guidelines to test mildly symptomatic cases● Set up National coronavirus diagnostic working group● Decentralised testing to state level
● Set own guidelines for testing suspected cases● Appointed designated Regional Public Health labs● Taking time to test new testing approach before roll out
● Decided to develop their own tests ● Response fluctuating between federal and state level● Shifted testing from solely public health labs to include other
COVID-19 testing strategies varied around the globe as countries rush to scale up diagnostic capacity
Source: Test Tracker, Foundation for Innovative New Diagnostics (FIND) April 5, 2020,https://www.finddx.org/covid-19/test-tracker/,
Illustrative examples
Countries’ testing strategies fall on a spectrum from limited and delayed to aggressive and early action on testing. While each of the countries has had its own experience, there are some commonalities from opposite sides of the spectrum:
The countries on the right side of the spectrum have taken measures to improve their testing capacity and notably took these measures early on, focusing their efforts on testing and tracing This included: laxing regulatory approvals, involving the private sector labs and increasing testing channels such as drive throughs such as in Korea and the UAE, turning primary care clinics to testing centers for example in Singapore.
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 taking action, rigid regulatory approval 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 delayed action makes it difficult to catch up. Germany, however, has been expanding the scope of testing to cover mild symptomatic patients.
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United States 8,523
United Kingdom 5,416 South Korea 10,118
Singapore 12,424 United Arab Emirates 59,969
Germany 15,730
Tests per million, as of April 14, 2020
Aggressive and EarlyLimited and Delayed
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There are a number of interrelated constraints that account for variation in diagnostic testing strategies
Testing capacity Economic impact
Compliance & safetyPolitical influence
Policy lag
Challenges with availability of sufficient testing kits and required equipment significantly impedes the speed and scalability of testing. This in addition to supply chain bottlenecks and required regulatory approvals is causing production difficulties and considerably limiting testing capacity.
The cost of testing and the size of the investment required to roll it out widely puts a strain on government budgets. More confirmed cases also impact on business continuity resulting in further economic challenges, especially in the early stages of the outbreak when its transmission mechanisms and gravity are not fully understood.
Diagnostic Testing and Social Distancing policies may conflict at times such as in testing locales which may lack effective and safe crowd management measures. This combined with limited awareness can impact the general public’s compliance.
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.
Weighing public health policy against economic and social considerations has a large impact on the speed and outcome of measures. These challenges are especially visible in countries with complex governance, regulatory, and political frameworks.
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-makingTesting 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.
ControlEarly 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.
Healthcare capacityLower incidence translates into lower hospitalisation. This relieves the strain on healthcare systems at the level of diagnosis, treatment, and supporting infra and equipment.
IncidenceWith more prevention and control measures in effect, the transmission of the virus acurbed significantly, and the total number of new cases begins to decline.
Patient outcomes 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
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 manufactures, businesses, healthcare providers, public and healthcare professionals and the general public
Engaging & Collaborative
Dynamic & Pro-active
Evidence-Based
Measurable
Features of the testing strategy
Plan for the worst… Act… Refresh1
Listen to the science...(when possible) balance Economy and Public Health2
Increase testing capacity... Involve the private sector3
Reduce regulatory & supply chain roadblocks… Speed is king4
Implement safely and responsibly5
Be proactive, plan for the worst, act quickly and keep refreshing your strategies as you measure their impact. 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.
Keep your strategies evidence-based, listen to science and support the scientific community and keep finding ways to balance economic and public health considerations
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.
Work to ease regulatory and supply chain roadblocks and act quickly.
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
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References (1/3)
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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
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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
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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/
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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-wuhan-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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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
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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/
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Hamish ClarkHealth Industries LeaderPwC Middle East
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Sandra Joy AtwehManager, Health IndustriesPwC Middle East
Clare RocheSenior Consultant, Health IndustriesPwC Middle East
Sara BaradaPartner, Health IndustriesPwC Middle East
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