importance of diagnostics in epidemic and pandemic preparedness CORD-Papers-2022-06-02 (Version 1)

Title: Importance of diagnostics in epidemic and pandemic preparedness
Abstract: Diagnostics are fundamental for successful outbreak containment. In this supplement Diagnostic preparedness for WHO Blueprint pathogens we describe specific diagnostic challenges presented by selected priority pathogens most likely to cause future epidemics. Some challenges to diagnostic preparedness are common to all outbreak situations as highlighted by recent outbreaks of Ebola Zika and yellow fever. In this article we review these overarching challenges and explore potential solutions. Challenges include fragmented and unreliable funding pathways limited access to specimens and reagents inadequate diagnostic testing capacity at both national and community levels of healthcare and lack of incentives for companies to develop and manufacture diagnostics for priority pathogens during non-outbreak periods. Addressing these challenges in an efficient and effective way will require multiple stakeholderspublic and privatecoordinated in implementing a holistic approach to diagnostics preparedness. All require strengthening of healthcare system diagnostic capacity (including surveillance and education of healthcare workers) establishment of sustainable financing and market strategies and integration of diagnostics with existing mechanisms. Identifying overlaps in diagnostic development needs across different priority pathogens would allow more timely and cost-effective use of resources than a pathogen by pathogen approach; target product profiles for diagnostics should be refined accordingly. We recommend the establishment of a global forum to bring together representatives from all key stakeholders required for the response to develop a coordinated implementation plan. In addition we should explore if and how existing mechanisms to address challenges to the vaccines sector such as Coalition for Epidemic Preparedness Innovations and Gavi could be expanded to cover diagnostics.
Published: 2019-01-29
Journal: BMJ Glob Health
DOI: 10.1136/bmjgh-2018-001179
DOI_URL: http://doi.org/10.1136/bmjgh-2018-001179
Author Name: Kelly Cirino Cassandra D
Author link: https://covid19-data.nist.gov/pid/rest/local/author/kelly_cirino_cassandra_d
Author Name: Nkengasong John
Author link: https://covid19-data.nist.gov/pid/rest/local/author/nkengasong_john
Author Name: Kettler Hannah
Author link: https://covid19-data.nist.gov/pid/rest/local/author/kettler_hannah
Author Name: Tongio Isabelle
Author link: https://covid19-data.nist.gov/pid/rest/local/author/tongio_isabelle
Author Name: Gay Andrieu Franoise
Author link: https://covid19-data.nist.gov/pid/rest/local/author/gay_andrieu_franoise
Author Name: Escadafal Camille
Author link: https://covid19-data.nist.gov/pid/rest/local/author/escadafal_camille
Author Name: Piot Peter
Author link: https://covid19-data.nist.gov/pid/rest/local/author/piot_peter
Author Name: Peeling Rosanna W
Author link: https://covid19-data.nist.gov/pid/rest/local/author/peeling_rosanna_w
Author Name: Gadde Renuka
Author link: https://covid19-data.nist.gov/pid/rest/local/author/gadde_renuka
Author Name: Boehme Catharina
Author link: https://covid19-data.nist.gov/pid/rest/local/author/boehme_catharina
sha: 9e9667fc7fcb441ee60a45d5cc2a8550205c9ad3
license: cc-by-nc
license_url: https://creativecommons.org/licenses/by-nc/4.0/
source_x: Medline; PMC
source_x_url: https://www.medline.com/https://www.ncbi.nlm.nih.gov/pubmed/
pubmed_id: 30815287
pubmed_id_url: https://www.ncbi.nlm.nih.gov/pubmed/30815287
pmcid: PMC6362765
pmcid_url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6362765
url: https://www.ncbi.nlm.nih.gov/pubmed/30815287/ https://doi.org/10.1136/bmjgh-2018-001179
has_full_text: TRUE
Keywords Extracted from Text Content: visceral Vaccine serum Zika bodies Blueprint pathogens CCHF human centre Blueprint pathogens recipients Unicef rk39 CCHF camels specimens US$ Food Link donors lines flaviviruses Senegal ( Lassa Zika virus CEPI tick-borne disease H1N1 influenza MERS-CoV. 18 19 Gavi Expand networks Nipah Crimean-Congo haemorrhagic samples patients
Extracted Text Content in Record: First 5000 Characters:► Diagnostics are a fundamental component of successful outbreak containment or control strategies, and each individual pathogen presents specific diagnostic challenges. Current diagnostic landscapes for selected priority pathogens are presented in this supplement. ► Recent outbreaks of Ebola, Zika and yellow fever have highlighted overarching barriers to diagnostic preparedness that are common to all outbreak/epidemic situations. ► A holistic, multistakeholder response through healthcare system strengthening, improved market sustainability and integration of diagnostics into existing preparedness mechanisms for vaccines is recommended to address these barriers and create a comprehensive overall epidemic and pandemic preparedness plan. ► Identifying overlaps in diagnostic development needs across different priority pathogens is recommended over a pathogen by pathogen approach to allow more timely and cost-effective use of resources. Diagnostics are fundamental for successful outbreak containment. In this supplement, 'Diagnostic preparedness for WHO Blueprint pathogens', we describe specific diagnostic challenges presented by selected priority pathogens most likely to cause future epidemics. Some challenges to diagnostic preparedness are common to all outbreak situations, as highlighted by recent outbreaks of Ebola, Zika and yellow fever. In this article, we review these overarching challenges and explore potential solutions. Challenges include fragmented and unreliable funding pathways, limited access to specimens and reagents, inadequate diagnostic testing capacity at both national and community levels of healthcare and lack of incentives for companies to develop and manufacture diagnostics for priority pathogens during non-outbreak periods. Addressing these challenges in an efficient and effective way will require multiple stakeholders-public and private-coordinated in implementing a holistic approach to diagnostics preparedness. All require strengthening of healthcare system diagnostic capacity (including surveillance and education of healthcare workers), establishment of sustainable financing and market strategies and integration of diagnostics with existing mechanisms. Identifying overlaps in diagnostic development needs across different priority pathogens would allow more timely and cost-effective use of resources than a pathogen by pathogen approach; target product profiles for diagnostics should be refined accordingly. We recommend the establishment of a global forum to bring together representatives from all key stakeholders required for the response to develop a coordinated implementation plan. In addition, we should explore if and how existing mechanisms to address challenges to the vaccines sector, such as Coalition for Epidemic Preparedness Innovations and Gavi, could be expanded to cover diagnostics. Diagnostic tests are a fundamental component of a successful outbreak containment strategy, being involved at every stage of an outbreak, from initial detection to eventual resolution. 1-3 Development of diagnostic tests suitable for epidemic prevention and containment is technically challenging, and processes for development, validation and implementation are complex and time consuming. The WHO R&D Blueprint for Epidemic Preparedness lists those pathogens thought most likely to cause a future epidemic, 4 but while diagnostic tests exist for the majority, availability is often poor at central laboratory level, and many tests are not available in a format that can be deployed at a community level (table 1) . 5 Poor diagnostic preparedness has contributed to significant delays in the identification of recent outbreaks for multiple pathogens, including Ebola, 2 Lassa fever, 6 yellow fever 7 and Zika, 8 primarily due to poor local diagnostic capacity. In the case of the 2013-2016 Ebola epidemic in West Africa, there was a 3-month delay between the index case and the identification of the causative agent; postoutbreak analyses suggest that diagnosing 60% of patients within 1 day instead of 5 days could have reduced the attack rate from 80% to nearly 0%. 2 9 In the end, it was diagnostics BMJ Global Health information coupled with appropriate interventions that led to eventual containment of the outbreak, but the delays resulted in the loss of thousands of lives and billions of dollars in the cost of response. 10 11 While improvements in availability of point-of-care diagnostics and a more rapid set up of laboratory facilities in transmission zones limited the spread of the April 2018 Ebola outbreak in the Democratic Republic of Congo, 12 13 logistical issues with delivery of supplies and shortages of experienced staff persisted. 14 BMJ Global Health Insufficient funding and lack of coordination between donors leading to duplication of effort ► Establish coordinating body for diagnostics funding. ► Match small start-up companies/academia with larger diagnostics or vaccine/pharmaceutical manufacturers wi
Keywords Extracted from PMC Text: visceral Vaccine use.37 serum Zika bodies Blueprint pathogens CCHF MERS-CoV.18 19 centre human Unicef 's chains.22 recipients rk39 flaviviruses).30 CCHF camels specimens epidemic,4 response.10 11 outbreak.7 US$ H1N1 Ebola,2 Lassa fever,6 yellow fever7 Food minimised.36 for.20 cases.7 Confirmatory antibody approval24 strategy.15 17 A Congo,12 13 donors Zika,8 Senegal ( Lassa Zika virus CEPI spots7 tick-borne disease be32 H1N1 influenza Gavi specimens.2 27 28 grants'.2 Nipah Crimean-Congo haemorrhagic place.8 response.34 market.26 vaccine research.33 based).32 36 samples patients 2015–2016
Extracted PMC Text Content in Record: First 5000 Characters:Diagnostic tests are a fundamental component of a successful outbreak containment strategy, being involved at every stage of an outbreak, from initial detection to eventual resolution.1–3 Development of diagnostic tests suitable for epidemic prevention and containment is technically challenging, and processes for development, validation and implementation are complex and time consuming. The WHO R&D Blueprint for Epidemic Preparedness lists those pathogens thought most likely to cause a future epidemic,4 but while diagnostic tests exist for the majority, availability is often poor at central laboratory level, and many tests are not available in a format that can be deployed at a community level (table 1).5 Poor diagnostic preparedness has contributed to significant delays in the identification of recent outbreaks for multiple pathogens, including Ebola,2 Lassa fever,6 yellow fever7 and Zika,8 primarily due to poor local diagnostic capacity. In the case of the 2013–2016 Ebola epidemic in West Africa, there was a 3-month delay between the index case and the identification of the causative agent; postoutbreak analyses suggest that diagnosing 60% of patients within 1 day instead of 5 days could have reduced the attack rate from 80% to nearly 0%.2 9 In the end, it was diagnostics information coupled with appropriate interventions that led to eventual containment of the outbreak, but the delays resulted in the loss of thousands of lives and billions of dollars in the cost of response.10 11 While improvements in availability of point-of-care diagnostics and a more rapid set up of laboratory facilities in transmission zones limited the spread of the April 2018 Ebola outbreak in the Democratic Republic of Congo,12 13 logistical issues with delivery of supplies and shortages of experienced staff persisted.14 It is vital that the current lack of rapid diagnostic tests for priority pathogens is addressed, to ensure that future outbreaks can be more effectively contained. Detailed descriptions of the diagnostic landscapes for selected WHO R&D Blueprint pathogens are provided in this supplement.15–19 Each of these pathogens presents specific challenges, due to differences in factors such as geographical location (Nipah infection primarily occurs in Asia, Middle East respiratory syndrome-coronavirus (MERS-CoV) in the Middle East and Lassa fever in Africa, while Crimean-Congo haemorrhagic fever (CCHF) is widespread) and mode of transmission (MERS-CoV in particular has a significant animal reservoir in dromedary camels, while CCHF is a tick-borne disease), among others. However, there are a common set of barriers to effective deployment and utilisation of diagnostic tests. In this article, we consider these overarching challenges to diagnostic preparedness and offer potential solutions (table 2), looking to existing systems already in place for vaccines preparedness for guidance. Poor diagnostic capacity at national and community levels of healthcare can greatly reduce the effectiveness of outbreak containment, as demonstrated by the recent yellow fever outbreak in Central Africa in 2016–2017.7 The yellow fever virus is endemic throughout Africa, and an effective vaccine has been available for almost 80 years; nevertheless, the outbreaks in Angola and Nigeria in 2016–2017 were not well prepared for.20 While detection of yellow fever in serum using ELISA is technically possible at national level, there was a severe shortage of reagents, meaning that laboratories were unable to carry out tests on the majority of suspected cases.7 Confirmatory antibody neutralisation testing could only be performed at a single central reference laboratory in Senegal (Institut Pasteur, Dakar; the only centre in Africa equipped for this), which can take up to a month, including time required to transport samples and receive testing results. This caused significant delays in recognising the outbreak, hindering the roll-out of the vaccination programme and diminishing the effectiveness of targeted vaccination, resulting in increased spread of disease and longer time to containment. The reagent shortage continued throughout 2016 and the first 8 months of 2017, and by the time the required reagents became available at national level, the disease had spread to multiple states.7 Improved access to rapid tests to speed up diagnosis of patients presenting to triage tents was badly needed. During the Ebola outbreak in early 2018, although availability of point-of-care testing and of testing facilities in transmission zones has been much improved,12 21 a delay in detection of initial cases and a lack of good epidemiological information has presented difficulties in estimating the true geographical extent and magnitude of the outbreak.13 The key lesson from these experiences is that diagnostic tests in a format adapted for field use are essential for rapid containment of outbreaks, even in the presence of an effective vaccine. This lack of affordable and
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