Roadmap for the development of diagnostic tests for coronaviruses

Sample type/transportation/preparation

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Sample type/transportation/preparation

Research Question

Technical and regulatory issues
Safe handling for operators
Preserve samples from variability of temperature in field condition transportation
Non-invasive sampling methods for wildlife (including restrictions on authority to sample wildlife for discovery)
Accessible matrix for livestock (e.g. bulk milk, faeces, oral fluids…)
Limitation from regulations to samples movements of high pathogenic virus (Nagoya protocol) vs need for rapid access to outbreak strains to develop diagnostics
Timeline for policy development/negotiation of sample sharing related to implementation of Nagoya protocol at country level

Find the Agent (FTA) card to transport genome without need for cold chain
Drone technology to speed up delivery and collection from the field to hubs for processing of samples
Standardised protocols for sampling on different species and matrix
Virtual biobanking, at least on a regional level (sera and clinical samples) with an overarching policy to allow sharing
Validate specificity of tests using banked samples
Sampling methods and transport for low resource settings
Generate synthetic virus / products (GM) from published sequence when wild types can’t be shared
Utilization of postmortem tissues for antibody surveillance (i.e. meat or lymph node exudates). Especially useful in wildlife or post-harvest sample
Develop guidelines for sample sharing
Influencing policy: working with government to address export control restrictions/Nagoya protocol

Proof of concept for lymph node exudates for antibody-based SARS surveillance in US White tailed deer (Poonsuk 2023)
Existing global standards and recommendations for Coronavirus:
- WOAH Terrestrial Manual CHAPTER 1.1.2. COLLECTION, SUBMISSION AND STORAGE OF DIAGNOSTIC SPECIMENS
- https://www.woah.org/fileadmin/Home/eng/Health_standards/tahm/1.01.02_COLLECTION_DIAG_SPECIMENS.pdf
- WOAH Terrestrial manual CHAPTER 1.1. 3 . TRANSPORT OF BIOLOGICAL MATERIALS: https://www.woah.org/fileadmin/Home/eng/Health_standards/tahm/1.01.03_TRANSPORT.pdf
- WOAH Terrestrial Manual CHAPTER 3 . 5.2 . MIDDLE EAST RESPIRATORY SYNDROME (INFECTION OF DROMEDARY CAMELS WITH MIDDLE EAST RESPIRATORY SYNDROME CORONAVIRUS): https://www.woah.org/fileadmin/Home/eng/Health_standards/tahm/3.05.02_MERS-CoV.pdf
- WOAH Considerations for sampling, testing, and reporting of SARS-CoV-2 in animals: https://www.woah.org/fileadmin/Home/MM/A_Sampling_Testing_and_Reporting_of_SARS-CoV-2_in_animals_3_July_2020.pdf