Centralised model (eg, tuberculosis) |
A physical biobank of clinical specimens and strains collected from different sites worldwide |
Single inventory; easy to assemble evaluation panels and distribute specimens to aid test development |
Most expensive model because of storage and shipping costs; risk of losing shipments or specimen quality, or both, during shipping |
Regional model (eg, dengue) |
Set up regional hubs: specimens are collected at different sites and then shipped to the hub in their region for characterisation and storage |
Tests are evaluated at the two regional hubs using samples from different endemic backgrounds or from people with different comorbidities |
Requires shipping from three-to-four sites in each region to a regional hub; difficult to aliquot samples from children for shipping; more organisation required to assemble regional panels |
Decentralised network model (eg, leishmaniasis, syphilis) |
All samples are collected, characterised, and stored at the site of collection; companies with tests under evaluation ship tests to the sites that have specimens required for evaluation; all sites use a common evaluation protocol |
Least expensive as no shipping is involved; tests are evaluated at each site using appropriate specimens from a range of endemic conditions; empower more countries to do evaluations and post-marketing surveillance |
Potentially more sample heterogeneity from site to site |