September 15, 2017
Getting a diagnostic test from development to its use at the point-of-care can take years. To make this process shorter, ZikaPLAN under the leadership of Prof Rosanna Peeling (the WP5 leader), aims to develop, validate and evaluate tools including Point of Care tests for ZIKV diagnosis, surveillance and research. ZikaPLAN will work with ZIKAlliance, ZIKAction and other groups like UNICEF, WHO to establish a virtual network of biobanks.
ZikaPLAN Work Package 5
Prof Rosanna Peeling, London School of Hygiene & Tropical Medicine, UK
Debi Boeras, Global Health Impact Group
The global effort to fill the need for reliable and approved Zika diagnostic tests has slowed down since the WHO declared that Zika is no longer a public health epidemic of international concern. Yet countries need to remain vigilant. At-risk communities need to have access to tests to identify infected persons, to monitor outbreaks through surveillance and to ascertain vaccine and treatment efficacy when those countermeasures are introduced into the community. As many as 50 or more commercial entities, public health agencies and academic institutions are racing towards developing improved tests but many of the novel technologies will not advance to market.
The key barrier in the Zika diagnostic crisis is the access to well-characterized, ethically obtained, standardized clinical specimens from confirmed Zika infected patients during different stages of disease. Such samples are critical to determine the reactivity of the assays during development and validation and to monitor performance of qualified diagnostics. A common set of reference materials including clinical specimens incorporated into evaluation panels would allow for comparison of the different technologies and their acuity in identifying Zika patients. This is essential if investors, regulators and scientists alike are to understand how well a test performs.
Currently, getting a diagnostic test from development to its use at the point-of-care can routinely take from 5-15 years. There is no single, coordinated, accessible programme that provides certified reference samples for use in evaluating test performance across the stages of the disease. Consequently, in order to be able to apply for regulatory approval, to maufacture and to market the tests, developers have to invest up to 80% of their time trying to obtain specimens for evaluation. The reference materials that have been developed are limited in quantity and are distributed only to selected parties. Commercial entities have filled this void by providing samples but these are authenticated in a non-coordinated manner or are sold with minimal metadata, making them unsatisfactory for use in rigorous, scientifically sound evaluation. Some countries also prohibit the export of ethically collected samples adding costs and effort to validation.
Overall, therefore, test developers are spending a lot of time, energy and funds and in return receive access to only very limited volumes of samples, many of which have been “validated” using questionable test methodologies. This lack of consistent standards has resulted in uneven clinical evaluations of promising technologies.
Such delays are avoidable and providing a solution to the problem would mean promising technologies could be on the market in months rather than years. Reference materials would reduce the time and expense while at the same time harmonize the approach and reduce unnecessary wastage of clinical specimens.
The aim of the ZikaPLAN diagnostics platform, therefore, is to develop, validate and evaluate tools (including Point of Care tests) for ZIKV diagnosis, surveillance and research. Part of this project will be to provide access to GCLP-compliant laboratory sites for evaluation of qualified Zika diagnostic tests.
Alongside ZikaAlliance, ZikaAction and partners, such as UNICEF and WHO, the ZikaPLAN platform will work to develop and validate innovative Zika diagnostics and to evaluate new and existing diagnostic assays via a virtual biobanking network. Reference materials for measuring the performance and acuity of Zika diagnostic tests are critically needed and ZikaPLAN can:
- Provide validated reference materials for the development and evaluation of quality Zika diagnostic tests
- Manage the validated reference materials and distribution to test developers per governance and guidance
- Coordinate and facilitate the access to the selected certified laboratory sites for test validation
- Ensure quality, consistency and responsiveness of the certified laboratory sites
In this way, market entry of promising quality Zika diagnostics can be accelerated and the framework for a sustainable network for bio banking to be used for future outbreaks can be established.