Better diagnostics are needed for Zika and one of the objectives of ZikaPLAN is to develop novel diagnostics that would allow physicians to quickly diagnose a patient that is infected. The tests available are very expensive and can be used only at the very early stages of infection, or when antibodies to Zika are detected. Further complications arise as these tests tend to cross react if a patient has been previously exposed to dengue or other arboviruses. The ZikaPLAN network of laboratories affiliated through the initiative allows for the development and evaluation across multiple sites working together.
“We need better diagnostics to accurately detect the people who are truly infected and to be able to understand the risk of complications as well as to manage the patient and monitor them if they are pregnant to know if the baby is safe.”
Prof. Rosanna Peeling, London School of Hygiene and Tropical Medicine
To build a platform to develop, validate and evaluate tools (including Point of Care tests) for ZIKV diagnosis, surveillance and research.
- Develop novel ZIKV diagnostic tests in accordance with WHO Target Product Profiles,
- Develop a Point of Care Test (POCT) for NS1/IgM for Zika,
- Set up a biobank with harmonized bio-banking procedures for use in facilitating test development, evaluation and research studies,
- Establish and disseminate Manual and Standard Operating Procedures on sample collection, and characterization,
- Accelerate the validation of the performance and operational characteristics of diagnostic tests by setting up a biobank of specimens and a network of laboratory and clinical sites, pre-approved for clinical trial protocols,
- Conduct landscape analyses of Zika diagnostic assays in development or commercially available,
- Determine the utility of novel ZIKV diagnostic tools for patient management, disease control and epidemiologic research.
Results and Achievements
- The Working Group established a bio bank and network of sites for the validation and evaluation of Zika diagnostic tests. This work has resulted in harmonized bio-banking procedures and a clinical trial protocol for use in facilitating test development, evaluation and research studies.
- Standard Operating Procedures on specimen collection, bio banking and evaluations were disseminated to achieve this work.
- UNICEF chose the ZikaPLAN network to run one-month evaluations of the products they were looking to procure for Zika diagnostics. ZikaPLAN laboratories and qualified sites in Senegal and Columbia assessed the diagnostics.
- Two prototype tests developed by the Mérieux Foundation were submitted for assessment: an antigen test for the detection of the Zika virus and a serological test for the detection of immunoglobulin M (IgM) and immuno-globulin G (IgG), which are antibodies produced as part of the patient’s immune response against the virus. The prototypes were evaluated in Lyon at the Mérieux Foundation and at the Institut Pasteur of Dakar.
- The prototype of the antigen test successfully detected virus strains and the performance of the serological test was superior to that of both the CE marked, rapid tests currently on the market and also to the ELISA tests used in laboratories. These tests could be used as companion tests before and after immunization campaigns.
- Two research scientists and two quality specialists from the Institut Pasteur of Dakar were trained by the Mérieux Foundation in the development of the prototypes as well as in production standards and regulations.
Assays that fulfil the target performance set by WHO will be selected to proceed to clinical performance studies which are conducted at a network of laboratories that include the Pan American Laboratory Network for Dengue and other arboviruses, RELDA (which comprises 18 laboratories in Latin America and 5 in the Caribbean), the WHO collaborating centre for arboviral diseases in Senegal (Institut Pasteur of Dakar), ITG Antwerp, and the International Vaccine Institute Korea (IVI)—all with access to a geographic diversity of samples to test for cross reactivity against an array of flaviviruses.
RELDA: Arbovirus Laboratory Network in Latin America
Group leader: Prof. Rosanna Peeling; Group coordinator: Debi Boeras PhD, London School of Hygiene & Tropical Medicine (LSHTM)
- Annelies Wilder-Smith, Umea University, Sweden
- Duane Gubler, National University of Singapore, Singapore
- Amadou Sall, Institut Pasteur de Dakar, Senegal
- Maria Guzman, Luis Pelegrino, Instituto Medicina Tropical Pedro Kouri, Cuba
- Andrew Falconer, LSHTM, UK and Universidad del Norte, Colombia
- Sébastien Quesney, Mérieux Foundation, France
- Kevin Arien, Institute of Tropical Medicine, Belgium
- Andreas Neumayr, Swiss Tropical and Public Health Institute, Switzerland
- Aravinda de Silva, University of North Carolina, USA