Diagnostics RDT / POC Technology for ZIKA related infections
Outline Overview of afternoon agenda Background Product Landscape analysis ZIKA scenarios of demand, areas of focus Lessons learnt..
ZIKA diagnostic testing Current diagnostic practice for ZKV is dependent on a wellfunctioning national surveillance and laboratory testing network. Multiple challenges exist to obtain reliable results in reasonable time frames. UNICEF, WHO and partners have identified the need for easy accessible Point of Care ( PoC ) diagnostics, which may include Rapid Tests similar to those used to test for malaria, HIV, other infectious diseases. Such technologies are not currently in the market..
Update on current pipeline on Zika diagnostic tests Dr Francis Moussy Health Systems and Innovation WHO HQ 11-12 May 2016 5 TITLE from VIEW and SLIDE MASTER 12 May 2016
Update on current landscape (Information source: public domain and/or as provided by developers and manufacturers; not verified by WHO as of 9 May 2016) Type Lab based detection: nucleic acid test kits No of tests (in various stages of development and regulatory approval) At least 31 (10 multiplex) 6 All Integrated NAT At least 3 0 Lab based detection: immunoassays (ie; ELISA) RDT type tests (ie; lateral flow immunoassays) At least 15 4 At least 14 (3 multiplex) 1 With regulatory approval/authorization/listing (ie; WHO EUAL, US FDA EUA, CE/IVD, ANVISA, others) 6 TITLE from VIEW and SLIDE MASTER 12 May 2016
Update on current landscape (submitted to WHO EUAL, as of 9 May 2016) Type No of submissions Plan to submit* (from diagnostic landscape survey) Lab based detection: nucleic acid test kits 6 (5 single test for ZIKV; 1 multiplex test) All Integrated NAT 0 1 Lab based detection: immunoassays (ie; ELISA) RDT type tests (ie; lateral flow immunoassays) 4 (2 IgM, 1- IgG, 1 IgG or IgM) 1 0 4 6 (5 single test for ZIKV; 1- multiplex test) 7 TITLE from VIEW and SLIDE MASTER 12 May 2016
Zika diagnostic testing where, when and how 8
Introducing innovative ZIKA diagnostic testing WHO has classified the countries and territories into five categories based on the route and the risks of transmission. (WHO Surveillance Guidelines on ZKV, microcephaly and Guillain-Barré Syndrome (GBS) Routes of transmission include A. Mosquito-borne ZKV transmission: Countries experiencing a first outbreak of Zika virus, Countries where there is evidence of ZKV transmission prior to 2015, with or without ongoing transmission or where outbreak is reported to be over. Countries at risk of mosquito-borne ZKV transmission. Countries with no risk of mosquito borne ZKV transmission. B. None Vector-borne ZKV transmission: Countries experiencing a person to person transmission of Zika virus List of 58 countries at risk of Mosquito borne disease, including 6 with person to person transmission Mapping of Aedes aegypti and Ae. Albopictus occurence ( Kraemer et al, 2015)
Guidance/algorithms for ZIKA diagnostic testing Current guidance based on centralized laboratory testing CDC guidance for persons residing in areas, travelers WHO is updating guidance for testing soon to be available WHO PAHO algorithms for suspected cases in acute and convalescent phases National guidance in affected countries on surveillance nad diagnosis
Opportunities for predicting options for ZIKA diagnostic testing at Point of Care
Lessons learnt in diagnostic testing There is significant experience with applications of technologies in screening and/or confirming diagnosis outside the ZIKA environment Scaling the response to the HIV epidemic is/was significantly affected by lack of laboratory capacity, counselling and testing capacity; Malaria test performance in low and high endemic countries initially created challenges in selection of appropriate products; Test outcomes resulted in unexpected behaviours and stigma in affected populations; Designing programmatic interventions ( including quality assurance), referral systems for patients and samples, results takes time; Decentralization and task shifting took longer than expected due to lack of trust in technology performance and use by non laboratory personnel; We look forward to continue collaboration with partners towards access to appropriate diagnostics
THANK YOU 13