Evaluation of Zika rapid tests as aids for clinical diagnosis and epidemic preparedness

Debi Boeras (1) , Cheikh Tidiane Diagne (2) , Jose L Pelegrino (3) , Marc Grandadam (4) , Veasna Duong (5) , Philippe Dussart (6) , Paul Brey (4) , Didye Ruiz (3) , Marisa Adati (7) , Annelies Wilder-Smith (8, 9) , Andrew K Falconar (10) , Claudia M Romero (10) , Maria Guzman (3) , Nagwa Hasanin (11) , Amadou Sall (2) , Rosanna W Peeling (9)

1 Global Health Impact Group
2 Institut Pasteur de Dakar
3 Pedro Kouri Institute of Tropical Medicine
4 Institut Pasteur du Laos
5 Institut Pasteur du Cambodge
6 Institut Pasteur de Madagascar
7 FIOCRUZ - Fundação Oswaldo Cruz / Oswaldo Cruz Foundation
8 Umeå University
9 LSHTM - London School of Hygiene and Tropical Medicine
10 Universidad del Norte, Barranquilla
11 UNICEF Headquarters

Background Development and evaluation of diagnostics for diseases of epidemic potential are often funded during epidemics, but not afterwards, leaving countries unprepared for the next epidemic. United Nations Children's Emergency Fund (UNICEF) partnered with the United States Agency for International Development (USAID) to address this important gap by investing in an advance purchase commitment (APC) mechanism to accelerate the development and evaluation of Zika rapid diagnostic tests (RDTs) for case detection and surveillance. This paper describes the performance evaluation of five Zika RDTs eligible for procurement. Methods A network of European Union-funded ZikaPLAN sites in Africa, Asia, Latin America with access to relevant serum specimens were selected to evaluate RDTs developed for the UNICEF APC mechanism. A standardised protocol and evaluation panels were developed and a call for specimens for the evaluation panels issued to different sites. Each site contributed specimens to the evaluation from their biobank. Data were collated, analysed and presented to the UNICEF Procurement Review Group for review. Findings Three RDTs met the criteria for UNICEF procurement of sensitivity and specificity of 85% against a refence standard. The sensitivity/specificity of the ChemBio anti-Zika Virus (ZIKV) immunoglobulin M (IgM) test was 86.4 %/86.7% and the ChemBio ZCD system for anti-ZIKV IgM was 79.0%/97.1%, anti-dengue virus (DENV) IgM 90.0%/89.2%, anti-Chikungunya virus (CHIKV) IgM 90.6%/97.2%. The sensitivity/specificity of the SD Biosensor anti-ZIKV IgM was 96.8 %/90.8%, anti-DENV IgM 71.8%/83.5%, the DENV nonstructural protein 1 (NS1) glycoprotein 90.0%/90.2%, anti- yellow fever virus (YFV) IgM 84.6%/92.4%, anti-CHIKV IgM 86.3%/97.5%. Interpretation Three RDTs fulfilled the performance thresholds set by WHO and were eligible for UNICEF procurement. These tests will improve the diagnosis of ZIKV and other arboviral infections as well as providing countries with better tools for surveillance and response to future epidemics.

Mots clés: Zika; Diagnostics; Clinical medicine; Epidemic preparedness; Evaluation; Advance purchase commitment; Biobanking network

Domaines: Sciences du Vivant [q-bio]

Debi Boeras, Cheikh Tidiane Diagne, Jose L Pelegrino, Marc Grandadam, Veasna Duong, et al.. Evaluation of Zika rapid tests as aids for clinical diagnosis and epidemic preparedness. EClinicalMedicine, 2022, 49, pp.101478. ⟨10.1016/j.eclinm.2022.101478⟩. ⟨pasteur-04096665⟩