RESUMEN
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. Funding: This work was supported by the USAID grant GHA-G-00-07-00007 and ZikaPLAN (European Union's Horizon 2020 Research and Innovation Programme under Grant Agreement No. 734584).
RESUMEN
O Instituto Nacional de Controle de Qualidade em Saúde - INCQS, unidade técnico-científica da Fundação Oswaldo Cruz - Fiocruz, desempenha seu papel no controle de qualidade pericial, de bens e serviços sujeitos ao regime de Vigilância Sanitária, em particular medicamentos denominados de hemoderivados. Este trabalho fundamentou-se na análise de 3.100 lotes de hemoderivados, no período de janeiro de 2000 a dezembro de 2004, assim distribuídos: 31,6 por cento (n=980) de albumina humana, 28,7 por cento (n=890) de fator VIII, 21,4 por cento (n=662) de imunoglobulina humana, 8,3 por cento (n=257) de fator IX, 7,1 por cento (n=220) de imunoglobulinas específicas como anti-Rho (D), antitetânica, anti-rábica, anti-Hepatite B e antivaricela zoster e 2,9 por cento (n=91) de complexo protrombínico. As amostras foram recebidas para análise oriundas dos segmentos: portos, aeroportos e fronteiras de Brasília, Rio de Janeiro e São Paulo e de apreensões realizadas pelos estados de Pernambuco, Santa Catarina, Rio de Janeiro e Rio Grande do Sul. Quanto à modalidade de análise: 92,3 por cento correspondem à análise controle, 5,9 por cento fiscal, 1,4 por cento orientação e 0,4 por cento análise prévia. Da internalização dos hemoderivados importados: 40,0 por cento ocorreram pelo aeroporto de Brasília, 26,9 por cento por São Paulo e 25,2 por cento pelo Rio de Janeiro. Concluindo, dos lotes de hemoderivados analisados, 99,1 por cento apresentaram resultados satisfatórios e 0,9 por cento foram insatisfatórios quanto ao ensaio de inspeção visual, solubilidade, ensaio de estabilidade e químico, e quanto ao teste de pirogênio e toxicidade inespecífica. Desta forma, monitorar a qualidade dos produtos hemoderivados é um instrumento fundamental no exercício das ações de Vigilância Sanitária.
The technical scientific unit of the National Institute of Quality Control in Health (INCQS), part of the Oswaldo Cruz Foundation, has a role of investigational quality control of products and services related to health surveillance, in particular medicines denominated plasma derivative products. This paper is based on the analysis of the 3100 plasma derivative products from January 2000 to December 2004: 31.6 percent (n=980) of human albumin, 28.7 percent (n=890) of factor VIII, 21.4 percent (n=662) of human immunoglobulins, 8.3 percent (n=257) of factor IX, 7.1 percent (n=22) of specific immunoglobulin classes containing anti-Rho (D) immunoglobulin, anti-hepatitis B, anti-tetanus, anti-rabies and anti-varicella-zoster and 2.91 percent (n=91) of prothrombin complex. The products submitted to analysis came from airports and frontiers of Brasília, Rio de Janeiro and São Paulo, and products confiscated by the states of Pernambuco, Santa Catarina, Rio de Janeiro and Rio Grande do Sul. The type of analysis was characterized as: 92.3 percent control analysis; 5.9 percent fiscal analysis; 1.4 percent guidance and 0.4 percent preliminary analysis. In respect to imported plasma derivatives, 40.0 percent originated from the airport in Brasilia, 26.9 percent in São Paulo and 25.2 percent in Rio de Janeiro. In conclusion, 99.1 percent of the plasma derivative products analyzed was considered satisfactory and 0.9 percent unsatisfactory as identified by visual inspection, solubility, stability and chemical assays and pyrogenic and unspecific toxicity tests. Thus, the assessment of the quality of plasma derivative products is an essential tool for health surveillance.
