Evaluation of the Virus-elimination Efficacy of Nanofiltration (Viresolve NFP) for the Parvovirus B19 and Hepatitis A Virus / 대한진단검사의학회지

BACKGROUND: The safety of plasma derivatives has been reinforced since 1980s by variable pathogen inactivation or elimination techniques. Nucleic acid amplification test (NAT) for the source plasma has also been implemented worldwide. Recently nanofiltration has been used in some country for ensuring safety of plasma derivatives to eliminate non-enveloped viruses such as parvovirus B19 (B19V) and hepatitis A virus (HAV). We evaluated the efficacy of nanofiltration for the elimination of B19V and HAV. METHODS: To verify the efficacy of nanofiltration, we adopted a 20 nm Viresolve NFP (Millipore, USA) in the scaling down (1:1,370) model of the antithrombin III production. As virus stock solutions, we used B19V reactive plasma and porcine parvovirus (PPV) and HAV obtained from cell culture. And 50% tissue culture infectious dose was consumed as infectious dose. The methods used to evaluate the virus-elimination efficacy were reverse-transcriptase polymerase chain reaction for B19V and the cytopathic effect calculation after filtration for PPV and HAV. RESULTS: B19V was not detected by RT-PCR in the filtered antithrombin III solutions with initial viral load of 6.42x10(5) IU/mL and 1.42x10(5) IU/mL before filtration. The virus-elimination efficacy of nanofiltration for PPV and HAV were > or =10(3.32) and > or =10(3.31), respectively. CONCLUSIONS: Nanofiltration would be an effective method for the elimination of B19V and HAV. It may be used as a substitute for NAT screening of these viruses in source plasma to ensure safety of plasma derivatives in Korea.

Resultados do controle de qualidade de produtos hemoderivados: análise sanitária / Results of quality control of plasma derivatives products: sanitary analysis

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.