Primary screening of blood donors by nat testing for HCV-RNA: development of an "in-house" method and results

Revista do Instituto de Medicina Tropical de São Paulo

Silvano Wendel²  José Eduardo Levi²  Deise Tihe Takaoka¹  Isabela Cristina Silva¹  Juliana Polachini De Castro¹  Mário A. Torezan-filho²  Jorge Ghaname¹  Romualdo Gioachini¹  Joselito Brandão¹  Edison Luis Durigon¹ 

[1],Hospital Sírio Libanês Banco de Sangue São Paulo SP ,Brasil

关键词: Nucleic Acid Testing;    Blood Donors;    RT-PCR;    Transfusional Risk;    Hepatitis C Virus;    HCV;   

DOI  :  10.1590/S0036-46652007000300008

来源: SciELO

【 摘 要 】

An "in-house" RT-PCR method was developed that allows the simultaneous detection of the RNA of the Hepatitis C Virus (HCV) and an artificial RNA employed as an external control. Samples were analyzed in pools of 6-12 donations, each donation included in two pools, one horizontal and one vertical, permitting the immediate identification of a reactive donation, obviating the need for pool dismembering. The whole process took 6-8 hours per day and results were issued in parallel to serology. The method was shown to detect all six HCV genotypes and a sensitivity of 500 IU/mL was achieved (95% hit rate). Until July 2005, 139,678 donations were tested and 315 (0.23%) were found reactive for HCV-RNA. Except for five false-positives, all 310 presented the corresponding antibody as well, so the yield of NAT-only donations was zero, presenting a specificity of 99.83%. Detection of a window period donation, in the population studied, will probably demand testing of a larger number of donations. International experience is showing a rate of 1:200,000 - 1:500,000 of isolated HCV-RNA reactive donations.

【 授权许可】

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