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

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.

Bibliographic Details

Main Authors:	Wendel,Silvano, Levi,José Eduardo, Takaoka,Deise Tihe, Silva,Isabela Cristina, Castro,Juliana Polachini de, Torezan-Filho,Mário A., Ghaname,Jorge, Gioachini,Romualdo, Brandão,Joselito, Durigon,Edison Luis
Format:	Digital revista
Language:	English
Published:	Instituto de Medicina Tropical de São Paulo 2007
Online Access:	http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0036-46652007000300008
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