Primary screening of blood donors by nat testing for HCV-RNA: development of an "in-house" method and results
Keywords:
Nucleic Acid Testing, Blood Donors, RT-PCR, Transfusional Risk, Hepatitis C Virus, HCVAbstract
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.Downloads
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Published
2007-06-01
Issue
Section
Nucleic Acid Testing
How to Cite
Wendel, S., Levi, J. E., Takaoka, D. T., Silva, I. C., Castro, J. P. de, Torezan-Filho, M. A., Ghaname, J., Gioachini, R., Brandão, J., & Durigon, E. L. (2007). 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, 49(3), 177-185. https://www.revistas.usp.br/rimtsp/article/view/31086