title: Replacement of HIV p24 Ag test by a multiplex RT-PCR method for primary screening of blood donors.
abstract: Nucleic Acid Testing (NAT) as a tool for primary screening of blood donors became a reality in the end of the 1990 decade. We report here the development of an "in-house" RT-PCR method that allows the simultaneous (multiplex) detection of HCV and HIV-RNA in addition to an artificial RNA employed as an external control. This method detects all HIV group M subtypes, plus group N and O, with a detection threshold of 500 IU/mL. After validation, the method replaced p24 Ag testing, in use for blood donation screening since 1996 at our services. From July 2001 to February 2006, 102,469 donations were tested and 41 (0.04%) were found HIV-RNA reactive. One NAT-only reactive donation (antibody non-reactive) was observed, with subsequent seroconversion of the implied donor, giving a yield of 1:102,469. This rate is in contrast to the international experience that reports a detection of approximately 1:600,000 - 1:3,100,000 of isolated HIV-RNA donations.
authors.affiliation: Banco de Sangue, Hospital Sírio Libanês, São Paulo, SP, Brasil. nat@cii-laboratorio.com.br
authors.forename: José Eduardo
authors.initials: JE
authors.lastname: Levi
authors.forename: Silvano
authors.initials: S
authors.lastname: Wendel
authors.forename: Deise Tihe
authors.initials: DT
authors.lastname: Takaoka
authors.forename: Isabela Cristina
authors.initials: IC
authors.lastname: Silva
authors.forename: Juliana Polachini de
authors.initials: JP
authors.lastname: Castro
authors.forename: Mário A
authors.initials: MA
authors.lastname: Torezan-Filho
authors.forename: Jorge
authors.initials: J
authors.lastname: Ghaname
authors.forename: Romualdo
authors.initials: R
authors.lastname: Gioachini
authors.forename: Joselito
authors.initials: J
authors.lastname: Brandão
authors.forename: Evaldo Pasquini
authors.initials: EP
authors.lastname: Landi
authors.forename: Antônio César
authors.initials: AC
authors.lastname: Teixeira
authors.forename: Edison Luis
authors.initials: EL
authors.lastname: Durigon
mesh_terms: D001782:Blood Donors; D015153:Blotting, Western; D016655:HIV Core Protein p24 / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D021141:Nucleic Acid Amplification Techniques; D012367:RNA, Viral / Q000097:blood; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity
chemical_list: D016655:HIV Core Protein p24; D012367:RNA, Viral